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
28.86Somakit-TATE Neuroendocrine tumor diagnosisApprovedApproved June 1 201606/02/2016
AAAP
28.86LutatheraInoperable progressive midgut NETsNDA filingNDA filed on or about April 29 201605/27/2016
AAAP
28.86Annexin V-128Rheumatoid arthritis and ankylosing spondylitisPhase 1/2Ongoing05/27/2016
AAAP
28.86Somakit-TOCNeuroendocrine cancersNDA filingNDA filed 1Q 201605/27/2016
ABEO
2.71ABO-102 Sanfilippo syndrome type A (MPS IIIA)Phase 1/2Phase 1/2 dosing initiated May 201605/27/2016
ABIO
2.90Gencaro - GENETIC-AF trial Chronic Heart FailurePhase 2bPhase 2b interim analysis due 2Q 201705/12/2016
ABUS
3.54TKM-PLK1 Hepatocellular carcinoma (HCC)Phase 2Phase 2 data due 2H 201605/27/2016
ABUS
3.54ARB-1467Hepatitis B (HBV)Phase 2Phase 2 single dose data due 3Q 2016, multiple dose data due 4Q 201605/12/2016
ACAD
33.50PimavanserinAlzheimer'sPhase 2Phase 2 top-line data due 4Q 201605/27/2016
ACAD
33.50PimavanserinParkinson’s disease psychosis (PDP)ApprovedApproved April 29 201604/30/2016
ACHN
8.71Odalasvir (ACH-3102), simeprevir and ALS-335Hepatitis C (HCV)Phase 2aPhase 2a top-line data due 3Q 201605/04/2016
ACHN
8.71Odalasvir (ACH-3102) and sofosbuvir Hepatitis C (HCV) Phase 2bPhase 2b trial to be initiated 3Q 201605/04/2016
ACHN
8.71ACH-4471Paroxysmal nocturnal hemoglobinuria (PNH)Phase 2Phase 2 interim data due by end of 201605/04/2016
ACOR
26.31CVT-301OFF episodes of Parkinson’s disease (PD)Phase 3Phase 3 data due 4Q 201605/28/2016
ACOR
26.31DalfampridinePost stroke deficitsPhase 3Phase 3 data due 4Q 201604/29/2016
ACOR
26.31TozadenantParkinson’s disease (PD)Phase 3To be acquired from Biotie Therapies Corp 2H 201604/29/2016
ACRS
18.21A-101Seborrheic keratosis (SK)Phase 3Phase 3 data due 3Q 201605/12/2016
ACRS
18.21A-101Common warts (verruca vulgaris)Phase 2Phase 2 data due 3Q 201605/12/2016
ACRX
2.73ARX-04Moderate-to-severe acute painPhase 3NDA to be filed 4Q 201605/27/2016
ACRX
2.73ZalvisoPost-operative pain following open abdominal surgery and hip or knee replacement surgeryCRLCRL Jul 26 2014. Additional clinical trial required.05/27/2016
ACST
1.52CaPre (TRIFECTA trial)HypertriglyceridemiaPhase 2Phase 3 planned 05/28/2016
ADAP
9.23NY-ESO T-cell therapyNon-small cell lung cancer (NSCLC)Phase 1/2Phase 1/2 initiated November 201501/08/2016
ADAP
9.23NY-ESO T-cell therapyMelanomaPhase 1/2Enrolling01/08/2016
ADAP
9.23NY-ESO T-cell therapyOvarian cancerPhase 1/2Enrolling01/08/2016
ADAP
9.23NY-ESO T-cell therapyMyelomaPhase 1/2Ongoing01/08/2016
ADHD
4.10MDX (Metadoxine Extended Release (MG01CI))Adult ADHDPhase 3Data from second Phase 3 trial due by end of 201605/17/2016
ADHD
4.10MDX (Metadoxine Extended Release (MG01CI))Pediatric ADHDPhase 2bPhase 2b data released March 2015. Secondary cognitive measures did not produce statistically significant results. In discussions with FDA regarding future trials05/17/2016
ADHD
4.10MDX (Metadoxine Extended Release (MG01CI))Fragile X SyndromePhase 2bPhase 2 trial did not meet endpoints - June 2015. In discussions with FDA regarding Phase 3 trial05/17/2016
ADMA
7.10RI-002Primary Immune Deficiency DiseasesPDUFAPDUFA date on or about July 31 2016 - BLA was filed July 31 201512/22/2015
ADMP
2.80Epinephrine Pre-filled Syringe (PFS) Emergency treatment of anaphylaxis. CRLCRL issued March 27 2015. NDA resubmitted. CRL issued again June 6, 2016. Intends to submit more data 2H 201606/07/2016
ADMP
2.80APC-3000Allergic RhinitisPhase 2Phase 3 planned02/04/2014
ADMP
2.80APC-1000Asthma/COPDPhase 2Phase 3 planned02/04/2014
ADMS
16.24ADS-5102 - EASE LID trialLevodopa-Induced DyskinesiaNDA filingPhase 3 data released December 2015. NDA filing due 201606/23/2016
ADMS
16.24ADS-5102Multiple sclerosis (MS) Phase 2Phase 2 initiated June 2015. Noted May 10 2016 that data are due in the coming weeks05/11/2016
ADMS
16.24NamzaricModerate to severe dementia of the Alzheimer's type.ApprovedApproved Dec 24 201412/26/2014
ADRO
10.93CRS-207 and GVAX Pancreas - ECLIPSE trial Pancreatic cancerPhase 2b Phase 2b primary endpoint not met - May 201605/17/2016
ADRO
10.93CRS-207 and GVAX Pancreas and nivolumab - STELLAR trial Pancreatic cancerPhase 2b Phase 2b interim data to be released 2H 201605/03/2016
ADRO
10.93Epacadostat and CRS-207 - SEASCAPEOvarian cancerPhase 1/2Phase 1/2 dosing initiated March 201603/25/2016
ADRO
10.93CRS-207Mesothelioma - cancerPhase 3 Phase 3 trial to be initiated 1H 2016. 03/09/2016
ADVM
3.55AVA-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
ADXS
8.17Axalimogene filolisbac (FAWCETT)Anal cancer Phase 2Phase 2 initiated June 201606/09/2016
ADXS
8.17Axalimogene filolisbac - AIM2CERV TrialHigh-risk, locally advanced cervical cancerPhase 3Phase 3 to commence in 201606/07/2016
ADXS
8.17Axalimogene filolisbac - GOG 0265 studyCervical cancerPhase 2Phase 2 preliminary data released June 2016 at ASCO. 06/07/2016
ADXS
8.17ADXS-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
8.17Axalimogene filolisbac + Incyte's epacadostat (IDO-1 inhibitor)Early stage cervical cancer Phase 2Phase 2 to be initiated 1H 201601/09/2016
ADXS
8.17Axalimogene 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
8.17ADXS-HER2 HER2-driven malignancies - cancerPhase 1bComplete enrollment of Phase 1b dose-escalation study 1H 201601/09/2016
AERI
18.18RhopressaGlaucomaNDA filingNDA filing due 3Q 201606/17/2016
AERI
18.18Roclatan - Mercury trialsGlaucomaPhase 3Phase 3 Mercury 1 data due 3Q 2016. Mercury 2 trial data due 2Q 201705/06/2016
AEZS
3.48ZoptrexCastration and taxane resistant prostate cancerPhase 3Phase 3 trial to be completed 3Q 201606/07/2016
AEZS
3.48Macimorelin Acetate - MacrilenAdult Growth Deficiency Phase 3CRL Nov 5 2014. Initiated Phase 3 trial in November 2015, to be completed 3Q 201605/10/2016
AEZS
3.48AEZS-108Endometrial cancerPhase 3Phase 3 trial to be completed September 2016. Data due estimated 4Q 201612/22/2015
AFMD
3.27AFM13Hodgkin Lymphoma - CancerPhase 2Phase 2a enrolment has slowed. Company to provide timeline update once enrolment trend is established05/19/2016
AGEN
4.20INCAGN1876Solid tumors - cancerPhase 1/2Phase 1/2 trial commenced June 201606/23/2016
AGIO
48.50AG-348Pyruvate kinase deficiencyPhase 2Phase 2 first data released at EHA meeting June 201606/12/2016
AGIO
48.50AG-221Relapsed/Refractory IDH2 mutant-positive Acute Myeloid Leukemia - Phase 1/2Phase 1/2 enrolment completed May 201605/29/2016
AGIO
48.50AG-120Frontline Acute myeloid leukemia (AML) harboring an IDH1 mutation - cancerPhase 3Phase 3 to be initiated 2H 201605/06/2016
AGIO
48.50AG-120IDH1 mutant positive cholangiocarcinoma - cancerPhase 2Phase 2 to be initiated 2H 201605/06/2016
AGIO
48.50AG-221 - IDHENTIFYRefractory Acute myeloid leukemia (AML) - cancerPhase 3Global Phase 3 study for AG-221 initiated October 2015. Continue to enrol through 201605/06/2016
AGIO
48.50AG-221Advanced Hematologic MalignanciesPhase 1/2Interim data released December 201512/22/2015
AGLE
4.80AEB1102Arginase I deficiencyPhase 1Phase 1 to be initated 1H 201605/27/2016
AGRX
7.28TwirlaContraceptive patch Phase 3CRL issued 2013. Phase 3 to be completed 4Q 2016. 05/29/2016
AIMT
12.31AR101Peanut AllergyPhase 3Phase 3 initiated January 2016. Enrollment to be completed 2H 2016 with trial to be completed 2H 2017 05/17/2016
AKAO
3.99Plazomicin - EPIC trialComplicated urinary tract infections (cUTI)Phase 3Phase 3 top-line results due 1Q 201706/03/2016
AKAO
3.99Plazomicin - CARESerious bacterial infections due to carbapenem-resistant Enterobacteriaceae (CRE)Phase 3Phase 3 topline data due 1H 201705/06/2016
AKBA
7.79Vadadustat - PRO2TECTNon-dialysis patients with anemia related to CKD (NDD-CKD)Phase 3Phase 3 initiated January 2016. NDA to be filed 2019 assuming postive data05/29/2016
AKBA
7.79VadadustatAnemia related to chronic kidney disease who are undergoing dialysis (DD-CKD)Phase 3Phase 3 planned for 3Q 201605/06/2016
ALDR
25.83ALD403 Chronic MigrainePhase 2b Phase 2b data released March 2016 met primary and secondary endpoints. 24 week data due 3Q 201605/26/2016
ALDR
25.83ALD403 - PROMISE 1Frequent episodic migrainePhase 3Phase 3 topline data due 1H 2017. PROMISE 2 trial to be initiated 2H 201604/29/2016
ALDR
5.14Clazakizumab Rheumatoid arthritis (RA)Phase 2bPhase 2b trial met endpoint early May 2015. Seeking partner for further development12/22/2015
ALDR
25.83Clazakizumab Psoriatic arthritis (PsA)Phase 2Phase 2 data released 4Q 2014. Further development requires partner which company is pursuing03/05/2015
ALDX
5.14NS2 Sjögren-Larsson Syndrome (SLS)Phase 2Phase 2 data due 3Q 201606/08/2016
ALDX
5.14NS2Noninfectious anterior uveitisPhase 2Phase 2/3 to begin 2H 2016. Data expected mid-201805/29/2016
ALDX
5.14NS2Allergic conjunctivitisPhase 2Phase 2/3 trial to begin 2H 2016. Data due 2H 201705/29/2016
ALIM
1.49IluvienDiabetic macular edemaApprovedApproved Sept 26 201409/28/2014
ALKS
43.75ALKS 8700Multiple sclerosis (MS) Phase 3Phase 3 trial to be initiated mid-2016 with data due 201805/29/2016
ALKS
43.75ALKS 6428 Opioid dependencePhase 3Phase 3 initated September 201505/29/2016
ALKS
43.75AristadaSchizophreniaApprovedApproved October 5 2015. sNDA filing due 2H 201605/29/2016
ALKS
43.75ALKS 3831 - ENLIGHTEN-1 and ENLIGHTEN-2SchizophreniaPhase 3Pivotal trials initiated December 2015 and February 201605/29/2016
ALKS
43.75ALKS 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
ALNY
56.95ALN-CC5Paroxysmal nocturnal hemoglobinuria (PNH)Phase 1/2Phase 1/2 initial data released June 11 2016 with Phase 2 trial to be initiated towards the end of 201606/12/2016
ALNY
56.95ALN-TTRsc02ATTR amyloidosisPhase 1Phase 3 to be initiated 2017 assuming positive Phase 1 initial data due end of 201606/10/2016
ALNY
56.95ALN-GO1Primary Hyperoxaluria Type 1 (PH1)Phase 1/2Phase 1/2 initiated March 2016. Initial data due late 201605/03/2016
ALNY
56.95Patisiran APOLLOFamilial Amyloidotic Polyneuropathy (FAP) in Patients with ATTRPhase 3Phase 3 data due mid 201705/03/2016
ALNY
56.95Revusiran ENDEAVOURATTR in patients with familial amyloidotic cardiomyopathy (FAC)Phase 3Phase 3 data due mid 201805/03/2016
ALNY
56.95Fitusiran HemophiliaPhase 3Phase 3 program to be initiated mid 201605/03/2016
ALXA
0.94AZ-002Acute repetitive seizuresPhase 2Phase 2a expected to be released 1H 201605/29/2016
AMAG
24.89FerahemeAdults with iron deficiency anemia (IDA)Phase 3Phase 3 dosing commenced March 2016. Enrolment to be completed 201705/29/2016
AMAG
24.89Makena - single-dose vialReduce the risk of preterm birth in women with a singleton pregnancyApprovedApproved February 23 201602/24/2016
AMPE
3.34AmpionOsteoarthritis of the KneePhase 3Data from STRIDE study released mid April 2015 did not meet endpoint. Second Phase 3 data are due mid 201605/29/2016
AMPE
3.34ZertanePremature ejaculationPhase 3Pivotal trial pending. 12/23/2015
AMPE
3.34OptinaDiabetic Macula EdemaPhase 2bPhase 2b data released May 201505/21/2015
AMRN
2.10Vascepa REDUCE-IT outcomes trial High Triglycerides With Mixed DyslipidemiaREDUCE-IT outcomes trialInterim analysis due September or October 2016 and, if not stopped early, for completion in 2017 and presentation/ publication of results in 201805/29/2016
ANAC
99.20Crisaborole Topical OintmentMild-to-moderate atopic dermatitisPDUFAPDUFA January 7 201703/23/2016
ANAC
99.20TavaboroleOnychomycosisApprovedApproved July 8 201407/09/2014
ANIK
51.10CingalOsteoarthritisPhase 3In disucssions with FDA regarding NDA submission05/29/2016
ANIK
51.10MonoviscOsteoarthritisApprovedApproved Feb 201402/16/2014
ANTH
3.10BlisibimodLupusPhase 3Missed primary endpoints in Phase 2b trial Jun 2012. Phase 3 final data due later in 201605/10/2016
ANTH
3.10BlisibimodIgA nephropathyPhase 2Enrolment stopped due to termination of partner agreement.Phase 2 data due 2Q 201605/10/2016
ANTH
3.10Sollpura (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
3.60Appy1Acute 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
3.10VitarosErectile dysfunctionNDA filingNDA to be resubmitted 3Q 201605/29/2016
APRI
3.10RayVa Secondary Raynaud's PhenomenonPhase 2bPhase 2b planned - seeking partnership05/29/2016
AQXP
6.72AQX-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. Phase 3 protocol submitted 2Q 201605/29/2016
AQXP
6.72AQX-1125 KINSHIPAtopic dermatitis (AD)Phase 2Phase 2 failed to demonstrate efficacy November 201512/23/2015
AQXP
6.72AQX-1125 FLAGSHIPChronic obstructive pulmonary disease (COPD)Phase 2Phase 2 trail failed - July 201512/23/2015
ARDM
4.34Pulmaquin - ORBIT 3Non-cystic fibrosis bronchiectasis (non-CF BE).Phase 3Phase 3 enrolment completed October 201512/23/2015
ARDX
8.27RDX227675HyperkalemiaPhase 3Phase 2b and Phase 3 trials to be initiated 4Q 201606/23/2016
ARDX
8.27TenapanorHyperphosphatemia in end-stage renal disease (ESRD) patientsPhase 2bPhase 2b data due 1Q 201706/23/2016
ARDX
8.27TenapanorConstipation-predominant irritable bowel syndrome (IBS-C) Phase 3Phase 3 trial initiated October 2015. Second trial initiated December 2015. Data from both trials due in 201705/10/2016
ARDX
8.27TenapanorHyperphosphatemia 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 expected. 03/06/2016
ARGS
5.60AGS-003 ADAPT Trial Metastatic renal cell carcinoma (mRCC)Phase 3Third interim analysis June 2016. Overall survival analysis due 1H 201706/14/2016
ARGS
5.60AGS-003 Early stage renal cell carcinoma (RCC) - cancerPhase 2Phase 2 trial initial data due 4Q 201605/29/2016
ARGS
5.60AGS-004 HIVPhase 2Phase 2 ongoing05/29/2016
ARGS
5.60AGS-003Non-Small Cell Lung CancerPhase 2Phase 2 initiated 1Q 2016 05/29/2016
ARIA
7.54Brigatinib - ALTA trialAnaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC)NDA filingNDA rolling submission filed June 2016. Submission to be completed 3Q 201606/18/2016
ARIA
7.54Iclusig (ponatinib) - OPTIC-2LCancer - second line chronic-phase CML (CP-CML) Phase 3Phase 3 enrolment to be completed in 201806/14/2016
ARIA
7.54AP32788Non-small cell lung cancer (NSCLC)Phase 1/2Phase 1/2 enrolling as of May 201605/11/2016
ARIA
7.54BrigatinibALK+ non-small cell lung cancer (NSCLC) - front linePhase 3Phase 3 trial initiated April 2016. Enrolment to be completed 201804/12/2016
ARIA
7.54Iclusig (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
ARLZ
3.41YOSPRALA (PA32540/PA8140) Secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcersPDUFAPDUFA date September 14 201603/30/2016
ARNA
1.91APD334Ulcerative colitisPhase 2Phase 2 initiated July 201512/23/2015
ARNA
1.91RalinepagPulmonary Arterial HypertensionPhase 2Phase 2 initiated mid Jan 201501/13/2015
ARNA
1.91Lorcaserin Smoking cessationPhase 2Phase 2 initiated March 2014. Data released Nov 201411/04/2014
ARQL
1.92Tivantinib (ARQ 197) METIV-HCC trialPreviously treated Inoperable Hepatocellular Carcinoma cancer Phase 3Phase 3 SPA agreed upon. Dosage reduced following recommendation from DMC. Final analysis late 2016 or early 201705/29/2016
ARQL
1.92ARQ 087intrahepatic cholangiocarcinoma (iCCA)Phase 2Phase 2 preliminary data due June 30, 2016 at ESMO 18th World Congress on Gastrointestinal Cancer06/24/2016
ARRY
