Company Pipeline Database

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
AAVL
37.02AVA-101Wet-AMDPhase 2aPhase 2a data due mid 201505/16/2015
ABIO
0.74GencaroChronic Heart FailurePhase 2b/3Phase 2b/3 to begin enrolment 1Q 201401/09/2014
ACAD
40.10PimavanserinParkinson’s disease psychosis (PDP)Phase 3NDA filing of Pimavanserin for Parkinson’s disease psychosis (PDP) due 2H 201505/08/2015
ACAD
40.10PimavanserinAlzheimer'sPhase 2Phase 2 initiated November 201311/15/2013
ACHN
9.24ACH-3422 in combination with ACH-3102HCV Hepatitis C - treatment durations of 6, 8 and 12 weeksPhase 2Phase 2 to be initiated 2Q 2015. SVR4 results are expected 2H 201505/09/2015
ACHN
9.24ACH-3102 and sovaprevir with sofosbuvir Hepatitis C viral infection (HCV) - for a treatment duration of 4 weeksPhase 2Phase 2 to be initiated 1H 2015. SVR4 results are expected 2H 201503/07/2015
ACHN
9.24RevusiranTreatment-naïve genotype 1 chronic hepatitis C virus (HCV) infectionPhase 2100 percent SVR4 results reported late December 2014 following six weeks of treatment12/23/2014
ACHN
9.24SovaprevirHepatitis C viral infection (HCV)Phase 2Placed on clinical hold Jul 2013.Clinical hold lifted June 201406/11/2014
ACOR
31.61DalfampridinePost stroke deficitsPhase 2b/3Annonuced Dec 15, 2015 that a Phase 3 trial has been initiated12/16/2014
ACOR
31.61CVT-301OFF episodes of Parkinson’s disease (PD)Phase 3Announced December 10 that enrolment in their Phase 3 trial has been initiated for the treatment of OFF episodes in Parkinson’s disease (PD)12/11/2014
ACOR
31.61Diazepam Nasal SprayEpilepsyCRLCRL issued May 201405/04/2014
ACOR
31.61AC105Acute treatment of spinal cord injuryPhase 2Phase 2 trial initiated Sept 201309/01/2013
ACRX
3.43ZalvisoPost-operative pain following open abdominal surgery and hip or knee replacement surgeryCRLCRL Jul 26 2014. NDA resubmission was due 1Q 2015 but announced in early March 2015 that an additional clinical trial is required before the resubmission. Noted early May 2015 that a Type B meeting with the FDA had been declined05/06/2015
ACRX
3.43ARX-04Moderate-to-severe acute painPhase 3Phase 3 trial initiated March 2015. Data due 4Q 201503/22/2015
ACST
0.35CaPre (TRIFECTA trial)HypertriglyceridemiaPhase 2Phase 2 trial of CaPre (TRIFECTA trial) completed Sept 201409/30/2014
ACUR
0.78Study AP-ADF-301 (Study 301)Abuse LiabilityPhase 2Disappointing data released Aug 201308/28/2013
ADHD
7.00MDX (Metadoxine Extended Release (MG01CI))Fragile X SyndromePhase 2bPhase 2b enrolment due to be completed 1Q 2015. Data due 2Q 201505/07/2015
ADHD
7.00MDX (Metadoxine Extended Release (MG01CI))Adult ADHDPhase 3Phase 3 initiated March 2014. Topline data released Oct 2014. Additional Phase 3 trial to be initiated 2Q 201505/07/2015
ADHD
7.00MDX (Metadoxine Extended Release (MG01CI))Pediatric ADHDPhase 2bPhase 2b data released March 2015. No safety concerns but analyses of secondary cognitive measures did not produce statistically significant results03/11/2015
ADMA
8.62RI-002Primary Immune Deficiency DiseasesPhase 3BLA to be filed in 201505/16/2015
ADMP
4.10Epinephrine PFSAnaphylaxisCRLCRL issued March 27 201503/29/2015
ADMP
4.10APC-3000Allergic RhinitisPhase 3Phase 3 planned02/04/2014
ADMP
4.10APC-1000Asthma/COPDPhase 3Phase 3 planned02/04/2014
ADMS
17.49ADS-5102Levodopa-Induced DyskinesiaPhase 3Phase 3 initiated June 2014. Further trial initiated Oct 2014. Enrolment to be completed in 2015. Data from first trial expected around the end of 2015. NDA planned for 2016.01/13/2015
ADMS
17.49NamzaricModerate to severe dementia of the Alzheimer's type.ApprovedApproved Dec 24 201412/26/2014
ADMS
17.49Amantadine Traumatic Brain InjuryPhase 2/3 Phase 2/3 planned for 201404/25/2014
ADMS
17.49AmantadineUnknownPhase 2/3Phase 2/3 planned for 201504/25/2014
AERI
10.62RhopressaGlaucomaPhase 3Phase 3 Rocket 1 trial data released April 2015 did not meet enpoint. Rocket 2 data due 3Q 201504/27/2015
AERI
10.62RoclatanGlaucomaPhase 3Phase 3 to be initiated 3Q 201504/27/2015
AEZS
0.30Macimorelin Acetate - MacrilenAdult Growth Deficiency CRLCRL Nov 5 2014. Announced mid-April 2015 plans to initiate a Phase 3 trial in 201505/09/2015
AEZS
