Company Pipeline Database

Biotech Pipeline Database. See FDA Calendar for Biotech Catalysts.

Updated daily!

OVER 1000 indications in Phase 2,3 or NDA development. Updated daily, includes PRs and live share price. AMEX/NASDAQ/NYSE. Generally no OTC.

NOTE:

SMALL/MID cap companies: Pipelines are shown in full from Phase 2 development onwards.

LARGE cap companies are generally NOT featured in the database, with the exception of companies with PDUFA dates. Over time, clinical catalysts from large cap companies might be added. There is no strict criteria as to which companies might or might not be featured.

TickerPriceDrugIndicationStageLinkClinical Trial IDUpdated
AAAP
34.10Somakit-TATE Diagnose somatostatinreceptor-positive NET lesionsPDUFA priority reviewPDUFA priority review. Extended to June 1 201602/26/2016
AAAP
34.10LutatheraInoperable progressive midgut NETsNDA filingNDA filing due 1Q 201601/08/2016
AAAP
34.10Annexin V-128Rheumatoid arthritis and ankylosing spondylitisPhase 1/2Ongoing01/08/2016
AAAP
34.10Somakit-TOCNeuroendocrine cancersNDA filingNDA filing due 01/08/2016
AAVL
5.70AVA-101Wet-AMDPhase 2aPhase 2a negative data released June 2015 (met primary endpoint but increase in retinal thickness). As a result Phase 2b development will not proceed.12/22/2015
ABEO
2.69ABO-102 Sanfilippo syndrome type A (MPS IIIA)Phase 1/2Phase 1/2 planned03/09/2016
ABIO
4.14Gencaro - GENETIC-AF trial Chronic Heart FailurePhase 2bPhase 2b interim analysis due 1H 201703/18/2016
ABUS
4.82ARB-1467 (TKM-HBV, RNAi)Hepatitis B virus infection (HBV)Phase 2Phase 2 initiated December 2015.HBsAg reduction results from single dose due 3Q 2016, multiple dose data due 4Q 201603/10/2016
ABUS
4.82TKM-PLK1 Hepatocellular carcinoma (HCC)Phase 2Phase 2 data due 1H 201603/10/2016
ACAD
33.00PimavanserinParkinson’s disease psychosis (PDP)ApprovedApproved April 29 201604/30/2016
ACAD
33.00PimavanserinAlzheimer'sPhase 2Phase 2 initiated November 2013 .Enrolment to be completed 1H 201612/22/2015
ACHN
8.82Odalasvir (ACH-3102), simeprevir and ALS-335Hepatitis C viral infection (HCV)Phase 2aPhase 2a topline SVR data due 1H 201602/26/2016
ACHN
8.82ACH-4471Paroxysmal nocturnal hemoglobinuria (PNH)Phase 2Phase 2 to be initiated 3Q 201602/26/2016
ACHN
8.82Odalasvir (ACH-3102) and sofosbuvir Hepatitis C viral infection (HCV) Phase 2Interim updated SVR data released October 2015 12/22/2015
ACOR
27.19DalfampridinePost stroke deficitsPhase 2b/3Phase 3 data due 4Q 201604/29/2016
ACOR
27.19TozadenantParkinson’s diseasePhase 3Announced January 2016 that it entered into an agreement to acquire Biotie Therapies Corp which is currently in Phase 3 development of Tozadenant for Parkinson’s disease01/20/2016
ACOR
27.19CVT-301OFF episodes of Parkinson’s disease (PD)Phase 3Phase 3 data due 201601/12/2016
ACOR
27.19Plumiaz - Diazepam Nasal SprayEpilepsyCRLCRL issued May 2014. Plans to refile in 2017 following PD, safety and open label trials, all to be completed by the end of 2016 12/22/2015
ACRS
20.41A-101Seborrheic keratosis (SK)Phase 3Phase 3 data due 3Q 201603/24/2016
ACRS
20.41A-101Common warts (verruca vulgaris)Phase 2Phase 2 data due 3Q 201603/24/2016
ACRX
3.25ARX-04Moderate-to-severe acute painPhase 3NDA to be filed 2H 201612/22/2015
ACRX
3.25ZalvisoPost-operative pain following open abdominal surgery and hip or knee replacement surgeryCRLCRL Jul 26 2014. Additional clinical trial required before the resubmission. Due to commence 1Q 201612/22/2015
ACST
1.41CaPre (TRIFECTA trial)HypertriglyceridemiaPhase 2Phase 2 trial of CaPre (TRIFECTA trial) completed Sept 2014. Phase 3 planned for 2016 or 201712/22/2015
ACUR
3.18Study AP-ADF-301 (Study 301)Abuse LiabilityPhase 2Disappointing data released Aug 201308/28/2013
ADAP
9.77NY-ESO T-cell therapyNon-small cell lung cancer (NSCLC)Phase 1/2Phase 1/2 initiated November 201501/08/2016
ADAP
9.77NY-ESO T-cell therapyMelanomaPhase 1/2Enrolling01/08/2016
ADAP
9.77NY-ESO T-cell therapyOvarian cancerPhase 1/2Enrolling01/08/2016
ADAP
9.77NY-ESO T-cell therapyMyelomaPhase 1/2Ongoing01/08/2016
ADHD
4.07MDX (Metadoxine Extended Release (MG01CI))Adult ADHDPhase 3Data from second Phase 3 trial due end of 201602/18/2016
ADHD
4.07MDX (Metadoxine Extended Release (MG01CI))Pediatric ADHDPhase 2bPhase 2b data released March 2015. No safety concerns but analyses of secondary cognitive measures did not produce statistically significant results. Phase 2 trial to be initiated soon.02/18/2016
ADHD
4.07MDX (Metadoxine Extended Release (MG01CI))Fragile X SyndromePhase 2bPhase 2 trial did not meet endpoints - June 2015. Additional trial planned for 201612/22/2015
ADMA
6.99RI-002Primary Immune Deficiency DiseasesPDUFAPDUFA date on or about July 31 201612/22/2015
ADMP
8.48Epinephrine Pre-filled Syringe (PFS) Emergency treatment of anaphylaxis. PDUFACRL issued March 27 2015. NDA resubmitted. New PDUFA date June 4, 201601/15/2016
ADMP
8.48APC-3000Allergic RhinitisPhase 3Phase 3 planned02/04/2014
ADMP
8.48APC-1000Asthma/COPDPhase 3Phase 3 planned02/04/2014
ADMS
17.00ADS-5102 - EASE LID trialLevodopa-Induced DyskinesiaPhase 3Phase 3 data released December 201512/27/2015
ADMS
17.00ADS-5102Multiple sclerosis (MS) Phase 2Phase 2 initiated June 2015. Data due 201612/22/2015
ADMS
17.00NamzaricModerate to severe dementia of the Alzheimer's type.ApprovedApproved Dec 24 201412/26/2014
ADRO
13.27CRS-207 and GVAX Pancreas - ECLIPSE trial Pancreatic cancerPhase 2b Phase 2b top-line data to be released 2Q 201605/03/2016
ADRO
13.27CRS-207 and GVAX Pancreas and nivolumab - STELLAR trial Pancreatic cancerPhase 2b Phase 2b interim data to be released 2H 201605/03/2016
ADRO
13.27Epacadostat and CRS-207 - SEASCAPEOvarian cancerPhase 1/2Phase 1/2 dosing initiated March 201603/25/2016
ADRO
13.27CRS-207MesotheliomaPhase 3 Phase 3 trial to be initiated 1H 2016. 03/09/2016
ADXS
7.80ADXS-PSA and KeytrudaCastrate-resistant prostate cancerPhase 1/2Completed the first two dose-escalation cohorts and launched the third dose-escalation cohort in April 201604/06/2016
ADXS
7.80Axalimogene filolisbacRecurrent cervical cancer Phase 2Dosing of first patient in expansion cohort of Phase 2 trial commenced March 201603/08/2016
ADXS
7.80Axalimogene filolisbac - AIM2CERV TrialHigh-risk, locally advanced cervical cancerPhase 3Phase 3 to commence in mid-201601/09/2016
ADXS
7.80Axalimogene filolisbac - GOG 0265 studyCervical cancerPhase 2Complete enrollment of Stage 2 in 201601/09/2016
ADXS
7.80Axalimogene filolisbac + Incyte's epacadostat (IDO-1 inhibitor)Early stage cervical cancer Phase 2Phase 2 to be initiated 1H 201601/09/2016
ADXS
7.80Axalimogene filolisbacAnal cancer (FAWCETT)Phase 2Commence enrollment of Phase 2 trial in 1H 201601/09/2016
ADXS
7.80Axalimogene filolisbacHPV-positive, non-squamous, non-small cell lung cancer following first-line induction chemotherapyPhase 2Commence enrollment of Phase 2 trial in 1H 201601/09/2016
ADXS
7.80ADXS-HER2 HER2-driven malignanciesPhase 1bComplete enrollment of Phase 1b dose-escalation study 1H 201601/09/2016
AERI
16.33Roclatan - Mercury trialsGlaucomaPhase 3Phase 3 Mercury 1 data due 3Q 2016. Mercury 2 trial data due 2Q 201703/29/2016
AERI
16.33RhopressaGlaucomaPhase 3NDA filing due 3Q 201603/28/2016
AEZS
3.92Macimorelin Acetate - MacrilenAdult Growth Deficiency Phase 3CRL Nov 5 2014. Initiated Phase 3 trial in November 2015, to be completed 3Q 201603/30/2016
AEZS
3.92ZoptrexCancer - castration- and taxane-resistant prostate cancerPhase 3Phase 3 trial to be completed 3Q 201603/30/2016
AEZS
3.92AEZS-108Cancer - Endometrial Phase 3Phase 3 trial initiated Jul 2013 under SPA. Second interim analysis October 2015 recommened continuation of trial12/22/2015
AFMD
4.07AFM13Hodgkin LymphomaPhase 2Phase 2a interim data due 2Q 2016. Final data due by the end of 201603/31/2016
AGIO
49.74AG-348Pyruvate kinase deficiencyPhase 2Phase 2 data due 1H 201601/12/2016
AGIO
49.74AG-221Previously treated AML patientsPhase 3Global Phase 3 study for AG-221 initiated October 2015. Enrolment to continue through 201601/12/2016
AGIO
49.74AG-120Frontline Acute myeloid leukemia (AML) harboring an IDH1 mutationPhase 3Phase 3 to be initiated 2H 201601/12/2016
AGIO
49.74AG-120IDH1 mutant positive cholangiocarcinomaPhase 2Phase 2 to be initiated 2H 201601/12/2016
AGIO
49.74AG-221Relapsed/Refractory Acute Myeloid LeukemiaPhase 1/2Phase 1/2 enrolment to be completed 2H 201601/12/2016
AGIO
49.74AG-221Advanced Hematologic MalignanciesPhase 1/2Interim data released December 201512/22/2015
AGRX
5.97TwirlaContraceptive patch Phase 3Phase 3 enrolment due to be completed 2H 2016. CRL issued 201312/22/2015
AIMT
13.12AR101Peanut AllergyPhase 3Phase 3 initiated January 2016. Enrollment to be completed 2H 2016 with trial to be completed 2H 2017 03/04/2016
AKAO
3.27Plazomicin - EPIC trialComplicated urinary tract infections (cUTI)Phase 3Phase 3 top-line results due 1Q 201704/06/2016
AKAO
3.27Plazomicin - CARESerious bacterial infections due to carbapenem-resistant Enterobacteriaceae (CRE)Phase 3Phase 3 topline data due 1H 201704/06/2016
AKBA
9.50Vadadustat - PRO2TECTNon-dialysis patients with anemia related to CKD (NDD-CKD)Phase 3Phase 3 initiated January 201601/05/2016
AKBA
9.50VadadustatAnemia related to chronic kidney disease who are undergoing dialysis (DD-CKD)Phase 3Phase 2 data released September 2015. Phase 3 planned12/22/2015
ALDR
27.48ALD403 - PROMISE 1Frequent episodic migrainePhase 3Phase 3 topline data due 1H 2017. PROMISE 2 trial to be initiated 2H 201604/29/2016
ALDR
27.48ALD403 Chronic MigrainePhase 2b Phase 2b data released March 2016 met primary and secondary endpoints03/29/2016
ALDR
6.24Clazakizumab Rheumatoid arthritis (RA)Phase 2bPhase 2b trial met endpoint early May 2015. Seeking partner for further development12/22/2015
ALDR
27.48Clazakizumab Psoriatic arthritis (PsA)Phase 2Phase 2 data released 4Q 2014. Further development requires partner which company is pursuing03/05/2015
ALDX
6.24NS2Noninfectious anterior uveitisPhase 2Phase 2 data due 2Q 201603/31/2016
ALDX
6.24NS2 Sjögren-Larsson Syndrome (SLS)Phase 2Phase 2 data due 2Q or 3Q 201603/31/2016
ALDX
6.24NS2Allergic conjunctivitisPhase 2Phase 2 postive data released late February 201603/01/2016
ALIM
2.24IluvienDiabetic macular edemaApprovedApproved Sept 26 201409/28/2014
ALIOF
160.50Selexipag - UptraviPulmonary arterial hypertension (PAH)ApprovedApproved Dec 22 201512/22/2015
ALIOF
160.50PonesimodRelapsing multiple sclerosisPhase 3Phase 3 initiated mid-April 2015. Ongoing as of late 201512/22/2015
ALIOF
160.50Macitentan (Opsumit)Pulmonary arterial hypertensionApprovedApproved Oct 18 201310/22/2013
ALKS
40.36ALKS 8700Multiple sclerosis (MS) Phase 3Pivotal program initiated December 2015, with EVOLVE-2, a head-to-head study planned for mid-2016 planned with potential NDA to be filed 201802/26/2016
ALKS
40.36ALKS 5461Major depressive disorder Phase 2Phase 3 data from first two trials did not meet their endpoints. FORWARD-5 data, the third of three trials, due by end of 201602/26/2016
ALKS
40.36AristadaSchizophreniaApprovedApproved October 5 2015. sNDA filing due 2H 201602/26/2016
ALKS
40.36ALKS 3831SchizophreniaPhase 2Pivotal trial initiated December 201512/23/2015
ALNY
68.79ALN-GO1Primary Hyperoxaluria Type 1 (PH1)Phase 1/2Phase 1/2 initiated March 2016. Initial data due late 201605/03/2016
ALNY
68.79Patisiran APOLLOFamilial Amyloidotic Polyneuropathy (FAP) in Patients with ATTRPhase 3Phase 3 data due mid 201705/03/2016
ALNY
68.79Revusiran ENDEAVOURATTR in patients with familial amyloidotic cardiomyopathy (FAC)Phase 3Phase 3 data due mid 201805/03/2016
ALNY
68.79ALN-CC5Paroxysmal nocturnal hemoglobinuria (PNH)Phase 1/2Phase 1/2 initial data due June 11 2016 with Phase 2 trial to be initiated towards the end of 201605/03/2016
ALNY
68.79Fitusiran HemophiliaPhase 3Phase 3 program to be initiated mid 201605/03/2016
ALNY
68.79ALN-TTRsc02ATTR amyloidosisPhase 1Phase 1 to be initiated mid 2016 with data due late 2016. Phase 3 to be initiated 2017 assuming positive data 02/12/2016
ALXA
0.59AZ-002Acute repetitive seizuresPhase 2Phase 2a data released December 201512/23/2015
AMAG
25.68FerahemeAdults with iron deficiency anemia (IDA)Phase 3Phase 3 dosing commenced March 201603/17/2016
AMAG
25.68Makena - single-dose vialReduce the risk of preterm birth in women with a singleton pregnancyApprovedApproved February 23 201602/24/2016
AMAG
25.68FerahemeIron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to all adult patients with IDA who have failed or could not tolerate oral iron treatmentCRLCRL issued May 22 201401/23/2014
AMPE
4.17AmpionOsteoarthritis of the KneePhase 3Data from STRIDE study released mid April 2015 did not meet endpoint. Second Phase 3 trial initiated October 2015. Data are due mid 201603/30/2016
AMPE
4.17ZertanePremature ejaculationPhase 3Pivotal trial pending. 12/23/2015
AMPE
4.17OptinaDiabetic Macula EdemaPhase 2bPhase 2b data released May 201505/21/2015
AMRN
1.94Vascepa REDUCE-IT outcomes trial High Triglycerides With Mixed DyslipidemiaREDUCE-IT outcomes trialREDUCE-IT outcomes trial interim efficacy look by the independent Data Monitoring Committee (DMC) due around the end of 3Q 2016 and, if not stopped early, for completion in 2017 and presentation/publication of results in 201804/01/2016
ANAC
66.08Crisaborole Topical OintmentMild-to-moderate atopic dermatitisPDUFAPDUFA January 7 201703/23/2016
ANAC
66.08TavaboroleOnychomycosisApprovedApproved July 8 201407/09/2014
ANIK
45.57CingalOsteoarthritisTo proceed through NDA process with FDA12/21/2015
ANIK
45.57MonoviscOsteoarthritisApprovedApproved Feb 201402/16/2014
ANTH
3.57BlisibimodLupusPhase 3Missed primary endpoints in Phase 2b trial Jun 2012. Phase 3 trial initiated Mar 2013. Final data 3Q 2016.03/11/2016
ANTH
3.57BlisibimodIgA nephropathyPhase 3Enrolment stopped due to termination of partner agreement.Phase 3 data due 2Q 201603/11/2016
ANTH
3.57Sollpura (liprotamase)Cystic fibrosis who suffer from exocrine pancreatic insufficiencyPhase 3Phase 3 initiated October 2015. Top-line data due end of 2016 or early 201703/11/2016
APPY
2.94Appy1Acute appendicitis Phase 3FDA turned down 510k filing on Jan 29, 2015 for their APPY1 Test. FDA determined that the test does not meet the criteria for substantial equivalence01/31/2015
APRI
3.57VitarosErectile dysfunctionNDA filingNDA to be resubmitted 3Q 201604/07/2016
APRI
3.57FispemifeneMen with symptomatic secondary hypogonadism.Phase 2Phase 2b data released 2016. Endpoints not met. Development to be discontinued03/29/2016
APRI
3.57RayVa Secondary Raynaud's PhenomenonPhase 2bPhase 2b trial to be initiated 2H 201603/10/2016
AQXP
8.48AQX-1125 LEADERSHIPBladder pain syndrome/interstitial cystitis (BPS/IC). Phase 2Phase 2 trial did not meet endpoints - June 2015 but postive secondary endpoint data - August 2015. Announced January 2016 that they intend to file a Phase 3 protocol submission to the FDA in 2Q 2016.01/12/2016
AQXP
8.48AQX-1125 KINSHIPAtopic dermatitis (AD)Phase 2Phase 2 failed to demonstrate efficacy November 201512/23/2015
AQXP
8.48AQX-1125 FLAGSHIPChronic obstructive pulmonary disease (COPD)Phase 2Phase 2 trail failed - July 201512/23/2015
ARDM
4.92Pulmaquin - ORBIT 3Non-cystic fibrosis bronchiectasis (non-CF BE).Phase 3Phase 3 enrolment completed October 201512/23/2015
ARDX
8.18RDX022HyperkalemiaPhase 3Phase 3 program to be initiated 2H 201603/06/2016
ARDX
8.18TenapanorConstipation-predominant irritable bowel syndrome (IBS-C) Phase 3Phase 3 trial initiated October 2015. Second trial initiated December 2015. Data from both trials due in 201703/06/2016
ARDX
8.18TenapanorCKD patients with hyperphosphatemia on dialysis Phase 2bPhase 2b trial to be initiated in December 2015. Results due 2H 201603/06/2016
ARDX
8.18TenapanorHyperphosphatemia in end stage renal disease (ESRD) patients on hemodialysisPhase 2bPhase 2b data released early Feb 2015 met primary endpoint. However, the rate of diarrhea was distinctly higher than expected02/03/2015
ARGS
6.09AGS-003 ADAPT Trial mRCCPhase 3Second Interim analysis recommends continuation of trial. Third interim analysis due June 2016. Overall survival analysis due 1H 201705/03/2016
ARGS
6.09AGS-003 Early stage RCCPhase 2Phase 2 trial initiated 3Q 201512/23/2015
ARGS
6.09AGS-004 HIVPhase 2bPhase 2b trial did not meet endpoint - early Jan 2015. Phase 2 ongoing12/22/2015
ARIA
7.30BrigatinibALK+ non-small cell lung cancer (NSCLC) - front linePhase 3Phase 3 trial initiated April 2016. Enrolment to be completed 201804/12/2016
ARIA
7.30AP32788Cancer - non-small cell lung cancer (NSCLC)Phase 1/2Phase 1/2 trial to be initiated in 201602/24/2016
ARIA
7.30Brigatinib - ALTA trialAnaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC)Phase 2 pivotalFirst data due at ASCO 2016. FDA Filing due 3Q 201602/24/2016
ARIA
7.30Iclusig (ponatinib) Cancer - second line chronic-phase CML (CP-CML) Phase 3Phase 3 trial initiated December 201512/23/2015
ARIA
7.30Iclusig (ponatinib)Cancer - third line chronic-phase CML (CP-CML)Phase 2Phase 2 dose ranging trial initiated August 2015. Preliminary data due end of 201612/23/2015
ARIA
7.30Oral ponatinib - IclusigCancer - chronic myeloid leukemia, acute lymphoblastic leukemiaApproved. Marketing to resume under restricitons following earlier suspensionApproved. Marketing to resume under restricitons following earlier suspension12/21/2013
ARLZ
4.00YOSPRALA (PA32540/PA8140) Secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcersPDUFAPDUFA date September 14 201603/30/2016
ARNA
1.71APD334Ulcerative colitisPhase 2Phase 2 initiated July 201512/23/2015
ARNA
1.71RalinepagPulmonary Arterial HypertensionPhase 2Phase 2 initiated mid Jan 201501/13/2015
ARNA
1.71Lorcaserin Smoking cessationPhase 2Phase 2 initiated March 2014. Data released Nov 201411/04/2014
ARQL
1.63Tivantinib (ARQ 197) METIV-HCC trialInoperable Hepatocellular Carcinoma Who Have Been Treated With One Prior TherapyPhase 3Phase 3 SPA agreed upon. Enrolment initiated Jan 2013. Dosage reduced following recommendation from DMC. Completion of accrual December 2015. Interim analysis completed March 2016 determined that trial will continue to its final analysis03/23/2016
ARQL
1.63ARQ 087intrahepatic cholangiocarcinoma (iCCA)Phase 2Phase 2 trial continues to enrol as of February 201603/01/2016
ARRY
3.31Binimetinib - MILORecurrent low-grade serous ovarian cancer (LGSOC)Phase 3Phase 3 trial discontinued April 2016 04/02/2016
ARRY
3.31Binimetinib (NEMO)Cancer - NRAS melanomaPhase 3Endpoint met December 2015. NDA filing expected 1H 201602/03/2016
ARRY
3.31Selumetinib - SELECT-1Cancer - differentiated thyroid cancer Phase 3Phase 3 data due mid 201602/03/2016
ARRY
3.31Binimetinib - COLUMBUSCancer - BRAF mutant melanomaPhase 3Phase 3 data due 1H 201602/03/2016
ARRY
3.31ARRY 797LMNA-Related DCMPhase 2Ongoing02/03/2016
ARRY
3.31ARRY-520 (Filanesib)Cancer - Refractory Multiple Myeloma MMPhase 2Phase 2 interim data due 2016 but no plans to advnace program12/23/2015
ARWR
6.02ARC-520 injection in combination with entecavir or tenofovirChronic HBVPhase 2bPartial clinical hold placed by FDA in early Jan 2015. Phase 2b trial to proceed with lower doses than initially proposed. Dosing commenced January 201601/08/2016
ASMB