3.58Binimetinib (NEMO)NRAS melanoma - cancerNDA filingEndpoint met December 2015. NDA filing expected June 201606/07/2016
ARRY
3.58Encorafenib and cetuximab - BEACON CRCBRAF-Mutant Colorectal CancerPhase 3Phase 3 initiated June 2016. Enrolment to be completed 201806/05/2016
ARRY
3.58Selumetinib - SELECT-1Differentiated thyroid cancer Phase 3Phase 3 data due 2H 201605/04/2016
ARRY
3.58Binimetinib - COLUMBUSBRAF mutant melanoma cancerPhase 3Phase 3 data due 3Q 201605/04/2016
ARRY
3.58ARRY 797LMNA A/C-related dilated cardiomyopathy (DCM)Phase 2Phase 2 data to be presented at the European Society of Cardiology on August 30, 201605/04/2016
ARRY
3.58ARRY-520 (Filanesib)Refractory Multiple Myeloma CancerPhase 2Phase 2 interim data due 2016 but no plans to advance program12/23/2015
ARWR
5.88ARC-521 Chronic Hepititis B (HBV)Phase 1/2Phase 1/2 initiated June 201606/10/2016
ARWR
5.88ARC-520 injection in combination with entecavir or tenofovirChronic Hepititis B (HBV)Phase 2Partial clinical hold placed by FDA in early Jan 2015. Phase 2 trial to proceed with lower doses than initially proposed. Dosing commenced January 201601/08/2016
ASMB
5.67VEN 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
13.86TransConGrowth hormone deficiency in childrenPhase 2Phase 3 planned for mid 201605/20/2016
AST
2.99AST-VAC1Acute myeloid leukemia (AML)Phase 2Phase 3 planned for late 201705/29/2016
AST
2.99AST-OPC1Cervical spinal cord injuryPhase 1/2Phase 1/2 continues to enrol as of May 201605/29/2016
ATHX
2.00MultistemAcute myocardial infarctionPhase 2Phase 2 enrolment but reported May 2016 that enrolment is slower than expected05/06/2016
ATHX
2.00MultistemIschemic strokePhase 2Phase 2 data released mid April 2015. Endpoints not met.04/21/2015
ATNM
1.75Actimab-AAcute Myeloid Leukemia (AML)Phase 1/2Phase 2 to be initiated 2H 201606/02/2016
ATNM
1.75Iomab-BHematopoietic Stem Cells TransplantationPhase 2Phase 3 to commence 1H 201605/29/2016
ATOS
0.29FulvestrantCuctal carcinoma in situ(DCIS) - invasive breast cancerPhase 2Phase 2 initiated March 201603/31/2016
ATRA
22.06PINTA 745Protein-energy wastingPhase 2Phase 2 endpoint not met December 201512/23/2015
ATRA
22.06CMV-CTLRefractory CMV Chorioretinitis or MeningoencephalitisPhase 2Phase 2 data released at ASH 201512/23/2015
ATRS
1.01VIBEX QuickShotTestosterone deficiencyPhase 3Phase 3 initiated July 2014. Completed October 2015. NDA to be filed late 2016 or early 201705/29/2016
ATRS
1.01OTREXUPRheumatoid arthritis (RA)ApprovedApproved Oct 14 201310/16/2013
AUPH
2.66VoclosporinLupusPhase 2bEnrolment completed January 2015. Data due 3Q 201605/12/2016
AVEO
0.98TIVO-3 - tivozanib Third line treatment of patients with renal cell cancerPhase 3Phase 3 dosing commenced May 2016. Data due 1Q 201805/27/2016
AVIR
1.28BTA074 5% topical gel CondylomaPhase 2Phase 2 top-line data due 2H 201705/29/2016
AVIR
1.28BTA585Respiratory syncytial virus (RSV)Phase 2aPhase 2a initiated April 2016. Enrolment halted May 2016 due to safety issues05/29/2016
AVIR
1.28Vapendavir - SPIRITUS trialHuman rhinovirus (HRV)Phase 2bPhase 2b top-line data due 2H 201605/29/2016
AVXL
4.27ANAVEX 2-73 Mild to moderate Alzheimer’s diseasePhase 2aPhase 2a interim data released January 2016. Trial is ongoing. Additional Phase 2/3 trial planned05/12/2016
AVXS
40.32AVXS-101 Spinal muscular atrophy (SMA) Type 1Phase 1Phase 1 ongoing. Pivotal trial to be initiated 1H 201705/27/2016
AXON
12.25Nelotanserin DLB patients experiencing REM Behavior Disorder (RBD).Phase 2Phase 2 data due 2H 201605/29/2016
AXON
12.25Nelotanserin - HEADWAY-DLBDementia with Lewy bodies (DLB) Phase 2Phase 2 initiated 1Q 201605/29/2016
AXON
12.25RVT-101 Dementia with Lewy bodies (DLB)Phase 2bPhase 2b to be initiated 1Q 201601/08/2016
AXON
12.25RVT-101 - MINDSET Alzheimer's diseasePhase 3Phase 3 initiated October 2015. Data are due 201701/08/2016
AXSM
7.41AXS-02 Complex regional pain syndrome (CRPS)Phase 3Initiated July 2015. Expect to complete trial by end of 201705/29/2016
AXSM
7.41AXS-02 COAST-1Knee Osteoarthritis Associated with Bone Marrow LesionsPhase 3Phase 3 commenced March 201605/29/2016
AXSM
7.41AXS-02 Chronic Low Back Pain Associated with Modic ChangesPhase 3Phase 3 to be initiated 4Q 2016 or 1Q 201703/25/2016
AXSM
7.41AXS-05 STRIDE-1Treatment resistant depressionPhase 3Phase 3 initiated March 201603/25/2016
BCLI
2.38NurOwn Amytrophic lateral sclerosis (ALS)Phase 2Phase 2 data likely mid 201605/11/2016
BCRX
2.94BCX7353 Reduce or eliminate attacks in HAE patients is Phase 2Phase 2 to be initiated 201605/29/2016
BCRX
2.94BCX4161 - OPuS-2Hereditary angioedemaPhase 2bPhase 2b data released February 2016 - primary endpoint not met02/09/2016
BCRX
2.94Peramivir - Study 303INFLUENZA ACUTE ApprovedApproved Dec 22 201412/23/2014
BDSI
2.39Clonidine 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 201705/11/2016
BDSI
2.39BEMA BuprenorphinePainApprovedApproved October 26 201512/23/2015
BDSI
2.39BEMA Buprenorphine/Naloxone (BNX) - BUNAVAILOpioid dependenceApprovedApproved June 7 201406/08/2014
BGNE
30.74BGB-3111B-cell lymphoid malignanciesPhase 1bPhase 1b enrolling05/27/2016
BIND
0.40 BIND-014 iNSITE 1 Cancer - Non-small cell lung cancer (NSCLC) with squamous histologyPhase 2Partner required to continue with program04/07/2016
BIND
0.40 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
0.40 BIND-014 Cancer - Prostate CancerPhase 2Phase 2 overall survival data due but sees more promising opportunites in areas besides mCRPC02/05/2015
BIOD
0.31BIOD-531 Type 2 diabetesPhase 2bPhase 2b initiated mid May 2015. Partial clinical hold lifted October 201512/24/2015
BLCM
12.99BPX-401Hematological cancers that express the CD19 antigenPhase 1/2Phase 1/2 planned 2H 201605/29/2016
BLCM
12.99BPX-601Pancreatic cancerPhase 1/2Phase 1/2 planned mid 201605/29/2016
BLCM
12.99BPX-701PRAME (preferentially-expressed antigen in melanoma) -expressing melanoma, sarcomas and neuroblastoma cancerPhase 1/2Phase 1/2 planned mid 201605/29/2016
BLCM
12.99BPX-501Adjunct T-cell therapy administered after allogeneic HSCT - (hematopoietic stem cell transplantation) - cancerPhase 1/2Phase 1/2 interim data presented April 201604/06/2016
BLPH
1.89INOpulse delivery devicePulmonary Arterial Hypertension (PAH)Phase 3Phase 3 commenced enrolment June 201606/17/2016
BLPH
1.89INOpulse delivery devicePulmonary Hypertension associated with COPD (PH-COPD)Phase 2Phase 2 to be initiated 201605/11/2016
BLPH
1.89INOpulse delivery devicePulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis (PH-IPF)Phase 2Phase 2 to be initiated 201605/11/2016
BLRX
0.82BL-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 201705/18/2016
BLRX
0.82BL-8040 in combination with KEYTRUDAPancreatic cancerPhase 2Phase 2 to be initiated mid 201605/18/2016
BLRX
0.82BL-7010Gluten sensitivity Efficacy study to be initiated later in 201605/18/2016
BLRX
0.82BL-8040Acute myeloid leukemia (AML) cancer relapsed and refractory Phase 2Phase 2 data released March 201603/30/2016
BLRX
0.82BL-8040Consolidation treatment for AML cancer patientsPhase 2bPhase 2b initiated August 201512/24/2015
BLUE
42.25Lenti-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
42.25LentiGlobin β-ThalassemiaPhase 1/2Update expected at ASH December 201601/12/2016
BLUE
42.25LentiGlobin - HGB-206Sickle diseasePhase 1/2Update expected at ASH December 201601/12/2016
BMRN
83.65PEG-PALPhenylketonuria (PKU) Phase 3Phase 3 data released March 2016. Primary endpoint hit. Key secondary endpoint missed. NDA (BLA) filing to be filed 2H 2016 05/29/2016
BMRN
83.65Cerliponase alfaBatten DiseaseNDA filingPhase 1/2 data released March 2 2016. NDA filing due mid 201605/29/2016
BMRN
83.65VosoritideAchondroplasiaPhase 2Phase 2 data released April 2016. Phase 3 trial to be initiated end of 201604/21/2016
BMRN
83.65Reveglucosidase alfa (BMN 701)Pompe DiseasePhase 2Interim data released January 201601/12/2016
BMRN
83.65Vimizim (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
1.28TT-034Hepatitis C Phase 1/2Announced late February 2016 plans to discontinue development02/26/2016
BPMX
0.60BPX-03Moderate to severe periodic breast pain associated with FBC (fibrocystic breast condition) and cyclic mastalgiaPhase 3 Phase 3 to be initiated in 201706/15/2016
BPMX
0.60BPX-01AcnePhase 2aPhase 2b to be initiated July 201604/26/2016
BSTC
38.87XIAFLEXEdematous fibrosclerotic panniculopathy (“cellulite”)Phase 2bPhase 2b initiated February 2016 by partner Endo05/29/2016
BSTC
38.87XIAFLEXHuman lipomasPhase 2Phase 2 topline data due June 201605/11/2016
BSTC
38.87XIAFLEXAdhesive Capsulitis (“Frozen Shoulder syndrome”)Phase 2bPhase 2b trial did not meet endpoint 05/15/2015
BTX
2.45OpRegenDry age-related macular degeneration (AMDPhase 1/2Review of safety data due 2Q 201605/11/2016
BTX
2.45AST-VAC1Maintenance of relapse-free-survival in acute myeloid leukemia (AML)Phase 3Phase 3 planned05/11/2016
BVXV
3.89M-001Universal flu vaccinePhase 2bPhase 2b enrolment commenced March 2016. Data are due late 2016 or early 201706/01/2016
CANF
2.67CF101Rheumatoid arthritisPhase 3Phase 3 to be initiated 2Q or 3Q 201606/02/2016
CANF
2.67CF101Psoriasis Phase 2/3Phase 2/3 trial did not meet primary endpoint late March 2015. Additional Phase 3 planned for 201605/28/2016
CANF
2.67CF102Cancer - advanced liver cancer second linePhase 2Phase 2 enrolment to be completed 2H 201605/28/2016
CANF
2.67CF101GlaucomaPhase 2Phase 2 data due June 201605/28/2016
CANF
2.67CF101Non-alcoholic steatohepatitis (NASH)Phase 2Phase 2 planned05/28/2016
CAPR
4.38CenderitideAmbulatory heart failure Phase 2Phase 2 completed. Waiting on data from additional study to determine future05/30/2016
CAPR
4.38CAP-1002 HOPE-DuchenneDuchenne Muscular Dystrophy (DMD)Phase 1/2Phase 1/2 data due 1Q 201706/24/2016
CAPR
4.38CAP-1002 ALLSTAR Myocardial infarction (heart attack)Phase 2Phase 2 enrolling. 6 month data due 1Q 201705/13/2016
CARA
5.07IV CR845Acute painPhase 3Phase 3 initiated September 2015. Placed on clinical hold February 2016. Clinical hold released April 2016 with enrolment resuming June 201606/07/2016
CARA
5.07CR845 Osteoarthritis (OA) of the knee or hipPhase 2Phase 2a data released December 2015. Phase 2b trial to be initiated 2H 201605/30/2016
CARA
5.07IV CR845Chronic painPhase 2bPhase 2b initiation due 2H 201605/06/2016
CARA
5.07IV CR845Uremic pruritusPhase 2Phase 2/3 program to be initiated 2Q 201605/06/2016
CASC
0.95ONT-380 and T-DM1HER2+ Metastatic Breast Cancer (MBC)Phase 1bPhase 1b updated data released at ASCO 2016. Further data due by end of 201606/15/2016
CASC
0.95ONT-380 + Herceptin and XelodaHER2+ Metastatic Breast Cancer (MBC)Phase 2Phase 2 combination trial initiated February 201603/01/2016
CASI
1.23ENMD-2076 Cancer - Advanced/Metastatic Soft Tissue SarcomaPhase 2Phase 2 initiated Jan 2013. Ongoing as of Nov 201512/24/2015
CASI
1.23ENMD-2076Cancer - triple-negative breast cancerPhase 2Phase 2 initiated Jul 2012. Ongoing as of Nov 201512/24/2015
CASI
1.23ENMD-2076Cancer - fibrolamellar carcinoma (FLC).Phase 2Phase 2 initiated October 201512/24/2015
CATB
4.00CAT-2054 HypercholesterolemiaPhase 2aPhase 2a did not meet primary endpoint - June 201606/08/2016
CATB
4.00CAT-1004 Duchenne muscular dystrophy (DMD)Phase 2Phase 2 data due late 201605/13/2016
CBAY
1.79MBX-8025 Primary biliary cholangitis (PBC)Phase 2Phase 2 top-line data released late May 201606/01/2016
CBAY
1.79ArhalofenateGoutPhase 3Phase 3 planned - partner required05/12/2016
CBLI
2.57Entolimod - Russia trialNeo-adjuvant therapy in treatment-naïve patients with primary colorectal cancerPhase 2Phase 2 ongoing02/23/2016
CBLI
2.57CBLB612 - Russia trialBreast cancerPhase 2Phase 2 ongoing02/23/2016
CBYL
0.77Hydros-TA Osteoarthritis of the kneePhase 3Not pursuing further development05/29/2016
CCXI
4.68CCX168Associated vasculitis (AAV)Phase 2Phase 3 to be initiated in 2016. Phase 2 top-line data from the CLASSIC trial released June 201606/17/2016
CCXI
4.68Vercirnon CCX282 Crohn's diseasePhase 3Partner required to continue with Phase 3 program05/29/2016
CCXI
4.68CCX140Diabetic nephropathy Phase 2Phase 2 topline data released Dec 12 2014. End of Phase 2 meeting planned with FDA in 201605/11/2016
CCXI
4.68CCX872Non-resectable pancreatic cancerPhase 1bPhase 1b early response data due mid 2016. Initial PFS data due 2H 201605/11/2016
CCXI
4.68CCX168 atypical Hemolytic Uremic Syndrome (aHUS)Phase 2Phase 2 data due 201605/11/2016
CDTX
10.90CD101 TopicalVulvovaginal candidiasis (VVC)Phase 2Phase 2 initiated June 201606/10/2016
CDTX
10.90CD101 IVCandidemiaPhase 2Phase 2 to be initiated soon05/13/2016
CEMP
18.56CEM-101 (solithromycin )CAPBNDA filingRolling NDA filing completed April 201605/03/2016
CEMP
18.56SolithromycinCOPDPhase 2Phase 2 ongoing as of May 201605/03/2016
CEMP
18.56SolithromycinNASHPhase 2Phase 2 dosing initiated January 2016. Ongoing as of May 201605/03/2016
CEMP
18.56CEM-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
18.56Taksta Acute bacterial skin and skin structure infections (ABSSSI)Phase 3Phase 3 initiated December 2015. Trial to be completed 1H 201705/03/2016
CERC
2.30CERC-501Smoking cessationPhase 2Phase 2 top-line data due 4Q 201605/17/2016
CERC
2.30CERC-301Major depressive disorder (MDD)Phase 2Phase 2 data due 1H 201705/17/2016
CERS
6.29INTERCEPT PlateletsApprovedPMA approved Dec 18 201412/19/2014
CERS
6.29INTERCEPT B123PlasmaApprovedPMA approved Dec 16 201412/18/2014
CERU
2.14CRLX101 and Avastin - RCC Trial3rd and 4th line Relapsed Renal Cell Carcinoma cancerPhase 2Phase 2 data due 3Q 201605/31/2016
CERU
2.14CRLX101, in combination with LYNPARZASolid tumors - cancerPhase 1/2Phase 1/2 trial commenced dosing May 2016. Top-line data due 1H 201705/11/2016
CERU
2.14CRLX301Solid tumours - cancerPhase 2aPhase 2a portion of Phase 1/2a trial commenced dosing June 201606/24/2016
CERU
2.14CRLX101 in Combination with Chemotherapy and Radiation Rectal CancerPhase 1b/2Initial data released mid March 2015. Further interim data due 2H 201605/03/2016
CERU
2.14CRLX101 and AvastinRelapsed ovarian cancerPhase 2Further interim data due 2H 201605/03/2016
CFRX
2.98CF-301Serious infections caused byStaph aureus including MRSAPhase 2Phase 2 to be initiated 4Q 201605/18/2016
CHMA
2.14MycapssaAcromegalyCRLCRL April 15 201604/16/2016
CHMA
2.14MycapssaNeuroendocrine tumors (NET)Phase 2Phase 2 to be initiated late 201601/09/2016
CHRS
16.47CHS-1701Pegfilgrastim biosimilarPK/PD study expected to read-out late 1H 2016 with BLA to filed after 05/10/2016
CHRS
16.47CHS-1420PsoriasisPhase 3Enrolment to be completed 1H 2016. Data due 2H 201605/10/2016
CHRS
16.47CHS-0214Rheumatoid arthritis Phase 3Phase 3 data released January 2016. Endpoints met. However, commercialization not possible in US before 2029 due to patent issues01/12/2016
CHRS
16.47CHS-0214PsoriasisPhase 3Phase 3 trial met endpoint November 2015. However, commercialization not possible in US before 2029 due to patent issues12/24/2015
CLBS
0.53CLBS03Type 1 diabetesPhase 2Phase 2 initiated March 2016. Initial safety data due early 201705/30/2016
CLCD
6.72Lasmiditan - SAMURAIMigrainePhase 3Phase 3 enrolling. Top-line data available 3Q 2016.06/08/2016
CLCD