0.30AEZS-108Cancer - Endometrial Phase 3Phase 3 trial initiated Jul 2013 under SPA. Second interim analysis due end of 201505/09/2015
AFMD
9.61AFM13Hodgkin LymphomaPhase 2Phase 2a initial data due late 2015. Final data due 2H 201605/22/2015
AGEN
7.25G-100 HSPPC-96 Vaccine Cancer - Glioblastoma (GBM) first linePhase 2Prelim data released May 1 2013. Plans to meet with FDA later in an End of Phase 2 trial 10/26/2013
AGEN
7.25G-200Cancer - Glioblastoma (GBM) 2nd linePhase 2Enrolling 1H 201309/01/2013
AGIO
119.05AG-348Pyruvate kinase deficiencyPhase 2Phase 2 trial to be initiated 1H 201505/09/2015
AGIO
119.05AG-221Previously treated AML patientsPhase 3Global Phase 3 study for AG-221 to be initiated 201505/09/2015
AGRX
10.25TwirlaContraceptive patch Phase 3Phase 3 enrolment due to be completed 3Q 2016. CRL issued 201305/16/2015
AKBA
7.97AKB-6548Anemia associated with chronic kidney disease (CKD)Phase 2bPhase 3 planned for 2015. 05/15/2015
AKBA
7.97AKB-6548Anemia related to chronic kidney disease (CKD) who are undergoing dialysisPhase 2aPhase 2a enrolment completed March 2015. Data due 3Q 201505/15/2015
ALDR
39.79ALD403 MigrainePhase 2b Phase 2b data due 2H 2015. Plans to initiate a pivotal trial early 2H 201505/08/2015
ALDR
6.87Clazakizumab Rheumatoid arthritis (RA)Phase 2bPhase 2b trial met endpoint early May 201505/06/2015
ALDR
39.79Clazakizumab Psoriatic arthritis (PsA)Phase 2Phase 2 data released 4Q 2014. Further development requires partner which company is pursuing03/05/2015
ALDX
39.79NS2Noninfectious anterior uveitisPhase 2Phase 2 initiated late March 2015. Preliminary due by end of 201503/29/2015
ALDX
6.87NS2 Sjögren-Larsson Syndrome (SLS)Phase 2Phase 3 initiated March 2015. Prelim data due by end of 201503/25/2015
ALIM
4.24IluvienDiabetic macular edemaApprovedApproved Sept 26 201409/28/2014
ALIOF
140.21PonesimodRelapsing multiple sclerosisPhase 3Phase 3 initiated mid-April 201504/17/2015
ALIOF
140.21Selexipag - UptraviPulmonary arterial hypertension (PAH)PDUFAPDUFA Dec 22 201503/04/2015
ALIOF
140.21Macitentan (Opsumit)Pulmonary arterial hypertensionApprovedApproved Oct 18 201310/22/2013
ALKS
59.81ALKS 5461Major depressive disorder Phase 2Phase 3 (two trials) initiated Jun 2014. Data due 2016. Third Phase 3 trial initiated mid 2014. Data due 2016.02/26/2015
ALKS
59.81Three-Month INVEGA SUSTENNA (paliperidone palmitate)SchizophreniaPDUFANDA filed approx Nov 24 2014. Priority Review. Estimated PDUFA July 24 2015. 01/26/2015
ALKS
59.81ALKS 3831SchizophreniaPhase 2Phase 2 data released Jan 2015.Met primary endpoint, equivalence to olanzapine. Pivotal trial planned for 201501/08/2015
ALKS
59.81ALKS 9070 aripiprazole lauroxilSchizophreniaPDUFAPDUFA August 22 201510/23/2014
ALKS
59.81ALKS 3831SchizophreniaPhase 2Second Phase 2 trial initiated June 2014. Data due mid 201706/03/2014
ALNY
127.87Patisiran APOLLOFamilial Amyloidotic Polyneuropathy (FAP) in Patients with ATTRPhase 3Phase 3 ongoing. 05/09/2015
ALNY
127.87RevusiranATTR in patients with familial amyloidotic cardiomyopathy (FAC)Phase 3Phase 3 ongoing. 05/09/2015
ALXA
1.18AZ-002Acute repetitive seizuresPhase 2Phase 2 initiated late Jan 2014. Data due by end of 201505/07/2015
ALXN
165.94Asfotase alfaHypophosphatasia (HPP)BLARolling BLA filing ongoing07/27/2014
AMAG
65.45Makena - single-dose (1 mL) vialReduce the risk of preterm birth in women with a singleton pregnancyPDUFAFDA decision due 2Q 201502/12/2015
AMAG
65.45FerahemeIron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to all adult patients with IDA who have failed or could not tolerate oral iron treatmentCRLCRL issued May 22 201401/23/2014
AMGN
159.01KyprolisRelapsed multiple myeloma - patients who have received at least one prior therapysNDA filingsNDA PDUFA priority review July 26, 201503/31/2015
AMGN
159.01Talimogene laherparepvecMelanomaPDUFAPDUFA July 28 2015. Adcom meeting April 29, 201502/12/2015
AMGN
159.01BlinatumomabAcute Lymphoblastic LeukemiaPDUFAPDUFA May 19, 2015. Priority review01/28/2015
AMGN
159.01ABP 501 (adalimumab) Moderate-to-severe rheumatoid arthritisPhase 3Phase 3 data due 1Q 201501/28/2015
AMGN
159.01AMG 416Secondary hyperparathyroidismPhase 3Phase 3 data from its head-to-head study vs Sensipar due 1H 201501/28/2015
AMGN