5.58VEN 307 (diltiazem cream)Anal fissuresPhase 3Phase 3 data from second trial did not meet primary endpoint - Feb 2014. Will not pursue future development12/23/2015
ASND
17.17TransConGrowth hormone deficiency in childrenPhase 2Phase 3 planned for mid 201604/15/2016
AST
4.70AST-VAC1Acute myeloid leukemia (AML)Phase 2Phase 3 planned02/25/2016
ATHX
2.33MultistemAcute myocardial infarctionPhase 2Phase 2 planned 12/23/2015
ATHX
2.33MultistemIschemic strokePhase 2Phase 2 data released mid April 2015. Endpoints not met.04/21/2015
ATNM
1.88Actimab-AAcute Myeloid Leukemia (AML)Phase 2Phase 2 to commence mid-201603/15/2016
ATNM
1.88Iomab-BHematopoietic Stem Cells TransplantationPhase 3Phase 3 to commence 1H 201601/10/2016
ATOS
0.34FulvestrantCuctal carcinoma in situ(DCIS) - invasive breast cancerPhase 2Phase 2 initiated March 201603/31/2016
ATRA
17.94PINTA 745Protein-energy wastingPhase 2Phase 2 endpoint not met December 201512/23/2015
ATRA
17.94CMV-CTLRefractory CMV Chorioretinitis or MeningoencephalitisPhase 2Phase 2 data released at ASH 201512/23/2015
ATRS
1.12VIBEX QuickShotTestosterone deficiencyPhase 3Phase 3 initiated July 2014. Completed October 2015. NDA to be filed late 2016 or early 201703/17/2016
ATRS
1.12OTREXUPRheumatoid arthritis (RA)ApprovedApproved Oct 14 201310/16/2013
AUPH
3.00VoclosporinLupusPhase 2bEnrolment completed January 2015. Data due 3Q 201603/30/2016
AVEO
0.92TIVO-3 - tivozanib Third line treatment of patients with renal cell cancerPhase 3Phase 3 trial to commence 2Q 2016 subject to settlement discussions with the SEC03/16/2016
AVIR
1.68BTA585Respiratory syncytial virus (RSV)Phase 2aPhase 2a initiated April 201604/12/2016
AVIR
1.68BTA074 5% topical gel CondylomaPhase 2Phase 2 patient dosing commenced February 201602/09/2016
AVIR
1.68Vapendavir - SPIRITUS trialHuman rhinovirus (HRV)Phase 2bPhase 2b top-line data due 2H 201602/06/2016
AVIR
1.68Laninamivir Octanoate - IGLOO Adults with symptomatic influenza A or B infectionPhase 2Phase 2 initiated Jun 2013. Topline data did not meet the primary endpoint - July 201408/03/2014
AVXL
5.24ANAVEX 2-73 Mild to moderate Alzheimer’s diseasePhase 2aPhase 2a interim data released January 2016. Trial is ongoing. Additional Phase 2/3 trial planned02/09/2016
AXON
14.13RVT-101 Dementia with Lewy bodies (DLB)Phase 2bPhase 2b to be initiated 1Q 201601/08/2016
AXON
14.13Nelotanserin Dementia with Lewy bodies (DLB) or Parkinson's disease dementia (PDD) who suffer from visual hallucinationsPhase 2Phase 2 to be initiated 1Q 201601/08/2016
AXON
14.13Nelotanserin DLB patients experiencing REM Behavior Disorder (RBD).Phase 2Phase 2 to be initiated 1Q 201601/08/2016
AXON
14.13RVT-101 - MINDSET Alzheimer's diseasePhase 3Phase 3 initiated October 2015. Data are due 201701/08/2016
AXSM
11.15AXS-02 Chronic Low Back Pain Associated with Modic ChangesPhase 3Phase 3 to be initiated 4Q 2016 or 1Q 201703/25/2016
AXSM
11.15AXS-05 STRIDE-1Treatment resistant depressionPhase 3Phase 3 initiated March 201603/25/2016
AXSM
11.15AXS-02 COAST-1Knee Osteoarthritis Associated with Bone Marrow LesionsPhase 3Phase 3 planned01/08/2016
AXSM
11.15AXS-02 Complex regional pain syndrome (CRPS)Phase 3Initiated July 2015. Expect to complete trial by end of 201701/08/2016
BCLI
2.20NurOwn Amytrophic lateral sclerosis (ALS)Phase 2Phase 2 data due 2Q or mid 201603/17/2016
BCRX
3.43BCX7353 Reduce or eliminate attacks in HAE patients is Phase 2Phase 2 results expected by the end of 201602/24/2016
BCRX
3.43BCX4161 - OPuS-2Hereditary angioedemaPhase 2bPhase 2b data released February 2016 - primary endpoint not met02/09/2016
BCRX
3.43Peramivir - Study 303INFLUENZA ACUTE ApprovedApproved Dec 22 201412/23/2014
BDSI
3.11Clonidine gelPainful diabetic neuropathy (PDN) Phase 2bPhase 3 trial failed to meet primary endpoint late March 2015. New trial initiated late 2015. Data due from Phase 2b trial 1Q 201703/11/2016
BDSI
3.11BEMA BuprenorphineManagement of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequateApprovedApproved October 26 201512/23/2015
BDSI
3.11BEMA Buprenorphine/Naloxone (BNX) - BUNAVAILOpioid dependenceApprovedApproved June 7 201406/08/2014
BIND
0.38 BIND-014 iNSITE 1 Cancer - Non-small cell lung cancer (NSCLC) with squamous histologyPhase 2Partner required to continue with program04/07/2016
BIND
0.38 BIND-014 iNSITE 2Cancer - advanced cervical and head and neck cancersPhase 2Phase 2 enrolment to be halted following disappointing data released - April 201604/07/2016
BIND
0.38 BIND-014 Cancer - Prostate CancerPhase 2Phase 2 overall survival data due but sees more promising opportunites in areas besides mCRPC02/05/2015
BIOD
0.42BIOD-531 Study 3-157Type 2 diabetesPhase 2Phase 2 initiated November 2015. Data due 1Q 201612/24/2015
BIOD
0.42BIOD-531 Type 2 diabetesPhase 2bPhase 2b initiated mid May 2015. Partial clinical hold lifted October 201512/24/2015
BLCM
10.10BPX-501Adjunct T-cell therapy administered after allogeneic HSCT - (hematopoietic stem cell transplantation)Phase 1/2Phase 1/2 interim data presented April 201604/06/2016
BLCM
10.10BPX-401Hematological cancers that express the CD19 antigenPhase 1/2Phase 1/2 planned 2H 201603/15/2016
BLCM
10.10BPX-601Pancreatic cancerPhase 1/2Phase 1/2 planned mid 201603/15/2016
BLCM
10.10BPX-701PRAME (preferentially-expressed antigen in melanoma) -expressing melanoma, sarcomas and neuroblastomaPhase 1/2Phase 1/2 planned mid 201603/15/2016
BLPH
2.00INOpulse delivery devicePulmonary Arterial Hypertension (PAH)Phase 3Company indicated in March 2016 that they are preparing to enrol patients in the Phase 3 trial03/22/2016
BLPH
2.00INOpulse delivery devicePulmonary Hypertension associated with COPD (PH-COPD)Phase 2Phase 2 to be initiated 2Q 201603/22/2016
BLPH
2.00INOpulse delivery devicePulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis (PH-IPF)Phase 2Phase 2 to be initiated 1H 201603/22/2016
BLRX
0.98BL-8040Cancer - Acute myeloid leukemia (AML) relapsed and refractory Phase 2Phase 2 data released March 201603/30/2016
BLRX
0.98BL-8040Mobilization and collection of bone marrow stem cellsPhase 2Phase 2 trial initiated March 2016. Partial data due by end of 2016 with topline data due by the end of 201703/24/2016
BLRX
0.98BL-8040Cancer - consolidation treatment for AML patientsPhase 2bPhase 2b initiated August 201512/24/2015
BLUE
45.87Lenti-DChildhood cerebral adrenoleukodystrophy (CCALD)Phase 2/3Phase 2/3 trial initiated October 2013. Interim data released at AAN Conference April 20, 2016. 04/21/2016
BLUE
45.87 LentiGlobin β-ThalassemiaPhase 1/2Update expected at ASH December 201601/12/2016
BLUE
45.87LentiGlobin - HGB-206Sickle diseasePhase 1/2Update expected at ASH December 201601/12/2016
BMRN
86.90VosoritideAchondroplasiaPhase 2Phase 2 data released April 2016. Phase 3 trial to be initiated end of 201604/21/2016
BMRN
86.90PEG-PALPhenylketonuria (PKU) Phase 3Phase 3 data released March 2016. Primary endpoint hit. Key secondary endpoint missed.03/22/2016
BMRN
86.90Cerliponase alfaBatten DiseasePhase 1/2Phase 1/2 data released March 2 2016. NDA filing due mid 201603/03/2016
BMRN
86.90KyndrisaDuchenne Muscular Dystrophy (DMD)CRLCRL issued January 14 201601/15/2016
BMRN
86.90Reveglucosidase alfa (BMN 701)Pompe DiseasePhase 2Interim data released January 201601/12/2016
BMRN
86.90Vimizim (GALNS)(MPS IVA) Morquio A SyndromeApprovedApproved Feb 14 201402/16/2014
BNHLF
0.06MCNANon-muscle invasive bladder cancer patients who have failed BCG therapyCRLCRL February 2 2016. Further trials required02/03/2016
BNTC
1.68TT-034Hepatitis C Phase 1/2Announced late February 2016 plans to discontinue development02/26/2016
BPMX
0.74BPX-01AcnePhase 2Phase 2a enrolment completed April 2016. Trial expected to end by mid 201604/26/2016
BSTC
35.23XIAFLEXHuman lipomasPhase 2Phase 2 topline data due 2Q 201603/15/2016
BSTC
35.23XIAFLEXEdematous fibrosclerotic panniculopathy (“cellulite”)Phase 2bPhase 2b to commence shortly by partner Endo12/24/2015
BSTC
35.23XIAFLEXAdhesive Capsulitis (“Frozen Shoulder syndrome”)Phase 2bPhase 2b trial did not meet endpoint 05/15/2015
BVXV
3.80M-001Universal flu vaccinePhase 2bPhase 2b enrolment commenced March 2016. Data are due late 2016 or early 201703/29/2016
CANF
2.90CF101Rheumatoid arthritisPhase 3Phase 3 to be initiated 2Q or 3Q 201604/02/2016
CANF
2.90CF101Psoriasis Phase 2/3Phase 2/3 trial did not meet primary endpoint late March 2015. Additional Phase 3 planned for 4Q 201604/02/2016
CANF
2.90CF102Cancer - advanced liver cancer second linePhase 2Phase 2 enrolment to be completed 2H 201604/02/2016
CANF
2.90CF101GlaucomaPhase 2Phase 2 data due 2Q 201604/02/2016
CANF
2.90CF101Non-alcoholic steatohepatitis (NASH)Phase 2Phase 2 planned04/02/2016
CAPR
3.71CAP-1002 HOPE-DuchenneDuchenne Muscular Dystrophy (DMD)Phase 1/2Phase 1/2 data due 1Q 201704/05/2016
CAPR
3.71CAP-1002 ALLSTAR Myocardial infarction (heart attack)Phase 2Phase 2 enrolling. 6 month data due 1Q 201703/18/2016
CAPR
3.71CenderitideAmbulatory heart failure Phase 2Phase 2 completed12/21/2015
CARA
6.11IV CR845Acute painPhase 3Phase 3 initiated September 2015. Placed on clinical hold February 2016. Clinical hold released April 2016 with enrolment to continue as a three-arm trial testing two doses 04/21/2016
CARA
6.11IV CR845Chronic painPhase 2bPhase 2b initiation due 2H 201603/11/2016
CARA
6.11IV CR845Uremic pruritusPhase 2Registration program to be initiated 1H 201603/11/2016
CARA
6.11CR845 Osteoarthritis (OA) of the knee or hipPhase 2Phase 2 data released December 201512/24/2015
CASI
1.50ENMD-2076 Cancer - Advanced/Metastatic Soft Tissue SarcomaPhase 2Phase 2 initiated Jan 2013. Ongoing as of Nov 201512/24/2015
CASI
1.50ENMD-2076Cancer - triple-negative breast cancerPhase 2Phase 2 initiated Jul 2012. Ongoing as of Nov 201512/24/2015
CASI
1.50ENMD-2076Cancer - fibrolamellar carcinoma (FLC).Phase 2Phase 2 initiated October 201512/24/2015
CASI
1.50ENMD-2076Cancer - Ovarian Clear Cell CarcinomasPhase 2Phase 2 initiated Oct 2013. 11/02/2013
CATB
4.90CAT-1004 Duchenne muscular dystrophy (DMD)Phase 2Phase 2 data due late 201603/03/2016
CATB
4.90CAT-2054 HypercholesterolemiaPhase 2aPhase 2a due 3Q 201603/03/2016
CBAY
2.51ArhalofenateGoutPhase 3Phase 3 planned for 2016 - partner required03/30/2016
CBAY
2.51MBX-8025 Primary biliary cholangitis (PBC)Phase 2Phase 2 trial to be completed in 4Q 201603/30/2016
CBLI
2.20Entolimod - Russia trialNeo-adjuvant therapy in treatment-naïve patients with primary colorectal cancerPhase 2Phase 2 ongoing02/23/2016
CBLI
2.20CBLB612 - Russia trialBreast cancerPhase 2Phase 2 ongoing02/23/2016
CBYL
0.76Hydros-TA Osteoarthritis of the kneePhase 3Phase 3 data released early February 2016. One of two endpoints met, the other not met02/02/2016
CCXI
2.38CCX168Associated vasculitis (AAV)Phase 2Phase 2 data released early January 2016. Phase 3 to be initiated in 2016. Phase 2 top-line data from the CLASSIC trial are expected in mid 201603/15/2016
CCXI
2.38CCX140Diabetic nephropathy Phase 2Phase 2 topline data released Dec 12 2014. End of Phase 2 meeting planned 03/15/2016
CCXI
2.38CCX872Non-resectable pancreatic cancerPhase 1bPhase 1b early response data due 1H 2016. Initial PFS data due 2H 201603/15/2016
CCXI
2.38CCX168 atypical Hemolytic Uremic Syndrome (aHUS)Phase 2Phase 2 data due 201603/15/2016
CCXI
2.38Vercirnon CCX282 Crohn's diseasePhase 3Partner required to continue with Phase 3 program12/24/2015
CDTX
14.00CD101 IVCandidemiaPhase 2Phase 2 to be initiated 1H 201603/19/2016
CDTX
14.00CD101 TopicalVulvovaginal candidiasis (VVC)Phase 2Phase 2 to be initiated by mid 201603/19/2016
CEMP
17.39CEM-101 (solithromycin )CAPBNDA filingRolling NDA filing completed April 201605/03/2016
CEMP
17.39SolithromycinCOPDPhase 2Phase 2 ongoing as of May 201605/03/2016
CEMP
17.39SolithromycinNASHPhase 2Phase 2 dosing initiated January 2016. Ongoing as of May 201605/03/2016
CEMP
17.39CEM-101 (solithromycin )Uncomplicated urogenital gonococcal infectionsPhase 3Phase 3 initiated August 2014. Enrolment completed December 2015 but decided to increase enrolment. Ongoing as of May 201605/03/2016
CEMP
17.39Taksta Acute bacterial skin and skin structure infections (ABSSSI)Phase 3Phase 3 initiated December 2015. Trial to be completed 1H 201705/03/2016
CERC
3.83CERC-501Smoking cessationPhase 2Announced initiation of a Phase 2 trial in February 2016. Data due 2H 201603/24/2016
CERC
3.83CERC-301Major depressive disorder (MDD)Phase 2Phase 2 data due 2H 201603/24/2016
CERS
6.24INTERCEPT PlateletsApprovedPMA approved Dec 18 201412/19/2014
CERS
6.24INTERCEPT B123PlasmaApprovedPMA approved Dec 16 201412/18/2014
CERU
3.10CRLX301Cancer - solid tumoursPhase 1/2aCommence Phase 2a portion in 1H 201605/03/2016
CERU
3.10CRLX101, in combination with AvastinCancer - Renal Cell CarcinomaPhase 2Data due 2H 201605/03/2016
CERU
3.10CRLX101 in Combination with Chemotherapy and Radiation Rectal CancerPhase 1b/2Initial data released mid March 2015. Further interim data due 2H 201605/03/2016
CERU
3.10CRLX101, in combination with AvastinCancer - relapsed ovarianPhase 2Second stage of Phase 2 trial commenced September 2015. Further interim data due 2H 201605/03/2016
CERU
3.10CRLX101, in combination with AvastinCancer - 3rd and 4th line Relapsed Renal Cell Carcinoma Phase 3Phase 3 to be initiated 4Q 201603/11/2016
CFRX
3.46CF-301Serious infections caused byStaph aureus including MRSAPhase 2Phase 2 to be initiated 2H 201603/16/2016
CHMA
3.10MycapssaAcromegalyCRLCRL April 15 201604/16/2016
CHMA
3.10Oral octreotide Neuroendocrine tumors (NET)Phase 2Phase 2 to be initiated late 201601/09/2016
CHRS
19.97CHS-1701Pegfilgrastim biosimilarPK/PD study to be completed by the end of 1H 2016 with BLA to filed after 03/01/2016
CHRS
19.97CHS-1420PsoriasisPhase 3Enrolment to be completed 1H 2016. Data due 2H 201603/01/2016
CHRS
19.97CHS-0214Rheumatoid arthritis Phase 3Phase 3 data released January 2016. Endpoints met.01/12/2016
CHRS
19.97CHS-0214PsoriasisPhase 3Phase 3 trial met endpoint November 201512/24/2015
CLBS
0.70CLBS03Type 1 diabetesPhase 2Phase 2 initiated March 2016. Initial safety data due early 201703/30/2016
CLBS
0.70CLBS20 Metastatic melanomaPhase 3Announced January 2016 that Phase 3 trial has been discontinued01/09/2016
CLCD
6.94Lasmiditan - SAMURAIMigrainePhase 3Phase 3 enrolling. Top-line data available 3Q 2016.01/08/2016
CLDX
4.15Glembatumumab vedotinCancer - Squamous cell lung cancer Phase 1/2Phase 1/2 commenced April 201604/28/2016
CLDX
4.15CDX-110 rindopepimut - ACT IVCancer- glioblastoma multiforme (GBM) front linePhase 3Trial discontinued early March 2016 as unlikely to meet primary endpoint03/08/2016
CLDX
4.15Glembatumumab vedotinCancer - metastatic triple negative breast cancers that overexpress gpNMBPhase 2bPhase 2b enrolment to be completed 2H 201602/26/2016
CLDX
4.15Glembatumumab vedotinCancer - melanomaPhase 2Phase 2 initiated December 2014. Enrolment to be completed 1H 2016 with data to be presented 2H 201602/26/2016
CLDX
4.15Varlilumab and nivolumabCancer - solid tumorsPhase 2Phase 2 to be initiated 2Q 201602/26/2016
CLDX
4.15Varlilumab and atezolizumab (anti-PDL1)Cancer- renal cell carcinomaPhase 1/2Phase 1 part of trial is enrolling02/26/2016
CLDX
4.15Varlilumab and sunitinib (Sutent) iCancer - clear cell renal cell carcinoma (CC-RCC).Phase 1/2Enrolling02/26/2016
CLDX
4.15CDX-110 (rindopepimut) in combination with Avastin - ReACTCancer- glioblastoma multiforme (GBM) refractoryPhase 2Phase 2 endpoint met - ASCO 201506/01/2015
CLSN
1.51ThermoDoxCancer - Hepatocellular carcinoma - liver cancerPhase 3Failed to meet primary endpoint. New Phase 3 enrolling as of March 201603/30/2016
CLSN
1.51GEN-1 OVATIONCancer - ovarianPhase 1bPhase 1b initiated October 201512/24/2015
CLSN
1.51ThermoDox - DignityRecurrent Chest Wall Breast Cancer (RCWBC)Phase 2Interim data released July 201512/24/2015
CLVS
14.54Rociletinib Cancer - mutant EGFR T790M-positive lung cancerPDUFAOriginal PDUFA date of March 30, 2016 delayed due to release of data during review cycle of much lower than expected overall response rates. New date June 28, 2016. Oncologic Drugs Advisory Committee (ODAC) met on April 12, 2016 and recommended the FDA wait to see results from the Phase 3 TIGER-3 trial of rociletinib, before making an approval decision. Enrollment is expected to be completed in late 2018.04/13/2016
CLVS
14.54Rucaparib ARIEL2Cancer - ovarian second linePhase 2NDA filing for rucaparib expected to be completed 2Q 201602/26/2016
CLVS
14.54Rucaparib ARIEL3 Cancer - advanced ovarian cancer patients with a BRCA-like mutationPivotalPivotal trial initiated late 2013. Enrolment to be completed around mid 2016. Data due around mid 201702/26/2016
CLVS
14.54LucitanibCancer - breastPhase 2Phase 2 dosing initiated Oct 2014. Enrolling as of February 201602/26/2016
CLVS
14.54Rociletinib in combination with atezolizumabCancer - advanced EGFR-mutant non-small cell lung cancerPhase 1b/2Phase 1b/2 trial initiated January 201601/28/2016
CLVS
14.54Rucaparib RUCAPANCCancer - pancreaticPhase 2Phase 2 initiated June 201406/17/2014
CMRX
5.89Brincidofovir - Advise trialAdenovirus InfectionPhase 3Phase 3 initiated April 2014. Expects to meet with FDA duirng summer of 2016 to review data03/01/2016
CMRX
5.89Brincidofovir - SUSTAIN Cytomegalovirus (CMV) infectionPhase 3Phase 3 discontinued following poor data from SUPPRESS trial02/23/2016
CMRX
5.89Brincidofovir - SURPASSCytomegalovirus (CMV) infectionPhase 3Phase 3 discontinued following poor data from SUPPRESS trial02/23/2016
CMRX
5.89Brincidofovir - SUPPRESS Cytomegalovirus (CMV) infection following an allogeneic hematopoietic stem cell transplant (HSCT)Phase 3Phase 3 endpoints not met December 201512/29/2015
CNAT
2.72EmricasanLiver fibrosis post-orthotopic liver transplant due to Hepatitis C virus infection (HCV-POLT)Phase 2bPhase 2b initiated May 2014. Topline data due 1H 201803/10/2016
CNAT
2.72EmricasanNASH fibrosis - ENCORE-NF trialPhase 2Phase 2 trial initiated January 2016. Data are due 201803/10/2016
CNAT
2.72EmricasanLiver CirrhosisPhase 2Phase 2 topline data released early January 201601/06/2016
CNAT
2.72EmricasanPortal Hypertension Phase 2Phase 2 data released September 2015. 12/24/2015
CNAT
2.72Emricasan Acute-on-Chronic Liver Failure (ACLF) Phase 2Phase 2 topline data released Jan 201501/09/2015
CNCE
14.35AVP-786 Major depressive disorderPhase Phase 2 to be completed 2Q 201603/02/2016
CNCE
14.35AVP-786 Agitation in patients with Alzheimer's diseasePhase 3Phase 3 initiated December 201512/25/2015
CNCE
14.35CTP-499 Diabetic Kidney DiseasePhase 2Phase 3 planned. Needs partner12/25/2015
COLL
19.10Xtampza ER (oxycodone) Severe painApprovedApproved April 26 201604/27/2016
CORI
4.75AG200-15ContraceptivePhase 3Additional Phase 3 required following rejection of NDA. Trial is ongoing by partner Agile12/26/2015
CORI
4.75MicroCor PTHOsteoporosisPhase 2aPhase 2a data released July 201512/26/2015
CORT
5.05Mifepristone in combination with eribulin Cancer - triple-negative breast cancerPhase 1/2Phase 1/2 data due mid 201603/02/2016
CORT
5.05CORT125134Cushing’s syndromePhase 2Phase 2 trial to be initiated by end of 1Q 201603/02/2016
CORT
5.05CORT125134Solid tumorsPhase 2Phase 2 trial to be initiated by end of 1Q 201603/02/2016
CPRX
0.66Firdapse Lambert-Easton Myasthenic Syndrome (LEMS)RTF - Refusal to fileRefusal to file letter reported on Feb 17 2016 for Dec 2015 NDA filing. Noted on April 26 2016 that the FDA has requested more trials to be initiated04/27/2016