6.72Lasmiditan - SPARTANMigrainePhase 3Phase 3 top-line data due mid 201705/30/2016
CLDX
4.57Glembatumumab vedotinMetastatic triple negative breast cancers that overexpress gpNMBPhase 2bPhase 2b enrolment to be completed by end of 201605/06/2016
CLDX
4.57Glembatumumab vedotinMelanoma - cancerPhase 2Phase 2 initiated December 2014. Data to be presented 2H 201605/06/2016
CLDX
4.57Varlilumab and nivolumabSolid tumors - cancerPhase 2Phase 2 initiated April 201605/06/2016
CLDX
4.57Varlilumab and atezolizumab (anti-PDL1)Renal cell carcinoma (RCC) cancerPhase 1/2Phase 1 part of trial is enrolling05/06/2016
CLDX
4.57Varlilumab and sunitinib (Sutent) Clear cell renal cell carcinoma (CC-RCC) cancerPhase 1/2Enrolling05/06/2016
CLDX
4.57Glembatumumab vedotinSquamous cell lung cancer Phase 1/2Phase 1/2 commenced April 201604/28/2016
CLDX
4.57CDX-110 (rindopepimut) in combination with Avastin - ReACTGlioblastoma multiforme (GBM) refractory cancerPhase 2Phase 2 endpoint met - ASCO 201506/01/2015
CLSN
1.29ThermoDox - DignityRecurrent Chest Wall Breast Cancer (RCWBC)Phase 2Final data released December 201505/30/2016
CLSN
1.29ThermoDoxHepatocellular carcinoma - liver cancerPhase 3Failed to meet primary endpoint. New Phase 3 enrolment to be completed late 2017 or early 201805/17/2016
CLSN
1.29GEN-1 OVATIONOvarian cancerPhase 1bPhase 1b initiated October 201512/24/2015
CLVS
13.93Rociletinib Mutant EGFR T790M-positive lung cancerPDUFAPDUFA date June 28, 2016. Company expects CRL. Phase 3 TIGER-3 also terminated05/06/2016
CLVS
13.93Rucaparib ARIEL2Ovarian cancer second lineNDA filingNDA filing for rucaparib expected to be completed 2Q 201605/06/2016
CLVS
13.93Rucaparib ARIEL3 Ovarian cancer patients with a BRCA-like mutationPhase 3Pivotal trial initiated late 2013. Enrolment completed 2Q 2016. Data due around mid 201705/06/2016
CLVS
13.93LucitanibBreast cancerPhase 2Phase 2 enrolment completed 1Q 2016. Expects to make a decision regarding future development by the end of 2016.05/06/2016
CLVS
13.93Rociletinib in combination with atezolizumabEGFR-mutant non-small cell lung cancerPhase 1b/2Phase 1b/2 trial initiated January 201601/28/2016
CMRX
3.79Brincidofovir - Advise trialAdenovirus InfectionPhase 3Phase 3 interim analysis released May 201605/09/2016
CNAT
2.13EmricasanLiver fibrosis post-orthotopic liver transplant due to Hepatitis C virus infection (HCV-POLT)Phase 2bPhase 2b initiated May 2014. Topline data due 1H 201805/06/2016
CNAT
2.13EmricasanNASH fibrosis - ENCORE-NF trialPhase 2Phase 2 trial initiated January 2016. Data are due 201805/06/2016
CNAT
2.13EmricasanLiver CirrhosisPhase 2Phase 2 topline data released early January 201601/06/2016
CNAT
2.13EmricasanPortal Hypertension Phase 2Phase 2 data released September 2015. 12/24/2015
CNAT
2.13Emricasan Acute-on-Chronic Liver Failure (ACLF) Phase 2Phase 2 topline data released Jan 201501/09/2015
CNCE
11.32CTP-656Cystic fibrosisPhase 2Phase 2 planned for 2H 201605/30/2016
CNCE
11.32AVP-786 Major depressive disorderPhase Phase 2 to be completed 2Q 201603/02/2016
CNCE
11.32AVP-786 Agitation in patients with Alzheimer's diseasePhase 3Phase 3 initiated December 201512/25/2015
COLL
13.70Xtampza ER (oxycodone) Severe painApprovedApproved April 26 201604/27/2016
CORI
4.00Corplex DonepezilPilot bioequivalence study to be initiated 2016 followed by a pivotal bioequivalence study starting mid-2017, with a 505(b)(2) NDA mid-2018.05/30/2016
CORI
4.00TwirlaContraceptive patch Phase 3CRL issued 2013. Phase 3 to be completed 4Q 2016. 05/29/2016
CORI
4.00MicroCor PTHOsteoporosisPhase 2aPhase 2a data released July 201512/26/2015
CORT
5.47Mifepristone in combination with eribulin Cancer - triple-negative breast cancerPhase 1/2Phase 1/2 data due mid 201606/03/2016
CORT
5.47Mifepristone plus enzalutamideCastration-resistant prostate cancer (CRPC)Phase 2Phase 2 enrolling06/03/2016
CORT
5.47Mifepristone plus AbraxaneTriple-negative breast cancerPhase 2Phase 2 planned06/03/2016
CORT
5.47CORT125134Cushing’s syndromePhase 2Phase 2 trial to be initiated 2Q 201605/30/2016
CORT
5.47CORT125134Solid tumors - cancerPhase 2Phase 2 initiated 1Q 201605/30/2016
CPRX
0.88Firdapse Lambert-Easton Myasthenic Syndrome (LEMS)Phase 3Refusal 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
30.15VYXEOSSecondary AML - cancerPhase 3Overall survival data released March 2016. Primary endpoint met. NDA planned for 2016 03/15/2016
CPXX
30.15VYXEOS Study 206Adult patients with hematologic malignanciesPhase 2Phase 2 pharmacokinetic and pharmacodynamics study is ongoing. Enrolment closed June 201512/26/2015
CRBP
3.01ResunabSystemic SclerosisPhase 2Phase 2 data due 4Q 201606/17/2016
CRBP
3.01ResunabSystemic lupus erythematosus (SLE)Phase 2Phase 2 trial to be initiated 1Q 201705/17/2016
CRBP
3.01ResunabDermatomyositisPhase 2Phase 2 to be completed 1Q 201705/17/2016
CRBP
3.01ResunabCystic FibrosisPhase 2Phase 2 data due 4Q 201605/17/2016
CRIS
1.66CUDC-907Diffuse-large B-cell lymphoma (DLBCL)Phase 2Phase 2 initiated January 201603/01/2016
CRMD
2.06Neutrolin - LOCK-IT 100Hemodialysis patients with central venous cathetersPhase 3Phase 3 enrolment to be completed in 2016. Interim analysis due by end of 201605/12/2016
CRMD
2.06Neutrolin - LOCK-IT 200Oncology patients on Total Parental Nutrition (TPN)Phase 3Phase 3 to be initiated in 201705/12/2016
CRVS
13.46CPI-444Solid tumors - cancerPhase 1bPhase 1/1b enrolling05/27/2016
CTIC
0.40TosedostatOlder patients with AML or high-risk myelodysplastic syndrome (MDS) - cancerPhase 2Phase 3 trial potentially starting in 2016, depending on discussions with FDA01/12/2016
CTIC
0.40OPAXIOOvarian cancerPhase 3Phase 3 second of four analyses completed early Feb 2014. Trial to continue as planned02/04/2015
CTIX
1.39BrilacidinUlcerative proctitisPhase 2Phase 2 dosing to commence late June 201606/16/2016
CTIX
1.39CellceutixPlacque psoriasisPhase 2Phase 2 top line data released May 201605/25/2016
CTIX
1.39KevetrinOvarian cancerPhase 2Phase 2 planned01/20/2016
CTIX
1.39BrilacidinOral mucositisPhase 2Phase 2 ongoing12/26/2015
CTIX
1.39BrilacidinAcute Bacterial Skin and Skin Structure Infections (ABSSSI)Phase 2Phase 3 planned12/26/2015
CTRV
1.09CMX157Hepatitis BPhase 2Phase 2 dosing initiated June 2016. Trial to be completed 4Q 201606/22/2016
CTRV
1.09FV-100 ShinglesPhase 3Phase 3 ongoing04/12/2016
CUR
0.29 NSI-566Amyotrophic lateral sclerosis (Lou Gehrig's)Phase 2Phase 2 data released early March 2015. A larger controlled Phase 2 trial is dependent on funding06/01/2016
CUR
0.29NSI-189Major depressive disorderPhase 2Phase 2 initiated March 2016. Data are due 2H 201705/10/2016
CUR
0.29NSI-189Cognitive deficit in schizophreniaPhase 1bPhase 1b to be initiated 201612/26/2015
CUR
0.29NSI-566Motor deficits due to ischemic strokePhase 1/2Phase 2 portion of the trial to be initiated 201612/26/2015
CVM
0.44MultiklineHead and Neck cancerPhase 3Initiated Dec 2010. Full enrolment due to be completed 201601/09/2016
CYAD
43.71C-Cure - Chart 1 trialChronic Heart Failure secondary to ischemic cardiomyopathyPhase 3Phase 3 CHART-1 read-out due end of June 201603/15/2016
CYCC
5.27Sapacitabine (SEAMLESS)Acute myeloid leukemia - cancerPhase 3Noted mid-Dec 2014 that interim analysis suggests that trial will fail. Top-line data due around mid 201605/12/2016
CYCC
5.27SeliciclibCushing's diseasePhase 2Phase 2 ongoing12/26/2015
CYNA
16.48APL-130277 - CTH-300OFF episodes in patients with Parkinson’s diseasePhase 3Phase 3 top-line data due 2Q or 3Q 201606/01/2016
CYNA
16.48APL-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
8.99CK-2127107COPDPhase 2Phase 2 to be initiated 1H 201604/29/2016
CYTK
8.99Omecamtiv 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
8.99CK-2127107Spinal muscular atrophy (SMA)Phase 2Phase 2 initiated January 2016. Enrollment to be completed 2H 201604/29/2016
CYTK
8.99TirasemtivALSPhase 3Phase 3 initiated July 2015. Enrollment to be completed by end of 1H 201604/29/2016
CYTR
2.39Aldoxorubicin with doxorubicinSoft tissue sarcomas refractory cancerPhase 3Phase 3 PFS data due in July 2016 06/08/2016
CYTR
2.39AldoxorubicinUnresectable glioblastoma - cancerPhase 2Phase 2 overall survival data due 2H 2016. Updated interim data at ASCO 201604/21/2016
CYTR
2.39AldoxorubicinRelapsed/refractory small cell lung cancerPhase 2bPhase 2b data due 2H 201603/12/2016
CYTR
2.39AldoxorubicinCancer - AIDS-related Kaposi’s sarcomaPhase 2bPhase 2b ongoing12/26/2015
CYTX
2.00ECCS-50SclerodermaPhase 3Pivotal trial initiated August 2015. Enrolment completed June 2016. Data are due mid 201706/08/2016
CYTX
2.00ECCO-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 201605/11/2016
CYTX
2.00Cell Enriched AdiposeEarly stage female and male pattern hair lossPhase 2Enrolling01/24/2016
CYTX
2.00Cytori Cell Therapy Crohn’s DiseasePhase 2Announced mid-January 2016 that first patients have been enrolled01/20/2016
DBVT
29.92Viaskin Peanut Peanut allergyPhase 3Phase 3 data due 2H 201706/01/2016
DBVT
29.92Viaskin MilkCow’s milk protein allergy (CMPA)Phase 1/2Phase 1/2 data due 2H 201706/01/2016
DCTH
0.26Melphalan 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
0.26Melphalan Hepatic Delivery System (Melphalan HDS)Hepatocellular carcinoma (HCC) - cancerPhase 2Phase 2 ongoing12/26/2015
DCTH
0.26CHEMOSAT systemUnresectable metastatic ocular melanoma in the liverCRLCRL Sept 13 201309/15/2013
DEPO
19.67SEFELSAHot flashesCRLCRL May 31 201306/01/2013
DERM
30.05DRM04Primary axillary hyperhidrosisNDA filingPhase 3 data released June 2016. NDA filing 2H 201706/02/2016
DERM
30.05CimziaModerate-to-severe plaque psoriasis Phase 3Phase 3 data due by end of 1Q 201705/11/2016
DERM
30.05DRM01AcnePhase 2bPhase 2b data released May 2016. Phase 3 planned for 1H 201705/11/2016
DMPID
#N/AVAL-083Refractory glioblastomaPhase 2End of Phase 2 meeting completed May 2016. Phase 3 planned05/26/2016
DMTX
7.00DTX101hemophilia BPhase 1/2Phase 1/2 initial data due 2H 201606/01/2016
DNAI
2.07PNT2258 Richter's TransformationPhase 2Development suspended - June 201606/07/2016
DNAI
2.07PNT2258Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) - cancerPhase 2Discontinued following poor efficacy - June 201606/07/2016
DPRX
10.16LocilexMild infections of diabetic foot ulcersPhase 3Phase 3 top-line data are due 3Q 201705/17/2016
DRRX
1.24DUR-928 Nonalcoholic steatohepatitis (NASH)Phase 1bPhase 1b data due 2Q 201606/01/2016
DRRX
1.24RemoxyChronic painPDUFAPDUFA September 25 2016. Advisory Committee tentatively scheduled for August 5 201605/20/2016
DRRX
1.24POSIMIR -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
1.24ReldaySchizophreniaPhase 3Phase 3 to be initiated by ZGNX once partner is found03/01/2016
DSCI
4.01DSC127 Diabetic foot ulcersPhase 3Phase 3 trial stopped early due to lack of effiacy - November 201512/27/2015
DVAX
15.01AZD1419AsthmaPhase 2aPhase 2 trial to be initiated 2H 201606/01/2016
DVAX
15.01HEPLISAV-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
DYAX
0.00DX-2930Hereditary angioedema (HAE) Phase 3Phase 3 planned - company to be acquired by SPHG in 1H 201612/27/2015
EARS
4.00AM-111 HEALOS/ASSENTAcute inner ear hearing lossPhase 3Commenced HEALOS (EU) trial in November 2015.ASSENT trial (US) commenced June 2016. HEALOS data due 2H 2017 06/18/2016
EARS
4.00AM-111 REACHSurgery-induced hearing lossPhase 2Phase 2 trial (REACH) to begin enrollment in 1H 2017 pending funding06/02/2016
EARS
4.00AM-101Acute inner ear tinnitusPhase 3Phase 3 enrolment completed March 2016 with topline data due August 201605/12/2016
EBIO
2.29Isunakinra (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
2.29Isunakinra (EBI-005)Moderate to severe dry eye diseasePhase 3Phase 3 topline data showed endpoints not met mid May 201505/20/2015
EBS
30.65BioThrax Anthrax Vaccine AdsorbedApprovedApproved November 24 201512/27/2015
EBS
30.65Anthrax Immune Globulin Intravenous (Human) [AIGIV] AnthraxApprovedApproved March 25 201503/27/2015
ECYT
3.52EC1456Solid tumors - cancerPhase 1Phase 1 enrolling06/02/2016
EDAP
3.11 Ablatherm-HIFU (High Intensity Focused Ultrasound) Cancer - Low risk, localized prostate cancerApprovedApproved November 9 201512/27/2015
EDGE
9.81EG-1962Improving patient outcomes following an aneurysmal subarachnoid hemorrhage (aSAH)Phase 3Phase 3 planned for mid-201606/02/2016
EDTXF
0.68Polymyxin B Hemoperfusion (PMX)Endotoxemic septic shockPhase 3Phase 3 enrolment to be completed by end of June 201606/02/2016
EGLT
5.61Egalet-002Moderate to severe chronic painPhase 3Phase 3 ongoing. NDA planned for mid 201706/02/2016
EGLT
5.61ARYMO ER (Egalet-001)Abuse-Deterrent MorphinePDUFAPDUFA October 14 201603/01/2016
EGRX
39.40KANGIO (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
39.40Docetaxel InjectionBreast, non-small cell lung, prostate gastric adenocarcinoma, and head and neck cancerApprovedApproved December 24 201512/27/2015
EGRX
39.40RyanodexMalignant hyperthermia - cancerApprovedApproved July 22, 2014 under priority review07/24/2014
EGRX
39.40EP-3101 (bendamustine RTD) Chronic lymphocytic leukemia; Indolent non-Hodgkin's lymphoma - cancerApproved 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
18.79MYDICAR - CUPID 2 TrialIschemic or dilated cardiomyopathyPhase 2bPhase 2b negative data released April 2015. Formerly CLDN pre-merger03/23/2016
ELTP
0.32SequestOxModerate to severe painPDUFA priority reviewPDUFA July 14 2016 under priority review03/18/2016
ENDP
15.84OPANA ERManagement of painPDUFAAdvisory Committee Meeting planned for fall of 2016. PDUFA July 29 2016 will not be met.06/16/2016
ENDP
15.84XIAFLEXEdematous fibrosclerotic panniculopathy (“cellulite”)Phase 2bPhase 2b initiated February 2016 05/29/2016
ENDP
15.84BEMA 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
15.84XIAFLEXAdhesive Capsulitis (“Frozen Shoulder syndrome”)Phase 2bPhase 2 trial did not meet endpoint05/16/2015
ENDP
15.84AVEED (testosterone undecanoate) intramuscular injectionMen diagnosed with hypogonadismApprovedApproved March 6 201409/06/2013
ENTA
23.83ABT-493HCV Phase 2bPhase 2b ongoing. Data released November 2015. Phase 3 initiated12/27/2015
ENTA
23.83VIEKIRA PAKHCV - genotype 1ApprovedApproved December 19 201412/22/2014
EPIX
2.93EPI-506 Castrate resistant prostate cancerPhase 1/2Phase 1/2 trial initiated December 2015. Enrolment continues as of May 201606/02/2016
EPRS
0.54BOW015Rheumatoid Arthritis (RA)Phase 3Phase 3 trial suspended May 2016 due to cost-savings06/02/2016
EPZM
10.44Tazemetostat and TecentriqRelapsed or refractory diffuse large B-cell lymphoma (DLBCL)Phase 1bPhase 1b to be commence enrolment 2H 201606/23/2016
EPZM
10.44TazemetostatRelapsed or refractory B-cell NHL cancerPhase 2Phase 2 update at the American Society of Hematology (ASH) Meeting on Lymphoma Biology - June 18 201606/21/2016
EPZM
10.44TazemetostatAdult patients with mesothelioma characterized by BAP1 loss-of-functionPhase 2Phase 2 to be initiated 3Q 201605/10/2016
ESPR
16.90Bempedoic 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 201706/02/2016
ESPR
16.90Bempedoic acid (ETC-1002-035)Patients treated with high-dose statin therapyPhase 2Phase 2 (PK/PD) top-line data due 3Q 201605/05/2016