159.01BrodalumabModerate-to-severe plaque psoriasisBLA filingBLA to be filed in 201501/28/2015
AMGN
159.01ABP 215 (bevacizumab) in the second half of 201Advanced non-small cell lung cancerPhase 3Phase 3 data due 2H 201501/28/2015
AMGN
159.01RomosozumabPostmenopausal osteoporosisPhase 3Phase 3 data due 1H 2016 01/28/2015
AMGN
159.01Corlanor (ivabradine)Chronic heart failurePDUFAOriginal PDUFA Feb 27, 2015. 3 month extension due to request for more clinical data. New PDUFA under priority review is May 27, 201501/28/2015
AMGN
159.01AMG 334MigrainePhase 3Phase 3 planned for 2015. 01/28/2015
AMGN
159.01EvolocumabLDL Cholesterol-Lowering Medication PDUFAPDUFA Aug. 27, 201501/26/2015
AMPE
2.22OptinaDiabetic Macula EdemaPhase 2bPhase 2b data released May 201505/21/2015
AMPE
2.22AmpionOsteoarthritis of the KneePhase 3Data from STRIDE study released mid April 2015 did not meet endpoint04/22/2015
AMPE
2.22ZertanePremature ejaculationPhase 3Pivotal trial pending. Will spin off Zertane into a standalone company called Vyrix Pharmaceuticals, Inc12/15/2013
AMRN
1.92Vascepa REDUCE-IT outcomes trial High Triglycerides With Mixed DyslipidemiaREDUCE-IT outcomes trialREDUCE-IT outcomes trial interim efficacy look by the independent Data Monitoring Committee (DMC) due 2016 and, if not stopped early, for completion in 2017 and presentation/publication of results in 201805/09/2015
ANAC
66.63AN2728Mild-to-moderate atopic dermatitisPhase 3Phase 3 data due 3Q 201505/07/2015
ANAC
66.63TavaboroleOnychomycosisApprovedApproved July 8 201407/09/2014
ANIK
32.83CingalOsteoarthritisPMAPMA filed on or about Feb 11 201502/12/2015
ANIK
32.83MonoviscOsteoarthritisApprovedApproved Feb 201402/16/2014
ANTH
4.93BlisibimodLupusPhase 3Missed primary endpoints in Phase 2b trial Jun 2012. Phase 3 trial initiated Mar 2013. Interim analysis completed Feb 2015. Expects enrolment to be completed 2H 2015 with final data 3Q 2016.03/22/2015
ANTH
4.93BlisibimodIgA nephropathyPhase 3Phase 3 data due 2H 201603/22/2015
ANTH
4.93Sollpura (liprotamase)Exocrine Pancreatic InsufficiencyPhase 3Phase 3 due to be initiated mid 201507/15/2014
APPY
0.53Appy1Acute 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
4.93RayVa Secondary Raynaud's PhenomenonPhase 2aPhase 2a initiated December 2014. Expects Data Monitoring Committee (DMC) decision in June 201505/16/2015
APRI
4.93FispemifeneMen with symptomatic secondary hypogonadism.Phase 2Expects to make a go/no go decision to proceed with a Phase 2b trial in June 201505/16/2015
AQXP
7.41AQX-1125 LEADERSHIPBladder pain syndrome/interstitial cystitis (BPS/IC). Phase 2Phase 2 enrolment completed March 2015. Data due mid 201505/16/2015
AQXP
7.41AQX-1125 FLAGSHIPChronic obstructive pulmonary disease (COPD)Phase 2Phase 2 enrolment completed early Feb 2015. Data due mid 201505/16/2015
AQXP
7.41AQX-1125 KINSHIPAtopic dermatitis (AD)Phase 2Phase 2 initiated late Dec 2014. Enrolment completed May 2015. Data due 1Q 201605/16/2015
ARDM
6.45Pulmaquin - ORBIT 3Non-cystic fibrosis bronchiectasis (non-CF BE).Phase 3Phase 3 enrolling as of April 201505/10/2015
ARDX
10.91TenapanorLate-stage chronic kidney disease (CKD) Phase 2aPhase 2a data released early May 2015 - failed to meet primary endpoint05/06/2015
ARDX
10.91TenapanorHyperphosphatemia in end stage renal disease (ESRD) patients on hemodialysisPhase 2bPhase 2b data released early Feb 2015 met primary endpoint. However, the rate of diarrhea was distinctly higher than expected02/03/2015
ARDX
10.91TenapanorConstipation-predominant irritable bowel syndrome (IBS-C) Phase 2bData released Oct 201410/11/2014
ARGS
7.84AGS-003 ADAPT Trial mRCCPhase 3AGS-003 Phase 3 ADAPT Trial on track to complete enrollment 2Q 2015, Interim analysis due at ASCO 201505/16/2015
ARGS
7.84AGS-004 HIVPhase 2bPhase 2b trial did not meet endpoint - early Jan 2015. Phase 2a planned 04/02/2015
ARGS
7.84AGS-003 Early stage RCC, non-clear cell mRCC, and other solid tumorsPhase 2Phase 2 trials planned for 201503/31/2015
ARIA
8.96Brigatinib - ALTA trialAnaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC)Phase 2 pivotalExpect to complete enrolment 3Q 2015 and to file for approval in 2016.05/09/2015
ARIA
8.96Iclusig (ponatinib) Cancer - second line chronic-phase CML (CP-CML) Phase 3Phase 2 dose ranging trial to be initiated 2H 201501/13/2015