CPXX
15.29VYXEOSSecondary AMLPhase 3Overall survival data released March 2016. Primary endpoint met. NDA planned for 2016 03/15/2016
CPXX
15.29VYXEOS Study 206Adult patients with hematologic malignanciesPhase 2Phase 2 pharmacokinetic and pharmacodynamics study is ongoing. Enrolment closed June 201512/26/2015
CRBP
2.22ResunabSystemic lupus erythematosus (SLE)Phase 2Phase 2 trial to be initiated 1Q 201703/30/2016
CRBP
2.22ResunabDermatomyositisPhase 2Phase 2 to be completed 1Q 201703/30/2016
CRBP
2.22ResunabCystic FibrosisPhase 2Phase 2 data due by end of 201603/25/2016
CRBP
2.22ResunabSystemic SclerosisPhase 2Phase 2 data due by end of 201603/25/2016
CRIS
2.01CUDC-907Diffuse-large B-cell lymphoma (DLBCL)Phase 2Phase 2 initiated January 201603/01/2016
CRIS
2.01Erivedge (vismodegib)Cancer - myelofibrosisPhase 1b/2Phase 1b planned12/26/2015
CRMD
4.29Neutrolin - LOCK-IT 100Hemodialysis patients with central venous cathetersPhase 3Phase 3 enrolment to be completed in 2016. Interim analysis due by end of 201603/17/2016
CRMD
4.29Neutrolin - LOCK-IT 200Oncology patients on Total Parental Nutrition (TPN)Phase 3Phase 3 to be initiated by fall 201603/17/2016
CSII
13.86Orbital atherectomy systemCalcified coronary arteriesPMAPMA approved Oct 22 201310/23/2013
CTIC
0.51Pacritinib -PERSIST-1MyelofibrosisNDA filing withdrawnAnnounced February 9, 2016 that NDA submission has been withdrawn because of full clinical hold placed on Pacritinib02/10/2016
CTIC
0.51TosedostatCancer - older patients with AML or high-risk myelodysplastic syndrome (MDS).Phase 2Phase 3 trial potentially starting in 2016, depending on discussions with FDA01/12/2016
CTIC
0.51OPAXIOOvarian cancerPhase 3Phase 3 second of four analyses completed early Feb 2014. Trial to continue as planned02/04/2015
CTIX
1.84CellceutixPlacque psoriasisPhase 2Phase 2 top line data due early May 201603/02/2016
CTIX
1.84KevetrinCancer - ovarianPhase 2Phase 2 planned01/20/2016
CTIX
1.84BrilacidinOral mucositisPhase 2Phase 2 ongoing12/26/2015
CTIX
1.84BrilacidinAcute Bacterial Skin and Skin Structure Infections (ABSSSI)Phase 2Phase 3 planned12/26/2015
CTRV
0.97FV-100 ShinglesPhase 3Phase 3 ongoing04/12/2016
CTRV
0.97CMX157Hepatitis BPhase 2Phase 2 trial planned in Asia04/12/2016
CUR
0.59NSI-189DepressionPhase 2Phase 2 to be initiated 2Q 201603/15/2016
CUR
0.59 NSI-566Amyotrophic lateral sclerosis (Lou Gehrig's)Phase 2Phase 2 data released early March 2015. A larger controlled Phase 2 trial is planned12/26/2015
CUR
0.59NSI-189Cognitive deficit in schizophreniaPhase 1bPhase 1b to be initiated 201612/26/2015
CUR
0.59NSI-566Motor deficits due to ischemic strokePhase 1/2Phase 2 portion of the trial to be initiated 201612/26/2015
CVM
0.55MultiklineCancer - Head and NeckPhase 3Initiated Dec 2010. Full enrolment due to be completed 201601/09/2016
CYAD
49.02C-Cure - Chart 1 trialChronic Heart Failure secondary to ischemic cardiomyopathyPhase 3Phase 3 CHART-1 read-out due mid-201603/15/2016
CYCC
0.36Sapacitabine (SEAMLESS)Cancer - Acute myeloid leukemiaPhase 3Noted mid-Dec 2014 that interim analysis suggests that trial will fail. Top-line data due by end of 2Q 201603/24/2016
CYCC
0.36SeliciclibCushing's diseasePhase 2Phase 2 ongoing12/26/2015
CYNA
11.97APL-130277 - CTH-300OFF episodes in patients with Parkinson’s diseasePhase 3Phase 3 top-line data due 2Q or 3Q 201603/10/2016
CYNA
11.97APL-130277 - CTH-301OFF episodes in patients with Parkinson’s diseasePhase 3Phase 3 top-line safety data due 4Q 2016 or 1Q 201703/10/2016
CYTK
8.48CK-2127107COPDPhase 2Phase 2 to be initiated 1H 201604/29/2016
CYTK
8.48Omecamtiv mecarbil ATOMIC-AHFAcute heart failurePhase 2bPhase 2 released October 2015. Phase 3 to be possibly initiated in 2016. Decision to be made in coming months04/29/2016
CYTK
8.48CK-2127107Spinal muscular atrophy (SMA)Phase 2Phase 2 initiated January 2016. Enrollment to be completed 2H 201604/29/2016
CYTK
8.48TirasemtivALSPhase 3Phase 3 initiated July 2015. Enrollment to be completed by end of 1H 201604/29/2016
CYTR
3.42Aldoxorubicin with doxorubicinCancer - soft tissue sarcomas refractoryPhase 3Phase 3 initiated March 2014 under SPA. Announced April 4 2016 that the target number of progression events has been reached. PFS data due June 2016 04/21/2016
CYTR
3.42AldoxorubicinCancer - unresectable glioblastomaPhase 2Phase 2 overall survival data due 2H 2016. Updated interim data at ASCO 201604/21/2016
CYTR
3.42AldoxorubicinCancer - relapsed/refractory small cell lung cancerPhase 2bPhase 2b data due 2H 201603/12/2016
CYTR
3.42AldoxorubicinCancer - AIDS-related Kaposi’s sarcomaPhase 2bPhase 2b ongoing12/26/2015
CYTR
3.42AldoxorubicinCancer - soft tissue sarcomas first linePhase 2bOverall survival data - secondary endpoint released Jan 2015 - HR 0.73 CI 0.44-1.20 - OS 16.0 months vs 14.4 (p=0.21) - not statistically significant01/23/2015
CYTX
0.30ECCS-50SclerodermaPhase 3Pivotal trial initiated August 2015. Noted late April 2016 that enrolment is expected to be completed by mid-June 201604/28/2016
CYTX
0.30ECCO-50 cellular therapeuticOsteoarthritis of the kneePhase 2Phase 2 interim data released February 2016 noted that the pre-specified primary endpoint did not obtain statistical significance. Full data due 3Q 201602/09/2016
CYTX
0.30Cell Enriched AdiposeEarly stage female and male pattern hair lossPhase 2Enrolling01/24/2016
CYTX
0.30Cytori Cell Therapy Crohn’s DiseasePhase 2Announced mid-January 2016 that first patients have been enrolled01/20/2016
DBVT
33.77Viaskin Peanut Peanut allergyPhase 3Phase 3 initiated December 201512/26/2015
DCTH
0.30Melphalan Hepatic Delivery System (Melphalan HDS)Ocular Melanoma (OM) Liver MetastasesPhase 3Phase 3 planned. Noted in January 2016 that they have received Special Protocol Assessment (SPA) from the FDA01/20/2016
DCTH
0.30Melphalan Hepatic Delivery System (Melphalan HDS)Hepatocellular carcinoma (HCC)Phase 2Phase 2 ongoing12/26/2015
DCTH
0.30CHEMOSAT systemCancer - unresectable metastatic ocular melanoma in the liverCRLCRL Sept 13 201309/15/2013
DEPO
17.27SEFELSAHot flashesCRLCRL May 31 201306/01/2013
DERM
25.38CimziaModerate-to-severe plaque psoriasis Phase 3Phase 3 initiated Jan 2015. Enrolment completed January 2016. Data due by end of 1Q 201703/04/2016
DERM
25.38DRM04Primary axillary hyperhidrosisPhase 2bPhase 3 enrolment reported completed late February 2016 with data due 2Q 2016.03/01/2016
DERM
25.38DRM01AcnePhase 2bPhase 2b initiated April 2015. Enrolment completed. Data due 2Q 201601/09/2016
DMTX
7.47DTX101hemophilia BPhase 1/2Phase 1/2 initiated January 2016. Cohort data due 2H 201603/25/2016
DNAI
5.56PNT2258Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)Phase 2Phase 2 initial data due 2Q 201603/04/2016
DNAI
5.56PNT2258 Richter's TransformationPhase 2Phase 2 initiated October 2015. Interim data due by end of 201603/04/2016
DPRX
12.30LocilexMild infections of diabetic foot ulcersPhase 3Phase 3 enrolment of two trials 75 percent complete as of early February 2016. Top-line data are due 3Q 201703/24/2016
DRRX
1.36RemoxyChronic painPDUFAPDUFA September 25 201604/13/2016
DRRX
1.36POSIMIR -PERSIST 3Post-operative pain relief Phase 3CRL Feb 12 2014. Phase 3 commenced November 2015 in response to CRL. Enrolment originally expected to take one year but the company announced ammendments to the trial on April 7, 2016, which will result in time added to complete the trial04/08/2016
DRRX
1.36ReldaySchizophreniaPhase 3Phase 3 to be initiated by ZGNX once partner is found03/01/2016
DRRX
1.36DUR-928 Nonalcoholic steatohepatitis (NASH)Phase 1bPhase 1b initiated January 2016, to be completed 1H 201601/12/2016
DSCI
3.33DSC127 Diabetic foot ulcersPhase 3Phase 3 trial stopped early due to lack of effiacy - November 201512/27/2015
DVAX
16.22HEPLISAV-B Hepatitis BPDUFACRL Feb 25 2013. New PDUFA for BLA orginally set for September 15 2016 has been delayed until December 15 2016.04/28/2016
DVAX
16.22AZD1419AsthmaPhase 2aPhase 2 trial to be initiated 1H 201612/27/2015
DYAX
0.00DX-2930Hereditary angioedema (HAE) Phase 3Phase 3 planned - company to be acquired by SPHG in 1H 201612/27/2015
EARS
3.64AM-101Acute inner ear tinnitusPhase 3Phase 3 enrolment completed March 2016 with topline data due August 201603/31/2016
EARS
3.64AM-111 HEALOS/ASSENTAcute inner ear hearing lossPhase 3Commenced HEALOS (EU) trial in November 2015 and in the ASSENT trial (US) in 1H 2016. HEALOS data due 2017 12/27/2015
EARS
3.64AM-111 REACHSurgery-induced hearing lossPhase 2Phase 2 trial (REACH) to begin enrollment in 1H 2016.12/27/2015
EBIO
0.78Isunakinra (EBI-005)Moderate to severe allergic conjunctivitisPhase 3Phase 2 primary endpoint not met October 2014. Phase 3 data released January 2016, endpoint not met01/16/2016
EBIO
0.78Isunakinra (EBI-005)Moderate to severe dry eye diseasePhase 3Phase 3 topline data showed endpoints not met mid May 201505/20/2015
EBS
39.77BioThrax Anthrax Vaccine AdsorbedApprovedApproved November 24 201512/27/2015
EBS
39.77Anthrax Immune Globulin Intravenous (Human) [AIGIV] AnthraxApprovedApproved March 25 201503/27/2015
ECYT
3.90vintafolideCancer - ovarianPhase 3Trial stopped due to poor efficacy05/04/2014
ECYT
3.90Vintafolide (TARGET)Cancer - NSCLCPhase 2bPhase 2b topline data released March 2014. Endpoint met.03/23/2014
EDAP
3.48 Ablatherm-HIFU (High Intensity Focused Ultrasound) Cancer - Low risk, localized prostate cancerApprovedApproved November 9 201512/27/2015
EDGE
8.41EG-1962Improving patient outcomes following an aneurysmal subarachnoid hemorrhage (aSAH)Phase 3Phase 3 planned01/08/2016
EDTXF
0.70Polymyxin B Hemoperfusion (PMX)Endotoxemic septic shockPhase 3Phase 3 to be completed in 1H 201605/03/2016
EGLT
6.44Egalet-001Abuse-Deterrent MorphinePDUFAPDUFA October 14 201603/01/2016
EGLT
6.44Egalet-002Moderate to severe chronic painPhase 3Phase 3 trial planned 12/27/2015
EGRX
39.61KANGIO (bivalirudin injection)Percutaneous Coronary Intervention (PCI) and Percutaneous Transluminal Coronary Angioplasty (PTCA)CRLCRL March 18 2016. FDA requested further characterization of bivalirudin-related substances in the drug product03/19/2016
EGRX
39.61Docetaxel InjectionBreast, non-small cell lung, prostate gastric adenocarcinoma, and head and neck cancerApprovedApproved December 24 201512/27/2015
EGRX
39.61RyanodexMalignant hyperthermiaApprovedApproved July 22, 2014 under priority review07/24/2014
EGRX
39.61EP-3101 (bendamustine RTD) Chronic lymphocytic leukemia; Indolent non-Hodgkin's lymphomaApproved (tentative)Tentative approval July 2 2014. Teva has also received orphan drug and related pediatric exclusivity expiring in September 2015 and May 2016 for the CLL and NHL indications, respectively. 07/03/2014
EIGR
20.40MYDICAR - CUPID 2 TrialIschemic or dilated cardiomyopathyPhase 2bPhase 2b negative data released April 2015. Formerly CLDN pre-merger03/23/2016
ELTP
0.31SequestOxModerate to severe painPDUFA priority reviewPDUFA July 14 2016 under priority review03/18/2016
ENDP
27.18XIAFLEXEdematous fibrosclerotic panniculopathy (“cellulite”)Phase 2aPhase 2b planned12/27/2015
ENDP
27.18BEMA BuprenorphineManagement of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequateApprovedApproved October 26 201512/23/2015
ENDP
27.18XIAFLEXAdhesive Capsulitis (“Frozen Shoulder syndrome”)Phase 2bPhase 2 trial did not meet endpoint05/16/2015
ENDP
27.18AVEED (testosterone undecanoate) intramuscular injectionMen diagnosed with hypogonadismApprovedApproved March 6 201409/06/2013
ENTA
27.54VIEKIRA PAK - once-daily, fixed-dose formulation through AbbvieHCV - genotype PDUFAPDUFA 2H 201612/27/2015
ENTA
27.54ABT-493HCV Phase 2bPhase 2b ongoing. Data released November 2015. Phase 3 initiated12/27/2015
ENTA
27.54VIEKIRA PAKHCV - genotype 1ApprovedApproved December 19 201412/22/2014
EPIX
3.00EPI-506 Cancer - castrate resistant prostate cancerPhase 1/2Phase 1/2 trial initiated December 201502/13/2016
EPRS
2.95BOW015Rheumatoid Arthritis (RA)Phase 3Phase 3 trial initiated February 201602/10/2016
EPZM
10.67TazemetostatRelapsed or refractory B-cell NHLPhase 2Phase 2 interim data due mid 201612/27/2015
EPZM
10.67EPZ-5676INI1-negative tumors or synovial sarcomaPhase 2Phase 2 planned12/27/2015
ESPR
16.03Bempedoic acid (ETC-1002-035)Patients treated with high-dose statin therapyPhase 2 (PK/PD) Phase 2 top-line data due 3Q 201602/26/2016
ESPR
16.03Bempedoic acidHypercholesterolemia - statin intolerancePhase 2Initiation of the Phase 3 efficacy study in patients with statin intolerance 4Q 201602/26/2016
ESPR
16.03Bempedoic acidHypercholesterolemiaPhase 2Plans regarding Phase 3 cardiovascular outcomes due to be released 2Q 201602/26/2016
ESPR
16.03Bempedoic acid (ETC-1002-040)Hyperlipidemia whose LDL-C is not adequately controlled with low- and moderate-dose statinsPhase 3Phase 3 long-term safety and tolerability trial initiated January 2015. Top-line results due 4Q 201701/14/2016
ESPR
16.03Bempedoic acid ETC-1002-014Hypercholesterolemia and hypertensionPhase 2Phase 2 data released July 201512/27/2015
ETRM
0.80VBLOCObesityApprovedApproved Jan 14, 201501/15/2015
EVOK
4.81EVK-001Female diabetic gastroparesisPhase 3Phase 3 initiated April 2014. Enrolment due to be completed 1H 201612/27/2015
EXAS
6.99CologuardCancer - Colorectal DNA testApprovedApproved August 201408/16/2014
EXEL
4.82CABOMETYX (cabozantinib)Cancer - metastatic renal cell cancer (RCC)ApprovedApproved April 25 2016.04/26/2016
EXEL
4.82XL184 cabozantinib (CELESTIAL)Cancer - advanced hepatocellular cancer (HCC)Phase 3Phase 3 initiated Sept 2013. Data due 201703/01/2016
EXEL
4.82Cabozantinib - CABOSUNCancer - First-Line RCCPhase 2Phase 2 data due 201603/01/2016
EXEL
4.82CABOMETYX (cabozantinib)Recurrent endometrial cancerPhase 2Phase 2 data due 201603/01/2016
EXEL
4.82VemurafenibCancer - BRAF V600 Mutation-Positive Advanced MelanomaApprovedApproved November 1012/27/2015
EXEL
4.82CabozantinibCancer - Castration-Resistant Prostate CancerPhase 3Phase 3 COMET-2 trial did not meet endpoint December 1 201412/02/2014
EYEG
3.38EGP-437Non-infectious anterior uveitisPhase 3Phase 3 enrolment commenced January 201601/20/2016
EYEG
3.38EGP-437 Macular Edema Phase 1b/2aPhase 1b/2a data released November 2015. 01/08/2016
FATE
1.86ProHemaAcute graft-versus-host disease (GvHD) Phase 1/2Phase 1/2 trial to be initiated mid 201603/04/2016
FATE
1.86ProHema Adult hematologic malignanciesPhase 2Phase 2 data released 201512/27/2015
FBIO
3.55Triplex vaccineCMV control in allogeneic stem cell transplant recipientsPhase 2Phase 2 data due 1H 201703/16/2016
FCSC
2.72azficel-T Chronic DysphoniaPhase 2Phase 2 data due 2Q 201604/22/2016
FCSC
2.72FCX-007Recessive dystrophic epidermolysis bullosaPhase 1/2Phase 1/2 to be initiated 2Q 201604/19/2016
FGEN
18.37Roxadustat FG-4592Anemia in chronic kidney diseasePhase 3Phase 3 ongoing. Expects to file NDA in 2018 assuming positive data03/01/2016
FGEN
18.37FG-3019Idiopathic pulmonary fibrosisPhase 2Phase 2 ongoing. Two-thirds of patients enrolled as of February 2016. Enrolment to be completed 3Q 2016. Data due 1H 201703/01/2016
FGEN
18.37FG-3019Pancreatic cancer Phase 2Phase 2 data presented at 2016 Gastrointestinal Cancers Symposium of ASCO GI in January 201601/28/2016
FGEN
18.37FG-3019Duchenne muscular dystrophyPhase 2Phase 2 trial enrolment commenced January 201601/08/2016
FGEN
18.37FG-3019Liver fibrosisPhase 2Phase 2 ongoing in Hong Kong. Future development uncertain02/01/2015
FLML
12.32AkovazHypotensionApprovedAnnounced approval May 2 201605/03/2016
FLML
12.32Micropump Sodium OxybateNarcolepsyPhase 3Phase 3 SPA filed March 2016. Company noted in January 2016 that if they initiated the trial in 2Q as planned, trial completion should occur in mid 201704/01/2016
FLML
12.32VAZCULEP (phenylephrine hydrochloride)Clinically important hypotension resulting primarily from vasodilation in the setting of anesthesiaApprovedApproved June 30 201407/01/2014
FLML
12.32Bloxiverz (neostigmine methylsulfate)Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgeryApprovedApproved Jun 306/05/2013
FLXN
10.63Zilretta - FX006Osteoarthritis of the knee Phase 3Phase 2b data released November 2015 (primary endpoint not met). Phase 3 data released mid February 2016. Primary endpoint met, missed secondary endpoint of improving daily pain rating. NDA to be filed 2H 201603/11/2016
FLXN
10.63Zilretta - FX006OA of the knee with type 2 adult diabetesPhase 2Phase 2 safety trial to be initiated in 201603/11/2016
FOLD
7.53Migalastat HCl monotherapy (012)Fabry DiseasePhase 3NDA filing delayed following meeting with FDA. Expects to meet with FDA in 2Q 2016.03/01/2016
FOLD
7.53SD-101 Epidermolysis Bullosa (EB)Phase 3Phase 3 completion of enrollment due mid 2016, top-line data 2H16 03/01/2016
FOLD
7.53ATB200Pompe DiseasePhase 1/2Phase 2 interim and final data due 201612/27/2015
FOMX
6.39FDX104Acne-like rash in cancer patientsPhase 2Phase 2 data released December 201512/27/2015
FOMX
6.39FDX101AcnePhase 2Phase 3 to be initiated early 201612/27/2015
FOMX
6.39FDX102ImpetigoPhase 2Awaiting guidance from FDA regarding future development12/27/2015
FOMX
6.39FDX103Papulopustular rosaceaPhase 2Phase 2 initiated October 201512/27/2015
FPRX
48.49FPA008 Pigmented Villonodular Synovitis (PVNS)Phase 1/2Phase 2 dose expansion phase to be initiated mid 201603/11/2016
FPRX
48.49FP-1039MesotheliomaPhase 1bPhase 1b NSCLC halted, mesothelioma to continue01/11/2016
FWP
20.39FP187Multiple sclerosisPhase 3Phase 3 planned for 2H 201604/13/2016
FWP
20.39FP187PsoriasisPhase 3Phase 3 planned 12/28/2015
GALE
1.35GALE-301/302Ovarian cancerPhase 2bPhase 2b to be initiated 2H 2016. GALE-301 Phase 2a primary analysis to be presented at ASCO 201604/20/2016
GALE
1.35NeuVax (E75) - PRESENTCancer - low-to-intermediate HER2+ breast cancerPhase 3Initiated Phase 3 Jan 2012 under SPA. Final endpoint expected to be reached in 2018. Interim safety and futility analysis due 2Q 201603/11/2016
GALE
1.35NeuVax Ductal Carcinoma in Situ (DCIS)Phase 2Phase 2 to be initiated 201603/11/2016
GALE
1.35NeuVax Gastric cancerPhase 2Phase 2 to be initiated 201603/11/2016
GALE
1.35NeuVax in combination with HerceptinBreast cancerPhase 2bPhase 2b interim safety data and patient immunology data on the A24 and A25 Human Leukocyte Antigen (HLA) status due 4Q 201601/14/2016
GALE
1.35GALE-401Essential Thrombocythemia (ET)Phase 2Phase 2 initiated September 2014. Top-line data released mid 2015.12/28/2015
GBIM
1.96GI-6301ChordomaPhase 2Phase 2 initiated by NCI April 2015. Enrolling as of March 201603/17/2016
GBIM
1.96GS-4774 - 1401 trialChronic hepatitis B infectionPhase 2Phase 2 initiated by GILD in 2014. 48-week results are expected to be available 2H 2016. 24 week data due 2Q 201603/17/2016
GBIM
1.96GI-6207Cancer - MTC (medullary thyroid cancer)Phase 2Phase 2 data due 2H 201603/17/2016
GBIM
1.96GI-4000Cancer - Non-small cell lung cancerPhase 2Further development dependent on funding12/28/2015
GBIM
1.96GI-4000Cancer - colorectal cancer Phase 2Further development dependent on funding12/28/2015
GBIM
1.96GS-4774 - 0101 trialChronic hepatitis B infectionPhase 2Phase 2 initiated by GILD Sept 2013. 48-week results released May 2015 were not significant05/28/2015
GBT
20.80GBT440Sickle cell diseasePhase 1/2Phase 1/2 initial data released at ASH 201501/08/2016