ESPR
16.90Bempedoic acidHypercholesterolemia - statin intolerancePhase 2Initiation of the Phase 3 efficacy study in patients with statin intolerance 4Q 201605/05/2016
ETRM
0.42VBLOCObesityApprovedApproved Jan 14, 201501/15/2015
EVOK
6.41EVK-001Female diabetic gastroparesisPhase 3Phase 3 data due 3Q 201605/04/2016
EXAS
11.09CologuardCancer - Colorectal DNA testApprovedApproved August 201408/16/2014
EXEL
7.85CABOMETYX (cabozantinib)Recurrent endometrial cancerPhase 2Phase 2 data due 201606/02/2016
EXEL
7.85Cabozantinib - CABOSUNFirst-Line RCC - cancerPhase 2Phase 2 data released May 201605/24/2016
EXEL
7.85XL184 cabozantinib (CELESTIAL)Advanced hepatocellular cancer (HCC)Phase 3Phase 3 initiated Sept 2013. Data due 201705/05/2016
EXEL
7.85CABOMETYX (cabozantinib)Metastatic renal cell cancer (RCC)ApprovedApproved April 25 2016.04/26/2016
EXEL
7.85VemurafenibBRAF V600 Mutation-Positive Advanced Melanoma - Cancer ApprovedApproved November 1012/27/2015
EYEG
2.95EGP-437 Ocular inflammation and pain post cataract surgery Phase 1/2Phase 1/2 interim data released June 201606/02/2016
EYEG
2.95EGP-437Non-infectious anterior uveitisPhase 3Phase 3 enrolment commenced January 2016. Top-line data due 1Q 201705/14/2016
FATE
1.83ProHema Adult hematologic malignanciesPhase 1/2Phase 1/2 enrolment commenced June 201606/21/2016
FATE
1.83ProHemaAcute graft-versus-host disease (GvHD) Phase 1/2Phase 1/2 trial to be initiated mid 201605/10/2016
FBIO
2.72Triplex vaccineCMV control in allogeneic stem cell transplant recipientsPhase 2Phase 2 data due 1H 201703/16/2016
FCSC
0.97FCX-007Recessive dystrophic epidermolysis bullosaPhase 1/2Phase 1/2 initiated June 201606/14/2016
FCSC
0.97azficel-T Chronic DysphoniaPhase 2Phase 2 endpoints not met - June 201606/09/2016
FGEN
16.17FG-3019Pancreatic cancer Phase 2Phase 2 ongoing06/02/2016
FGEN
16.17Roxadustat FG-4592Anemia in chronic kidney diseasePhase 3Phase 3 ongoing. Expects to file NDA in 2018 assuming positive data05/10/2016
FGEN
16.17FG-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
16.17FG-3019Duchenne muscular dystrophyPhase 2Phase 2 trial enrolment commenced January 201601/08/2016
FLKS
11.30FLX-787Multiple SclerosisPhase 2Phase 2 initiated June 201606/16/2016
FLML
10.00AkovazHypotensionApprovedAnnounced approval May 2 201605/03/2016
FLML
10.00Micropump 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
10.00VAZCULEP (phenylephrine hydrochloride)Clinically important hypotension resulting primarily from vasodilation in the setting of anesthesiaApprovedApproved June 30 201407/01/2014
FLML
10.00Bloxiverz (neostigmine methylsulfate)Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgeryApprovedApproved Jun 306/05/2013
FLXN
14.84Zilretta - FX006Osteoarthritis of the knee with type 2 adult diabetesPhase 2Phase 2 safety trial initiated April 201606/03/2016
FLXN
14.84Zilretta - FX006Osteoarthritis of the knee NDA filingNDA to be filed 4Q 201605/27/2016
FOLD
5.91Migalastat HCl monotherapy (012)Fabry DiseasePhase 3NDA filing delayed following meeting with FDA. Expects to meet with FDA in mid 2016 to discuss path forward05/04/2016
FOLD
5.91SD-101 Epidermolysis Bullosa (EB)Phase 3Phase 3 top-line data due 2H 2016 05/04/2016
FOLD
5.91ATB200Pompe DiseasePhase 1/2Phase 2 interim data due 201605/04/2016
FOMX
6.14FDX102ImpetigoPhase 2Phototoxicity study to be initiated later in 201606/03/2016
FOMX
6.14FDX103Papulopustular rosaceaPhase 2Phase 2 initiated October 2015. Enrolment completed May 2016. Top-line data due by the end of 201605/11/2016
FOMX
6.14FDX101AcnePhase 3Phase 3 dosing initiated May 2016. Data are due 1H 201705/10/2016
FOMX
6.14FDX104Acne-like rash in cancer patientsPhase 2Phase 2 data released December 201512/27/2015
FPRX
40.78FPA008 Pigmented Villonodular Synovitis (PVNS)Phase 1/2Phase 2 dose expansion phase to be initiated mid 201603/11/2016
FPRX
40.78FP-1039Mesothelioma cancerPhase 1bPhase 1b NSCLC halted, mesothelioma to continue01/11/2016
FWP
18.50FP187Multiple sclerosisPhase 3Phase 3 planned for 2H 201606/03/2016
GALE
2.15GALE-301/302Ovarian cancerPhase 2bPhase 2b to be initiated 2H 2016. GALE-301 Phase 2a primary analysis presented at ASCO 201606/06/2016
GALE
2.15NeuVax Ductal Carcinoma in Situ (DCIS)Phase 2Phase 2 planned06/03/2016
GALE
2.15NeuVax Gastric cancerPhase 2Phase 2 to be initiated 201606/03/2016
GALE
2.15NeuVax (E75) - PRESENTLow-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 201605/11/2016
GALE
2.15NeuVax 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
2.15GALE-401Essential Thrombocythemia (ET)Phase 2Phase 2 initiated September 2014. Top-line data released mid 2015.12/28/2015
GBIM
2.20GI-6301Chordoma cancerPhase 2Phase 2 initiated by NCI April 2015. Enrolling as of May 201605/13/2016
GBIM
2.20GS-4774 - 1401 trialChronic hepatitis B infectionPhase 2Phase 2 initiated by GILD in 2014. 24 week data showed no statistical improvement - May 2016. 48-week results are expected to be available 2H 2016. 05/13/2016
GBIM
2.20GI-6207Cancer - MTC (medullary thyroid cancer)Phase 2Phase 2 data due 2H 201605/13/2016
GBIM
2.20GI-4000Non-small cell lung cancerPhase 2Further development dependent on funding12/28/2015
GBIM
2.20GI-4000Colorectal cancer Phase 2Further development dependent on funding12/28/2015
GBIM
2.20GS-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
16.74GBT440Idiopathic pulmonary fibrosis (IPF)Phase 2aPhase 2a initiated June 201606/21/2016
GBT
16.74GBT440Sickle cell diseasePhase 1/2Phase 1/2 data from ongoing trial presented at EHA Annual Congress on June 10 201606/12/2016
GERN
2.75Imetelstat - IMerge StudyMyelodysplastic syndromesPhase 2Announced mid-January 2016 that Phase 2 dosing has been initiated. Internal review to be conducted 2H 201602/26/2016
GERN
2.75Imetelstat - IMbarkStudyMyelofibrosisPhase 2Phase 2 clinical hold lifted Nov 2014. Phase 2 initiated September 2015. Internal review to be conducted 2H 201602/26/2016
GLMD
4.91Aramchol - 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
4.91Aramchol - ARRIVE HIV-associated lipodystrophy and nonalcoholic fatty liver disease (NAFLD)Phase 2Phase 2 initiated dosing February 201603/02/2016
GLYC
7.06GMI-1271Acute myeloid leukemia (AML) - cancerPhase 2Phase 2 dosing initiated June 201606/07/2016
GLYC
7.06GMI-1070 (rivipansel)Vaso-occlusive crisis of sickle cell diseasePhase 3Phase 3 initiated June 201506/29/2015
GNCA
4.67GEN-003Genital herpesPhase 2bPhase 2 12 month data released March 2016. Phase 2b virologic efficacy data due 3Q 2016. 6-month efficacy data due late 201605/06/2016
GNCA
4.67GEN-004Universal vaccine candidate against pneumococcusPhase 2Topline data did not meet endpoints - September 201512/28/2015
GNVC
0.61CGF166Hearing lossPhase 1/2Trial halted January 2016 due to safety review. Enrolment to resume with trial completion due in 2017. 05/13/2016
GTXI
0.60Enobosarm Postmenopausal women with stress urinary incontinence (SUI)Phase 2Phase 2 initiated January 2016. Top-line data are due 201605/11/2016
GTXI
0.60Enobosarm Breast cancer - advanced AR+ TNBCPhase 2Phase 2 prelim data due by end of 201605/11/2016
GTXI
0.60Enobosarm Breast cancer - metastatic or locally advanced, ER+/AR+ breast cancerPhase 2Phase 2 prelim data due by end of 201605/11/2016
GWPH
89.14EpidiolexInfantile spasms (IS)Phase 3Phase 3 to be initiated 4Q 201606/22/2016
GWPH
89.14EpidiolexDravet SyndromeNDA filingTop line Phase 3 data released March 2016 met primary endpoint. NDA filing likely 1H 201705/06/2016
GWPH
89.14EpidiolexLennox-Gastaut syndrome (LGS)Phase 3First and Second Phase 3 trial data due June and 3Q 2016, respectively05/06/2016
GWPH
89.14EpidiolexTuberous Sclerosis ComplexPhase 3Phase 3 data due 2H 201705/06/2016
GWPH
89.14GWP42004Type 2 diabetesPhase 2Phase 2 data due late 2Q or early 3Q 201605/06/2016
GWPH
89.14SativexMultiple Sclerosis (MS) spasticityPhase 2Phase 2 data due 4Q 201605/06/2016
GWPH
89.14SativexCancer painPhase 3Phase 3 trials failed. Evaluating whether there are any next steps05/06/2016
GWPH
89.14GWP42006EpilepsyPhase 2Phase 2 initiated May 2015. Data due 1Q 201705/06/2016
GWPH
89.14GWP42003SchizophreniaPhase 2Phase 2 data released September 2015. Currently evaluating next steps05/06/2016
GWPH
89.14EpidiolexDravet SyndromePhase 3Second Phase 3 trial initiated mid April 2015. Topline data due 2H 201602/11/2016
HALO
9.19PEGPH20 Pancreatic cancer Phase 2Phase 3 dosing initiated March 2016. Phase 2 PFS data due 4Q 201606/05/2016
HALO
9.19PEGPH20 in Combination with docetaxelNon-small cell lung cancer (NSCLC)Phase 1bEnrolling as of 4Q 2015. On track to move to Phase 2 dose expansion stage in 2H 201605/10/2016
HALO
9.19PEGPH20 in combination with KEYTRUDANon-small cell lung cancer (NSCLC)Phase 1bPhase 1b initiated November 201512/28/2015
HALO
9.19HYQVIASubcutaneous treatment for patients with primary immunodeficiency (PI)ApprovedApproved Sept 12 201409/14/2014
HRTX
18.14HTX-019Prevention of chemotherapy-induced nausea and vomiting (CINV)NDA filingNDA filing due 2H 201606/04/2016
HRTX
18.14HTX-011Inguinal hernia repairPhase 2Phase 2 intiated June 2015. Data due late 2Q 201605/06/2016
HRTX
18.14APF530 - 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
HSGX
1.83NeoCartCartilage defects in the kneePhase 3Phase 3 enrolment due to be completed 2Q 2017. 05/13/2016
HTBX
0.80HS-410Bladder cancerPhase 2Phase 2 data due 4Q 2016. Announced February 2016 that they will no longer enroll new patients in the monotherapy trial arm06/04/2016
HTBX
0.80HS-110Non-small cell lung cancer (NSCLC)Phase 1bPhase 1b topline data due 4Q 201606/04/2016
HZNP
17.44ACTIMMUNEFriedreich's Ataxia (FA)Phase 3Phase 3 data due by the end of 201605/06/2016
ICPT
154.26Obeticholic acid (OCA)Primary biliary cirrhosis (PBC) - POISEApprovedApproved May 27 2016. 05/29/2016
ICPT
154.26Obeticholic acid (OCA)Primary Sclerosing Cholangitis (PSC)Phase 2Phase 2 enrolment to be completed by the end of 201605/06/2016
ICPT
154.26Obeticholic acid (OCA) - REGENERATEAdult nonalcoholic steatohepatitis (NASH) patients. Phase 3FLINT trial stopped early due to strong efficacy Jan 2014. Phase 3 initiated September 2015. Enrolment to be completed 1H 201705/06/2016
IDRA
1.53IMO-8400Waldenström’s MacroglobulinemiaPhase 1/2Phase 2 data due 1H 201705/10/2016
IDRA
1.53IMO-8400Diffuse Large B-cell Lymphoma (DLBCL) Phase 1/2Phase 2 data due 1H 201705/10/2016
IDRA
1.53IMO-8400DermatomyositisPhase 2Phase 2 initiated November 2015. Enrolment to be completed 1H 201705/10/2016
IDRA
1.53IMO-2125Cancer - melanomaPhase 1/2Phase 1/2 trial initiated December 201512/28/2015
IMDZ
8.30CMB305 Cancer - solid tumorsPhase 2Phase 2 first analysis due 4Q 201605/11/2016
IMGN
3.32IMGN529 and rituximabCancer - diffuse-large B-cell lymphoma (DLBCL)Phase 2Phase 2 initiated 201606/04/2016
IMGN
3.32Mirvetuximab 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 endpoint. Meeting with FDA 3Q 2016 with trial initiation 4Q 2016.05/19/2016
IMGN
3.32Coltuximab ravtansine Cancer - diffuse-large B-cell lymphoma (DLBCL)Phase 2Phase 2 to be initiated 2H 201601/30/2016
IMGN
3.32Kadcyla KRISTINE trialHER2-positive breast cancer - neo-adjuvant settingPhase 3Phase 3 data due 201601/30/2016
IMGN
3.32Anetumab ravtansineMesotheliomaPhase 2Phase 2 ongoing01/27/2016
IMGN
3.32Kadcyla GATSBY trialCancer - metastatic HER2+ gastric cancer Phase 3Endpoint not met - October 201512/28/2015
IMGN
3.32Kadcyla (KAITLIN) HER2-positive breast cancer - adjuvant usePhase 3Phase 3 enrolling01/31/2015
IMGN
3.32Kadcyla (KATHERINE).HER2-positive breast cancer - residual invasive diseasePhase 3Phase 3 enrolling01/31/2015
IMMU
2.50SACITUZUMAB GOVITECANNon-small cell lung cancer (NSCLC)) Phase 2Phase 2 update provided at ASCO June 201606/07/2016
IMMU
2.50SACTUZUMAB GOVITECAN (IMMU-132) Cancer - metastatic triple-negative breast cancerPhase 2Phase 3 trial planned towards end of 2016 under SPA06/04/2016
IMMU
2.50Labetuzumab govitecanMetastatic colorectal cancer (mCRC)Phase 2Phase 2 interim data presented April 201604/19/2016
IMMVF
0.52DPX-Survivac and low-dose cyclophosphamide and epacadostatRecurrent ovarian cancerPhase 1bPhase 1b to be initiated 2Q 201606/04/2016
IMUC
0.24ICT-107 dendritic cell vaccineGlioblastoma antigens and cancer stem cellsPhase 3Phase 2b failed to meet primary endpoint. Phase 3 initiated dosing June 201606/08/2016
INCY
81.66Epacadostat with Keytruda - ECHO-301Cancer - first-line metastatic melanoma.Phase 3Phase 3 initiated June 2016. Initial data due 201806/23/2016
INCY
81.66RuxolitinibGraft versus host diseasePhase 3Phase 3 to be initiated 2H 201605/10/2016
INCY
81.66RuxolitinibColorectal cancerPhase 2Phase 2 trial stopped January 2016 due to lack of efficacy01/28/2016
INCY
81.66BaricitinibRheumatoid arthritisNDA filingAnnounced January 19 2016 that their NDA filing has been submitted by partner Eli Lilly 01/20/2016
INCY
81.66RuxolitinibBreast CancerPhase 2Phase 2 data due 201601/12/2016
INCY
81.66INCB39110 and TagrissoSecond-line EGFR mutation-positive non-small cell lung cancer (NSCLC)Phase 1/2Phase 1/2 planned01/12/2016
INCY
81.66EpacadostatCancer - OvarianPhase 2Ongoing12/28/2015
INCY
81.66Ruxolitinib cream Topical treatment of alopecia areataPhase 2Phase 2 initiated October 201512/28/2015
INCY
81.66Ruxolitinib Non-small cell lung cancer (NSCLC)Phase 2Phase 2 ongoing12/28/2015
INCY
81.66Jakafi (ruxolitinib) (RESPONSE)Polycythemia VeraApprovedApproved December 4 201412/05/2014
INFI
1.30Duvelisib (IPI-145) DYNAMOIndolent non-Hodgkin lymphomaPhase 2Phase 2 data released June 2016 - short of expectations06/15/2016
INFI
1.30Duvelisib - ConetempoTreatment-naïve patients with follicular lymphomaPhase 1b/2Phase 1/2 initial data due at the 21st Congress of European Hematology Association June 9 - 12, 201605/20/2016
INFI
1.30Duvelisib - DUOCancer - relapsed/refractory chronic lymphocytic leukemia (CLL)Phase 3Phase 3 enrolment completed November 2015. Interim analysis due early 2H 201605/05/2016
INFI
1.30Duvelisib and venetoclaxRelapsed or refractory CLL, small lymphocytic lymphoma, iNHL or aggressive NHLPhase 1b/2Phase 1b/2 trial initiated 1H 201605/05/2016
INNL
5.50XaraColl Post-operative painNDA filingNDA filing due later in 201606/04/2016
INNL
5.50CogenziaDiabetic foot ulcer infectionsPhase 3Data due 3Q or early 4Q 201606/24/2016
INO
9.85VGX-3100Cervical dysplasiaPhase 3Phase 3 to be initiated 201605/10/2016
INSM
10.28ARIKAYCENon-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 201605/06/2016
INSM
10.28ARIKAYCECystic fibrosisPhase 3 Phase 3 Euro data released 1 July 2013. Met endpoint but slighly inferior data to competition07/02/2013
INSY
13.07CannabidiolEpilepsyPhase 3Phase 3 to be initiated 2H 201606/04/2016
INSY
13.07BuprenorphineAcute pain in patients undergoing a bunionectomy procedurePhase 3Phase 3 data due 2016.06/04/2016
INSY
13.07Dronabinol Oral SolutionAIDS-related anorexia PDUFAPDUFA April 1 2016 extended to July 1 201603/23/2016
INSY
13.07Pharmaceutical Cannabidiol (CBD)Infantile spasms (IS)Phase 2Phase 2 enrolment initiated February 201602/10/2016
IONS