ARIA
8.96Iclusig (ponatinib)Cancer - third line chronic-phase CML (CP-CML)Phase 2Phase 2 dose ranging trial to be initiated mid 201501/13/2015
ARIA
8.96PonatinibGastrointestinal stromal tumors (GIST)Phase 2Enrolment paused Oct 2013 due to safety issues. Initial data released at ASCO 2014. Trial resumed 2Q 201406/02/2014
ARIA
8.96Oral ponatinib - IclusigCancer - chronic myeloid leukemia, acute lymphoblastic leukemiaApproved. Marketing to resume under restricitons following earlier suspensionApproved. Marketing to resume under restricitons following earlier suspension12/21/2013
ARIA
8.96Iclusig (ponatinib) Advanced Medullary Thyroid CancerPhase 2Partial hold lifted. Ongoing10/11/2013
ARNA
4.10RalinepagPulmonary Arterial HypertensionPhase 2Phase 2 initiated mid Jan 201501/13/2015
ARNA
4.10Lorcaserin Smoking cessationPhase 2Phase 2 initiated March 2014. Data released Nov 201411/04/2014
ARQL
1.80Tivantinib (ARQ 197) METIV-HCC trialInoperable Hepatocellular Carcinoma Who Have Been Treated With One Prior TherapyPhase 3Phase 3 SPA agreed upon. Enrolment initiated Jan 2013. Dosage reduced following recommendation from DMC. DMC recommended continuation of trial Jan 2014. Patient accrual end of 201505/07/2015
ARRY
7.49Binimetinib (NEMO)Cancer - NRAS melanomaPhase 3Phase 3 initiated Jul 2013. NDA filing expected 1H 201611/05/2014
ARRY
7.49Selumetinib (AZD6244) combined with radioactive iodine - ASTRACancer - differentiated thyroid cancer Phase 3Pivotal trial initiated August 2013. The estimated primary completion date for the ASTRA study is June 201608/17/2014
ARRY
7.49Selumetinib (AZD6244) in Combination With DocetaxelCancer - NSCLC second line non small lung cancerPhase 3Phase 3 initiated Oct 2013. The estimated primary completion date for the SELECT-1 study is July 201608/17/2014
ARRY
7.49ARRY 797LMNA-Related DCMPhase 2Phase 2 preliminary results from this study due by the end of 2014.08/16/2014
ARRY
7.49ARRY-520 (Filanesib)Cancer - Refractory Multiple Myeloma MMPhase 2Phase 3 to be initiated 2H 201408/16/2014
ARRY
7.49ARRY 502Asthma Phase 2aPhase 2 topline data released July 23 2013. Endpoint met. Full data released Mar 201403/04/2014
ARRY
7.49Selumetinib (AZD6244) + plus dacarbazine SUMITCancer - metastatic uveal melanoma Phase 3Phase 3 estimated primary completion date for the trial is mid-201502/05/2014
ARRY
7.49MEK162 (ARRY-162) - COLUMBUSCancer - BRAF mutant melanomaPhase 3Phase 3 initiated 2H 201311/02/2013
ARRY
7.49AMG 151 (ARRY-403) Glucokinase activatorType 2 diabetesPhase 2AMG returned rights to ARRY08/07/2013
ARRY
7.49ARRY 380Cancer - metastatic breast cancerPhase 3Phase 3 planned with ONCY08/07/2013
ARRY
7.49MEK162 (ARRY-162) - MILORecurrent low-grade serous ovarian cancer (LGSOC)Phase 3Phase 3 initiated July 201307/03/2013
ARWR
6.12ARC-520 injection in combination with entecavir or tenofovirChronic HBVPhase 2bPartial clinical hold placed by FDA in early Jan 2015. Phase 2b trial to proceed with lower doses than initially proposed01/13/2015
ASMB
15.27VEN 307 (diltiazem cream)Anal fissuresPhase 3Phase 3 data from second trial did not meet primary endpoint - Feb 2014. Type B pre-NDA meeting on Thursday, June 19, 201404/10/2014
ASND
17.31TransConGrowth hormone deficiency in childrenPhase 2Phase 2 topline data due mid end of July 201505/20/2015
ASPX
100.96SD-809Tardive Dyskinesia (TD)Phase 2/3Phase 2b enrolment completed early Feb 2015. Topline data due mid 2015. Data from Phase 3 trial due 201603/22/2015
ASPX
100.96SD-809Huntington's disease (HD)Phase 3Phase 3 topline released Dec 16 2014 met endpoints. NDA filing due by mid 201503/22/2015
ATHX
1.36MultistemIschemic strokePhase 2Phase 2 data released mid April 2015. Endpoints not met.04/21/2015
ATHX
1.36MultistemAcute myocardial infarctionPhase 1Phase 2 planned for 201511/12/2014
ATRA
38.54PINTA 745Protein-energy wastingPhase 2Phase 2 unblinding of data due by end of 201502/28/2015
ATRS
2.10VIBEX QuickShotTestosterone deficiencyPhase 3Phase 3 initiated July 2014. Final patient dosed Nov 2015. Top-line pharmacokinetic data released Feb 2015. Endpoint met.02/26/2015
ATRS
2.10OTREXUPRheumatoid arthritis (RA)ApprovedApproved Oct 14 201310/16/2013