GERN
3.00Imetelstat - IMerge StudyMyelodysplastic syndromesPhase 2Announced mid-January 2016 that Phase 2 dosing has been initiated. Internal review to be conducted 2H 201602/26/2016
GERN
3.00Imetelstat - IMbarkStudyMyelofibrosisPhase 2Phase 2 clinical hold lifted Nov 2014. Phase 2 initiated September 2015. Internal review to be conducted 2H 201602/26/2016
GLMD
5.88Aramchol - ARRESTNon-Alcoholic Steatohepatitis (NASH)Phase 2bInitiated Phase 2b March 2015. Interim analysis due December 2016 or early 2017. Final data due 1Q 201803/23/2016
GLMD
5.88Aramchol - ARRIVE HIV-associated lipodystrophy and nonalcoholic fatty liver disease (NAFLD)Phase 2Phase 2 initiated dosing February 201603/02/2016
GLYC
6.49GMI-1271Acute myeloid leukemia (AMLPhase 1/2Phase 1/2 enrolling. Data will be available to report in 2Q 201603/01/2016
GLYC
6.49GMI-1070 (rivipansel)Vaso-occlusive crisis of sickle cell diseasePhase 3Phase 3 initiated June 201506/29/2015
GNCA
4.27GEN-003Genital herpesPhase 2bPhase 2 12 month data released March 2016. Phase 2b virologic efficacy data due 3Q 2016. 6-month efficacy data due late 201604/01/2016
GNCA
4.27GEN-004Universal vaccine candidate against pneumococcusPhase 2Topline data did not meet endpoints - September 201512/28/2015
GNVC
0.80CGF166Hearing lossPhase 1/2Trial halted January 2016 due to safety review. Company indicated in May 2016 that enrolment will most likely resume in the next coming months with trial completion due in 2017. 05/03/2016
GTXI
0.70Enobosarm Postmenopausal women with stress urinary incontinence (SUI)Phase 2Phase 2 initiated January 2016. Top-line data are due 201603/04/2016
GTXI
0.70Enobosarm Breast cancer - advanced AR+ TNBCPhase 2Phase 2 prelim data due by end of 201603/04/2016
GTXI
0.70Enobosarm Breast cancer - metastatic or locally advanced, ER+/AR+ breast cancerPhase 2Phase 2 prelim data due by end of 201603/04/2016
GWPH
82.53EpidiolexDravet SyndromePhase 3Top line Phase 3 data released March 2016 met primary endpoint03/15/2016
GWPH
82.53EpidiolexLennox-Gastaut syndrome (LGS)Phase 3First and Second Phase 3 trial data due 2Q and mid 2016, respectively03/15/2016
GWPH
82.53GWP42004Type 2 diabetesPhase 2Phase 2 data due 2Q 201602/11/2016
GWPH
82.53SativexMultiple Sclerosis (MS) spasticityPhase 2Phase 2 data due 2H 201602/11/2016
GWPH
82.53SativexCancer painPhase 3Phase 3 trials failed. Plan to meet FDA during 1Q 2016 regarding possible NDA filing02/11/2016
GWPH
82.53EpidiolexDravet SyndromePhase 3Second Phase 3 trial initiated mid April 2015. Topline data due 2H 201602/11/2016
GWPH
82.53EpidiolexTuberous Sclerosis ComplexPhase 3Phase 3 to be initiated 1Q 201602/11/2016
GWPH
82.53GWP42006EpilepsyPhase 2Phase 2 initiated May 2015. Data due 4Q 201602/11/2016
GWPH
82.53GWP42003SchizophreniaPhase 2Phase 2 data released September 2015. 12/28/2015
HALO
10.85PEGPH20 Cancer - pancreaticPhase 2Phase 3 dosing initiated March 2016. Phase 2 PFS data due 4Q 201603/17/2016
HALO
10.85PEGPH20 in Combination with docetaxelCancer - NSCLCPhase 1bEnrolling as of 4Q 201512/28/2015
HALO
10.85PEGPH20 in combination with KEYTRUDACancer - NSCLCPhase 1bPhase 1b initiated November 201512/28/2015
HALO
10.85HYQVIASubcutaneous treatment for patients with primary immunodeficiency (PI)ApprovedApproved Sept 12 201409/14/2014
HALO
10.85HTI-501CelluoitePhase 2Phase 2 topline data released 1Q 201403/26/2014
HRTX
22.33APF530 - SustolPrevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)PDUFANoted on March 3 that a decision will be made by early April 2016. Further update provided April 18, 2016 that indicated that the FDA noted there are no substantive deficiencies in the NDA and they have begun labeling discussions 04/19/2016
HRTX
22.33HTX-019Prevention of chemotherapy-induced nausea and vomiting (CINV)NDA filing due 2H 201612/28/2015
HRTX
22.33HTX-011Inguinal hernia repairPhase 2Phase 2 intiated June 2015. Data due 1H 201612/28/2015
HSGX
2.25NeoCartCartilage defects in the kneePhase 3Phase 3 enrolment due to be completed 2Q 2017. 03/11/2016
HTBX
0.67HS-410Cancer - bladder cancerPhase 2Phase 2 initiated Oct 2014. Data due 4Q 2016. Trial placed on partial clinical hold in early February 2016 but lifted a week later. Announced February 2016 that they will no longer enroll new patients in the monotherapy trial arm02/26/2016
HTBX
0.67HS-110Cancer - NSCLC non-small cell lung cancer Phase 1bPhase 1b topline data due 4Q 201602/19/2016
HZNP
15.31ACTIMMUNEFriedreich's Ataxia (FA)Phase 3Phase 3 data due by the end of 201612/28/2015
ICPT
150.40Obeticholic acid (OCA)Primary biliary cirrhosis (PBC) - POISEPDUFAPDUFA May 29 2016. Advisory Committee meeting April 7 2016 voted 17 to 0 to recommend approval04/08/2016
ICPT
150.40Obeticholic acid (OCA)Primary Sclerosing Cholangitis (PSC)Phase 2Phase 2 enrolling02/24/2016
ICPT
150.40Obeticholic acid (OCA) - REGENERATEAdult nonalcoholic steatohepatitis (NASH) patients. Phase 3FLINT trial stopped early due to strong efficacy Jan 2014. Phase 3 initiated September 201512/28/2015
IDRA
1.68IMO-2125Cancer - melanomaPhase 1/2Phase 1/2 trial initiated December 201512/28/2015
IDRA
1.68IMO-8400Waldenström’s MacroglobulinemiaPhase 1/2Phase 1/2 data from ongoing trial presented at ASH 201512/28/2015
IDRA
1.68IMO-8400DermatomyositisPhase 2Phase 2 initiated November 201512/28/2015
IDRA
1.68IMO-8400 DLBCL who harbor the MYD88 L265P mutationPhase 1/2Phase 1/2 data due 201612/28/2015
IDRA
1.68IMO-8400PsoriasisPhase 2Phase 2 initiated Jun 2013. Data released Mar 201404/25/2014
IMGN
6.61Mirvetuximab soravtansine - FORWARD I and FORWARD II Cancer - ovarian cancer and relapsed endometrial cancerPhase 3Reported April 2016 that FORWARD I, initially a Phase 2 trial, will now be a Phase 3 trial with progression-free survival as the primary endpoint04/30/2016
IMGN
6.61IMGN529 and rituximabCancer - diffuse-large B-cell lymphoma (DLBCL)Phase 2Phase 2 to be initiated early 201601/30/2016
IMGN
6.61Coltuximab ravtansine Cancer - diffuse-large B-cell lymphoma (DLBCL)Phase 2Phase 2 to be initiated 2H 201601/30/2016
IMGN
6.61Kadcyla KRISTINE trialHER2-positive breast cancer - neo-adjuvant settingPhase 3Phase 3 data due 201601/30/2016
IMGN
6.61Anetumab ravtansineMesotheliomaPhase 2Announced late January 2016 that a milestone payment has been received from partner Bayer following the initiation of a Phase 2 trial01/27/2016
IMGN
6.61Kadcyla GATSBY trialCancer - metastatic HER2+ gastric cancer Phase 3Endpoint not met - October 201512/28/2015
IMGN
6.61Kadcyla (KAITLIN) HER2-positive breast cancer - adjuvant usePhase 3Phase 3 enrolling01/31/2015
IMGN
6.61Kadcyla (KATHERINE).HER2-positive breast cancer - residual invasive diseasePhase 3Phase 3 enrolling01/31/2015
IMGN
6.61Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) - Kadcyla - MARIANNE trialCancer - 1st-line HER2+ Metastatic Breast Cancer Phase 3Phase 3 data released Dec 18 2014. Met non-inferiority endpoint but did NOT significantly improve PFS compared to Herceptin and chemotherapy12/19/2014
IMMU
3.68Labetuzumab govitecanMetastatic colorectal cancer (mCRC)Phase 2Phase 2 interim data presented April 201604/19/2016
IMMU
3.68Clivatuzumab tetraxetanCancer - PancreaticPhase 3Phase 3 trial terminated due to poor efficacy03/15/2016
IMMU
3.68ISACTUZUMAB GOVITECAN (IMMU-132) Cancer - metastatic triple-negative breast cancerPhase 3Phase 3 SPA agreed on. Phase 3 trial planned02/04/2016
IMMU
3.68Epratuzumab (EMBODY 1 and 2)LupusPhase 3Endpoints not met July 201512/28/2015
IMMU
3.68SACITUZUMAB GOVITECANCancer - non-small cell lung cancer (NSCLC) Phase 2Phase 2 data released Feb 201502/21/2015
IMMVF
0.53DPX-Survivac and low-dose cyclophosphamide and epacadostatRecurrent ovarian cancerPhase 1bPhase 1b to be initiated 2Q 201601/12/2016
IMUC
0.26ICT-107 dendritic cell vaccineGlioblastoma antigens and cancer stem cellsPhase 2bPhase 2b failed to meet primary endpoint. Phase 3 initiation due late 2015 or early 201612/28/2015
INCY
74.36Epacadostat with Keytruda - ECHO-301Cancer - first-line metastatic melanoma.Phase 3Phase 3 to be initiated 1H 201602/12/2016
INCY
74.36Ruxolitinib - JANUS 1 and JANUS 2Cancer - PancreaticPhase 3Phase 3 trial discontinued due to lack of efficacy02/12/2016
INCY
74.36RuxolitinibColorectal cancerPhase 2Phase 2 trial stopped January 2016 due to lack of efficacy01/28/2016
INCY
74.36BaricitinibRheumatoid arthritisNDA filingAnnounced January 19 2016 that their NDA filing has been submitted by partner Eli Lilly 01/20/2016
INCY
74.36RuxolitinibBreast CancerPhase 2Phase 2 data due 201601/12/2016
INCY
74.36INCB39110 and TagrissoSecond-line EGFR mutation-positive non-small cell lung cancer (NSCLC)Phase 1/2Phase 1/2 planned01/12/2016
INCY
74.36Ruxolitinib cream Topical treatment of alopecia areataPhase 2Phase 2 initiated October 201512/28/2015
INCY
74.36INCB39110 and erlotinibNon-small cell lung cancerPhase 2Phase 2 stopped due to slow enrolment12/28/2015
INCY
74.36EpacadostatCancer - OvarianPhase 2Ongoing12/28/2015
INCY
74.36Ruxolitinib Non-small cell lung cancerPhase 2Phase 2 ongoing12/28/2015
INCY
74.36Jakafi (ruxolitinib) (RESPONSE)Polycythemia VeraApprovedApproved December 4 201412/05/2014
INCY
74.36Jakafi (ruxolitinib) (RELIEF)Disease-related symptoms in patients with Polycythemia VeraPhase 3Endpoint not met, mid-201407/24/2014
INFI
5.87Duvelisib (IPI-145) DYNAMOIndolent non-Hodgkin lymphomaPhase 2Phase 2 data due early 3Q 201502/24/2016
INFI
5.87Duvelisib - DUOCancer - relapsed/refractory chronic lymphocytic leukemia (CLL)Phase 3Phase 3 enrolment completed November 2015. Interim analysis due early 2H 201602/24/2016
INFI
5.87Duvelisib - ConetempoTreatment-naïve patients with follicular lymphomaPhase 1b/2Phase 1/2 initial data due 2H 201602/24/2016
INFI
5.87Duvelisib and venetoclaxRelapsed or refractory CLL, small lymphocytic lymphoma, iNHL or aggressive NHLPhase 1b/2Phase 1b/2 trial to be initiated 1H 201601/12/2016
INFI
5.87Duvelisib (IPI-145)Rheumatoid arthritisPhase 2Phase 2 failed to meet endpoint - Jan 201501/09/2015
INFI
5.87Retaspimycin Hydrochloride with everolimusCancer - NSCLCPhase 2Phase 2 enrolment completed. Does not plan to further development09/27/2013
INNL
7.99XaraColl Post-operative painPhase 3Data due 2Q 201612/28/2015
INNL
7.99CogenziaDiabetic foot ulcer infectionsPhase 3Data due 3Q 201612/28/2015
INO
10.88VGX-3100Cervical dysplasiaPhase 3Phase 3 to be initiated mid-201603/15/2016
INSM
12.45ARIKAYCENon-tuberculous Mycobacterial Lung DiseasePhase 3Clinical hold lifted Jan 2012. Topline data released March 26 2014. Missed primary endpoint. Met key secondary endpoint. Two Phase 3 trials to be initiated, enrolment expected to be completed during 2H 201602/26/2016
INSM
12.45ARIKAYCEcystic fibrosisPhase 3 Phase 3 Euro data released 1 July 2013. Met endpoint but slighly inferior data to competition07/02/2013
INSY
14.44Dronabinol Oral SolutionAIDS-related anorexia PDUFAPDUFA April 1 2016 extended to July 1 201603/23/2016
INSY
14.44Pharmaceutical Cannabidiol (CBD)Infantile spasms (IS)Phase 2Phase 2 enrolment initiated February 201602/10/2016
INSY
14.44CannabidiolEpilepsyPhase 3Phase 3 to be initiated 2H 201501/13/2015
INSY
14.44SubsysAcute post-operative painPhase 3Dose ranging trial to be initiated 1H 2015, with Phase 3 to be initiated 2H 2015. Data due 2016.01/13/2015
INSY
14.44BuprenorphineAcute pain in patients undergoing a bunionectomy procedurePhase 3Phase 3 to be initiated 1H 2015. Data due 2016.01/13/2015
IONS
40.40IONIS-TTRRxCARDIO-TTR - Cardiomyopathy form of TTR amyloidosis.Phase 2Phase 2 data due 2016. Phase 3 placed on clinical hold04/08/2016
IONS
40.40IONIS-TTRRxNEURO-TTR - familial amyloid polyneuropathy (FAP).Phase 3Phase 3 to be completed in 1H 201704/07/2016
IONS
40.40IONIS-STAT3-2.5RxCancerPhase 2Phase 2 data due 201604/07/2016
IONS
40.40IONIS-STAT3-2.5RxCancerPhase 2Phase 2 data due 201604/07/2016
IONS
40.40NusinersenCHERISH - Children with spinal muscular atrophy (SMA). ENDEAR trial - nusinersen in infants with spinal muscular atrophy SMAPhase 3Phase 3 CHERISH study reached target enrolment early January 2016. Additional Phase 3 ENDEAR enrolment due to be completed 1H 2016. Data are due 201704/07/2016
IONS
40.40IONIS-DMPK-2.5RxMyotonic Dystrophy Type 1 (DM1)Phase 1/2Phase 1/2 ongoing04/07/2016
IONS
40.40IONIS-FXIRxEnd-stage renal diseasePhase 2Phase 2 data due 201604/07/2016
IONS
40.40Volanesorsen - APROACHFamilial chylomicronemia syndrome (FCS)Phase 3Phase 3 enrolment completed04/07/2016
IONS
40.40IONIS-APO(a)RxHigh lipoprotein(a), or Lp(a)Phase 2Phase 2 data released 3Q 201512/29/2015
IONS
40.40IONIS-GCGRRxType 2 diabetesPhase 2Phase 2 ongoing12/29/2015
IONS
40.40VolanesorsenFamilial partial lipodystrophy (FPL)Phase 3Phase 3 initiated November 201512/29/2015
IONS
40.40VolanesorsenPartial lipodystrophy rapidlyPhase 3Phase 3 initiated November 201512/29/2015
IONS
40.40IONIS-PTP1BRxType 2 diabetesPhase 2Phase 2 released Feb 2015. Achieved statistically significant results but data released was as of 36 weeks rather than 27 weeks for the primary endpoint02/04/2015
IPXL
33.13IPX066Parkinson's ApprovedApproved Jan 8 201501/09/2015
IRWD
10.76IW-9179GastroparesisPhase 2aPhase 2a data released April 2016. Development to be discontinued due to disappointing data04/06/2016
IRWD
10.76 IW-3718 Gastroesophageal reflux disease (GERD) Phase 2bPhase 2b initiated March 2016. Data are due in 201703/24/2016
IRWD
10.76Linaclotide Colonic ReleaseIrritable Bowel Syndrome with Constipation (IBS-C)Phase 2bPhase 2b data due 2H 201602/19/2016
ITCI
35.08ITI-007-302SchizophreniaPhase 3Phase 3 enrolment to be completed 2Q 2016. Data due later in 201602/26/2016
ITCI
35.08ITI-007 Bipolar depressionPhase 3Phase 3 ongoing02/26/2016
ITEK
10.35RabodenosonPrimary open-angle glaucoma (POAG)Phase 3Phase 3 initiated October 2015. Top-line data due 4Q 201603/24/2016
JUNO
42.29JCAR014R/R NHL or R/R ALLPhase 1/2Phase 1/2 ongoing but no plans to advance JCAR014 into registration trials12/29/2015
JUNO
42.29JCAR015Relapsed/ refractory B cell acute lymphoblastic leukemiaPhase 2Phase 2 initiated 3Q 201512/29/2015
JUNO
42.29JCAR017r/r B cell non-Hodgkin lymphomaPhase 1/2Phase 1 initiated 3Q 201512/29/2015
KBIOQ
4.92KB001-ACystic fibrosis (CF) patients with chronic Pseudomonas aeruginosa (Pa) lung colonizationPhase 2Phase 2 data released early January 2015 did not meet endpoint. Development discontinued01/07/2015
KERX
5.96AuryxiaIron deficiency anemia in non-dialysis dependent CKD patientsPhase 3Phase 3 top line data released late March 2016. sNDA to be filed 3Q 201604/29/2016
KERX
5.96AuryxiaHyperphosphatemiaApprovedApproved Sept 5 201409/07/2014
KITE
47.80KTE-C19 (ZUMA-1)Refractory Non-Hodgkin's Lymphoma (NHL)Phase 2 PivotalPhase 2 pivotal initiated November 2015. Interim data due 2H 201603/01/2016
KITE
47.80KTE-C19 (ZUMA-4)Pediatric and young adult patients with r/r ALLPhase 1/2 PivotalPhase 1/2 initated December 201512/29/2015
KITE
47.80KTE-C19 (ZUMA-3) Adult patients with r/r ALLPhase 1/2 PivotalPhase 1/2 pivotal trial initiated December 201512/29/2015
KITE
47.80KTE-C19 (ZUMA-2)Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL)Phase 2 PivotalPhase 2 pivotal initiated November 201512/29/2015
KMDA
4.15Alpha-1 antitrypsin (AAT)Prevention of lung transplant rejectionPhase 2Phase 2 initiated April 201604/07/2016
KMDA
4.15Alpha-1 antitrypsin (AAT)Graft Versus Host Disease (GvHD)Phase 1/2Phase 1/2 interim data reported January 201601/09/2016
KMDA
4.15KamRABProphylaxis of rabies diseasePhase 3BLA filing due mid 201612/29/2015
KMDA
4.15Inhaled formulation of AATAATD - Alpha-1 Antitrypsin deficiencyPhase 2Top-line data due mid 201612/29/2015
KMDA
4.15GlassiaPediatric patients newly diagnosed with type 1 diabetesPhase 2/3Phase 2/3 initiated Mar 201403/06/2014
KMPH
17.04KP201/APAP Acute pain.PDUFA priority reviewPDUFA date under priority review is June 9 2016. Advisory Committee Meeting May 5 201603/15/2016
KPTI
9.52Selinexor - SEALDedifferentiated liposarcomaPhase 2/3Phase 2/3 trial initiated January 2016. Data from Phase 2 portion of trial due early 201701/15/2016
KPTI
9.52Selinexor - STORMQuadruple Refractory Multiple MyelomaPhase 2Phase 2 initiated May 2015. Interim data due mid 201612/29/2015
KPTI
9.52Selinexor - STOMPMultiple myelomaPhase 1/2Phase 1/2 data due 201712/29/2015
KPTI
9.52Selinexor - SADAL Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2bPhase 2b initiated Dec 2014. Preliminary topline data due 4Q 2016.12/29/2015
KPTI
9.52Selinexor SOPRACancer - Relapsed/Refractory Acute Myeloid Leukemia (AML)Phase 2Phase 2 initiated June 25 2014. Initial data due mid 2016. Preliminary topline data due 4Q 2016.12/29/2015
KPTI
9.52SelinexorCancer - Advanced Gynecologic Malignancies (SIGN Study)Phase 2Phase 2 initiated April 2014. Interim data at ASCO 201505/13/2015
KPTI
9.52Selinexor - (KING study)Cancer - glioblastoma Phase 2Phase 2 initiated April 2014. Interim data at ASCO 201505/13/2015
KPTI
9.52Selinexor - SIRRTRichter's transformation Phase 2Phase 2 initiated November 201411/11/2014
KPTI
9.52Selinexor - SHIPCancer - hormone-refractory prostate cancer (HRPC)Phase 2Phase 2 initiated June 201406/10/2014
LIFE
3.67ResolarisAdult patients with facioscapulohumeral muscular dystrophy (FSHD)Phase 1b/2Phase 1b/2 data released March 201603/31/2016
LIFE
3.67ResolarisInterstitial lung disease (ILD)Phase 1b/2Decision to be made whether to initiate trial by end of 201601/12/2016
LIFE
3.67ResolarisLimb girdle muscular dystrophy (LGMD) 2BPhase 1b/2Phase 1b/2 initiated October 201501/08/2016
LJPC
18.96LJPC-501Catecholamine-resistant hypotension (CRH).Phase 3Phase 3 initiated late March 2015 under SPA. Data due by end of 201602/26/2016
LJPC
18.96GCS-100Chronic kidney diseasePhase 2Phase 2b initiated mid March 201503/22/2015
LNTH
2.10flurpiridaz F 18Coronary artery disease (CAD)Phase 3First Phase 3 trial complete. Partner required for second Phase 3 trial01/08/2016
LOXO
24.98LOXO-101Solid tumors that harbor a TRK fusion.Phase 2Phase 2 basket trial initiated October 201503/16/2016
LPCN
9.87LPCN 1107 Prevention of preterm birth ("PTB").PK study completed February 201602/17/2016
LPCN
9.87LPCN 1111Oral testosterone productPhase 2aPhase 2b to be initiated 4Q 2015 12/29/2015
LPCN
9.87LPCN 1021Men with low testosterone (Low T)PDUFAPDUFA June 28 201612/29/2015
LPTN
0.22iSONEPWet-AMDPhase 2Phase 2 trial did not meet endpoints12/29/2015
LPTN
0.22ASONEPRenal cell carcinoma (RCC)Phase 2aPhase 2a failed to meet primary endpoint late March 201503/25/2015
LXRX
14.25LX1032 Telotristat etiprateCarcinoid SyndromeNDA filingAnnounced March 30 2016 NDA submission03/31/2016
LXRX
14.25SotagliflozinType 1 DiabetesPhase 3Phase 3 data due 2H 201603/02/2016
LXRX
14.25SotagliflozinType 2 DiabetesPhase 3Phase 3 trial to be initiated by the end of 201603/02/2016
MACK
7.28MM-141Cancer - front line pancreatic cancerPhase 2Phase 2 data due 201805/03/2016
MACK
7.28ONIVYDECancer - front line pancreaticPhase 2Phase 2 initiated October 2015. Data due 201705/03/2016
MACK
7.28MM-121Cancer - Heregulin Positive Non-Small Cell Lung CancerPhase 2Phase 2 initiated mid Feb 2015. Data due 201805/03/2016
MACK
7.28MM-302 HERMIONECancer - HER2-positive locally advanced or metastatic breast cancerPhase 2Phase 2 initiated August 2014. Data due 201705/03/2016
MACK