23.60NusinersenCHERISH - Children with spinal muscular atrophy (SMA). ENDEAR trial - nusinersen in infants with spinal muscular atrophy SMAPhase 3Phase 3 CHERISH and ENDEAR data due 1H 201706/04/2016
IONS
23.60IONIS-TTRRxNEURO-TTR - familial amyloid polyneuropathy (FAP).Phase 3Phase 3 to be completed in 1H 201705/27/2016
IONS
23.60IONIS-TTRRxCARDIO-TTR - Cardiomyopathy form of TTR amyloidosis.Phase 2Partner GSK announced May 2016 decision not to be proceed with Phase 3 outcome trial05/27/2016
IONS
23.60IONIS-DMPK-2.5RxMyotonic Dystrophy Type 1 (DM1)Phase 1/2Phase 1/2 ongoing04/07/2016
IONS
23.60Volanesorsen - APROACHFamilial chylomicronemia syndrome (FCS)Phase 3Phase 3 enrolment completed04/07/2016
IONS
23.60IONIS-STAT3-2.5RxCancerPhase 2Phase 2 data due 201604/07/2016
IONS
23.60IONIS-STAT3-2.5RxCancerPhase 2Phase 2 data due 201604/07/2016
IONS
23.60IONIS-FXIRxEnd-stage renal diseasePhase 2Phase 2 data due 201604/07/2016
IONS
23.60IONIS-APO(a)RxHigh lipoprotein(a), or Lp(a)Phase 2Phase 2 data released 3Q 201512/29/2015
IONS
23.60IONIS-GCGRRxType 2 diabetesPhase 2Phase 2 ongoing12/29/2015
IONS
23.60VolanesorsenFamilial partial lipodystrophy (FPL)Phase 3Phase 3 initiated November 201512/29/2015
IONS
23.60VolanesorsenPartial lipodystrophy rapidlyPhase 3Phase 3 initiated November 201512/29/2015
IONS
23.60IONIS-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
30.33IPX066Parkinson's ApprovedApproved Jan 8 201501/09/2015
IRWD
12.95Linaclotide 72 mcg dose for use in the treatment of adults with Chronic idiopathic constipation (CIC)sNDAPDUFA date early 201706/10/2016
IRWD
12.95 IW-3718 Gastroesophageal reflux disease (GERD) Phase 2bPhase 2b initiated March 2016. Data are due in 201706/04/2016
IRWD
12.95Linaclotide Colonic ReleaseIrritable Bowel Syndrome with Constipation (IBS-C)Phase 2bPhase 2b data due 2H 201606/04/2016
ITCI
37.74ITI-007-302SchizophreniaPhase 3Phase 3 enrolment to be completed 2Q 2016. Data due mid 201606/04/2016
ITCI
37.74ITI-007 Bipolar depressionPhase 3Phase 3 ongoing02/26/2016
ITEK
7.61RabodenosonPrimary open-angle glaucoma (POAG)Phase 3Phase 3 initiated October 2015. Top-line data due 4Q 201605/12/2016
ITEK
7.61Trabodenoson and latanoprostGlaucomaPhase 2Phase 2 to be initiated 2H 201605/12/2016
JUNO
43.70JCAR015Relapsed/ refractory B cell acute lymphoblastic leukemia - cancerPhase 2Phase 2 initiated 3Q 201512/29/2015
JUNO
43.70JCAR017r/r B cell non-Hodgkin lymphoma - cancerPhase 1/2Phase 1 initiated 3Q 201512/29/2015
KERX
6.20AuryxiaIron 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
6.20AuryxiaHyperphosphatemiaApprovedApproved Sept 5 201409/07/2014
KITE
53.11KTE-C19 (ZUMA-1)Refractory Non-Hodgkin's Lymphoma (NHL) - cancerPhase 2 Phase 2 pivotal initiated November 2015. Interim data due 2H 2016 with BLA filing due late 201605/10/2016
KITE
53.11KTE-C19 (ZUMA-4)Pediatric and young adult patients with r/r ALL - cancerPhase 1/2 Phase 1/2 initated December 2015. Enrolling as of June 201612/29/2015
KITE
53.11KTE-C19 (ZUMA-3) Adult patients with r/r ALL - cancerPhase 1/2 Phase 1/2 pivotal trial initiated December 201512/29/2015
KITE
53.11KTE-C19 (ZUMA-2)Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL) - cancerPhase 2 Phase 2 pivotal initiated November 201512/29/2015
KMDA
3.68KamRABProphylaxis of rabies diseasePhase 3BLA filing due mid 201606/04/2016
KMDA
3.68Inhaled formulation of AATAATD - Alpha-1 Antitrypsin deficiencyPhase 2Top-line data due mid 201606/04/2016
KMDA
3.68Alpha-1 antitrypsin (AAT)Prevention of lung transplant rejectionPhase 2Phase 2 initiated April 201604/07/2016
KMDA
3.68Alpha-1 antitrypsin (AAT)Graft Versus Host Disease (GvHD)Phase 1/2Phase 1/2 interim data reported January 201601/09/2016
KMDA
3.68GlassiaPediatric patients newly diagnosed with type 1 diabetesPhase 2/3Phase 2/3 initiated Mar 201403/06/2014
KMPH
4.40KP201/APAP Acute pain.CRLCRL issued November 201506/14/2016
KPTI
8.03Selinexor - STORMQuadruple Refractory Multiple MyelomaPhase 2Phase 2 top-line data due mid 201606/17/2016
KPTI
8.03Selinexor - SEALDedifferentiated liposarcomaPhase 2/3Phase 2/3 trial initiated January 2016. Data from Phase 2 portion of trial due mid 201705/10/2016
KPTI
8.03Selinexor - STOMPMultiple myelomaPhase 1/2Phase 1/2 data due late 201605/10/2016
KPTI
8.03Selinexor - SADAL Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2bPhase 2b initiated Dec 2014. Preliminary topline data due early 201705/10/2016
KPTI
8.03Selinexor SOPRACancer - Relapsed/Refractory Acute Myeloid Leukemia (AML)Phase 2Phase 2 initiated June 25 2014. Preliminary topline data due late 2016 with top-line data due mid 201705/10/2016
KPTI
8.03SelinexorCancer - Advanced Gynecologic Malignancies (SIGN Study)Phase 2Phase 2 initiated April 2014. Interim data at ASCO 201505/13/2015
KPTI
8.03Selinexor - (KING study)Cancer - glioblastoma Phase 2Phase 2 initiated April 2014. Interim data at ASCO 201505/13/2015
KPTI
8.03Selinexor - SIRRTRichter's transformation Phase 2Phase 2 initiated November 201411/11/2014
KPTI
8.03Selinexor - SHIPCancer - hormone-refractory prostate cancer (HRPC)Phase 2Phase 2 initiated June 201406/10/2014
KTOV
3.81KIT-302Osteoarthritis and HypertensionNDA filingNDA filing to be submitted by the end of 201605/13/2016
KURA
2.69TipifarnibLower risk myelodysplastic syndromes (MDS) - cancerPhase 2Phase 2 dosing commenced June 201606/18/2016
KURA
2.69TipifarnibHRAS mutant solid tumors - cancerPhase 2Phase 2 top-line data due 2H 201606/18/2016
KURA
2.69TipifarnibRelapsed or refractory peripheral T-cell lymphomaPhase 2Phase 2 enrolling06/18/2016
KURA
2.69TipifarnibChronic myelomonocytic leukemia (CMML) - cancerPhase 2Phase 2 to be initiated 2H 201606/18/2016
LBIO
8.26LN-144Refractory metastatic melanomaPhase 2Phase 2 continues to enrol as of May 201605/10/2016
LBIO
8.26LN-145Cervical cancer, and head and neck squamous cell carcinomaPhase 2Phase 2 planned for initiation by the end of 201605/10/2016
LIFE
2.94ResolarisLimb girdle muscular dystrophy (LGMD) 2BPhase 1b/2Phase 1b/2 data due 4Q 201605/12/2016
LIFE
2.94ResolarisAdult patients with facioscapulohumeral muscular dystrophy (FSHD)Phase 1b/2Phase 1b/2 data released March 201603/31/2016
LIFE
2.94ResolarisInterstitial lung disease (ILD)Phase 1b/2Decision to be made whether to initiate trial by end of 201601/12/2016
LJPC
18.47LJPC-501Catecholamine-resistant hypotension (CRH).Phase 3Phase 3 initiated late March 2015 under SPA. Data due by end of 201605/08/2016
LJPC
18.47GCS-100Chronic kidney diseasePhase 2Phase 2b initiated mid March 201503/22/2015
LNTH
2.70flurpiridaz F 18Coronary artery disease (CAD)Phase 3First Phase 3 trial complete. Partner required for second Phase 3 trial01/08/2016
LOXO
24.06LOXO-101Solid tumors that harbor a TRK fusion.Phase 2Phase 2 basket trial initiated October 2015. Enrolment updated due 2H 201605/05/2016
LPCN
7.19LPCN 1111Oral testosterone productPhase 2aPhase 2b initiated January 201606/04/2016
LPCN
7.19LPCN 1107 Prevention of preterm birth ("PTB").PK study completed February 201602/17/2016
LPCN
7.19LPCN 1021Men with low testosterone (Low T)PDUFAPDUFA June 28 201612/29/2015
LPTN
2.36iSONEPWet-AMDPhase 2Phase 2 trial did not meet endpoints12/29/2015
LPTN
2.36ASONEPRenal cell carcinoma (RCC)Phase 2aPhase 2a failed to meet primary endpoint late March 201503/25/2015
LXRX
13.93Telotristat etiprateCarcinoid SyndromePDUFA Priority ReviewPDUFA November 30, 2016 under priority review06/01/2016
LXRX
13.93SotagliflozinType 1 DiabetesPhase 3Phase 3 data due 2H 201605/04/2016
LXRX
13.93SotagliflozinType 2 DiabetesPhase 3Phase 3 trial to be initiated by the end of 201605/04/2016
MACK
6.12ONIVYDECancer - HER2-negative gastric cancerPhase 3Phase 3 planned06/04/2016
MACK
6.12MM-141Cancer - front line pancreatic cancerPhase 2Phase 2 data due 201805/03/2016
MACK
6.12ONIVYDECancer - front line pancreaticPhase 2Phase 2 initiated October 2015. Data due 201705/03/2016
MACK
6.12MM-121Cancer - Heregulin Positive Non-Small Cell Lung CancerPhase 2Phase 2 initiated mid Feb 2015. Data due 201805/03/2016
MACK
6.12MM-302 HERMIONECancer - HER2-positive locally advanced or metastatic breast cancerPhase 2Phase 2 initiated August 2014. Data due 201705/03/2016
MACK
6.12ONIVYDECancer - second line pancreaticApprovedApproved October 22 2015 12/29/2015
MATN
0.72CA4P Fosbretabulin Platinum-Resistant Ovarian CancerPhase 2/3Phase 2/3 trial to commence 2Q 201606/05/2016
MATN
0.72CA4P with PazopanibOvarian cancerPhase 2Phase 2 to commence 2Q 201606/05/2016
MATN
0.72OXi4503 Acute myeloid leukemia (AML)Phase 1b/2Initiated October 2015. Data due 201612/31/2015
MATN
0.72CA4P FosbretabulinGastrointestinal neuroendocrine tumors - cancerPhase 2Phase 2 initiated Sept 2014. Interim data released October 2015. Full data due 2H 201612/31/2015
MBRX
6.99AnnamycinAcute myeloid leukemia (AML) - cancerPhase 2 Phase 2 planned06/03/2016
MCRB
30.37SER-109Recurrent C. Difficile infectionPhase 2Phase 2 data due mid 2016. Phase 3 to be initiated 2H 201605/17/2016
MCRB
30.37SER-287 Mild-to-Moderate Ulcerative ColitisPhase 1bPhase 1b initiated December 2015. Enrolment ongoing as of May 201605/17/2016
MCUR
1.31CureXcellDiabetic Foot UlcersPhase 3Phase 3 data fail October 201512/29/2015
MCUR
1.31CureXcellVenous Leg Ulcers Phase 3Phase 3 endpoint not met August 201512/29/2015
MDCO
34.54CARBAVANCESerious Bacterial Infections Due to Gram-Negative BacteriaPhase 3Phase 3 ongoing. 06/04/2016
MDCO
34.54ALN-PCSscAtherosclerotic cardiovascular disease (ASCVD)Phase 2Phase 2 initiated January 201601/12/2016
MDCO
34.54CangrelorReduction 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
34.54RAPLIXAHemostasisApprovedApproved April 30 201505/02/2015
MDCO
34.54IONSYSAcute postoperative painApprovedApproved April 30 201505/02/2015
MDCO
34.54OritavancinABSSSIApprovedApproved August 6 2014 under priority review08/10/2014
MDGN
5.73NFC-1 - SAGAmGluR mutation positive ADHD Phase 2/3Phase 2/3 initiated June 2016. Initial top-line data are due 2H 201606/18/2016
MDGN
5.73MDGN-201 -TARGTEPOESRD patients who are undergoing peritoneal dialysisPhase 2Enrolling12/29/2015
MDVN
59.26EnzalutamideMetastatic hormone-sensitive prostate cancer (mHSPC)Phase 3Phase 3 initiated January 201606/04/2016
MDVN
59.26EnzalutamideEstrogen receptors and progesterone receptors (ER/PgR)+ BC - cancerPhase 2Phase 2 data due 2H 201606/04/2016
MDVN
59.26Enzalutamide - PROSPERNon-metastatic Castrate-resistant Prostate Cancer (CRPC)Phase 3Phase 3 enrolment to be completed mid 201706/04/2016
MDVN
59.26Talazoparib - EMBRACA BRCA-mutated breast cancer Phase 3Phase 3 data due 1H 201706/04/2016
MDVN
59.26Enzalutamide Triple-negative breast cancer (TNBC)Phase 2Phase 3 to be initiated 4Q 201606/03/2016
MDVN
59.26Enzalutamide cf Bicalutamide STRIVE trialProstate cancerPDUFAPDUFA October 22 2016 for sNDA 02/23/2016
MDVN
59.26EnzalutamideHepatocellular carcinomaPhase 2Phase 2 initiated by Astellas in May 201512/29/2015
MDVN
59.26PidilizumabCancer - relapsed or refractory diffuse large B-cell lymphoma (DLBCL)Phase 2 Phase 2 Pivotal initiated December 201512/29/2015
MDVN
59.26XTANDICancer - mCRPC who have not received chemotherapyApprovedApproved Sept 10 201409/11/2014
MDVN
59.26Enzalutamide - EMBARKNon-metastatic prostate cancerPhase 3Phase 3 initiated January 2015
MDWD
8.00NexoBridSevere burnsPhase 3Phase 3 initiated mid April 2015. Data due 1H 201706/04/2016
MDWD
8.00EscharEx 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
MEIP
1.34Pracinostat in combination with VidazaElderly patients with newly diagnosed acute myeloid leukemia (AML)Phase 2Phase 3 is planned for 2H 201606/04/2016
MEIP
1.34Pracinostat 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
MESO
3.99MPC-150-IMChronic heart failure (CHF)Phase 3Phase 3 data due 2H 201706/14/2016
MESO
3.99MSC-100-IV acute graft versus host disease (aGVHD) in childrenPhase 3Ongoing06/04/2016
MESO
3.99MPC-06-IDChronic low back painPhase 3Ongoing06/04/2016
MESO
3.99MPC-300-IVRheumatoid arthritisPhase 2Phase 2 data from both two cohorts due 3Q 201606/04/2016
MGNX
26.39Margetuximab in combination with pembrolizumabGastric cancerPhase 1/2Phase 1/2 initiated 1Q 201606/04/2016
MGNX
26.39Margetuximab SOPHIA studyMetastatic breast cancerPhase 3Phase 3 enrolling. Completion of trial expected in 201805/05/2016
MIRN
4.26MRX34Melanoma - cancerPhase 2Phase 2 to be initiated in 201605/13/2016
MIRN
4.26MRX34Renal cell carcinoma (RCC) - cancerPhase 2Phase 2 to be initiated in 201605/13/2016
MNKD
1.24AFREZZA Type 1/2 diabetesApprovedApproved June 27 201406/28/2014
MNOV
7.11MN-166Amyotrophic lateral sclerosis (ALS)Phase 2Phase 2 interim data released April 201604/21/2016
MNOV
7.11MN-001NASH (nonalcoholic steatohepatitis)Phase 2Phase 2 planned12/29/2015
MNOV
7.11MN-166Progressive multiple sclerosis (progressive MS)Phase 2bEnrolment completed May 2015. Interim analysis due fall of 201606/13/2015
MNOV
7.11MN-166Opioid dependence Phase 2Phase 2 data released August 201408/19/2014
MNTA
10.97Necuparanib Advanced metastatic pancreatic cancerPhase 2Topline data due 2H 201706/04/2016
MNTA
10.97Generic CopaxoneMultiple sclerosisApprovedFiled 2007. Approved April 16 201504/17/2015
MRNS
1.43GanaxoloneFocal onset seizuresPhase 3Phase 3 data did not meet endpoints - June 201606/14/2016
MRNS
1.43GanaxolonePCDH19Phase 2Phase 2 data due mid 201605/03/2016
MRNS
1.43GanaxoloneFragile X SyndromePhase 2Phase 2 data due 2Q 2016 - noted May 2 2016 that data are due in the upcoming weeks05/03/2016
MRTX
6.46Mocetinostat and durvalumabNon-small cell lung cancer (NSCLC)Phase 2Phase 2 combination trial to be initiated 2Q 201605/06/2016
MRTX
6.46Glesatinib (MGCD265)Non-small cell lung cancer (NSCLC) patients with driver alterations in METPhase 2Phase 2 initiated December 2015. Initial data due by end of 201603/10/2016
MRUS
7.86MCLA-128HER2-expressing solid tumorsPhase 1/2Phase 1/2 top-line data due 2H 201705/28/2016
MRUS
7.86MCLA-117Acute myeloid leukemia (AML)Phase 1/2Phase 1/2 initiated May 201605/28/2016
MSTX
0.46ANX-188 - VepoloxamerSickle cell diseasePhase 3Phase 3 database lock due in July with top-line data due shortly thereafter 06/07/2016
MSTX
0.46AIR001Heart failure with preserved ejection fraction (HFpEF)Phase 2Phase 2 100 patient trial expected to begin in 3Q 201605/08/2016
MSTX
0.46ANX-188 - VepoloxamerHeart Failure Phase 2Phase 2 initiated October 201512/29/2015
NAVB
0.66LymphoseekRheumatoid arthritisPhase 1/2Phase 1/2 to be initiated 2H 201605/18/2016
NAVB
0.66LymphoseekUterine Cervical NeoplasmsPhase 2Phase 2 enrolment commenced February 201602/12/2016
NAVB
0.66NAV4694Predicting Progression to Alzheimer's Disease (AD) in Subjects With Mild Cognitive Impairment (MCI)Phase 3Phase 3 - seeking partner to continue development12/29/2015
NAVB
0.66NAV5001 Imaging Agent for Parkinson’s DiseasePhase 3Phase 3 initiated Dec 2013. Ongoing12/29/2015
NAVB
0.66LymphoseekHead and Neck CancerApprovedApproved Jun 13 201406/14/2014
NBIX
44.59Elagolix 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 201705/06/2016
NBIX
44.59NBI-98854 (Valbenazine)Tourette syndromePhase 2Phase 2 data due by end of 201605/06/2016
NBIX