AUXL
36.47XIAFLEXPeyronie’sApprovedApproved Dec 6 201312/08/2013
AVNR
16.96AVP-825Acute migraineCRLCRL November 26 2014 - likely to resubmit 1H 201511/27/2014
AVNR
16.96NUEDEXTA AVP-923Agitation in patients with Alzheimer's disease (AD)Phase 2Phase 2 data released September 201409/16/2014
BAX
67.22BAX111Von Willebrand DiseasePDUFABLA filed about Dec 22 2014. Estimated PDFUA Dec 22 2015 01/26/2015
BAX
67.22BAX 855Hemophilia APDUFABLA filed about Dec 1 2014. Estimated PDUFA Dec 1 201501/26/2015
BAYRY
144.50BAY 81-8973Hemophilia APDUFABLA filed about Dec 17 2014. Estimated PDUFA Dec 17 201501/26/2015
BCLI
3.91NurOwn Amytrophic lateral sclerosis (ALS)Phase 2Phase 2a data (Israel) released Jan 5 2015. 11 of 12 patients experienced an improvement in the rate disease progression. US Phase 2 trial due to be completed in 2016.05/16/2015
BCRX
11.28BCX4161 - OPuS-2Hereditary angioedemaPhase 2bPhase 2b data due by end of 201505/09/2015
BCRX
11.28Peramivir - Study 303INFLUENZA ACUTE ApprovedApproved Dec 22 201412/23/2014
BCRX
11.28UlodesineGoutPhase 2bPhase 3 initiation pending partnership09/02/2013
BCRX
11.28UlodesineModerate renal impairmentPhase 2Phase 3 initiation pending partnership09/02/2013
BDSI
7.93Clonidine gelPainful diabetic neuropathy (PDN) Phase 3Phase 3 trial failed to meet primary endpoint late March 201503/31/2015
BDSI
7.93BEMA BuprenorphineManagement of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequatePDUFAAnnounced Dec 23 2014 that they have submitted their NDA filing. Estimated PDUFA date October 23 201502/24/2015
BDSI
7.93BEMA Buprenorphine/Naloxone (BNX) - BUNAVAILOpioid dependenceApprovedApproved June 7 201406/08/2014
BDSI
7.93BEMA BuprenorphineModerate to severe chronic pain in opioid naive subjectsPhase 3Phase 3 data released Jan 201401/24/2014
BIND
5.97 BIND-014 Cancer - Advanced KRAS Mutant or Squamous NSCLCPhase 2Preliminary data due 4Q 201503/14/2015
BIND
5.97 BIND-014 Cancer - NSCLC broad patient populationPhase 2Phase 2 final overall survival data due 201503/14/2015
BIND
5.97 BIND-014 Cancer - Cholangiocarinoma, cervical cancer, bladder cancer and head and neck cancersPhase 2First patient enrollment in 2Q 2015 03/14/2015
BIND
5.97 BIND-014 Cancer - Prostate CancerPhase 2Phase 2 overall survival data due 2H 2015 but sees more promising opportunites in areas besides mCRPC02/05/2015
BIOD
1.11BIOD-531 Type 2 diabetesPhase 2bPhase 2b initiated mid May 2015. Data due mid 201605/22/2015
BIOD
1.11BIOD-123Diabetes - Type 1Phase 2Phase 2 data released Sept 201309/09/2013
BLCM
23.93BPX-501Adjunct T-cell therapy administered after allogeneic HSCT - (hematopoietic stem cell transplantation)Phase 1/2Phase 1/2 topline data due 2H 201502/01/2015
BLCM
23.93BPX-401Hematological cancers that express the CD19 antigenPhase 1/2Phase 1/2 planned 1H 201602/01/2015
BLCM
23.93BPX-601Solid tumorsPhase 1/2Phase 1/2 planned 2H 201602/01/2015
BLCM
23.93BPX-701PRAME (preferentially-expressed antigen in melanoma) -expressing melanoma, sarcomas and neuroblastomaPhase 1/2Phase 1/2 planned 2H 201502/01/2015
BLRX
1.95BL-8040Cancer - AML patients with the FLT3-ITD mutationPhase 1/2Phase 2 planned05/20/2015
BLRX
1.95BL-8040Cancer - Acute myeloid leukemia (AML) Phase 2aPhase 2a enrolment began Jun 2013. Partial data released Dec 2013. Full data 4Q 201505/20/2015
BLRX
1.95BL-8040Cancer - consolidation treatment for AML patientsPhase 2bPhase 2b to be initiated around mid-2015 (anticpated in the next few months as of Mar 2015)03/04/2015
BLRX
1.95 BL-7010Celiac diseasePhase 1/2Efficacy trial to be initiated 2H 2015.11/06/2014
BLUE
183.69 LentiGlobin β-ThalassemiaPhase 1/2Data presented at ASH 2014 showed that first four patients are transfusion free. NIH RAC will review HGB-208 Pediatric Study Protocol on June 9, 201505/20/2015
BLUE
183.69LentiGlobin - HGB-206Sickle diseasePhase 1/2Most likely to have initial data 1H 2015, as per JPM estimate12/12/2014
BLUE
183.69Lenti-DChildhood cerebral adrenoleukodystrophy (CCALD)Phase 2/3Phase 2/3 trial initiated October 2013. Enrolment due to be completed 201503/06/2014
BMRN
127.11BMN-111AchondroplasiaPhase 1/2Phase 2 initiated Jan 2014: Data on first three cohorts in Phase 1/2 with BMN 111 for the treatment of achondroplasia due 2Q 201505/02/2015