7.28ONIVYDECancer - HER2-negative gastric cancerPhase 3Phase 3 to be initiated in 201612/29/2015
MACK
7.28ONIVYDECancer - second line pancreaticApprovedApproved October 22 2015 under priority review12/29/2015
MACK
7.28MM-121 Cancer - triple negative breast cancer cohort in the neoadjuvant settingPhase 2Phase 2 data released June 201406/22/2014
MCRB
29.70SER-109Recurrent C. Difficile infectionPhase 2Phase 2 data due mid 2016. Phase 3 to be initiated 2H 201605/03/2016
MCRB
29.70SER-287 Mild-to-Moderate Ulcerative ColitisPhase 1bPhase 1b initiated December 201501/08/2016
MCUR
0.98CureXcellDiabetic Foot UlcersPhase 3Phase 3 data fail October 201512/29/2015
MCUR
0.98CureXcellVenous Leg Ulcers Phase 3Phase 3 endpoint not met August 201512/29/2015
MDCO
35.62ALN-PCSscAtherosclerotic cardiovascular disease (ASCVD)Phase 2Phase 2 initiated January 201601/12/2016
MDCO
35.62CARBAVANCESerious Bacterial Infections Due to Gram-Negative BacteriaPhase 3Phase 3 ongoing. 12/29/2015
MDCO
35.62CangrelorReduction of thrombotic cardiovascular events including stent thrombosis in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI)ApprovedApproved June 22 201506/29/2015
MDCO
35.62RAPLIXAHemostasisPDUFAApproved April 30 201505/02/2015
MDCO
35.62IONSYSAcute postoperative painApprovedApproved April 30 201505/02/2015
MDCO
35.62OritavancinABSSSIApprovedApproved August 6 2014 under priority review08/10/2014
MDGN
5.10NFC-1mGluR mutation positive ADHD Phase 2/3Phase 2/3 to be initiated 1Q 2016. Initial top-line data are due 2H 201602/18/2016
MDGN
5.10MDGN-201 -TARGTEPOESRD patients who are undergoing peritoneal dialysisPhase 2Enrolling12/29/2015
MDGN
5.10MDGN-201 -TARGTEPOAnemiaPhase 2Phase 1/2 trial commenced enrolment Jun 2014. Initial data released Oct 15 201410/19/2014
MDVN
58.01Enzalutamide cf Bicalutamide STRIVE trialCancer - prostate cancerPDUFAPDUFA October 22 2016 for sNDA 02/23/2016
MDVN
58.01EnzalutamideAdvanced Breast Cancer That Is Estrogen or Progesterone Receptor Positive and HER2 NormalPhase 2Phase 2 initiated Dec 2013. Enrolment completed May 201512/29/2015
MDVN
58.01EnzalutamideHepatocellular carcinomaPhase 2Phase 2 initiated by Astellas in May 201512/29/2015
MDVN
58.01MDV3800 talazoparibGermline BRCA mutated breast cancerPhase 3Phase 3 ongoing - from BMRN12/29/2015
MDVN
58.01MDV9300 (pidilizumab) Cancer - relapsed or refractory diffuse large B-cell lymphoma (DLBCL)Phase 2 PivotalPhase 2 Pivotal initiated December 201512/29/2015
MDVN
58.01Enzalutamide Triple-negative breast cancer (TNBC)Phase 2Phase 2 data reported September 201512/29/2015
MDVN
58.01Talazoparib (BMN 673)Cancer -gBRCA breast cancer Phase 3Ongoing. Acquired from BMRN12/24/2015
MDVN
58.01XTANDICancer - mCRPC who have not received chemotherapyApprovedApproved Sept 10 201409/11/2014
MDWD
8.30EscharEx Chronic and other hard-to-heal woundsPhase 2Phase 2 data released early February 2016. Primary endpoint met. Secondary endpoint of time to complete debridement not met02/03/2016
MDWD
8.30NexoBridSevere burnsPhase 3Phase 3 initiated mid April 2015. Data due 1H 201712/29/2015
MEIP
1.44Pracinostat in combination with VidazaElderly patients with newly diagnosed acute myeloid leukemia (AML)Phase 2Phase 3 is planned for 2H 201612/29/2015
MEIP
1.44Pracinostat in combination with Vidaza First line intermediate-2 or high-risk Myelodysplastic SyndromePhase 2Phase 2 topline data released late March 2015 did not meet primary endpoint03/24/2015
MEIP
1.44Pracinostat and Vidaza or DacogenMyelodysplastic SyndromePhase 2Ongoing11/13/2014
MESO
8.27MPC-150-IMChronic heart failure (CHF)Phase 3Advised January 2016 that the size of Phase 3 trial to be reduced from 1,165 to approximately 600 patients due to a proposed change in the primary endpoint01/12/2016
MGNX
20.81Margetuximab SOPHIA studyCancer - metastatic breast cancerPhase 3Phase 3 enrolling. Completion of trial expected in 201803/01/2016
MGNX
20.81Margetuximab in combination with pembrolizumabCancer - gastricPhase 1/2Phase 1/2 initiated in early 201603/01/2016
MIRN
4.56MRX34Melanoma Phase 2Phase 2 to be initiated in 201603/30/2016
MIRN
4.56MRX34Renal cell carcinomaPhase 2Phase 2 to be initiated in 201603/30/2016
MNKD
1.45AFREZZA Type 1/2 diabetesApprovedApproved June 27 201406/28/2014
MNOV
7.00MN-166Amyotrophic lateral sclerosis (ALS)Phase 2Phase 2 interim data released April 201604/21/2016
MNOV
7.00MN-001NASH (nonalcoholic steatohepatitis)Phase 2Phase 2 planned12/29/2015
MNOV
7.00MN-166Progressive multiple sclerosis (progressive MS).Phase 2bEnrolment completed May 2015. Interim analysis due fall of 201606/13/2015
MNOV
7.00MN-166Opioid dependence Phase 2Phase 2 interim data released August 201408/19/2014
MNTA
9.76Necuparanib (MOM-M402-103)Cancer - advanced metastatic pancreatic cancerPhase 1/2Topline data due 2H 201702/19/2016
MNTA
9.76Generic CopaxoneMultiple sclerosisApprovedFiled 2007. Approved April 16 201504/17/2015
MRNS
5.42GanaxoloneEpilepsyPhase 3Phase 3 top-line data due mid 201605/03/2016
MRNS
5.42GanaxolonePCDH19Phase 2Phase 2 data due mid 201605/03/2016
MRNS
5.42GanaxoloneFragile X SyndromePhase 2Phase 2 data due 2Q 2016 - noted May 2 2016 that data are due in the upcoming weeks05/03/2016
MRTX
21.55Mocetinostat and durvalumabNSCLC including those who are PD-L1 low and who have failed prior checkpoint inhibitor treatmentPhase 2Phase 2 combination trial to be initiated 2Q 201603/10/2016
MRTX
21.55Glesatinib (MGCD265)NSCLC patients with driver alterations in METPhase 2Phase 2 initiated December 2015. Initial data due by end of 201603/10/2016
MSTX
0.29ANX-188 - VepoloxamerSickle cell diseasePhase 3Phase 3 initiated Jan 2013. Enrolment completed February 2015. Top-line data due 2Q 201603/15/2016
MSTX
0.29AIR001Heart failure with preserved ejection fraction (HFpEF)Phase 2Phase 2 topline data released February 2016. Preliminary data from second trial due mid 201602/02/2016
MSTX
0.29ANX-188 - VepoloxamerHeart Failure Phase 2Phase 2 initiated October 201512/29/2015
MSTX
0.29ANX-188 - VepoloxamerAcute limb ischemia (ALI)Phase 2Initiated Phase 2 March 2014. 11/03/2014
MSTX
0.29AIR001 Pulmonary Hypertension Phase 2Phase 2 prelim data released Sept 201409/09/2014
NAVB
1.50LymphoseekRheumatoid arthritisPhase 1/2Phase 1/2 initiated 2H 201604/05/2016
NAVB
1.50LymphoseekUterine Cervical NeoplasmsPhase 2Phase 2 enrolment commenced February 201602/12/2016
NAVB
1.50NAV4694Predicting Progression to Alzheimer's Disease (AD) in Subjects With Mild Cognitive Impairment (MCI)Phase 3Phase 3 - seeking partner to continue development12/29/2015
NAVB
1.50NAV5001 Imaging Agent for Parkinson’s DiseasePhase 3Phase 3 initiated Dec 2013. Ongoing12/29/2015
NAVB
1.50LymphoseekHead and Neck CancerApprovedApproved Jun 13 201406/14/2014
NBIX
46.71Elagolix EndometriosisPhase 3First Phase 3 trial met both co-primary endpoints - Jan 2015. Data from second Phase 3 released February 2016 also met endpoints. NDA filing due 201702/11/2016
NBIX
46.71NBI-98854 (Valbenazine)Tourette syndromePhase 2Phase 2 data due by end of 201602/03/2016
NBIX
46.71Elagolix Uterine FibroidsPhase 3Phase 3 initiated by partner Abbvie in January 201601/29/2016
NBIX
46.71NBI-98854 (Valbenazine)Tardive dyskinesiaPhase 3Phase 3 initiated Oct 2014. Data released October 2015. NDA filing due 201612/29/2015
NBRV
8.80Lefamulin Moderate to severe Community Acquired Bacterial Pneumonia (CABP)Phase 3Phase 3 topline data from two trials due late 201701/08/2016
NBY
2.71Auriclosene (NVC-422)Viral conjunctivitisPhase 2bData released August 2014. Endpoints not met08/21/2014
NBY
2.71Auriclosene (NVC-422)Impetigo skin infection studyPhase 2bFailed to meet endpoint Nov 2013. Plans to reinitiate trial in 201412/20/2013
NDRM
17.06ND0612HSevere Parkinson's DiseasePhase 2US Phase 2 safety trial planned for 2Q 201604/01/2016
NDRM
17.06ND0612LModerate Parkinson's DiseasePhase 3Phase 3 planned for mid 201604/01/2016
NEOS
17.06Adzenys XR-ODTAttention deficit hyperactivity disorder (ADHD)ApprovedApproved January 27, 201601/28/2016
NEOS
17.06Cotempla XR-ODTAttention deficit hyperactivity disorder (ADHD)CRLCRL issued November 201501/08/2016
NEOT
0.95LIPO-202Reduction of central abdominal bulging Phase 3Phase 3 endpoints not met December 2015. Phase 2 trial to be initiated 3Q 2016 with data due in 1Q 201703/29/2016
NERV
6.32MIN-117Major Depressive DisorderPhase 2bPhase 1b topline data released March 2016. Phase 2a data due 2Q 2016. 03/15/2016
NERV
6.32MIN-101SchizophreniaPhase 2bPhase 2b data due 2Q 201603/15/2016
NERV
6.32MIN-202Primary insomniaPhase 2aPhase 2 data released January 201601/12/2016
NKTR
15.98ADYNOVATEHemophilia A - pediatric indicationsNDAFDA filing submitted February 2503/03/2016
NKTR
15.98NKTR-181 Lower back painPhase 3Phase 3 initiated late Feb 2015. Data due early 201703/02/2016
NKTR
15.98FovistaWet-AMDPhase 3Phase 3 ongoing12/29/2015
NKTR
15.98Inhaled Amikacin Solution (BAY41-6551T)Gram-Negative Pneumonia (INHALE 1)Phase 3Phase 3 enrolling12/29/2015
NKTR
15.98Etirinotecan pegol NKTR-102 (BEACON)Cancer - Metastatic Breast CancerPhase 3Phase 3 topline data mid March 2015 did not reach primary endpoint03/21/2015
NKTR
15.98ADYNOVATEHemophilia A ApprovedApproved November 16 201512/02/2014
NKTR
15.98MOVANTIK (Naloxegol)Opioid-induced constipation (OIC)ApprovedApproved Sept 16 201409/17/2014
NLNK
17.61HyperAcute Pancreas - IMPRESSSurgically resected pancreatic cancerPhase 3Data due 2Q 201604/30/2016
NLNK
17.61Sipuleucel-T (PROVENGE®) plus indoximod (D-1MT/NLG8189) Asymptomatic or minimally symptomatic metastatic hormone refractory prostate cancerriglPhase 2Phase 2 initiated Sep 2012. Ongoing as of November 201512/29/2015
NLNK
17.61HyperAcute Pancreas - PILLARPancreatic cancerPhase 3Phase 3 enrolment completed December 201512/29/2015
NLNK
17.61Indoximod in combination with docetaxelCancer - breastPhase 2Phase 2 enrolment goal reached December 201512/29/2015
NLNK
17.61Tergenpumatucel-LCancer - NSCLCPhase 2Ongoing12/29/2015
NLNK
17.61Dorgenmeltucel-LCancer - melanomaPhase 2Ongoing12/29/2015
NRX
0.17PyridorinDiabetic nephropathyPhase 3Phase 3 initiated June 2014. Enrolment due to be half complete by mid 201612/30/2015
NTEC
3.40AP-CDLD Advanced Parkinson's Disease Phase 3Phase 3 initiated April 201604/05/2016
NVAX
5.32RSV vaccine - Resolve trialRespiratory Syncytial Virus (RSV) in older adultsPhase 3Phase 3 data due 3Q 201603/01/2016
NVAX
5.32RSV F Vaccine rollover trial Respiratory Syncytial Virus (RSV) in older adultsPhase 2Phase 2 data due 2H 201603/01/2016
NVAX
5.32RSV vaccine - prepare trialRespiratory Syncytial Virus (RSV) in healthy pregnant women - protect infants via maternal immunizationPhase 3Phase 3 initiated December 201512/30/2015
NVAX
5.32Seasonal Influenza VaccineSeasonal FluPhase 2Further Phase 2 trials planned09/18/2013
NVCR
12.81Optune systemGlioblastomaPMAPMA supplement application filed December 22 201501/08/2016
NVCR
12.81Tumor Treating Fields (TTFields)Brain Metastases Originating from Non-Small Cell Lung CancerPhase 2Preliminary Phase 2 data released Deecember 201501/08/2016
NVCR
12.81Tumor Treating Fields (TTFields)MesotheliomaPhase 2Phase 2 enrolment commenced February 201501/08/2016
NVCR
12.81Tumor Treating Fields (TTFields)Pancreatic cancerPhase 2Phase 2 enrolment completed January 201501/08/2016
NVIV
5.32Neuro-Spinal ScaffoldComplete Thoracic AIS A Spinal Cord InjuryPivotalReported in March 2016 that the 7th patient has been enrolled in the pivotal trial. Enrollment to be completed by end of 2016, HDE (Humanitarian Device Exemption) submission due in 2017. Also noted April 26 2016 that the 6th patient has improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury.04/27/2016
NVLS
4.19N91115Cystic FibrosisPhase 2Phase 2 initiated December 2015. 50 percent enroled as of April 2016. Data due 4Q 201604/06/2016
NWBO
1.34DCVaxCancer - Glioblastoma multiforme (GBM) brain cancerPhase 3As of December 2015, 300 of the total 348 planned patients had been recruited. However, new screening of patient candidates for additional recruitment has been temporarily suspended. Suspension remains as of May 2016.05/03/2016
NWBO
1.34DCVaxCancer - inoperable solid tumor cancersPhase 1/2Phase 1 part of trial completed. Phase 2 part planned12/30/2015
NYMX
2.34NX-1207 long-term NX03-0040 trialLow grade localized prostate cancerPhase 2Data released February 2016 met endpoint02/10/2016
NYMX
2.34NX-1207BPHPhase 3Phase 3 endpoints met in extension trial July 2015. Filing planned12/30/2015
OASM
4.36Paclical/Apealea Epithelial ovarian cancerPhase 3Phase 3 data released April 2016. NDA filing planned04/28/2016
OCRX
2.93OCR-002 (IV)Hepatic encephalopathyPhase 2bPhase 2b trial to complete enrolment 4Q 2016. Data due shortly after.03/04/2016
OCRX
2.93OCR-002 Cirrhosis and upper gastrointestinal bleedingPhase 2aPhase 2a preliminary data released mid-Feb 201502/21/2015
OCUL
11.90OTX-TPGlaucoma and ocular hypertensionPhase 3Phase 3 to be initiated 3Q 201604/28/2016
OCUL
11.90DEXTENZADry Eye DiseasePhase 2Phase 2 data released December 201512/30/2015
OCUL
11.90DEXTENZAOcular inflammation and pain following cataract surgeryPDUFAPDUFA July 24 201612/30/2015
OCUL
11.90DEXTENZAAllergic conjunctivitisPhase 3Second Phase 3 trial initiated November 2015. First trial met endpoints12/30/2015
OGXI
0.91Apatorsen Borealis-2Cancer - advanced or metastatic bladder cancerPhase 2Phase 2 initiated Apr 2013. Data due 2H 201603/10/2016
OGXI
0.91Custirsen ENSPIRITCancer - NSCLCPhase 3Phase 3 initiated Oct 2012. First interim analysis released August 2014, second interim futility analysis July 2015. Data likely 1H 201703/10/2016
OGXI
0.91Apatorsen plus gemcitabine and carboplatin - Spruce2 trial (Cedar Trial)Non-squamous, non-small cell lung cancer (NSCLC)Phase 2Phase 2 open label initiated July 2014. Data are due 2H 201603/10/2016
OGXI
0.91Custirsen in combination with Jevtana (cabazitaxel)- AFFINITYCancer - castrate-resistant prostate second-linePhase 3Phase 3 final data due 3Q 2016 but noted that a subpopulation who had multiple poor prognostic risk factors did NOT show improvement in survival02/06/2016
OGXI
0.91Apatorsen and carboplatin and pemetrexed - SpruceTrialNon-squamous, non-small cell lung cancer (NSCLC)Phase 2Phase 2 PFS data released January 2016 did not show a statistical improvement in PFS.01/21/2016
OGXI
0.91Apatorsen in Combination with ABRAXANE plus Gemcitabine - Rainier TrialMetastatic Pancreatic CancerPhase 2Not pursuing future development12/30/2015
OGXI
0.91Apatorsen and Zytiga - Pacific trialCancer - chemotherapy-naive patients with metastatic CRPCPhase 2Phase 2 trial was initiated in December 2012 and is enrolling patients12/30/2015
OHRP
3.32OHR-102Neovascular (Wet) Age-related Macular Degeneration (AMD)Phase 2Topline data released late March 2015 failed to show statistical significance in overall population. First of two Phase 3 trials under SPA initiated March 201603/30/2016
OHRP
3.32OHR-102Retinal vein occlusion (CRVO)Phase 2Phase 2 data released July 201512/30/2015
OMED
12.41Demcizumab plus Abraxane - YOSEMITEFirst-line pancreatic cancerPhase 2Phase 2 enrolment to be completed by end of 2016. Data are due 1H 201703/11/2016
OMED
12.41Demcizumab plus carboplatin and pemetrexed - DENALIFirst-line non-squamous NSCLCPhase 2Phase 2 data are due in late 2017 or in 201803/11/2016
OMED
12.41Tarextumab plus platinum chemotherapy and etoposideFirst-line extensive-stage small cell lung cancerPhase 2Phase 2 data due early 201703/11/2016
OMED
12.41Tarextumab ALPINE Pancreatic CancerPhase 2Company announced late January 2016 that they plan to unblind the trial following notice from the DSMB that suggests a low likelihood of a statistically significant benefit in overall survival. Subsequently, in February 2016 an announcement was made to discontine the trial02/09/2016
OMED
12.41Tarextumab - PINNACLE trialSmall cell lung cancer Phase 2Announced February 2016 that trial will continue following discussions with DSMB02/09/2016
OMER
13.25OMS721 Orticosteroid-dependent renal diseasesPhase 2Phase 2 dosing initiated April 201604/21/2016
OMER
13.25OMS721 Atypical hemolytic uremic syndrome (aHUS) Phase 3Phase 3 initiated March 201603/09/2016
OMER
13.25OMER824Huntington diseasePhase 2Phase 2 initiated Feb 2014. Trial was placed on hold due to preclinical concerns. To resume with with dosing limitations12/30/2015
OMER
13.25OmidriaCataract surgeryApprovedApproved June 2 201406/03/2014
OMER
13.25OMER824SchizophreniaPhase 2Phase 2 initiated Sept 2013. Data released Jan 201401/30/2014
ONCE
37.62SPK-CHMChoroideremia Phase 1/2Phase 1/2 dosing commenced 1Q 2015. Initial data due 2H 201603/10/2016
ONCE
37.62SPK-RPE65Inherited retinal dystrophiesPhase 3BLA filing due 2H 201603/10/2016
ONCS
1.88ImmunoPulse IL-12MelanomaPhase 2Phase 2 extension study enrolment completed March 2016. Data due 3Q 201603/03/2016
ONTX
0.43Oral Rigosertib and azacitidine 09-08 trialCancer - MDS and AMLPhase 2Interim data released December 2015. Phase 2 oral rigosertib + azacitidine in MDS updated data due 2Q 201603/30/2016
ONTX
0.43RigosertibCancer - MDS high riskPhase 3Original Phase 3 trial did not meet endpoint in Feb 2014. However, the company announced in Feb 2015 that following "subgroup analyses" and lack of current treatment options that they initiated a Phase 3 trial in December 201512/30/2015
ONTY
1.28ONT-380 + Herceptin and XelodaCancer - HER2-positive metastatic breast cancerPhase 2Phase 2 combination trial initiated February 201603/01/2016
OPHT
47.32FovistaWet-AMDPhase 3Phase 3 initial topline data due 4Q 201602/25/2016
OPHT
47.32ZimuraGeographic atrophyPhase 2/3Phase 2/3 trial initiated January 201601/28/2016
OPK
10.46RAYALDEESecondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) and vitamin D insufficiencyPDUFACRL March 29 2016 - citing third-party manufacturer issues. NDA refiled. New PDUFA date October 22 201604/28/2016
OPK
10.46hGH-CTPAdults - growth hormone deficiencyPhase 3Initiated Phase 3 Jun 2013. Phase 3 data 2H 201603/01/2016
OPK
10.46Factor VIIa-CTPHemophiliaPhase 2Phase 2 initiated February 201603/01/2016
OPK
10.46hGH-CTPChildren - growth hormone deficiencyPhase 3Phase 3 to be initiated 2H 201603/01/2016
OPK
10.46Neurokinin-1 (“NK-1”) - Rolapitant (partnered with TSRO)Prevention of chemotherapy induced nausea and vomiting, or CINV ApprovedApproved September 2 201512/30/2015
OPK
10.46Fermagate Tabletshyperphosphatemia in CKD patients on chronic hemodialysisPhase 3Phase 3 planned12/30/2015
OPXA
2.52Tovaxin (Tcelna)Secondary Progressive MS (SPMS)Phase 2bPhase 2b initiated Sept 2012. Top-line data early 4Q 201603/16/2016
OREX
0.47ContraveObesityApprovedApproved September 11 2014. CV outcomes trial terminated May 2015. New safety trial to be initiated later in 2015. Due to be completed in 2022.05/16/2015
ORMP
9.06ORMD-0801Type 2 DiabetesPhase 2Phase 2 top-line data due 2Q 201604/06/2016
ORMP
9.06ORMD-0901DiabetesPhase 1bPhase 1b data due 1Q 2016. Phase 2b trial to be initiated later in 201601/09/2016
ORPN
2.23CabalettaOculopharyngeal Muscular DystrophyPhase 2bPhase 2b to be initiated rather than initial plans for a Phase 3 trial12/30/2015
OSIR
5.75GrafixDiabetic Foot UlcersData released Aug 201308/14/2013
OTIC
13.96OTIPRIOAcute otitis externaPhase 3Phase 3 to be initiated 2Q 2016. Data due 4Q 201604/19/2016
OTIC