44.59NBI-98854 (Valbenazine)Tardive dyskinesiaNDA FilingPhase 3 initiated Oct 2014. Data released October 2015. NDA filing due 201605/06/2016
NBIX
44.59Elagolix Uterine FibroidsPhase 3Phase 3 initiated by partner Abbvie in January 201601/29/2016
NBRV
7.27Lefamulin Moderate to severe Community Acquired Bacterial Pneumonia (CABP)Phase 3Phase 3 topline data from two trials due 2H 201705/12/2016
NBY
2.61Auriclosene (NVC-422)Viral conjunctivitisPhase 2bData released August 2014. Endpoints not met08/21/2014
NDRM
16.84ND0612HSevere Parkinson's DiseasePhase 2Pharmacokinetic (PK) dose finding (EU) topline results due 2Q 201605/27/2016
NDRM
16.84ND0612LModerate Parkinson's DiseasePhase 3Phase 3 planned for 3Q 201605/27/2016
NEOS
16.84Adzenys XR-ODTAttention deficit hyperactivity disorder (ADHD)ApprovedApproved January 27, 201601/28/2016
NEOS
16.84Cotempla XR-ODTAttention deficit hyperactivity disorder (ADHD)CRLCRL issued November 201501/08/2016
NEOT
1.09LIPO-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 201705/13/2016
NERV
10.80MIN-117Major Depressive DisorderPhase 2aPhase 2a data released May 2016. Endpoints met.05/27/2016
NERV
10.80MIN-101SchizophreniaPhase 2bPhase 2b data released May 2016. Endpoints met.05/27/2016
NERV
10.80MIN-202Primary insomniaPhase 2aPhase 2 data released January 201601/12/2016
NKTR
15.54FovistaWet-AMDPhase 3Phase 3 data due 2H 201606/04/2016
NKTR
15.54Inhaled Amikacin Solution (BAY41-6551T)Gram-Negative Pneumonia (INHALE 1)Phase 3Phase 3 data due early 201706/04/2016
NKTR
15.54Cipro DPI BronchiectasisPhase 3Phase 3 data due 2H 201606/04/2016
NKTR
15.54NKTR-181 Lower back painPhase 3Phase 3 initiated late Feb 2015. Data due early 201705/04/2016
NKTR
15.54NKTR-214Solid tumors - cancerPhase 1/2Phase 1/2 initial topline data due 2H 201605/04/2016
NKTR
15.54ADYNOVATEHemophilia A - pediatric indicationsNDAFDA filing submitted February 2503/03/2016
NKTR
15.54Etirinotecan pegol NKTR-102 (BEACON)Cancer - Metastatic Breast CancerPhase 3Phase 3 topline data mid March 2015 did not reach primary endpoint03/21/2015
NKTR
15.54ADYNOVATEHemophilia A ApprovedApproved November 16 201512/02/2014
NKTR
15.54MOVANTIK (Naloxegol)Opioid-induced constipation (OIC)ApprovedApproved Sept 16 201409/17/2014
NLNK
11.24Indoximod + gemcitabine and nab-paclitaxelPancreatic cancerPhase 2Enrolling as of May 201606/05/2016
NLNK
11.24Indoximod + temozolomideGlioblastoma multiforme cancerPhase 2Enrolling as of May 201606/05/2016
NLNK
11.24Indoximod + ipilimumab and PD-1 inhibitorsMelanoma - cancerPhase 2Enrolling as of May 201606/05/2016
NLNK
11.24Tergenpumatucel-LNon-small cell lung cancer (NSCLC)Phase 2Enrolling06/04/2016
NLNK
11.24Dorgenmeltucel-LMelanoma - cancerPhase 2Ongoing06/04/2016
NLNK
11.24HyperAcute Pancreas - IMPRESSSurgically resected pancreatic cancerPhase 3Phase 3 failed to meet primary endpoint - May 201605/10/2016
NLNK
11.24Sipuleucel-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
11.24HyperAcute Pancreas - PILLARPancreatic cancerPhase 3Phase 3 enrolment completed December 201512/29/2015
NLNK
11.24Indoximod + taxaneBreast cancerPhase 2Phase 2 enrolment goal reached December 201512/29/2015
NRXGQ
0.09PyridorinDiabetic nephropathyPhase 3Enrolment halted - Chapter 11/seeking sale of company06/05/2016
NTEC
4.62AP-CDLD Advanced Parkinson's Disease Phase 3Phase 3 initiated April 201604/05/2016
NVAX
6.91RSV vaccine - prepare trialRespiratory Syncytial Virus (RSV) in healthy pregnant women - protect infants via maternal immunizationPhase 3Phase 3 initiated December 2015. Expected to take 2-4 years to complete06/05/2016
NVAX
6.91RSV vaccine - Resolve trialRespiratory Syncytial Virus (RSV) in older adultsPhase 3Phase 3 data due 3Q 201605/26/2016
NVAX
6.91RSV F Vaccine rollover trial Respiratory Syncytial Virus (RSV) in older adultsPhase 2Phase 2 data due 2H 201605/05/2016
NVCR
10.96Tumor Treating Fields (TTFields) - PANOVAPancreatic cancerPhase 2Phase 2 enrolment completed May 2016. Data due 201706/05/2016
NVCR
10.96Tumor Treating Fields (TTFields) - INNOVATEOvarian cancerPhase 2Phase 2 enrolment to be completed by end of 2016. 06/05/2016
NVCR
10.96Tumor Treating Fields (TTFields) METISBrain Metastases - cancerPhase 2Phase 3 to be initiated 201606/05/2016
NVCR
10.96Tumor Treating Fields (TTFields) LUNARNon-small cell lung cancer (NSCLC)Phase 2Phase 3 to be initiated 201606/05/2016
NVCR
10.96Tumor Treating Fields (TTFields) STELLARMesotheliomaPhase 2Phase 2 enrolment commenced February 2015. Enrolment expected to be completed 201706/05/2016
NVCR
10.96Optune systemGlioblastoma - cancerPMA supplement application filed December 22 201501/08/2016
NVIV
6.91Neuro-Spinal ScaffoldComplete Thoracic AIS A Spinal Cord InjuryPhase 3Enrollment to be completed by end of 2016. HDE (Humanitarian Device Exemption) submission due in 2017. 04/27/2016
NVLS
4.27N91115Cystic FibrosisPhase 2Phase 2 data from second trial due 1H 201706/05/2016
NVLS
4.27N91115Cystic FibrosisPhase 2Phase 2 initiated December 2015. 50 percent enroled as of April 2016. Data due 4Q 201606/05/2016
NWBO
0.69DCVaxSolid tumor cancersPhase 1/2Phase 1 part of trial completed. Phase 2 part planned06/05/2016
NWBO
0.69DCVaxCancer - Glioblastoma multiforme (GBM) brain cancerPhase 3As of December 2015, 300 of the total 348 planned patients had been recruited. Enrollment has been temporarily suspended. Suspension remains as of May 2016.05/03/2016
NYMX
2.91NX-1207 long-term NX03-0040 trialLow grade localized prostate cancerPhase 2Data released February 2016 met endpoint02/10/2016
NYMX
2.91NX-1207BPHPhase 3Phase 3 endpoints met in extension trial July 2015. Filing planned12/30/2015
OASM
3.60Paclical/Apealea Epithelial ovarian cancerPhase 3Phase 3 data released April 2016. NDA filing planned04/28/2016
OCRX
1.98OCR-002 (IV)Hepatic encephalopathyPhase 2bPhase 2b trial to complete enrolment 4Q 2016. Data due shortly after.06/05/2016
OCRX
1.98OCR-002 Cirrhosis and upper gastrointestinal bleedingPhase 2aPhase 2a preliminary data released mid-Feb 201502/21/2015
OCUL
5.41DEXTENZAAllergic conjunctivitisPhase 3Phase 3 trial did not meet primary endpoint - June 201606/07/2016
OCUL
5.41DEXTENZAPost-surgical ocular inflammation and painPhase 3Phase 3 data due 4Q 201606/05/2016
OCUL
5.41DEXTENZADry eye diseasePhase 2Phase 2 complete. Intends to meet FDA mid-2016 regarding Phase 3 trial06/05/2016
OCUL
5.41OTX-TPGlaucoma and ocular hypertensionPhase 3Phase 3 to be initiated 3Q 201605/11/2016
OCUL
5.41DEXTENZAOcular inflammation and pain following cataract surgeryPDUFAPDUFA July 24 201612/30/2015
OGXI
1.02Apatorsen Borealis-2Advanced or metastatic bladder cancerPhase 2Phase 2 initiated Apr 2013. Data due 2H 201605/13/2016
OGXI
1.02Custirsen ENSPIRITNon-small cell lung cancer (NSCLC)Phase 3Phase 3 initiated Oct 2012. First interim analysis released August 2014, second interim futility analysis July 2015. Data likely 1H 201705/13/2016
OGXI
1.02Custirsen in combination with Jevtana (cabazitaxel)- AFFINITYCastrate-resistant prostate second-line - cancerPhase 3Phase 3 final data due 3Q 2016 but noted that a subpopulation who had multiple poor prognostic risk factors did NOT show improvement in survival05/13/2016
OGXI
1.02Apatorsen - SpruceNon-squamous, non-small cell lung cancer (NSCLC)Phase 2Phase 2 open label initiated July 2014. Data are due 2H 201603/10/2016
OGXI
1.02Apatorsen and Zytiga - Pacific trialChemotherapy-naive patients with metastatic CRPC - cancerPhase 2Phase 2 trial was initiated in December 2012 and is enrolling patients12/30/2015
OHRP
2.74OHR-102Neovascular (Wet) Age-related Macular Degeneration (AMD)Phase 3First of two Phase 3 trials under SPA initiated March 201603/30/2016
OHRP
2.74OHR-102Retinal vein occlusion (CRVO)Phase 2Phase 2 data released July 201512/30/2015
OMED
12.77Demcizumab plus Abraxane - YOSEMITEFirst-line pancreatic cancerPhase 2Phase 2 enrolment to be completed by end of 2016. Data are due 1H 201703/11/2016
OMED
12.77Demcizumab plus carboplatin and pemetrexed - DENALIFirst-line non-squamous Non-small cell lung cancer (NSCLC)Phase 2Phase 2 data are due in late 2017 or in 201803/11/2016
OMED
12.77Tarextumab plus platinum chemotherapy and etoposideFirst-line extensive-stage small cell lung cancerPhase 2Phase 2 data due early 201703/11/2016
OMED
12.77Tarextumab - PINNACLE trialSmall cell lung cancer Phase 2Announced February 2016 that trial will continue following discussions with DSMB02/09/2016
OMER
10.98OMS721 Atypical hemolytic uremic syndrome (aHUS) Phase 3Phase 3 initiated March 2016. Enrolment expected to commence later in 201605/11/2016
OMER
10.98OMS721 Orticosteroid-dependent renal diseasesPhase 2Phase 2 dosing initiated April 201604/21/2016
OMER
10.98OMER824Huntington diseasePhase 2Phase 2 initiated Feb 2014. Trial was placed on hold due to preclinical concerns. To resume with with dosing limitations12/30/2015
OMER
10.98OmidriaCataract surgeryApprovedApproved June 2 201406/03/2014
ONCE
47.64SPK-9001Hemophilia BPhase 1/2Phase 1/2 updated data released at EHA June 11 201606/14/2016
ONCE
47.64SPK-8011Hemophilia APhase 1/2Phase 1/2 trial to be initiated 2H 2016 with initial data due 1H 201706/14/2016
ONCE
47.64SPK-RPE65Inherited retinal dystrophiesPhase 3BLA filing due 2H 201606/05/2016
ONCE
47.64SPK-CHMChoroideremia Phase 1/2Phase 1/2 dosing commenced 1Q 2015. Initial data due 2H 201605/05/2016
ONCS
1.60ImmunoPulse IL-12Squamous cell carcinoma of the head and neck (HNSCC) - cancerPhase 2Phase 2 enrolment paused - June 201606/17/2016
ONCS
1.60ImmunoPulse IL-12Melanoma - cancerPhase 2Phase 2 enrolment to be completed by end of 201606/05/2016
ONTX
6.15Oral Rigosertib and azacitidine 09-08 trialMyelodysplastic Syndromes (MDS) and Acute myeloid leukemia (AML) cancerPhase 2Phase 2 updated data presented June 2016 at EHA. End of Phase 2 meeting planned for 2H 201606/14/2016
ONTX
6.15RigosertibMyelodysplastic Syndromes (MDS) cancer high riskPhase 3Original Phase 3 trial did not meet endpoint in Feb 2014. However, following "subgroup analyses" and lack of current treatment options a further Phase 3 trial was initiated in December 201512/30/2015
OPHT
55.88FovistaWet-AMDPhase 3Phase 3 initial topline data due 4Q 201606/21/2016
OPHT
55.88ZimuraGeographic atrophyPhase 2/3Phase 2/3 trial initiated January 201601/28/2016
OPK
9.75RAYALDEESecondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) and vitamin D insufficiencyApprovedAnnounced June 21 2016 FDA Approval06/21/2016
OPK
9.75hGH-CTPAdults - growth hormone deficiencyPhase 3Initiated Phase 3 Jun 2013. Phase 3 data 2H 201605/10/2016
OPK
9.75hGH-CTPChildren - growth hormone deficiencyPhase 3Phase 3 to be initiated 2H 201605/10/2016
OPK
9.75Factor VIIa-CTPHemophiliaPhase 2Phase 2 initiated February 201603/01/2016
OPK
9.75Neurokinin-1 (“NK-1”) - Rolapitant (partnered with TSRO)Prevention of chemotherapy induced nausea and vomiting, or CINV ApprovedApproved September 2 201512/30/2015
OPK
9.75Fermagate Tabletshyperphosphatemia in CKD patients on chronic hemodialysisPhase 3Phase 3 planned12/30/2015
OPXA
3.87Tovaxin (Tcelna)Secondary Progressive MS (SPMS)Phase 2bPhase 2b initiated Sept 2012. Top-line data early 4Q 201605/13/2016
OREX
0.50ContraveObesityApprovedApproved September 11 2014. CV outcomes trial terminated May 2015. New safety trial CONVENE initiated 2016. Due to be completed January 2022.06/05/2016
ORMP
8.15Oral GLP-1 - ORMD-0901DiabetesPhase 1bPhase 2b trial to be initiated 4Q 201606/05/2016
ORMP
8.15ORMD-0801Type 2 DiabetesPhase 2Phase 2 top-line data endpoints were met - detailed data TBA at a later date05/19/2016
ORPN
1.74CabalettaOculopharyngeal Muscular DystrophyPhase 2bPhase 2b to be initiated 2H 2016. 06/05/2016
OSIR
5.50GrafixDiabetic Foot UlcersData released Aug 201308/14/2013
OTIC
16.25OTIPRIOAcute otitis externaPhase 3Phase 3 initiated June 2016. Data due 4Q 201606/10/2016
OTIC
16.25OTO-104 AVERTS-1 and AVERTS-2Ménière's diseasePhase 3Second Phase 3 trial initiated March 2016. Data from both Phase 3 trials due 2H 201706/05/2016
OTIC
16.25OTIPRIOPediatric 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
16.25OTO-104 Pediatric patients undergoing cisplatin chemotherapyPhase 2Phase 2 to be initiated 2H 201603/08/2016
OTIC
16.25OTIPRIO (ciprofloxacin otic suspension) Ear Tube Placement SurgeryApprovedApproved December 11 201512/30/2015
PBMD
1.03IMP321Breast cancerPhase 2b Phase 2b initiated December 2015. Initial safety data released June 201606/22/2016
PBMD
1.03CAN-003Ovarian cancerPhase 2Phase 2 data released May 201512/31/2015
PBYI
33.65PB272 ExteNET trial Extended adjuvant HER2-positive early stage breast cancerNDA filingNDA filing due mid 2016 05/11/2016
PBYI
33.65PB272 (NSABP FB-7)Neoadjuvant treatment for patients with HER2-positive breast cancer Phase 2Phase 2 additional data due 2Q 201605/11/2016
PBYI
33.65Neratinib SUMMITHER2 non-amplified breast cancer that has a HER2 mutationPhase 2Phase 2 data due 4Q 201605/11/2016
PBYI
33.65Neratinib monotherapy with high dose loperamide prophylaxisExtended adjuvant treatment of early stage HER2-positive breast cancerPhase 2Phase 2 addtional data due 201605/11/2016
PBYI
33.65NeratinibThird-line HER2-positive metastatic breast cancerPhase 3Phase 3 data due 4Q 2016 or 1Q 201705/11/2016
PBYI
33.65Neratinib HER2-negative breast cancer with HER2 mutation Phase 2Phase 2 data due at ASCO 201605/11/2016
PBYI
33.65Neratinib - basket trial HER2 mutated non-small cell lung cancerPhase 2Phase 2 third cohort expanded December 201512/31/2015
PBYI
33.65Neratinib - NEfERTT trialHER2-positive breast cancer first linePhase 205/16/2015
PBYI
33.65Neratinib plus temsirolimusFourth line HER2-positive metastatic breast cancerPhase 3Phase 3 planned05/16/2015
PCRX
39.99EXPARELSingle-dose injection femoral nerve block for total knee arthroplasty surgeryPhase 3CRL March 2 2015. New Phase 3 trials initiated 1Q 201605/29/2015
PFNX
8.34PF582Biosimilar candidate to Lucentis for retinal diseasesPhase 1/2Phase 3 to be initiated 201605/10/2016
PGNX
4.78AzedraPheochromocytomaPhase 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 between December 2016 and March 201705/06/2016
PGNX
4.781404Help visualize prostate cancer by targeting prostate specific membrane antigen (PSMA)Phase 3Phase 3 interim analysis due 2H 201605/06/2016
PGNX
4.78Oral RELISTORChronic painPDUFAPDUFA extended from April 19 to July 19 201604/05/2016
PGNX
4.78Subcutaneous RELISTORChronic painApprovedApproved September 29 201410/01/2014
PLX
0.73PRX-102Fabry diseasePhase 3Phase 3 trial to be initiated mid 201605/10/2016
PLX
0.73PRX-110 Cystic FibrosisPhase 2Phase 2 to be initiated mid 201605/10/2016
PLX
0.73PRX-106Ulcerative ColitisPhase 2Phase 2 to be initiated mid 201605/10/2016
PPHM
0.40Bavituximab plus carboplatin or paclitaxelAdvanced or metastatic HER2 negative breast cancerPhase 2Phase 2/3 placed on hold06/05/2016
PRAN
4.77PBT-2Alzheimer'sPhase 2Phase 2 endpoint not met04/01/2014
PRQR
5.06QR-010 Cystic Fibrosis Phase 1bPhase 1b enrolment started June 2015. Preliminary data due at the North American Cystic Fibrosis Conference (NACFC) October 27 - 29, 2016 06/22/2016
PRTA