BMRN
127.11BMN 190Batten DiseasePhase 1/2Phase 1/2 initiated Sep 2013. Data due 2H 201505/02/2015
BMRN
127.11DrisapersenDuchenne Muscular Dystrophy (DMD)NDA filingAnnounced April 27 2015 that their rolling NDA filing has been completed 04/29/2015
BMRN
127.11PEG-PALPhenylketonuria (PKU) Phase 3Phase 3 data due 1Q 2016.02/26/2015
BMRN
127.11Reveglucosidase alfa (BMN 701)Pompe DiseasePhase 2Data due 4Q 201502/26/2015
BMRN
127.11Talazoparib (BMN 673)Cancer -gBRCA breast cancer Phase 3Phase 3 initiated Oct 2013: Enrollment completion due 2H 201502/26/2015
BMRN
127.11 PRO053DMDPhase 1/2Phase 1/2 initiated Jun 2013. Data due 1H 201508/16/2014
BMRN
127.11PRO044Duchenne Muscular Dystrophy (DMD) patients with a mutation around location 44 in the DNA for the dystrophin proteinPlacebo trial to commence 201508/16/2014
BMRN
127.11Vimizim (GALNS)(MPS IVA) Morquio A SyndromeApprovedApproved Feb 14 201402/16/2014
BNHLF
0.28MCNANon-muscle invasive bladder cancer patients who have failed BCG therapyBLA filingBLA filing due 2Q 201505/16/2015
BOTA
2.18Vapendavir - SPIRITUS trialHuman rhinovirus (HRV)Phase 2bPhase 2b top-line data due mid 201605/09/2015
BOTA
2.18AP611074Anogenital wartsPhase 2bPhase 2b to be initiated 2H 201505/09/2015
BOTA
2.18Laninamivir Octanoate - IGLOO Adults with symptomatic influenza A or B infectionPhase 2Phase 2 initiated Jun 2013. Topline data did not meet the primary endpoint - July 201408/03/2014
BSTC
39.90XIAFLEXEdematous fibrosclerotic panniculopathy (“cellulite”)Phase 2aPhase 2b to commence 201505/16/2015
BSTC
39.90XIAFLEXHuman lipomasPhase 2Phase 2 enrolment due to be completed 1H 201505/16/2015
BSTC
39.90XIAFLEXAdhesive Capsulitis (“Frozen Shoulder syndrome”)Phase 2bPhase 2b trial did not meet endpoint 05/15/2015
CALA
10.85CB-839Cancer - variousPhase 1Phase 2 planned for late 2015 or early 201610/25/2014
CANF
2.31CF101Psoriasis Phase 2/3Phase 2/3 trial did not meet primary endpoint late March 201503/31/2015
CANF
2.31CF102Cancer - advanced liver cancer second linePhase 2Phase 2 first patient dosed late Dec 2014. Enrolment to be completed by end of 201501/07/2015
CANF
2.31CF101Rheumatoid arthritisPhase 3Phase 3 planned. Design of study completed late Dec 201401/01/2015
CANF
2.31CF101GlaucomaPhase 2Phase 2 data due 2Q or 3Q 201512/02/2014
CAPR
5.90CenderitideAmbulatory heart failure Phase 2Phase 2 enrolment completed late March 2015. Topline data due 2H 201504/01/2015
CARA
9.61CR845 Uremic PruritusPhase 2Phase 2 topline data due 2Q 201505/16/2015
CARA
9.61IV CR845Acute painPhase 3Phase 3 planned for 3Q 201505/16/2015
CARA
9.61Oral CR845Acute painPhase 2Phase 2 planned with potential data release by end of 201505/16/2015
CASI
1.38ENMD-2076Cancer - fibrolamellar carcinoma (FLC).Phase 2Plans to initiate a Phase 2 trial in 201501/19/2015
CASI
1.38ENMD-2076 Cancer - Advanced/Metastatic Soft Tissue SarcomaPhase 2Phase 2 initiated Jan 2013. Enrolling as of Nov 201401/19/2015
CASI
1.38ENMD-2076Cancer - triple-negative breast cancerPhase 2Phase 2 initiated Jul 2012. Enrolling as of Nov 201401/19/2015
CASI
1.38ENMD-2076Cancer - Ovarian Clear Cell CarcinomasPhase 2Phase 2 initiated Oct 2013. 11/02/2013
CBST
101.94Ceftolozane/ tazobactam ZERBAXAComplicated Urinary Tract Infections (cUTI) and Complicated Intra-Abdominal Infections (cIAI)ApprovedApproved Dec 21 2014- priority review12/22/2014
CBST
101.94Tedizolid phosphateAcute bacterial skin and skin structure infections (ABSSSI)ApprovedApproved June 20 201406/22/2014
CBST
101.94Bevenopran (CB-5945) ASCENTChronic opioid-induced constipation (OIC).Phase 3Three Phase 3 efficacy trials initiated Jul 201307/21/2013
CCXI
7.37CCX140Diabetic nephropathy Phase 2Phase 2 topline data released Dec 12 2014. End of Phase 2 meeting planned 2H 201505/07/2015
CCXI
7.37CCX168Associated vasculitis (AAV)Phase 2Phase 2 enrolment to be completed 201505/07/2015
CCXI
7.37Vercirnon CCX282 - (SHIELD-4)Crohn's diseasePhase 3Data presented Oct 201410/21/2014
CCXI
7.37CCX354 (GSK2941266) - (CARAT-2)Rheumatoid arthritis.Phase 2Completed05/03/2013
CCXI
7.37Vercirnon CCX282 - (SHIELD-2)Crohn's diseasePhase 3Initiated in Nov 2011.05/03/2013
CEMP