13.96OTO-104 AVERTS-1 and AVERTS-2Ménière's diseasePhase 3Second Phase 3 trial initiated March 2016. Data from both Phase 3 trials due 2H 201703/24/2016
OTIC
13.96OTIPRIOPediatric patients with acute otitis media with tympanostomy tubes (AOMT)Phase 2Second Phase 2 trial initiated March 2016. Due to be completed 2H 201603/08/2016
OTIC
13.96OTO-104 Pediatric patients undergoing cisplatin chemotherapyPhase 2Phase 2 to be initiated 2H 201603/08/2016
OTIC
13.96OTIPRIO (ciprofloxacin otic suspension) Ear Tube Placement SurgeryApprovedApproved December 11 201512/30/2015
OXGN
0.59CA4P Fosbretabulin Cancer - Platinum-Resistant Ovarian CancerPhase 2/3Phase 2/3 trial to commence by mid 201603/29/2016
OXGN
0.59CA4P Fosbretabulin Glioblastoma multiforme (GBM)Phase 2/3Announced early February 2016 that they will not proceed with Phase 2/3 trial in 2016. Previous guidance was for a 2H 2016 trial initiation02/04/2016
OXGN
0.59OXi4503 Acute myeloid leukemia (AML)Phase 1b/2Initiated October 2015. Data due 201612/31/2015
OXGN
0.59CA4P FosbretabulinCancer - gastrointestinal neuroendocrine tumorsPhase 2Phase 2 initiated Sept 2014. Interim data released October 2015. Full data due 2H 201612/31/2015
PBMD
1.08IMP321Cancer - breast cancerPhase 2b intiated December 2015Phase 2b initiated December 201512/31/2015
PBMD
1.08IMP321Phase 2Phase 2 to be initiated 201612/31/2015
PBMD
1.08CAN-003Cancer - ovarianPhase 2Phase 2 data released May 201512/31/2015
PBYI
29.90PB272 ExteNET trial Extended adjuvant HER2-positive early stage breast cancerPhase 3NDA filing due dealyed until mid 2016 03/29/2016
PBYI
29.90PB272 (NSABP FB-7)Neoadjuvant treatment for patients with HER2-positive breast cancer Phase 2Phase 2 addtional data due 2Q 201603/01/2016
PBYI
29.90PB272 SUMMITHER2 non-amplified breast cancer that has a HER2 mutationPhase 2Phase 2 data due 4Q 201603/01/2016
PBYI
29.90Neratinib monotherapy with high dose loperamide prophylaxisExtended adjuvant treatment of early stage HER2-positive breast cancerPhase 2Phase 2 addtional data due 2Q 201603/01/2016
PBYI
29.90PB272 HER2 non-amplified breast cancer that has a HER2 mutationPhase 2Phase 2 data due 4Q 201603/01/2016
PBYI
29.90PB272 Third-line HER2-positive metastatic breast cancerPhase 3Phase 3 data due 4Q 2016 or 1Q 201703/01/2016
PBYI
29.90PB272 HER2-negative breast cancer with HER2 mutation Phase 2Phase 2 data due mid 201603/01/2016
PBYI
29.90PB272 - basket trial HER2 mutated non-small cell lung cancerPhase 2Phase 2 third cohort expanded December 201512/31/2015
PBYI
29.90PB272 - NEfERTT trialHER2-positive breast cancer first linePhase 205/16/2015
PBYI
29.90PB272 plus temsirolimusFourth line HER2-positive metastatic breast cancerPhase 3Phase 3 planned05/16/2015
PCRX
50.51EXPARELSingle-dose injection femoral nerve block for total knee arthroplasty surgeryCRLPDUFA CRL March 2 2015. New Phase 3 trials to be initiated by the end of 201505/29/2015
PFNX
8.03PF582Biosimilar candidate to Lucentis for retinal diseasesPhase 1/2Phase 3 to be initiated 201612/31/2015
PGNX
5.45Oral RELISTORchronic painPDUFAPDUFA extended from April 19 to July 19 201604/05/2016
PGNX
5.45AzedraPheochromocytomaPhase 2bPivotal Phase 2 trial resumed January 2015 following suspension of trial in 2010 due to lack of funding. Enrolment completed by end of 2015.Top-line data due late 2016 or early 201703/12/2016
PGNX
5.451404Help visualize prostate cancer by targeting prostate specific membrane antigen (PSMA)Phase 3Phase 3 planned12/31/2015
PGNX
5.45Subcutaneous RELISTORchronic painApprovedApproved September 29 201410/01/2014
PGNX
5.45PSMA ADCCancer - metastatic castrate resistant prostate cancer (mCRPC).Phase 2Abstract released at American Society of Clinical Oncology's 2014 Genitourinary Cancers Symposium Meeting in San Francisco in January 28 2014.01/29/2014
PLX
0.83PRX-102Fabry diseasePhase 3Phase 3 trial to be initiated 1H 201603/09/2016
PPHM
0.37BavituximabCancer - Refractory NSCLCPhase 3Phase 3 SUNRISE trial initiated discontinued due to poor efficacy - February 201602/26/2016
PPHM
0.37Bavituximab plus carboplatin or paclitaxelCancer - advanced or metastatic HER2 negative breast cancerPhase 2Phase 2/3 initial data may be available in late 2016 or early 201701/12/2016
PPHM
0.37BavituximabCancer - triple negative breast cancer (TNBC)Phase 2Phase 2 to be initiated 2016, initial data may be available in late 2016 or early 201701/12/2016
PPHM
0.37Bavituximab and DurvalumabCancer - previously treated locally advanced or metastatic NSCLC. Phase 2Phase 2 to be initiated 1Q 2016, initial data may be available in late 2016 or early 201701/12/2016
PPHM
0.37Bavituximab plus carboplatin and paclitaxelCancer - front-line NSCLCPhase 2PFS disappointing data released Mar 2013. OS data showed not statistical meaningful improvement. Will not pursue Phase 306/28/2013
PRAN
3.85PBT-2Alzheimer'sPhase 2Phase 2 endpoint not met04/01/2014
PRAN
3.85PBT-2Huntington's DiseasePhase 2Data released Feb 201402/19/2014
PRQR
5.25QR-010 Cystic Fibrosis Phase 1bPhase 1b enrolment started June 2015. Data due mid-late 201602/18/2016
PRTA
43.87NEOD001 VITALAL AmyloidosisPhase 3Phase 3 enrolment to be completed by 2Q 201702/19/2016
PRTA
43.87NEOD001 PRONTOPreviously-treated patients with AL amyloidosis and persistent cardiac dysfunctionPhase 2bPhase 2b data due late 2017 or early 201802/19/2016
PRTA
43.87NEOD001AL amyloidosis and persistent organ dysfunctionPhase 1/2Data expected 2Q 201612/31/2015
PRTK
13.62OmadacyclineAcute bacterial skin and skin structure infections (ABSSSI)Phase 3Phase 3 topline data due end of June 201605/03/2016
PRTK
13.62OmadacyclineCommunity-acquired bacterial pneumonia (CABP)Phase 3Phase 3 initiated November 2015. Data are due 3Q 201705/03/2016
PRTK
13.62SarecyclineSevere acne vulgarisPhase 3Phase 3 data due 201612/31/2015
PRTO
9.70Vonapanitase (PRT-201) PATENCY-1 Chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF)Phase 3Phase 3 initiated July 2014. Data due December 201603/15/2016
PRTO
9.70Vonapanitase (PRT-201) PATENCY-2 Chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF)Phase 3Phase 3 enrolment to be completed 1Q 201703/15/2016
PSDV
2.94MedidurPosterior uveitisPhase 3Phase 3 data released December 2015. NDA planned for 1H or mid 201704/23/2016
PSDV
2.94IluvienDiabetic macular edemaApprovedApproved Sept 26 201409/28/2014
PSTI
1.79PLX-PAD (stem cells)Intermittent claudication, or ICPhase 2Phase 2 put on clinical hold Jun 2013. Lifted Sept 2013. Ongoing12/31/2015
PTCT
7.75Translarna Nonsense mutation cystic fibrosisPhase 3Phase 3 initiated July 2014. Enrolment completed November 2015. Data due early 201703/01/2016
PTCT
7.75TranslarnaDuchenne muscular dystrophy caused by nonsense mutations (nmDMD)RTFReceived a Refusal to File letter for their NDA filing - February 23 201602/24/2016
PTCT
7.75RG7800Spinal Muscular Atrophy (SMAPhase 1/2Phase 1/2 initiated November 201411/22/2014
PTIE
2.45RemoxyChronic painPDUFAPDUFA September 25 201604/13/2016
PTLA
24.45Betrixaban (The APEX Study)Venous thromboembolism (VTE) PreventionPhase 3Phase 3 data released late March 2016 did not show superiority against standard of care. Company still intends to file NDA in 201603/25/2016
PTLA
24.45Andexanet alfaFactor Xa inhibitor reversal agentPDUFAPDUFA date August 17 2016 under priority review02/18/2016
PTLA
24.45Cerdulatinib (PRT2070)Refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia.Phase 1/2 Ongoing12/31/2015
PTN
0.56Bremelanotidefemale sexual dysfunction (FSD)Phase 3Phase 3 initiated Dec 2014. Enrolment completed December 2015. Top-line data due 3Q 201601/01/2016
PTN
0.56PL-3994Heart failurePhase 2aPhase 2a planned01/01/2016
PTX
0.98TREXIMETAdolescent migraine patientsApprovedApproved May 15 201505/16/2015
PULM
2.93PUR0200COPDPhase 1bPhase 1b complete01/02/2016
PVCT
0.44PV-10Cancer - MelanomaPhase 3Phase 3 dosing commenced 2015 with market update January 201601/13/2016
PVCT
0.44PH-10PsoriasisPhase 3Phase 3 to be initiated mid 201601/01/2016
PVCT
0.44PH-10Atopic dermatitisPhase 3Phase 3 to be initiated mid 201601/01/2016
QLTI
1.53QLT091001Impaired Dark Adaptation (IDA)Phase 2aPhase 2a data released December 201412/07/2014
QURE
12.98AMT-060hemophilia BPhase 1/2Phase 1/2 preliminary data released early January 2016. Data from first five patients due 2Q 201604/05/2016
QURE
12.98AMT-060Sanfilippo BPhase 1/2Phase 1/2 30 month follow up data due early 201704/05/2016
RARE
69.46KRN23Tumor-induced osteomalacia (TIO)Phase 2Interim data released April 201604/22/2016
RARE
69.46KRN23X-Linked Hypophosphatemia (XLH) - pediatric Phase 3Phase 3 to be initiated mid 201602/26/2016
RARE
69.46rhGUS Mucopolysaccharidosis 7 (MPS 7) Phase 3Announced Dec 15 that a Phase 3 trial has been initiated. Enrolment completed June 2015. Data due mid 2016.02/26/2016
RARE
69.46UX007 (triheptanoin)Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD)Phase 2Phase 2 interim data released October 2015. Further data due 2H 2016. Phase 3 planned for 201702/26/2016
RARE
69.46UX007 (triheptanoin)Glucose Transporter Type-1 Deficiency Syndrome (Glut1 DS)Phase 2Phase 2 initiated March 2014. Data due 2H 201602/26/2016
RARE
69.46UX007 (triheptanoin)Glut1 DS patients with the movement disorder phenotypePhase 3Phase 3 to be initiated 2H 201602/26/2016
RARE
69.46Aceneuramic acid extended release (Ace-ER)GNE MyopathyPhase 3Phase 3 data due 201702/26/2016
RARE
69.46KRN23X-Linked Hypophosphatemia (XLH) - adultPhase 3Phase 3 initiated December 201501/01/2016
RDHL
12.78RHB-104 MAP USCrohn’s diseasePhase 3Phase 3 interim data due 2H 201604/19/2016
RDHL
12.78RHB-105 H. pyloriPhase 3Phase 3 final data released March 2016. Additional Phase 3 trial planned for 2H 201604/19/2016
RDHL
12.78BEKINDA -GUARDGastroenteritis Phase 3Phase 3 top-line data due 2H 201604/19/2016
RDHL
12.78RHB-104 CEASE-MSMultiple sclerosisPhase 2aPhase 2a interim data released March 201604/01/2016
RDHL
12.78BEKINDA IBS-DPhase 2Phase 2 to be initiated around March or April 201603/09/2016
RDHL
12.78YELIVARefractory/relapsed diffuse large B-cell lymphoma (DLBCL)Phase 1/2Phase 1/2 ongoing03/09/2016
RDHL
12.78YELIVARefractory or relapsed multiple myelomaPhase 1/2Phase 1/2 trial to be initiated 2Q 201603/09/2016
RDHL
12.78YELIVAMucositis in cancer patientsPhase 2Phase 2 to be initiated 2H 201603/09/2016
RDUS
36.64Abaloparatide-SC OsteoporosisNDA filingAnnounced Marc 30 2016 that their NDA filing of Abaloparatide-SC for Osteoporosis has been filed03/31/2016
REPH
6.83Intravenous (IV) meloxicam Acute pain following bunionectomy surgeryPhase 3Two Phase 3 trial initiated January 2016. Top-line data due by end of 201603/25/2016
RGLS
5.93RG-101 and GSK2878175HCVPhase 2Phase 2 interim efficacy and safety data due by end of 201605/03/2016
RGLS
5.93RG-101 with multiple approved DAAsHCVPhase 2Additional Phase 2 interim data released April 2016. Primary endpoint data due late 2Q 201604/16/2016
RGNX
10.91RGX-501Homozygous familial hypercholesterolemia (HoFH)Phase 1/2Phase 1/2 to be initiated 1H 201601/08/2016
RGNX
10.91RGX-111 Mucopolysaccharidosis Type I (MPS I)Phase 1/2Phase 1/2 to be initiated 2H 201601/08/2016
RIGL
2.85Fostamatinib Immune Thrombocytopenic Purpura (ITP)Phase 3Phase 3 initiated July 2014. Enrolment of first Phase 3 trial completed January 2016. Second trial enrolment completed March 2016. Data from the first trial due mid 2016 with data from the second trial due shortly after04/02/2016
RIGL
2.85FostamatinibIgA nephropathyPhase 2Phase 2 data due by the end of 201603/09/2016
RIGL
2.85FostamatinibAutoimmune hemolytic anemia (AIHA)Phase 2Phase 2 data from first of two stages due by end of 201603/09/2016
RIGL
2.85R348Chronic dry eye disease - as a result of patients with acute or chronic graft vs. host disease (GvHD)Phase 2Phase 2 data due 201601/01/2016
RLYP
17.82VeltassaHyperkalemiaApprovedApproved October 21 2015. sNDA filing planned for mid 201602/25/2016
RMTI
9.22Soluble Ferric PyrophosphateIron deficiencyApprovedApproved Jan 26 201501/27/2015
RNN
0.30RX-3117Relapsed and refractory pancreatic cancer and advanced bladder cancer. Phase 1b/2 Phase 1b/2 trial initiated March 201603/30/2016
RNN
0.30ArchexinCancer - renal cell carcinomaPhase 2Phase 2a second stage enrolment commenced February 201602/09/2016
RPRX
2.34ProellexUterine fibroids (vaginal treatment)Phase 2bPhase 2b data released April 201604/13/2016
RPRX
2.34EnclomipheneSecondary hypogonadismPhase 2Phase 2 3-month and 6-month data due summer of 201602/17/2016
RPRX
2.34EnclomipheneSecondary hypogonadismCRLCRL November 30 2015. Announced early January 2016 that they plan to meet with the FDA in 2016 to discuss CRL. MAA to be submitted mid-201601/05/2016
RPRX
2.34ProellexEndometriosisPhase 2Phase 2 data due 3Q 201601/02/2016
RPRX
2.34ProellexUterine fibroids (oral treatment)Phase 2bPhase 2b initiated Dec 201401/01/2015
RPTP
4.95RP 103Mitochondrial disorders including Leigh syndromePhase 2Phase 2 second interim analysis due 2Q 201602/26/2016
RPTP
4.95MP-376 BronchiectasisPhase 2Phase 2 to be initiated 201602/26/2016
RPTP
4.95MP-376 Cystic fibrosisPlans to meet with FDA 2Q to discuss NDA filing02/26/2016
RPTP
4.95RP 103Huntington's DiseasePhase 2Data released December 201501/02/2016
RPTP
4.95RP 103Non-alcoholic fatty liver disease (NAFLD) in childrenPhase 2bPhase 2b endpoints not met September 201501/02/2016
RPTP
4.95PROCYSBICystinosisApprovedApproved08/09/2013
RTRX
14.26Sparsentan (DUET) Focal segmental glomerulosclerosis (FSGS)Phase 2/3Enrolment continues01/02/2016
RTRX
14.26CholbamRare Bile Acid Synthesis Disorders ApprovedApproved Mar 18 201503/21/2015
RTTR
1.72RP-G28Lactose intolerancePhase 2/3Phase 2/3 initiated March 2016. Top-line data are due early 201703/15/2016
RVNC
18.73RT001 - REALISE 1Lateral Canthal (Crow’s Feet) LinesPhase 3Phase 3 interim data due 2Q 2016. 03/03/2016
RVNC
18.73RT001 HyperhidrosisPhase 2Preliminary data released December 2015. Trial to be completed 1Q 2016. Larger Phase 2 trial planned for 2H 201603/03/2016
RVNC
18.73RT002Moderate to severe glabellar (frown) linesPhase 2Phase 2 interim data released October 2015. Final data to be released 1H 2016. Phase 3 to be initiated 2H 201603/03/2016
RVNC
18.73RT002Cervical dystoniaPhase 2Phase 2 initiated September 2015. Interim data due 1H 201603/03/2016
RVX
18.37RVX-208 Coronary artery disease (CAD) and type 2 diabetes mellitus (DM)Phase 3Phase 3 initiated November 201501/02/2016
RXDX
7.15TaladegibCancer - advanced basal cell carcinomaPhase 2One or more pivotal Phase 2 trials in 201601/12/2016
RXDX
7.15STARTRK-2 entrectinibCancer - solid tumorsPhase 2Phase 2 trial initiated September 201501/02/2016
RXII
2.22Samcyprone - RXI-SCP-1502Cutaneous wartsPhase 2Phase 2 preliminary data due 2H 201603/31/2016
RXII
2.22RXI-109-1501Retinal scarringPhase 1/2Phase 2 preliminary data due 2H 201603/31/2016
RXII
2.22RXI-109Suppressing recurrence of hypertrophic scars after bilateral scar revision surgery in the breast areaPhase 2aPhase 2a interim data released October 201501/02/2016
RXII
2.22 (RXI-109-1401)Recurrence of keloids after keloid revision surgeryPhase 2aPhase 2 initiated April 2014. Enrolment complete. Data collection ongoing as of May 201505/16/2015
RXII
2.22(RXI-109-1301)Anti-scarringPhase 2Phase 2 initiated November 2013. First data released Sept 2014. Announced completion of enrolment Dec 17 201412/18/2014
SAGE
38.22SAGE-547SRSEPhase 3Phase 3 data due 2H 201602/25/2016
SAGE
38.22SAGE-547Postpartum DepressionPhase 2Phase 2 proof of concept initated November 201501/02/2016
SAGE
38.22SAGE-547Essential tremorPhase 2Phase 2 proof of concept data released September 201501/02/2016
SCMP
10.56CobiprostoneOral MucositisPhase 2Phase 2a initiated September 2015. Futility analysis due 2H 201604/20/2016
SCMP
10.56Cobiprostone proton pump inhibitor (PPI)-refractory non-erosive reflux disease (NERD) or symptomatic gastroesophageal reflux disease (sGERD)Phase 2Phase 2a trial did not meet endpoints04/20/2016
SCMP
10.56LubiprostonePediatric functional constipationPhase 3Phase 3 initiated Dec 2013, ongoing01/02/2016
SCYX
3.91SCY-078Vulvovaginal candidiasis (VVC)Phase 2Phase 2 initiated December 2015. Topline data due 2Q 201603/08/2016
SCYX
3.91SCY-078Serious and life-threatening invasive fungal infectionsPhase 2Phase 2 topline data due 2Q 201603/08/2016
SGEN
36.37ADCETRIS in combination with chemotherapy ECHELON-1 Frontline Hodgkin lymphomaPhase 3Phase 3 data due between 2017 and mid-201804/29/2016
SGEN
36.37ADCETRISCancer - ALCANZA trial for relapsed CD30-positive cutaneous T-cell lymphomaPhase 3Phase 3 data due 3Q 201604/29/2016
SGEN
36.37Vadastuximab Talirine (SGN-CD33A) Cancer - acute myeloid leukemia AMLPhase 3Phase 3 to be initiated by 3Q 201604/29/2016
SGEN
36.37SGN-CD19A Cancer - frontline DLBCL Phase 2Phase 2 trial to be initiated 1H 201604/29/2016
SGEN
36.37ADCETRIS in combination with chemotherapy - ECHELON-2Cancer - frontline CD30-positive mature T-cell lymphomas Phase 3Phase 3 enrolment to be completed in 2016. Data are due 2017 or 201804/29/2016
SGEN
36.37ADCETRIS in combination with bendamustineCancer - second-line HLPhase 2Phase 2 ongoing01/02/2016
SGEN
36.37ADCETRIS - AETHERACancer - post-transplant Hodgkin lymphoma (HL) patientsApprovedApproved August 18, 2015 under priority review01/02/2016
SGMO
6.48SB-BCLmR-HSPCbeta-thalassemiaPhase 1/2Phase 1/2 data presented at ASH 201502/09/2016
SGMO
6.48SB-728-1401HIV/AIDSPhase 2Data presented Dec 201501/02/2016
SGMO
6.48SB-728-1101HIV/AIDSPhase 2Data presented Dec 201501/02/2016
SGYP
3.31PlecanatideChronic idiopathic constipation (CIC)PDUFAPDUFA January 29 201704/20/2016
SGYP
3.31PlecanatideConstipation-predominant irritable bowel syndrome (IBS-C).Phase 3Phase 3 data due 1H and 2H 201602/26/2016
SGYP
3.31DolcanatideMild-to-moderate ulcerative colitisPhase 1bPhase 1b data released January 201601/12/2016
SGYP
3.31SP-333Opioid-induced constipation (OIC)Phase 2Phase 2 initiated Oct 2013. Enrollment completed July 2014. Data released Nov 201411/22/2014
SMMT
9.76EzutromidDuchenne muscular dystrophyPhase 2Phase 2 trial to be initiated 3Q 201604/27/2016
SNGX
0.87SGX301 (synthetic hypericin)Cutaneous T-Cell Lymphoma (CTCL)Phase 3Phase 3 enrolment commenced December 2015 with results due 2H 201603/25/2016
SNGX
0.87SGX942 (dusquetide) Oral Mucositis in Patients with Head & Neck CancerPhase 2Preliminary results from Phase 2 trial released December 2015. Phase 2/3 trial planned01/27/2016
SNGX
0.87SGX203 Pediatric Crohn’s DiseasePhase 3Phase 3 initiation due 1H 2016 - pending funding01/27/2016
SNSS
0.50Vosaroxin in combination with cytarabine - VITAL Cancer - previously untreated acute myeloid leukemia (AML)Phase 2Phase 2 investigator sponosored trial initiated March 201603/25/2016
SNSS
0.50Vosaroxin in combination with decitabineOlder patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS)Phase 2Phase 2 updated data released at ASH 201501/02/2016
SNSS
0.50VoreloxinCancer - Acute myeloid leukemia AMLPhase 3Endpoint not met Oct 2014. Additional trials required. 01/02/2016
SNTA
0.41Ganetespib AML-LI trialCancer - AMLPhase 2/3Phase 3 ongoing01/02/2016
SNTA
0.41Ganetespib AML-18 trialCancer - AMLPhase 2/3Initiated in early 2015. Enrolling.01/02/2016
SNTA
0.41Ganetespib - I-SPY 2 TRIAL Cancer - breastPhase 2Phase 2 initiated Oct 2014. Ongoing01/02/2016
SNTA