40.55NEOD001 VITALAL AmyloidosisPhase 3Phase 3 enrolment to be completed by 2Q 201705/04/2016
PRTA
40.55NEOD001 PRONTOPreviously-treated patients with AL amyloidosis and persistent cardiac dysfunctionPhase 2bPhase 2b data due late 2017 or early 201805/04/2016
PRTA
40.55NEOD001AL amyloidosis and persistent organ dysfunctionPhase 1/2Data expected at International Symposium on Amyloidosis (ISA) to be held July 3-7 201605/04/2016
PRTK
13.42OmadacyclineAcute bacterial skin and skin structure infections (ABSSSI)Phase 3Phase 3 topline data met endpoints - June 201606/17/2016
PRTK
13.42SarecyclineSevere acne vulgarisPhase 3Phase 3 data due 2H 201606/05/2016
PRTK
13.42OmadacyclineCommunity-acquired bacterial pneumonia (CABP)Phase 3Phase 3 initiated November 2015. Data are due 3Q 201705/03/2016
PRTO
5.35Vonapanitase (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 201605/10/2016
PRTO
5.35Vonapanitase (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 201705/10/2016
PSDV
3.20MedidurPosterior uveitisPhase 3Phase 3 data released December 2015. NDA planned for 1H or mid 201704/23/2016
PSDV
3.20IluvienDiabetic macular edemaApprovedApproved Sept 26 201409/28/2014
PSTI
1.36PLX-PAD (stem cells)Intermittent claudication, or ICPhase 2Phase 2 put on clinical hold Jun 2013. Lifted Sept 2013. Enrolment completed May 2016. Data are due 201705/17/2016
PTCT
7.00Translarna Nonsense mutation cystic fibrosisPhase 3Phase 3 initiated July 2014. Enrolment completed November 2015. Data due early 201705/06/2016
PTCT
7.00TranslarnaDuchenne muscular dystrophy caused by nonsense mutations (nmDMD)NDA filingReceived a Refusal to File letter for their NDA filing - February 23 201602/24/2016
PTI
16.82PTI-428Cystic fibrosisPhase 1Phase 1 to be completed by end of 2016 with Phase 2 to be initiated 2H 201605/27/2016
PTIE
2.07RemoxyChronic painPDUFAPDUFA September 25 2016. Advisory Committee tentatively scheduled for August 5 201605/20/2016
PTLA
24.41Cerdulatinib (PRT2070)Refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia - cancerPhase 2Phase 2 enrolment commenced May 201606/02/2016
PTLA
24.41Betrixaban (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 2H 201605/28/2016
PTLA
24.41Andexanet alfaFactor Xa inhibitor reversal agentPDUFAPDUFA date August 17 2016 under priority review02/18/2016
PTN
0.48BremelanotideFemale sexual dysfunction (FSD)Phase 3Phase 3 initiated Dec 2014. Enrolment completed December 2015. Top-line data due 3Q 201605/18/2016
PTN
0.48PL-3994Heart failurePhase 2aPhase 2a planned01/01/2016
PTX
0.51TREXIMETAdolescent migraine patientsApprovedApproved May 15 201505/16/2015
PULM
2.43PUR0200COPDPhase 1bPhase 1b complete01/02/2016
PVCT
0.34PH-10PsoriasisPhase 2Phase 2 complete06/05/2016
PVCT
0.34PH-10Atopic dermatitisPhase 2Phase 2 complete06/05/2016
PVCT
0.34PV-10Cancer - MelanomaPhase 3Phase 3 dosing commenced 2015 with market update January 201601/13/2016
QLTI
1.43QLT091001Impaired Dark Adaptation (IDA)Phase 2aPhase 2a data released December 201412/07/2014
QURE
7.74AMT-060hemophilia BPhase 1/2Phase 1/2 data from first cohort released June 11 2016 at EHA meeting. Initial data from second cohort due by end of 201606/12/2016
QURE
7.74AMT-060Sanfilippo BPhase 1/2Phase 1/2 30 month follow up data due early 201704/05/2016
RARE
51.95KRN23Tumor-induced osteomalacia (TIO)Phase 2Interim data released April 2016. Additional data due 2H 201605/10/2016
RARE
51.95KRN23X-Linked Hypophosphatemia (XLH) - pediatric Phase 3Phase 3 to be initiated mid 201605/10/2016
RARE
51.95rhGUS Mucopolysaccharidosis 7 (MPS 7) Phase 3Announced Dec 15 that a Phase 3 trial has been initiated. Enrolment completed June 2015. Data due mid 2016.05/10/2016
RARE
51.95UX007 (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 201705/10/2016
RARE
51.95UX007 (triheptanoin)Glucose Transporter Type-1 Deficiency Syndrome (Glut1 DS)Phase 2Phase 2 initiated March 2014. Data due 2H 201605/10/2016
RARE
51.95UX007 (triheptanoin)Glut1 DS patients with the movement disorder phenotypePhase 3Phase 3 to be initiated 2H 201605/10/2016
RARE
51.95Aceneuramic acid extended release (Ace-ER)GNE MyopathyPhase 3Phase 3 data due 201705/10/2016
RARE
51.95KRN23X-Linked Hypophosphatemia (XLH) - adultPhase 3Phase 3 initiated December 201501/01/2016
RDHL
10.87BEKINDA IBS-DPhase 2Phase 2 first patients dosed June 201606/21/2016
RDHL
10.87BEKINDA -GUARDGastroenteritis Phase 3Phase 3 top-line data due 2H 201606/05/2016
RDHL
10.87YELIVARefractory/relapsed diffuse large B-cell lymphoma (DLBCL) - cancerPhase 1/2Phase 1/2 ongoing06/05/2016
RDHL
10.87YELIVARefractory or relapsed multiple myeloma - cancerPhase 1/2Phase 1/2 trial to be initiated 2Q 201606/05/2016
RDHL
10.87YELIVAHepatocellular carcinoma (HCC) - cancerPhase 2Phase 2 to be initiated 3Q 201606/05/2016
RDHL
10.87RIZAPORT (RHB-103)Migraine NDA filingPlanned resubmission of NDA due 4Q 201606/05/2016
RDHL
10.87RHB-104 MAP USCrohn’s diseasePhase 3Phase 3 safety and futility analysis due 2H 201606/05/2016
RDHL
10.87RHB-105 H. pyloriPhase 3Phase 3 final data released March 2016. Additional Phase 3 trial planned for 2H 201606/05/2016
RDHL
10.87RHB-104 CEASE-MSMultiple sclerosisPhase 2aPhase 2a interim data released March 201604/01/2016
RDUS
37.24Abaloparatide-SC OsteoporosisPDUFAAnnounced May 31 2016 that their NDA filing has been accpeted for review by FDA06/01/2016
REPH
7.94Intravenous (IV) meloxicam Acute pain following bunionectomy surgeryPhase 3Two Phase 3 trial initiated January 2016. Top-line data due by end of 201605/13/2016
RETA
19.89Bardoxolone methyl - CATALYSTPulmonary arterial hypertension associated with connective tissue disease - CTD-PAHPhase 3Phase 3 to commence enrolment 2H 2016 with data due 1H 201805/27/2016
RETA
19.89Bardoxolone methyl - LARIATPulmonary arterial hypertension (PAH)Phase 2Phase 2 interim data released June 201606/24/2016
RETA
19.89Bardoxolone methyl Pulmonary hypertension due to interstitial lung disease - PH-ILDPhase 2Phase 2 data due 2H 201705/27/2016
RETA
19.89Omaveloxolone - MOXIeFriedreich’s ataxia (FA)Phase 2Phase 2 initial data due 1H 201705/27/2016
RETA
19.89Omaveloxolone - MOTORMitochondrial myopathies (MM)Phase 2Phase 2 initial data due 1H 201705/27/2016
RETA
19.89Omaveloxolone - REVEALMetastatic melanomaPhase 1/2Phase 1/2 data due 2H 201705/27/2016
RGLS
5.74RG-101 with multiple approved DAAsHepatitis C virus (HCV) Phase 2Phase 2 top-line data released June 201606/08/2016
RGLS
5.74RG-101 and GSK2878175 - open labelHepatitis C virus (HCV) Phase 2Phase 2 interim efficacy and safety data due by end of 201606/02/2016
RGLS
5.74RG-101 and GSK2878175 - randomizedHepatitis C virus (HCV) Phase 2Phase 2 enrolment to commence 4Q 2016. Interim data due 2H 201706/02/2016
RGNX
9.92RGX-501Homozygous familial hypercholesterolemia (HoFH)Phase 1/2Phase 1/2 to be initiated 1H 201606/05/2016
RGNX
9.92RGX-111 Mucopolysaccharidosis Type I (MPS I)Phase 1/2Phase 1/2 to be initiated 3Q 201606/05/2016
RIGL
2.47R348Chronic dry eye disease - as a result of patients with acute or chronic graft vs. host disease (GvHD)Phase 2Phase 2 data due 201606/05/2016
RIGL
2.47Fostamatinib Immune Thrombocytopenic Purpura (ITP)Phase 3Phase 3 data from the first trial due mid 2016 with data from the second trial due shortly after05/04/2016
RIGL
2.47FostamatinibIgA nephropathyPhase 2Phase 2 data due by the end of 201605/04/2016
RIGL
2.47FostamatinibAutoimmune hemolytic anemia (AIHA)Phase 2Phase 2 data from first of two stages due by end of 201605/04/2016
RLYP
18.09VeltassaHyperkalemiaApprovedApproved October 21 2015. Noted May 25 2016 of a sNDA filing requesting label changes05/26/2016
RMTI
7.44Soluble Ferric PyrophosphateIron deficiencyApprovedApproved Jan 26 201501/27/2015
RNN
0.27RX-3117Relapsed and refractory pancreatic cancer and advanced bladder cancer. Phase 1b/2 Phase 1b/2 trial initiated March 2016. Interim data to be released 201603/30/2016
RNN
0.27ArchexinRenal cell carcinoma (RCC) - cancerPhase 2Phase 2a second stage enrolment commenced February 201602/09/2016
RPRX
1.70ProellexUterine fibroids (oral treatment)Phase 2bPhase 2b complete second course of treatment 2H 201606/05/2016
RPRX
1.70ProellexUterine fibroids (vaginal treatment)Phase 2bPhase 2b complete second course of treatment 2H 201606/05/2016
RPRX
1.70ProellexEndometriosisPhase 2Phase 2 data due 2H 201606/05/2016
RPRX
1.70EnclomipheneSecondary hypogonadismPhase 2Phase 2 3-month and 6-month data due 3Q 201606/02/2016
RPRX
1.70EnclomipheneSecondary hypogonadismCRLCRL November 30 2015. MAA to be submitted FALL-201606/02/2016
RPTP
5.46RP 103Huntington's DiseasePhase 2Data released December 2015. Partner required for further development06/05/2016
RPTP
5.46MP-376 Cystic fibrosisPhase 3In talks with FDA regarding NDA filing06/05/2016
RPTP
5.46MP-376 BronchiectasisPhase 2Phase 2 to be initiated 201605/06/2016
RPTP
5.46RP 103Mitochondrial disorders including Leigh syndromePhase 2Phase 2 interim analysis recommended trial continue05/05/2016
RPTP
5.46PROCYSBICystinosisApprovedApproved08/09/2013
RTRX
18.49Sparsentan (DUET) Focal segmental glomerulosclerosis (FSGS)Phase 2Phase 2 top-line data due 3Q 201606/05/2016
RTRX
18.49CholbamRare Bile Acid Synthesis Disorders ApprovedApproved Mar 18 201503/21/2015
RTTR
1.69RP-G28Lactose intolerancePhase 2/3Phase 2/3 initiated March 2016. Top-line data are due early 201706/05/2016
RVNC
13.99RT001 - REALISE 1Lateral Canthal (Crow’s Feet) LinesPhase 3Phase 3 endpoints not met June 201606/14/2016
RVNC
13.99RT002Cervical dystoniaPhase 2Phase 2 initiated September 2015. Further data to be released 2H 201606/14/2016
RVNC
13.99RT002Moderate to severe glabellar (frown) linesPhase 2Phase 2 interim data released October 2015. Final data to be released 2H 2016. Phase 3 to be initiated 2H 201605/10/2016
RVXCF
0.94RVX-208 Coronary artery disease (CAD) and type 2 diabetes mellitus (DM)Phase 3Phase 3 initiated November 201501/02/2016
RXDX
5.13TaladegibAdvanced basal cell carcinoma - cancerPhase 2One or more pivotal Phase 2 trials in 201601/12/2016
RXDX
5.13STARTRK-2 entrectinibSolid tumors - cancerPhase 2Phase 2 trial initiated September 201501/02/2016
RXII
2.81Samcyprone - RXI-SCP-1502Cutaneous wartsPhase 2Phase 2 preliminary data due 2H 201605/13/2016
RXII
2.81RXI-109-1501Retinal scarringPhase 1/2Phase 2 preliminary data due 2H 201605/13/2016
RXII
2.81RXI-109Suppressing recurrence of hypertrophic scars after bilateral scar revision surgery in the breast areaPhase 2aPhase 2a interim data released October 201501/02/2016
RXII
2.81 RXI-109-1401Recurrence of keloids after keloid revision surgeryPhase 2aPhase 2 initiated April 2014. Enrolment complete. Data collection ongoing as of May 201505/16/2015
RXII
2.81RXI-109-1301Anti-scarringPhase 2Phase 2 initiated November 2013. First data released Sept 2014. Announced completion of enrolment Dec 17 201412/18/2014
SAGE
30.80SAGE-217Postpartum depression (PPD)Phase 2Phase 2 trials to be initiated 2H 201606/08/2016
SAGE
30.80SAGE-547Essential tremorPhase 2Phase 2 initiation 2H 201606/05/2016
SAGE
30.80SAGE-547Postpartum DepressionPhase 2Phase 2 topline data due July 201605/27/2016
SAGE
30.80SAGE-547SRSEPhase 3Phase 3 data due 2H 201605/06/2016
SBPH
30.80SB 9200Hepatitis B (HBV)Phase 2aPhase 2a to be initiated 1H 201605/27/2016
SBPH
30.80SB 9200Respiratory syncytial virus (RSV)Phase 2Phase 2 to be initated pending funding05/27/2016
SCMP
10.95CobiprostoneOral MucositisPhase 2Phase 2a initiated September 2015. Futility analysis due 2H 201604/20/2016
SCMP
10.95LubiprostonePediatric functional constipationPhase 3Phase 3 initiated Dec 2013, ongoing01/02/2016
SCYX
2.19SCY-078Vulvovaginal candidiasis (VVC)Phase 2Phase 2 data released June 201606/09/2016
SCYX
2.19SCY-078Invasive Candida infectionsPhase 2Phase 2 topline data due July 201606/05/2016
SGEN
40.07Vadastuximab Talirine (SGN-CD33A) Acute myeloid leukemia (AML) - cancerPhase 3Phase 3 initiated May 201605/26/2016
SGEN
40.07ADCETRIS in combination with chemotherapy ECHELON-1 Frontline Hodgkin lymphomaPhase 3Phase 3 data due between 2017 and mid-201804/29/2016
SGEN
40.07ADCETRIS - ALCANZARelapsed CD30-positive cutaneous T-cell lymphoma cancerPhase 3Phase 3 data due 3Q 201604/29/2016
SGEN
40.07SGN-CD19A Frontline DLBCL cancerPhase 2Phase 2 trial to be initiated 1H 201604/29/2016
SGEN
40.07ADCETRIS in combination with chemotherapy - ECHELON-2Frontline CD30-positive mature T-cell lymphomas - cancerPhase 3Phase 3 enrolment to be completed in 2016. Data are due 2017 or 201804/29/2016
SGEN
40.07ADCETRIS in combination with bendamustineSecond-line Hodgkin lymphoma (HL) cancerPhase 2Phase 2 ongoing01/02/2016
SGEN
40.07ADCETRIS - AETHERAPost-transplant Hodgkin lymphoma (HL) cancerApprovedApproved August 18, 2015 under priority review01/02/2016
SGMO
5.92SB-913-1602MPS IIPhase 1/2Phase 1/2 to be initiated 2H 201606/21/2016
SGMO
5.92SB-BCLmR-HSPCbeta-thalassemiaPhase 1/2Phase 1/2 data presented at ASH 201502/09/2016
SGMO
5.92SB-728-1401HIV/AIDSPhase 2Data presented Dec 201501/02/2016
SGMO
5.92SB-728-1101HIV/AIDSPhase 2Data presented Dec 201501/02/2016
SGYP
3.80PlecanatideConstipation-predominant irritable bowel syndrome (IBS-C).Phase 3Phase 3 data due 3Q 201605/12/2016
SGYP
3.80PlecanatideChronic idiopathic constipation (CIC)PDUFAPDUFA January 29 201704/20/2016
SGYP
3.80DolcanatideMild-to-moderate ulcerative colitisPhase 1bPhase 1b data released January 201601/12/2016
SMMT
8.15EzutromidDuchenne muscular dystrophyPhase 2Phase 2 24-week data due January 201706/18/2016
SNDX
11.52Entinostat plus Keytruda - ENCORE 601Recurrent non-small cell lung cancer (NSCLC)Phase 1/2Phase 1b confirmation stage to be completed 3Q 201605/27/2016
SNDX
11.52E2112HR+, HER2- breast cancerPhase 3Phase 3 continues to enrol05/27/2016
SNGX
0.70SGX942 (dusquetide) Oral Mucositis in Patients with Head & Neck CancerPhase 2Phase 2/3 trial planned for 1H 201706/05/2016
SNGX
0.70SGX203 Pediatric Crohn’s DiseasePhase 3Phase 3 initiation due 2H 2016 - pending funding with data due 1H 201806/05/2016
SNGX
0.70SGX201Radiation EnteritisPhase 2bPhase 2b data 1H 2018 - pending funding06/05/2016
SNGX
0.70SGX301 (synthetic hypericin)Cutaneous T-Cell Lymphoma (CTCL) cancerPhase 3Phase 3 data due 2H 201606/05/2016
SNSS
0.55Vosaroxin in combination with cytarabine - VITAL Previously untreated acute myeloid leukemia (AML) cancerPhase 2Phase 2 investigator sponosored trial initiated March 201603/25/2016
SNSS
0.55Vosaroxin in combination with decitabineOlder patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) - cancerPhase 2Phase 2 updated data released at ASH 201501/02/2016
SNTA
0.31Ganetespib - GANNET53 Ovarian cancerPhase 2Company is no longer supporting the trial with the exception of ensuring supply of ganetespib to enrolled patients06/05/2016
SPHS
1.89PRX302Localized low to intermediate risk prostate cancerPhase 2Phase 2a data released June 201606/10/2016
SPHS
1.89PRX302Benign prostatic hyperplasia Phase 3Phase 3 primary endpoints met - November 201501/02/2016
SPPI
6.81EVOMELA (melphalan) for InjectionConditioning treatment prior to autologous stem cell transplant for patients with multiple myelomaApprovedApproved March 15 201603/16/2016