35.67Taksta CEM-102Prosthetic joint infection (PJI) Phase 2Plans to initiate Phase 3 trial possibly in 201505/02/2015
CEMP
35.67SolithromycinNASHPhase 2Phase 2 to be initiated 201505/02/2015
CEMP
35.67SolithromycinCOPDPhase 2Phase 2 to be initiated 201505/02/2015
CEMP
35.67CEM-101 (solithromycin )CAPBPhase 3Phase 3 data released early Jan 2015 met the primary objective of statistical non-inferiority 01/06/2015
CEMP
35.67CEM-101 (solithromycin )Uncomplicated urogenital gonococcal infectionsPhase 3Phase 3 initiated August 201408/16/2014
CERS
4.54INTERCEPT PlateletsApprovedPMA approved Dec 18 201412/19/2014
CERS
4.54INTERCEPT B123PlasmaApprovedPMA approved Dec 16 201412/18/2014
CERS
4.54INTERCEPT Acute and Chronic AnemiaPhase 3Phase 3 Eruopean trials initiated 201306/12/2013
CERU
5.95CRLX101, in combination with AvastinCancer - relapsed ovarianPhase 2Data due 201505/07/2015
CERU
5.95CRLX101, in combination with AvastinCancer - Relapsed Renal Cell CarcinomaPhase 2Data due 2Q 201605/07/2015
CERU
5.95CRLX101 in Combination with Chemotherapy and Radiation Rectal CancerPhase 1b/2Data released mid March 201503/21/2015
CERU
5.95CRLX301Cancer - solid tumoursPhase 2Phase 2 patient dosing initiated mid Dec 201412/18/2014
CERU
5.95CRLX101 and XelodaNeoadjuvant Rectal CancerPhase 1b/2Ongoing04/25/2014
CHRS
25.11CHS-1701Pegfilgrastim biosimilar351(k) BLA to be filed 4Q 2015 or 1Q 2016 pending positve data05/16/2015
CHRS
25.11CHS-1420PsoriasisPhase 3Phase 3 planned for mid 2015, with BLA filing in 2H 201605/16/2015
CHRS
25.11CHS-0214Rheumatoid arthritis Phase 3Phase 3 European trial ongoing with MAA filing due in 201603/24/2015
CHRS
25.11CHS-0214PsoriasisPhase 3Phase 3 European trial ongoing03/24/2015
CLDN
2.08MYDICAR - CUPID 2 TrialIschemic or dilated cardiomyopathyPhase 2bPhase 2b negative data released April 2015. 04/27/2015
CLDN
2.08MYDICAREnd-stage renal disease (ESRD)Phase 2aPhase 2a trial possibly going to be initiated 201511/13/2014
CLDX
27.87CDX-110 rindopepimut - ACT IVCancer- glioblastoma multiforme (GBM) front linePhase 3Initiated Phase 3 Dec 2011. First interim analysis due mid 201502/26/2015
CLDX
27.87Glemba Cancer - metastatic triple negative breast cancers that overexpress gpNMBPhase 2bPhase 2b enrolment to continue through to 201602/26/2015
CLDX
27.87Glembatumumab vedotinCancer - melanomaPhase 2Phase 2 initiated December 201412/05/2014
CLDX
27.87CDX-110 (rindopepimut) in combination with Avastin - ReACTCancer- glioblastoma multiforme (GBM) refractoryPhase 2Phase 2 inteirm data released Nov 201411/19/2014
CLDX
27.87CDX-011 EMERGECancer - Metastatic breastPhase 2bPrelim data released May 23 2012. Updated data released Dec 2012. Phase 3 trial initiated Dec 201303/04/2014
CLSN
2.62ThermoDoxRecurrent Chest Wall Breast Cancer (RCWBC)Phase 2Phase 2 enrolment to be completed 3Q 201504/17/2015
CLSN
2.62ThermoDoxCancer - Hepatocellular carcinoma - liver cancerPhase 3Failed to meet primary endpoint. New Phase 3 be initiated Sept 201409/03/2014
CLVS
92.21Rociletinib Cancer - 2nd line T790M+ NSCLC NDA filingRolling NDA submission expected to commence in June, and complete by July/August 201505/07/2015
CLVS
92.21Rucaparib ARIEL2Cancer - ovarian second linePhase 2Phase 2 dosing initiated Oct 2013. Interim data released November 2014. Enrolment continues as of May 2015. NDA filing for rucaparib planned for 201605/07/2015
CLVS
92.21LucitanibCancer - breastPhase 2Phase 2 dosing initiated Oct 2014. Initial data due by end of 201505/07/2015
CLVS
92.21Rucaparib ARIEL3 Cancer - ovarian second linePivotalPivotal trial initiated late 2013. Enrolment continues as of May 201505/07/2015
CLVS
92.21Rucaparib RUCAPANCCancer - pancreaticPhase 2Phase 2 initiated June 201406/17/2014
CMRX
42.47Brincidofovir - Advise trialAdenovirus InfectionPhase 3Phase 3 initiated April 2014. Continues to enrol as of May 201505/16/2015
CMRX
42.47Brincidofovir - SUPPRESS Cytomegalovirus (CMV) infection following an allogeneic hematopoietic stem cell transplant (HSCT)Phase 3Phase 3 dosing commenced Sept 2013. Enrolment to be completed summer 2015. Data early 201605/16/2015
CMRX
42.47Brincidofovir - SUSTAIN Cytomegalovirus (CMV) infectionPhase 3Phase 3 expected to begin 2H 201505/16/2015
CMRX