0.41STA-9090 Ganetespib - GALAXY-2Cancer - NSCLCPhase 3Phase 3 trial terminated due to poor effiacy01/02/2016
SNTA
0.41Ganetespib and paclitaxel - GANNET53Cancer - ovarianPhase 2Phase 2 initiated June 201506/06/2015
SPHS
1.34PRX302Localized low to intermediate risk prostate cancerPhase 2Phase 2 initiated May 2015. Initial data released late January 2016. Final data due 2Q 201603/24/2016
SPHS
1.34PRX302Benign prostatic hyperplasia Phase 3Phase 3 primary endpoints met - November 201501/02/2016
SPPI
7.30EVOMELA (melphalan) for InjectionConditioning treatment prior to autologous stem cell transplant for patients with multiple myelomaApprovedApproved March 15 201603/16/2016
SPPI
7.30PoziotinibBreast cancer Phase 2Phase 2 initiated March 201603/08/2016
SPPI
7.30ApaziquoneCancer - BladderPDUFAFailed to meet primary endpoint in Phase 3 trial - Apr 2012. PDUFA date December 11 2016. Advisory Committee Meeting likely to be scheduled.02/21/2016
SPPI
7.30SPI-2012 (also referred to as "LAPS-GCSF")Chemotherapy-Induced NeutropeniaPhase 3Phase 3 trial began enrolment January 2016. Enrolment expected to be completed in 201701/30/2016
SPPI
7.30BelinostatCancer - Peripheral T-Cell LymphomaApprovedApproved July 3 201407/04/2014
SRNE
6.98CynviloqCancerBioequivalence trialData analysis suggests that Cynviloq meets the bioequivalence (BE) criteria for both total and unbound paclitaxel05/16/2015
SRPT
17.92EteplirsenDuchenne muscular dystrophyPDUFAPDUFA date extended to May 26 2016. Advisory Committee Meeting April 25 2016 voted in key questions 6-7 and 3-7 both against eteplirsen04/26/2016
SSH
0.65C-Pulse Heart Assist System - COUNTER HFModerate to severe heart failurePivotal Announced early March that enrolment paused due to safety concerns. Resumed late May 2015. Enrolling01/02/2016
STEM
0.31HuCNS-SC cellsSpinal cord injury Phase 2Phase 2 trial initiated Oct 2014. Interim data presented April 2016. Phase 2 data final due 201704/19/2016
STEM
0.31HuCNS-SC cellsAge-Related Macular DegenerationPhase 1/2Development suspended. Funding from partnership required for future development01/02/2016
STML
5.45SL-401Cancer- adult relapsed or refractory acute myeloid leukemia (AML) Phase 1/2Phase 1/2 open01/02/2016
STML
5.45SL-401High Risk Myeloproliferative NeoplasmsPhase 1/2Phase 1/2 open01/02/2016
STML
5.45SL-701Cancer - second line glioblastoma (GBM)Phase 1/2Phase 1/2 open01/02/2016
STML
5.45SL-401Cancer - blastic plasmacytoid dendritic cell neoplasm (BPDCN)Phase 2b pivotalPhase 2b initial data presented at ASH 201501/02/2016
SUPN
16.87SPN-812ADHDPhase 2bPhase 2b commenced 4Q 201501/02/2016
SUPN
16.87SPN-810Impulsive Aggression in ADHDPhase 3Phase 3 commenced 3Q 201501/02/2016
SUPN
16.87Trokendi Migraine PDUFAPDUFA 2Q 2016 for sNDA of Trokendi01/02/2016
SUPN
16.87Trokendi EpilepsyApprovedApproved Aug 19 201308/22/2013
SYN
2.22SYN-010Constipation-Predominant Irritable Bowel Syndrome (C-IBS)Phase 2Second Phase 2 trial commenced October 2015. 12 week data met endpoints. Phase 3 planned for 2H 201603/11/2016
SYN
2.22 SYN-004C. difficile InfectionPhase 2bPhase 2b initiated September 2015. Topline results from the second Phase 2a trial + interim analysis from Phase 2b trial due 1H 2016. Phase 3 trial to be initiated 2H 201603/11/2016
SYN
2.22TrimestaRelapsing-remitting MS in womenPhase 2License terminated following lack of efficacy shown February 201602/03/2016
SYN
2.22FlupirtineFibromyalgiaPhase 2Pending. Partner Meda has received the go-ahead from the FDA to conduct a Phase 2 proof of concept trial04/27/2013
TBPH
21.20RevefenacinCOPDPhase 3Phase 3 data due 3Q 201603/10/2016
TBPH
21.20TD-4208Chronic obstructive pulmonary disease (COPDPhase 3Phase 3 data due in 201601/03/2016
TBPH
21.20Velusetrag (TD-5108)GastroparesisPhase 2Phase 2 initiated mid March 2015. Data due 201701/02/2016
TBPH
21.20TD-6450Hepatitis C virus (HCV) Phase 2aPhase 2a data due 201601/02/2016
TBPH
21.20TelavancinBacteremia Phase 3Phase 3 data due 2017 01/02/2016
TBPH
21.20TelavancinStaphylococcus aureus bacteremiaPhase 3Phase 3 first patient enrolled late February 2015. Data due 201701/02/2016
TBRA
8.13Cenicriviroc (CVC) - ORION studyObese subjects with prediabetes or Type 2 diabetes mellitus and suspected NALFD.Phase 2Phase 2a interim analysis released May 201605/03/2016
TBRA
8.13Cenicriviroc (CVC) - CENTAUR studyNon-alcoholic Steatohepatitis (NASH)Phase 2bPhase 2b data due 3Q 201605/03/2016
TCON
7.30TRC105 Renal Cell CarcinomaPhase 2Phase 2 initiated Dec 2014. Phase 2 data due late 201602/19/2016
TCON
7.30TRC105 AngiosarcomaPhase 2Phase 3 to be initiated 2H 201602/19/2016
TCON
7.30TRC105Soft tissue sarcomasPhase 2Phase 2 data due 1H 201602/19/2016
TCON
7.30TRC102 and TemodarGlioblastomaPhase 2Phase 2 trial initiated January 201601/28/2016
TCON
7.30TRC105 and NexavarHepatocellular carcinomaPhase 2Phase 2 data due 201701/03/2016
TCON
7.30TRC105 and TemodarGlioblastomaPhase 2Phase 2 data due 201601/03/2016
TCON
7.30TRC105Breast CancerPhase 2Phase 2 planned for 2015. Data due 201701/03/2016
TCON
7.30TRC102MesotheliomaPhase 2Phase 2 initiated October 201501/03/2016
TENX
7.30LevosimendanReduce the incidence of low cardiac output syndrome during cardiac surgeryPhase 3Phase 3 top line data due 4Q 2016. Interim analysis due 2Q 201603/17/2016
TGTX
9.28TG-1101 and TGR-1202 - UNITY-CLL studyChronic Lymphocytic Leukemia (CLL) and non-Hodgkin's Lymphoma (NHL)Phase 3Phase 3 enrolment to commence in 201601/20/2016
TGTX
9.28TG-1101 and IMBRUVICA (GENUINE trial)Chronic Lymphocytic Leukemia (CLL) Phase 3Phase 3 enrolment due to be completed by end of 201601/20/2016
TGTX
9.28TGR-1202 + TG-1101 + Pembrolizumab Chronic Lymphocytic Leukemia (CLL)Phase 1/2Phase 1/2 trial initiated Sep 2015. 01/03/2016
THERF
1.77Ibalizumab Multi-drug resistant HIV-1Phase 3Phase 3 top-line data due end of May 201604/28/2016
THLD
0.44TarloxotinibCancer - Recurrent or Metastatic Squamous Cell Carcinomas of the Head and Neck or SkinPhase 2Phase 2 initiated August 2015. Prelim data due mid 201603/11/2016
THLD
0.44TarloxotinibCancer - mutant EGFR-positive, T790M-negative advanced non-small cell lung cancerPhase 2Phase 2 initiated August 2015. Prelim data due mid 201603/11/2016
THLD
0.44EvofosfamideCancer - second line NSCLCPhase 2Independent Data Safety Monitoring Board conducted unlikely to reach primary endpoint - trial closed01/12/2016
THLD
0.44Evofosfamide MAESTROCancer - PancreaticPhase 3Phase 3 endpoints not met01/03/2016
THLD
0.44EvofosfamideCancer - soft tissue sarcoma (406 trial)Phase 3Phase 3 endpoints not met01/03/2016
TKAI
7.25Galeterone - ARMOR2Xtandi (enzalutamide) refractory metastatic castration-resistant prostate cancer (mCRPC) Phase 2Phase 2 expansion arm initiated dosing March 201603/31/2016
TKAI
7.25Galeterone - ARMOR3-SVCancer - castration-resistant prostate cancer (CRPC)Phase 3Enrolment to be completed 2H 2016. Topline data due mid 201703/11/2016
TLOG
0.27BirinapantMyelodysplastic syndromes, or MDSPhase 2bPhase 2b interim data early January 2016 did not meet primary endpoint. Trial terminated01/07/2016
TLOG
0.27SHAPECancer - Cutaneous T-Cell LymphomaPhase 2Phase 2 trial initiated mid-Dec 2014. Interim data released early January 201601/07/2016
TNXP
2.53TNX-102 SL Fibromyalgia Phase 3Phase 3 enrolment completed May 2016. Data due 3Q 201605/03/2016
TNXP
2.53TNX-201Episodic tension-type headachePhase 2Phase 2 data released February 2016 did not meet primary endpoint02/17/2016
TNXP
2.53TNX-102 SL PTSD - for the treatment of post-traumatic stress disorderPhase 2Phase 2 enrolment completed December 2015. Data due 2Q 201601/03/2016
TRVN
7.63Oliceridine (TRV130)Moderate to severe acute painPhase 3Phase 3 APOLLO-1 and APOLLO-2 to start 2Q 2016, with top-line data 1Q 2017.05/03/2016
TRVN
7.63TRV027 - BLAST-AHFAcute heart failurePhase 2bTopline data to be presented May 21 2016 at Heart Failure 2016 Conference04/16/2016
TSRO
41.92Rolapitant - intravenous (IV)Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patientsNDA filingNoted on March 14 2016 that NDA has been submitted03/15/2016
TSRO
41.92Niraparib - BRAVOCancer - breastPhase 3Phase 3 initiated 1Q 2014. Enrolling through 201602/26/2016
TSRO
41.92Niraparib - NOVA (Niraparib Ovarian) Cancer - ovarianPhase 3Phase 3 data due 2Q 2016.02/26/2016
TSRO
41.92Niraparib - (QUADRA trial) Cancer - ovarianPhase 2Phase 2 data due 2Q 2016.02/26/2016
TSRO
41.92RolapitantPrevention of chemotherapy induced nausea and vomiting, or CINV in HEC patientsApprovedPDUFA Sept 2 201501/03/2016
TTHI
0.78TT701Symptoms of androgen deficiency in men with prostate cancerPhase 2Phase 2 dosing commenced April 201604/26/2016
TTHI
0.78TT401 (LY2944876)Type 2 diabetesPhase 2Phase 2 initiated May 2014. Enrolment completed February 2015. Data released February 2016. Company announced April 2016 that partner Lilly will not advance drug into Phase 3 development04/19/2016
TTHI
0.78ELND005Alzheimer's DiseasePhase 2Phase 2/3 trial did not meet primary endpoint - June 2015. Expects to follow through with Phase 3 trial01/03/2016
TTHI
0.78ELND005Bipolar I Disorder (BPD 1)Phase 2Phase 2 data released Nov 2014 - development terminated02/12/2015
TTNP
6.10ProbuphineOpioid dependencePDUFAPDUFA February 27 2016 extended to May 27 2016. Psychopharmacologic Drugs Advisory Committee (PDAC) on January 12 2016 voted 12 to 5 in favor of approving Probuphin02/21/2016
TTPH
5.55Eravacycline (TP-434)cUTI - complicated urinary tract infectionsPhase 3Phase 3 trial did not meet endpoints September 2015. Phase 3 planned for 3Q 2016. Regulatory update expected 1Q 201603/24/2016
TTPH
5.55Eravacycline (TP-434)cIAI (complicated intra-abdominal infections)Phase 3Announced Dec 17, 2014 that their Phase 3 trial met endpoints03/07/2015
UTHR
110.19Oral treprostinilPulmonary arterial hypertension (PAH)ApprovedApproved Dec 20 201312/21/2013
VBLT
3.26VB-111Cancer - recurrent glioblastoma, or rGBMPhase 2Phase 3 initiated mid 2015. Interim data due 1H 201703/30/2016
VBLT
3.26VB-201Ulcerative colitisPhase 2Phase 2 failed to meet endpoints - Feb 2015 data02/21/2015
VBLT
3.26VB-201Psoriasis Phase 2Phase 2 failed to meet endpoints - Feb 2015 data02/21/2015
VCEL
3.01ixmyelocel-TStem cells - Dilated Cardiomyopathy Phase 2bPhase 2b topline data released March 2016. Full data released April 201604/05/2016
VCEL
3.01MACI Focal chondral cartilage defects in the knee.PDUFAPDUFA date January 3 201703/08/2016
VICL
0.38ASP0113 VaccineHematopoietic cell transplant recipientsPhase 3Initiated Phase 3 Jun 2013. Enrollment due to be completed 3Q 2016. Topline data due 4Q 201703/15/2016
VICL
0.38ASP0113 VaccineKidney transplant recipientsPhase 2Initiated Phase 2 Dec 2013. Data due 3Q 201603/15/2016
VICL
0.38Vaxfectin-formulated therapeutic vaccineHerpesPhase 1/2Data did not meet primary endpoint06/29/2015
VKTX
1.31VK2809HypercholesterolemiaPhase 2Phase 2 trial to commence mid 201604/12/2016
VKTX
1.31VK5211Accute Hip FracturePhase 2Phase 2 to be completed by end of 201601/08/2016
VNDA
8.89HETLIOZ (tasimelteon)Jet Lag DisorderPhase 3Phase 3 to be initiated 2H 201602/11/2016
VNDA
8.89HETLIOZ (tasimelteon)Smith-Magenis SyndromePhase 3Phase 3 to be initiated 2H 201602/11/2016
VNDA
8.89Fanapt Supplemental New Drug Application (sNDA) as a maintenance treatment of schizophrenia in adults.PDUFAPDUFA May 27 201601/01/2016
VNDA
8.89VLY-686 (tradipitant)Chronic pruritusPhase 2Phase 2 data released March 2015 FAIL - no statistical difference from placebo. Further Phase 2 trial planned 05/07/2015
VNDA
8.89HETLIOZ (tasimelteon)InsomniaApprovedApproved Jan 31 2014. 02/02/2014
VRTX
83.00VX-661Two Copies of the F508del MutationPhase 3Phase 3 trial to complete enrollment in mid-2016, and data are expected by early 2017.04/28/2016
VRTX
83.00VX-661Cystic fibrosis - one copy of the F508del mutation and a second mutation that results in a gating mutation Phase 3Phase 3 enrolment to be completed by the end of 2016 or early 201704/28/2016
VRTX
83.00VX-661Cystic fibrosis - one copy of the F508del mutation and a second mutation that results in minimal CFTR FunctionPhase 3Phase 3 interim futility analysis of efficacy data due 3Q 201604/28/2016
VRTX
83.00VX-661Cystic fibrosis - one copy of the F508del mutation and a second mutation that results in residual CFTR functionPhase 3Phase 3 enrolment to be completed 2H 201604/28/2016
VRTX
83.00VX-150OsteoarthritisPhase 2Phase 2 enrolment expected to be completed by the end or 201604/28/2016
VRTX
83.00KALYDECO (ivacaftor)Cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations.CRLCRL issued February 5, 201602/06/2016
VRTX
83.00ORKAMBICystic fibrosis (CF) ages 6-11 who have F508del mutation Phase 3Announced late January 2016 that Phase 3 data met primary endpoint and sNDA filing due 2Q 201601/28/2016
VRTX
83.00Lumacaftor and ivacaftorCystic fibrosis (CF) ages 12 and older who have two copies of the F508del mutation ApprovedApproved July 2 2015 01/01/2016
VRTX
83.00ALYDECO (ivacaftor)Children ages 2 to 5 with cystic fibrosis who have the G551D or one of the eight additional gating mutationsApprovedApproved March 17 201503/22/2015
VSAR
9.10VRS-317 VELOCITYGrowth hormone deficiency, or GHD - pediatricPhase 3Phase 3 initiated early Jan 2015. Partial clinical hold lifted July 2015. 6-month data due by the end of 2016 and top line data by mid-201701/03/2016
VSAR
9.10VRS-317 VITALGrowth hormone deficiency, or GHD - adultPhase 2/3Phase 2 trial initiated September 2015. Data due 3Q 201601/03/2016
VSTM
1.56VS-6063Mesothelioma prior to surgeryPhase 2Phase 2 interim analysis showed lack of efficacy. Trial stopped. September 201501/03/2016
VSTM
1.56VS-6063KRAS-mutated NSCLCPhase 2Phase 2 ongoing, Data released September 201501/03/2016
VTAE
7.37VTP-43742PsoriasisPhase 2aPhase 2a postive data released mid March 201603/17/2016
VTAE
7.37VTP-38543Atopic dermatitisPhase 2Phase 2 initiated December 2015. Topline data due 2H 201603/04/2016
VTAE
7.37VTP-34072Type 2 DiabetesPhase 2Phase 2 endpoints not met. December 201501/03/2016
VTL
8.44VTI-308Alcohol-induced liver decompensation, or AILDPhase 3Phase 3 VTI-208 trial fails. New VTI-308 trial to be initiated 1H 2016. Data due mid 201801/03/2016
VTL
8.44ELAD (VTI-210)Severe acute alcoholic hepatitisPhase 3Terminated September 2015 in order to reduce costs01/03/2016
VTL
8.44ELAD (VTI-212)Fulminant hepatic failure, or FHF, or surgery-induced acute liver failure, or SILFPhase 2/3Terminated September 2015 in order to reduce costs01/03/2016
VTVT
8.44TTP399 - AGATAType 2 DiabetesPhase 2bPhase 2 enrolment completed February 2016. Data due mid-201602/10/2016
VTVT
8.44TTP273 - LOGRAType 2 DiabetesPhase 2Phase 2 initiated January 2016. Topline results are expected at the end of 2016.02/10/2016
VTVT
8.44Azeliragon - STEADFAST Mild Alzheimer’s diseasePhase 3Phase 3 initiated 2Q 201501/08/2016
VVUS
1.58AvanafilErectile dysfunctionApprovedApproved Apr 27 2012. sNDA label change also approved 17 Sept 201409/18/2014
VYGR
12.48VY-AADC01 Advanced Parkinson’s diseasePhase 1b Phase 1b trial onoging. Topline data due 4Q 201603/18/2016
WINT
2.51AerosurfRespiratory Distress Syndrome Phase 2bPhase 2b enrolment to be completed by the end of 2016. Top-line data due 1Q 2017.03/25/2016
WINT
2.51AerosurfRespiratory Distress Syndrome Phase 2aPhase 2a data due 3Q 201603/25/2016
XENE
7.04XEN801AcnePhase 2Phase 2 initiated February 2016. Data due 4Q 201603/09/2016
XENE
7.04TV-45070Postherpetic neuralgiaPhase 2b Phase 2b initiated late March 2015. Data due 2H 201603/09/2016
XENE
7.04TV-45070OsteoarthritisPhase 2bPhase 2b trial did not meet endpoints - July 201501/03/2016
XENT
20.25RESOLVEIn-office treatment of patients with recurrent disease due to polypsPhase 3Phase initiated late Dec 2014. Enrolling01/03/2016
XENT
20.25PropelPatients undergoing frontal sinus surgerPMASubmitted a supplemental PMA submission to the FDA in September 01/03/2016
XENT
20.25NOVASinus ImplantInitiated trial July 201501/03/2016
XLRN
30.33Luspatercept - MEDALISTMyelodysplastic syndromes (MDS)Phase 3Phase 3 ongoing02/26/2016
XLRN
30.33Luspatercept - BELIEVE b -thalassemiaPhase 3Phase 3 ongoing02/26/2016
XLRN
30.33ACE-083Facioscapulohumeral muscular dystrophyPhase 2Phase 2 to be initiated 2H 201602/26/2016
XLRN
30.33Dalantercept - DART StudyRenal Cell CarcinomaPhase 2Phase 2 continues to enrol as of late February 2016. Preliminary data due year end 201602/26/2016
XLRN
30.33LuspaterceptAnemia in Patients with Myelodysplastic Syndrome.Phase 2Phase 2 ongoing. Enrolling01/03/2016
XLRN
30.33LuspaterceptEnd stage renal disease (ESRD) Phase 2bPhase 2b to be initiated 201501/13/2015
XNCR
12.33XmAb5871IgG4-Related Disease (IgG4-RD)Phase 2Phase 2 trial initiated March 2016. Initial data due 1H 201705/03/2016
XNCR
12.33XmAb5871Systemic Lupus Erythematosus (SLE)Phase 2Phase 2 trial initiated March 2016. Initial data due 201805/03/2016
XNCR
12.33XmAb5871Rheumatoid arthritisPhase 1b/2Phase 1b/2a top line data released January 201501/03/2016
XNCR
12.33JNJ-56022473Acute myeloid leukemia (AML)Phase 2Phase 2 initiated September 201501/03/2016
XNPT
4.51XP23829Moderate-to-severe plaque psoriasisPhase 2Noted in November 2015 that company will stop development. Partner needed to restart program01/03/2016
XNPT
4.51XP23829Relapsing forms of multiple sclerosis (MS)Noted in November 2015 that company will stop development. Partner needed to restart program01/03/2016
XNPT
4.51XP21279Parkinson's DiseasePhase 2bData released Dec 2011, no statistical improvement over Sinemet. Noted in November 2015 that company will stop development. Partner needed to restart program01/03/2016
XOMA
0.81XOMA 358Congenital hyperinsulinismPhase 2Phase 2 initiated October 2015. Data are due in 201603/10/2016
XOMA
0.81XOMA 358Hyperinsulinism post bariatric surgeryPhase 2Phase 2 to be initiated 2Q 201603/10/2016
XOMA
0.81XOMA 052 Gevokizumab Non-Infectious Uveitis (Active)Phase 3All Gevokizumab development terminated03/10/2016
XTLB
1.06hCDR1 Systemic Lupus Erythematosus (SLE)Phase 2Phase 2 to be initiated in 201603/22/2016
ZFGN
6.63BeloranibPrader-Willi Syndrome (PWS)Phase 3First of two Phase 3 trials to initiated Oct 2014. Enrolment completed late May 2015. In mid January 2016, the company noted that the trial met both co-primary endpoints with further data released April 201604/05/2016
ZFGN
6.63BeloranibSevere obesity Phase 2bPhase 2b data released February 2016. Primary endpoint met but saftey concerns evidents.02/19/2016
ZFGN
6.63BeloranibHypothalamic injury-associated obesity (HIAO)Phase 2aPhase 2a to be completed Jan 201503/11/2015
ZGNX
10.33ZX008Dravet syndromPhase 3Phase 3 initiated January 201601/20/2016
ZGNX
10.33 Abuse deterrent formulations of Zohydro ERModerate to severe painApprovedApproved January 30 201501/31/2015
ZGNX
10.33Zohydro ERModerate to severe painApprovedApproved Oct 25 201310/26/2013
ZIOP
7.88Ad-RTS-hIL-12Cancer - breastPhase 1/2Phase 1/2 updated data due in 201602/25/2016
ZIOP
7.88Ad-RTS-hIL-12 + veledimex Cancer - melanomaPhase 2Phase 2 completed01/01/2016
ZSAN
2.02ZP-TriptanMigrainePhase 2Phase 2 to be initiated in 201601/03/2016
ZSAN
2.02ZP-GlucagonSevere hypoglycemiaPhase 2Phase 2 data released September 2015. Considering Phase 3 initiation in 201601/03/2016
ZYNE
7.77ZYN002Refractory epilepsy, Fragile X syndrome and osteoarthritisPhase 2Phase 2 to be initiated in three indications 2H 201601/08/2016