SPPI
6.81PoziotinibBreast cancer Phase 2Phase 2 initiated March 201603/08/2016
SPPI
6.81ApaziquoneBladder cancerPDUFAFailed 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
6.81SPI-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
6.81BelinostatPeripheral T-Cell Lymphoma cancerApprovedApproved July 3 201407/04/2014
SRNE
5.88CynviloqCancerBioequivalence trialData analysis suggests that Cynviloq meets the bioequivalence (BE) criteria for both total and unbound paclitaxel05/16/2015
SRPT
17.88EteplirsenDuchenne muscular dystrophyPDUFACompany noted on May 25, 2016 a PDUFA goal date delay. No timeline given. This follows an original PDUFA date extention to May 26 2016. Advisory Committee Meeting April 25 2016 voted in key questions 6-7 and 3-7 both against eteplirsen05/26/2016
SSH
0.51C-Pulse Heart Assist System - COUNTER HFModerate to severe heart failurePhase 3Trial terminated March 201606/05/2016
STEM
0.43HuCNS-SC cellsAge-Related Macular DegenerationPhase 1/2Development suspended. Funding from partnership required for future development01/02/2016
STML
7.10SL-401Adult relapsed or refractory acute myeloid leukemia (AML) - cancerPhase 1/2Phase 1/2 open06/05/2016
STML
7.10SL-401High Risk Myeloproliferative NeoplasmsPhase 1/2Phase 1/2 open06/05/2016
STML
7.10SL-701Second line glioblastoma (GBM) cancerPhase 1/2Phase 1/2 open06/05/2016
STML
7.10SL-401Blastic plasmacytoid dendritic cell neoplasm (BPDCN) cancerPhase 2Phase 2 updated data released at ASCO June 201606/05/2016
SUPN
19.12Trokendi Migraine PDUFAPDUFA likely 3Q 2016 for sNDA of Trokendi06/17/2016
SUPN
19.12SPN-812ADHDPhase 2bPhase 2b data due early 201706/05/2016
SUPN
19.12SPN-810Impulsive Aggression in ADHDPhase 3Phase 3 data due mid 201706/05/2016
SUPN
19.12Trokendi EpilepsyApprovedApproved Aug 19 201308/22/2013
SYN
1.76 SYN-004C. difficile InfectionPhase 2bPhase 2b initiated September 2015, with interim analysis due summer of 2016. Phase 3 trial to be initiated 1H 201705/17/2016
SYN
1.76SYN-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 201605/06/2016
TBPH
23.06Closed TripleCOPDPhase 3Phase 3 data released June 201606/21/2016
TBPH
23.06TelavancinBacteremia Phase 3Phase 3 data due 2017 or 201806/05/2016
TBPH
23.06RevefenacinCOPDPhase 3Phase 3 data due late 3Q or early 4Q 201605/10/2016
TBPH
23.06Velusetrag (TD-5108)GastroparesisPhase 2Phase 2 initiated mid March 2015. Data due 201701/02/2016
TBPH
23.06TD-6450Hepatitis C virus (HCV) Phase 2aPhase 2a data due 201601/02/2016
TBRA
13.52Cenicriviroc (CVC) - ORION studyObese subjects with prediabetes or Type 2 diabetes mellitus and suspected NALFD.Phase 2Phase 2a interim analysis released May 2016. Phase 3 trial planned of 201705/10/2016
TBRA
13.52Cenicriviroc (CVC) - CENTAUR studyNon-alcoholic Steatohepatitis (NASH)Phase 2bPhase 2b data due 3Q 201605/10/2016
TBRA
13.52Cenicriviroc (CVC) - PERSEUS studyPrimary sclerosing cholangitis (PSC)Phase 2aPhase 2a data due 201705/10/2016
TCON
5.10TRC105 and NexavarHepatocellular carcinoma (HCC) - cancerPhase 2Phase 2 dosing initiated May 2016 with data due 201705/19/2016
TCON
5.10TRC105 and InlytaRenal Cell Carcinoma (RCC) - cancerPhase 2Phase 2 initiated Dec 2014. Phase 2 data due late 201605/12/2016
TCON
5.10TRC105 Angiosarcoma cancerPhase 2Phase 3 to be initiated 2H 201605/12/2016
TCON
5.10TRC105Soft tissue sarcomas - cancerPhase 2Phase 1/2 data at June ASCO 201605/12/2016
TCON
5.10TRC105 and AvastinGlioblastoma - cancerPhase 2Phase 2 data due by end of 201605/12/2016
TCON
5.10TRC105Gestational Trophoblastic Neoplasia cancerPhase 2Phase 2 planned for 2015. Data due 201705/12/2016
TCON
5.10TRC102 and TemodarGlioblastoma - cancerPhase 2Phase 2 trial initiated January 201601/28/2016
TCON
5.10TRC102Mesothelioma cancerPhase 2Phase 2 initiated October 201501/03/2016
TENX
5.10LevosimendanReduce the incidence of low cardiac output syndrome during cardiac surgeryPhase 3Phase 3 top line data due 4Q 2016. 06/09/2016
TGTX
6.72TG-1101 and TGR-1202 - UNITY-CLL studyDiffuse large B-cell lymphoma (DLBCL) cancerPhase 2bPhase 2b enrolment commenced June 201606/09/2016
TGTX
6.72TG-1101 and TGR-1202 - UNITY-CLL studyChronic Lymphocytic Leukemia (CLL) and non-Hodgkin's Lymphoma (NHL) cancerPhase 3Phase 3 enrolling05/11/2016
TGTX
6.72TG-1101 and IMBRUVICA (GENUINE trial)Chronic Lymphocytic Leukemia (CLL) cancerPhase 3Phase 3 continues to enrol05/11/2016
TGTX
6.72TGR-1202 + TG-1101 + Pembrolizumab Chronic Lymphocytic Leukemia (CLL)Phase 1/2Phase 1/2 trial initiated Sep 2015. 01/03/2016
THERF
2.20Ibalizumab Multi-drug resistant HIV-1Phase 3Phase 3 top-line released May 2016. 24 week treatment trial due to be completed by end of October 201605/27/2016
THLD
0.41TarloxotinibCancer - Recurrent or Metastatic Squamous Cell Carcinomas of the Head and Neck or SkinPhase 2Phase 2 initiated August 2015. Prelim data due mid 201606/05/2016
THLD
0.41TarloxotinibCancer - mutant EGFR-positive, T790M-negative advanced non-small cell lung cancerPhase 2Phase 2 initiated August 2015. Prelim data due mid 201606/05/2016
TKAI
5.87Galeterone - ARMOR3-SVCancer - castration-resistant prostate cancer (CRPC)Phase 3Enrolment to be completed 2H 2016. Topline data due mid 201705/11/2016
TKAI
5.87Galeterone - ARMOR2Xtandi (enzalutamide) refractory metastatic castration-resistant prostate cancer (mCRPC) Phase 2Phase 2 expansion arm initiated dosing March 201603/31/2016
TLOG
0.32SHAPECancer - Cutaneous T-Cell LymphomaPhase 2Phase 2 final data due mid 201605/29/2016
TNXP
2.15TNX-102 SL Fibromyalgia Phase 3Phase 3 enrolment completed May 2016. Data due 3Q 201605/10/2016
TRVN
6.21Oliceridine (TRV130)Moderate to severe acute painPhase 3Phase 3 APOLLO-1 and APOLLO-2 commenced June 2016. Top-line data 1Q 2017.06/09/2016
TSRO
45.17Rolapitant - intravenous (IV)Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patientsPDUFAPDUFA January 11 201706/05/2016
TSRO
45.17Niraparib - NOVA (Niraparib Ovarian) Cancer - ovarianPhase 3Phase 3 data due 2Q 2016.06/05/2016
TSRO
45.17Niraparib - BRAVOCancer - breastPhase 3Phase 3 initiated 1Q 2014. Continues to enrol as of May 201605/06/2016
TSRO
45.17Niraparib - (QUADRA trial) Cancer - ovarianPhase 2Phase 2 continues to enrol as of May 201605/06/2016
TSRO
45.17RolapitantPrevention of chemotherapy induced nausea and vomiting, or CINV in HEC patientsApprovedApproved01/03/2016
TTHI
0.79ELND005Alzheimer's DiseasePhase 2Phase 2/3 trial did not meet primary endpoint - June 2015. In talks with FDA regarding future development06/05/2016
TTHI
0.79TT701Symptoms of androgen deficiency in men with prostate cancerPhase 2Phase 2 dosing commenced April 201604/26/2016
TTHI
0.79TT401 (LY2944876)Type 2 diabetesPhase 2Company announced April 2016 that partner Lilly will not advance drug into Phase 3 development04/19/2016
TTNP
5.65ProbuphineOpioid dependenceApprovedApproved May 26 201605/27/2016
TTPH
4.09Eravacycline (TP-434)cUTI - complicated urinary tract infectionsPhase 3Phase 3 trial did not meet endpoints September 2015. Additional Phase 3 required05/14/2016
TTPH
4.09Eravacycline (TP-434)cIAI (complicated intra-abdominal infections)Phase 3Announced Dec 17, 2014 that their Phase 3 trial met endpoints. Additional Phase 3 trial required, to be initiated possibly in 4Q 2016 with data 4Q 201705/14/2016
UTHR
105.28Oral treprostinilPulmonary arterial hypertension (PAH)ApprovedApproved Dec 20 201312/21/2013
VBLT
4.21VB-111 Recurrent platinum resistant ovarian cancerPhase 2Preliminary Phase 2 data presented at ASCO 201606/05/2016
VBLT
4.21VB-111Recurrent glioblastoma (rGBM) cancerPhase 3Phase 3 initiated mid 2015. Interim data due 1H 2017. Full data late in 2017 or early 201803/30/2016
VCEL
2.29ixmyelocel-TStem cells - Dilated Cardiomyopathy Phase 2bPhase 2b topline data released March 2016. Full data released April 201604/05/2016
VCEL
2.29MACI Focal chondral cartilage defects in the knee.PDUFAPDUFA date January 3 201703/08/2016
VICL
4.60Bivalent VaccineGenital Herpes in AdultsPhase 1/2Phase 2 trial to be initiated 2H 201606/21/2016
VICL
4.60ASP0113 VaccineHematopoietic cell transplant recipientsPhase 3Initiated Phase 3 Jun 2013. Enrollment due to be completed 3Q 2016. Topline data due 4Q 201705/11/2016
VICL
4.60ASP0113 VaccineKidney transplant recipientsPhase 2Initiated Phase 2 Dec 2013. Data due 3Q 201605/11/2016
VKTX
1.23VK5211Acute Hip FracturePhase 2Phase 2 to be completed 1Q 201706/05/2016
VKTX
1.23VK2809HypercholesterolemiaPhase 2Phase 2 trial to commence mid 201605/11/2016
VNDA
11.35Fanapt Supplemental New Drug Application (sNDA) as a maintenance treatment of schizophrenia in adults.ApprovedApproved May 26 201605/27/2016
VNDA
11.35HETLIOZ (tasimelteon)Jet Lag DisorderPhase 2Phase 2 to be initiated 2H 201605/05/2016
VNDA
11.35HETLIOZ (tasimelteon)Smith-Magenis SyndromePhase 3Phase 3 to be initiated 2H 201605/05/2016
VNDA
11.35HETLIOZ (tasimelteon)InsomniaApprovedApproved Jan 31 2014. 02/02/2014
VRTX
88.20ORKAMBICystic fibrosis (CF) ages 6-11 who have F508del mutation PDUFA Priority ReviewPDUFA September 30 201606/01/2016
VRTX
88.20VX-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
88.20VX-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
88.20VX-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
88.20VX-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
88.20VX-150OsteoarthritisPhase 2Phase 2 enrolment expected to be completed by the end or 201604/28/2016
VRTX
88.20KALYDECO (ivacaftor)Cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations.CRLCRL issued February 5, 201602/06/2016
VRTX
88.20Lumacaftor and ivacaftorCystic fibrosis (CF) ages 12 and older who have two copies of the F508del mutation ApprovedApproved July 2 2015 01/01/2016
VRTX
88.20ALYDECO (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
VRX
47.71Brodalumab Subcutaneous InjectionModerate to Severe Plaque PsoriasisPDUFAPDUFA date November 16 2016. Advisory Committee Meeting July 16 201606/10/2016
VSAR
11.54VRS-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-201706/05/2016
VSAR
11.54VRS-317 VITALGrowth hormone deficiency, or GHD - adultPhase 2/3Phase 2 trial initiated September 2015. Data due 3Q 201606/05/2016
VSTM
1.34VS-6063KRAS-mutated Non-small cell lung cancer (NSCLC)Phase 2Phase 2 ongoing, Data released September 201501/03/2016
VTAE
10.54VTP-43742PsoriasisPhase 2aPhase 2a postive data released mid March 2016. Large Phase 2 trial to be initiated 4Q 201605/11/2016
VTAE
10.54VTP-38543Atopic dermatitisPhase 2Phase 2 initiated December 2015. Topline data due 2H 201605/11/2016
VTL
7.11VTI-308Alcohol-induced liver decompensation, or AILDPhase 3Phase 3 VTI-208 trial failed. New VTI-308 trial initiated May 2016. Data due mid 201805/24/2016
VTVT
7.11TTP399 - AGATAType 2 DiabetesPhase 2bPhase 2 enrolment completed February 2016. Data due summer of 201605/13/2016
VTVT
7.11TTP273 - LOGRAType 2 DiabetesPhase 2Phase 2 initiated January 2016. Topline results are expected at the end of 2016.05/13/2016
VTVT
7.11Azeliragon - STEADFAST Mild Alzheimer’s diseasePhase 3Phase 3 initiated 2Q 2015. Data due late 2017 or early 201805/13/2016
VVUS
1.10AvanafilErectile dysfunctionApprovedApproved Apr 27 2012. sNDA label change also approved 17 Sept 201409/18/2014
VYGR
12.51VY-AADC01 Advanced Parkinson’s diseasePhase 1b Phase 1b trial onoging. Topline data due 4Q 201606/05/2016
WINT
2.00AerosurfRespiratory Distress Syndrome Phase 2bPhase 2b enrolment to be completed by the end of 2016. Top-line data due 1Q 2017.06/05/2016
WINT
2.00AerosurfRespiratory Distress Syndrome Phase 2aPhase 2a data due 3Q 201606/05/2016
XBIT
2.00XilonixColorectal cancerPhase 3Phase 3 prelim data to be presented July 2 2016 at ESMO World Congress on Gastrointestinal Cancer05/25/2016
XENE
6.24XEN801AcnePhase 2Phase 2 initiated February 2016. Data due 4Q 201605/11/2016
XENE
6.24TV-45070Postherpetic neuralgiaPhase 2b Phase 2b initiated late March 2015. Data due 1H 201705/11/2016
XENT
13.54RESOLVE steroid-releasing implantRecurrent sinus obstructionPhase 3Phase 3 preliminary top-line data due 4Q 201606/05/2016
XENT
13.54NOVA Sinus ImplantSupport opening of sinusPhase 3PMA to be filed06/05/2016
XENT
13.54PropelFrontal Sinus DiseaseApprovedApproved March 201606/05/2016
XENT
13.54RESOLVEIn-office treatment of patients with recurrent disease due to polypsPhase 3Phase initiated late Dec 2014. Enrolling01/03/2016
XLRN
35.04Luspatercept - MEDALISTMyelodysplastic syndromes (MDS) cancerPhase 3Phase 3 ongoing05/06/2016
XLRN
35.04Luspatercept - BELIEVE b -thalassemiaPhase 3Phase 3 ongoing05/06/2016
XLRN
35.04ACE-083Facioscapulohumeral muscular dystrophyPhase 2Phase 2 to be initiated 2H 201605/06/2016
XLRN
35.04Dalantercept - DART StudyRenal Cell Carcinoma (RCC) - cancerPhase 2Phase 2 continues to enrol as of late February 2016. Preliminary data due year end 201602/26/2016
XNCR
14.43XmAb5871IgG4-Related Disease (IgG4-RD)Phase 2Phase 2 trial initiated March 2016. Initial data due 1H 201705/03/2016
XNCR
14.43XmAb5871Systemic Lupus Erythematosus (SLE)Phase 2Phase 2 trial initiated March 2016. Initial data due 201805/03/2016
XNCR
14.43XmAb5871Rheumatoid arthritisPhase 1b/2Phase 1b/2a top line data released January 201501/03/2016
XNCR
14.43JNJ-56022473Acute myeloid leukemia (AML)Phase 2Phase 2 initiated September 201501/03/2016
XNPT
7.03XP21279Parkinson'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
0.57XOMA 358Hypoglycemia Post Gastric Bypass SurgeryPhase 2Phase 2 initiated April 201605/05/2016
XOMA
0.57XOMA 358Congenital hyperinsulinismPhase 2Phase 2 initiated October 2015. Data are due in 201605/05/2016
XTLB
1.11hCDR1 Systemic Lupus Erythematosus (SLE)Phase 2Phase 2 to planned06/05/2016
ZFGN
6.28BeloranibHypothalamic injury-associated obesity (HIAO)Phase 2aPhase 2a to be completed Jan 2015. Beloranib IND currently on clinical hold06/05/2016
ZFGN
6.28BeloranibPrader-Willi Syndrome (PWS)Phase 3Both co-primary endpoints met with further data released April 201604/05/2016
ZFGN
6.28BeloranibSevere obesity Phase 2bPhase 2b data released February 2016. Primary endpoint met but saftey concerns evidents.02/19/2016
ZGNX
8.41ZX008 - (Study 1502)Dravet syndromPhase 3Second Phase 3 trial initiated June 201606/08/2016
ZGNX
8.41ZX008 - Study 1501Dravet syndromPhase 3Phase 3 initiated January 201601/20/2016
ZGNX
8.41 Abuse deterrent formulations of Zohydro ERModerate to severe painApprovedApproved January 30 201501/31/2015
ZGNX
8.41Zohydro ERModerate to severe painApprovedApproved Oct 25 201310/26/2013
ZIOP
6.07Ad-RTS-hIL-12Breast cancer Phase 1/2Phase 1/2 updated data due at ASCO 201605/11/2016
ZIOP
6.07Ad-RTS-hIL-12 + veledimex Melanoma - cancerPhase 2Phase 2 completed01/01/2016
ZSAN
1.26ZP-TriptanMigrainePhase 2 Pivotal trial to be completed 1Q 201705/13/2016
ZYNE
7.77ZYN002Refractory epilepsy, Fragile X syndrome and osteoarthritisPhase 2Phase 2 to be initiated in three indications 2H 201606/05/2016

About the author

Currently residing in New Zealand, Mr. A.Burden holds a Master of Commerce 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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