About the author

Currently residing in New Zealand and employed in the education industry, Mr. A. Burden holds a M.Com in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.

28 Responses to “Company Pipeline Database”

  1. Shamil says:

    Check dates for RIGL, they entered in a reverse order (07/03/2012, instead of 03/07/2012).

    • admin says:

      Thanks for that! I live in New Zealand so am used to having the date like 28/03/12 so unfortunately I’m always prone to making that error. Error has been fixed. Thanks!

  2. Shamil says:

    Tickers are gone! And could you sort the list update desc (newest at the top) by default?

    • admin says:

      I’m not sure what has happened with the system but will contact my webmaster and provide an update as soon as possible. Apologies for the inconvenience.

    • admin says:

      In response to the question about sorting the database by date, I think I will keep it as it is as it’s much easier for me to maintain it at my end. Also, you can just click the “updated” tab an it’ll sort it that way for you.

  3. Mark says:

    Site is great. Any reason the Phase III’s of the BMS’s and Pfizer’s of the world are left off?

    • admin says:

      Hi Mark,

      When I first started the FDA Calendar and Clinical Database about three years ago, I made the decision to focus on small-mid cap NASDAQ/AMEX listed companies, mainly due to reader demand and the sheer workload involved in having to follow large-cap companies as well.

      However, I made a decision this year that I will now add large cap companies to the database. I started with ACOR early this week and will continue to add a few each week. I’m aiming to have it all completed by the end of February.

      Adam

  4. Ken says:

    I’m not fond of your recent change with format of calendar and pipeline dates. It’s very, very difficult to follow test completion and test result dates.

    Also, why is there pre 2013 data shown on pages? Is this just for a historical record? This makes things all the more confusing.

    Thanks, Ken

    • admin says:

      Hi Ken,

      Thanks for your feedback.

      I am presuming you are referring to the “Primary/Completion Date” column. Is this correct? These dates are provided by clinicaltrials.gov but yes, they often differ from company guidance, which provides some confusion. A decision has already been made to remove this column and the “Clinical trials ID” column. This will occur later this year or in January.

      Could you clarify what you meant by “calendar AND pipeline dates”? Are you also referring to the FDA Calendar?

      In regard to your second question, yes, all the data shown in the pipeline database is “historical” and many of my readers have mentioned they would like a reference point to previous trials. Could you clarify where the confusion arises?

      The latest trial information should be listed in the database. If a company is undergoing Phase 3 trials and there are Phase 2 data in the database, then this is an error. On the other hand, if a company has released data in, say 2012, and there haven’t been any further updates, then the 2012 entry should be the most recent entry in the database.

  5. Ken says:

    My humble apologies. I managed to lose track of the FDA Calendar link and started viewing your Company Pipeline database. (I think because the fda calendar is retrieved by clicking on the toolbar and not clicking on its dropdown menu items.)

    Nonetheless, the problem arose when I noticed that the Company Pipeline data appears not as complete, comprehensive, and forward looking as the FDA calendar data I had observed earlier.

    Now that things are working again on my end…

    Thank you for your remarkable website.

    -Ken

    • admin says:

      Thanks Ken,

      Actually, I appreciate your comments there as I’m sure you’re not the only person who has missed the FDA Calendar because it doesn’t appear in the dropdown menu.

      I’ve made a slight change so that you can now access the FDA Calendar by either clicking on the toolbar or through the dropdown menu.

      Thanks,

      Adam

  6. Anat says:

    Hi,

    Thanks for the great work!

    You have one mistake in CBRX, which needs to be removed (it’s about CPRX).

  7. zeng says:

    the interim data of BDSI’s PDN trial(phas 3)was expected in 3Q,2014,not the end of 2014.
    “We are very pleased with the rapid progression of this study, which we expect will allow for an independent interim analysis based on 50% of the patients completed during the third quarter of this year – one quarter ahead of schedule,” Based on the enrollment of this trial, and assuming no additional patients will be required following the interim analysis, we should have top-line study results by the end of the year.

  8. Will says:

    PVCT – you have PH-10 listed for the enrolling melanoma trial but it is PV-10.

    PH-10 is for Psoriasis not cancer.

    Thanks.

    • admin says:

      Thanks Will.

      Error has been fixed. By the way, Clinical trial IDs are not longer included in the database. I need to removed that column.

      Regards,

      Adam

  9. Kevin says:

    Great site, thank you! ZSAN will report results from Phase 2 of ZP-Glucagon in September of this year (2015) per the link.

    Thanks.

  10. Rakesh says:

    Where can I find archives of important data? in a similar table? I wanted to do some research about the previous years!

    Thanks

    Rakesh

  11. Steinberg says:

    thanks for this great resource! I think for RDUS, they are guiding Q1’2016 for NDA submission.

    • admin says:

      Thanks Steinberg! I must admit that when I rebuilt the calendar I just read their November financial results PR and missed the updated guidance a few days after that so much appreciate the heads up! I’ll make the change now!

  12. Emma says:

    DVAX P3 trial of HB-23 top-line results met primary endpoints – hepatitis B vaccine – Stock up dramatically today.

  13. CARL Rushmore says:

    Dear Mr Burden,

    Thank you so much for a much needed info ref biotech events website.

    I got one query: as I am new to biotech investing, I noticed some baffling events while investing in this sector.

    For example. Some successful investors, keep posting their strong positive/negative sentiment toward a specific stock, mentioning “in advance”! the due date of PDUFA, FDA application review result, etc.

    These and other FDA announcement are not only very crucial to the timing of entry/exit into certain stocks, but provide an exciting window from which to anticipate your winnings/losses.

    I asked around but no one has answer!

    I realize that you kindly mention dates here. But what I am talking about people with access to specific short/near term dates.

    Best Wishes

    Carlman

    • admin says:

      Carlman,

      Thank you for your enquiry. Yes, many investors do tend to post a particular sentiment towards a stock. This might by based on solid evidence or it might be simply because the investor has a position in the stock and is attempting to drum up more support for his/her sentiment. The PDUFA and Advisory Committee dates are posted on BioPharmCatalyst. You can access these dates on the FDA Calendar http://www.biopharmcatalyst.com/fda-calendar/ .
      Some clinical data dates are also noted here but very rarely do companies list specific dates when Phase 2/3 clinical data will be released.

      • CARL Rushmore says:

        Thanks for the info.

        To rephrase my query. Take CPXX as example.

        Some people knew one day in advance that they gona announce phase 3 result for Vyxeos on March 15. Price was changing hands around 1.5$ for months, then the day before i.e. March 14 some 8.5 million shares traded!

        How did they know?

        I am told that this cud be insider info, etc. AND in any case it is not an FDA event but company news of phase 3 result.

        This is confusing! Phase 3 trial is a closed event, i.e. within company confines, or belongs to FDA side testing/evaluation/trials?

        One just require clear info “to follow crucial clinical biotech events”, don’t want more than that. And I am lost in tracing phase 3 developments between company sudden press releases and FDA announcements !

        K Rgds.

        • admin says:

          Carl,

          Thanks for the clarification. Regarding CPXX, the company only announced publicly that the data would be released in March. They did not announce a specific date for the data release. This information would have only been privy to those associated with the company (insiders) so some might presume that the trading activity prior to the date was due to some kind of insider activity.

          If you have any other questions you can email me directly at adam@biopharmcatalyst.com

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