42.47Brincidofovir - SURPASSCytomegalovirus (CMV) infectionPhase 3Phase 3 expected to begin 2H 201505/16/2015
CNAT
5.17EmricasanPortal Hypertension Phase 2Phase 2 data due 3Q 201505/08/2015
CNAT
5.17EmricasanLiver CirrhosisPhase 2Phase 2 topline data due 4Q 201505/08/2015
CNAT
5.17EmricasanLiver fibrosis post-orthotopic liver transplant due to Hepatitis C virus infection (HCV-POLT)Phase 2bPhase 2b initiated May 2014. Initial open-label biomarker data expected 2Q 2015.05/08/2015
CNAT
5.17EmricasanNon-alcoholic steatohepatitis (NASH)Phase 2Phase 2 trial met primary endpoint late March 201503/29/2015
CNAT
5.17Emricasan Acute-on-Chronic Liver Failure (ACLF) Phase 2Phase 2 topline data released Jan 201501/09/2015
CNAT
5.17EmricasanSevere alcoholic hepatitisPhase 2Phase 2 initiated Sept 201309/22/2013
CNCE
#N/AAVP-786 Agitation in patients with Alzheimer's diseasePhase 3Phase 3 planned05/09/2015
CNCE
#N/ACTP-499 Diabetic Kidney DiseasePhase 2Phase 3 planned. Needs partner11/13/2014
CNCE
#N/AAVP-786 Neurologic and Psychiatric DisordersPhase 2Phase 2 initiated August 201408/27/2014
CNDO
#N/ATSO - (CNDO-201) (TRUST-I)Crohn’s diseasePhase 2Phase 2 endpoint not met Oct 201310/15/2013
CNDO
#N/ATSO - (CNDO-201)Ulcerative colitisPhase 2Phase 2 initiated Sep 201309/15/2013
CORI
13.00MicroCor PTHOsteoporosisPhase 2aPhase 2a data due 3Q 201505/09/2015
CORI
13.00AG200-15ContraceptivePhase 3Additional Phase 3 planned following rejection of NDA04/25/2014
CORI
13.00Corplex Tamsulosin Benign prostatic hyperplasiaPhase 2Phase 2 planned 1H 201504/25/2014
CORT
5.78Corlux - KorlymCancer - triple-negative breast cancerPhase 1/2Phase 1/2 data due 201503/05/2015
CPRX
3.99Firdapse Lambert-Easton Myasthenic Syndrome (LEMS)Phase 3Rolling NDA to start 3Q 2015 and to be completed 4Q 201505/13/2015
CPXX
2.23CPX-351 Secondary AMLPhase 3Phase 3 initial induction response rate analysis due 2Q 2015. Overall survival data due 1Q 2016. 02/04/2015
CPXX
2.23CPX-351 Adult patients with hematologic malignanciesPhase 2Phase 2 pharmacokinetic and pharmacodynamics study is also ongoing02/04/2015
CRIS
3.12CUDC-907Diffuse-large B-cell lymphoma (DLBCL)Phase 2Announced May 2015 that Phase 2 planned to initiated later in 201505/09/2015
CRIS
3.12CUDC-427Advanced and refractory solid tumors or lymphomasPhase 1Placed on partial clinical hold due to death of patient. Submission to FDA due shortly as of Jan 201401/14/2014
CRIS
3.12Erivedge (vismodegib)Cancer - relapsed/ refractory acute myelogenous leukemia (AML) and relapsed/refractory high-risk myelodysplastic syndrome (MDS)Phase 1b/2Phase 1b/2 initiated Oct 201310/06/2013
CRME
9.22Vernakalant IV Atrial fibrillationPhase 3Phase 3 placed on clinical hold Oct 2010 due to patient death07/07/2014
CSII
27.52Orbital atherectomy systemCalcified coronary arteriesPMAPMA approved Oct 22 201310/23/2013
CTIC
1.66Pacritinib -PERSIST-1MyelofibrosisPhase 3Announced early March that primary endpoint met with full data to be released at an upcoming scientific meeting. Data from second trial and NDA filing due by late 201505/07/2015
CTIC
1.66OPAXIOOvarian cancerPhase 3Phase 3 second of four analyses completed early Feb 2014. Trial to continue as planned02/04/2015
CTIC
1.66TosedostatCancer - older patients with AML or high-risk myelodysplastic syndrome (MDS).Phase 2Phase 2 data due 2015, with pivotal trial to possibly commence in 2016 pending data and discussions with FDA01/08/2015
CTIC
1.66OpaxioCancer - OvarianPhase 3Enrolment completed Jan 201401/29/2014
CTIC
1.66OpaxioCancer - glioblastoma multiformePhase 2Ongoing12/07/2013
CTIC
1.66OpaxioCancer - head and neck cancerPhase 1/2Ongoing12/07/2013
CTIC
1.66PacritinibMyelofibrosisPhase 3Second Phase 3 trial (PERSIST-2) is planned to initiate in 4Q 2013. 10/08/2013
CTIC
1.66BrostallicinCancer - breastPhase 2Interim data released Dec 2012. Final data released ASCO 201306/03/2013
CTIX
2.76CellceutixPlacque psoriasisPhase 2Given green light in November 2014 to initiate a Phase 2 trial12/18/2014
CTIX
2.76BrilacidinOral mucositisPhase 2Phase 2 trial to be initiated Dec 201412/18/2014
CTIX
2.76BrilacidinAcute Bacterial Skin and Skin Structure Infections (ABSSSI)Phase 2Will meet with the FDA in December 2014 regarding their planned Phase 3 trial12/18/2014
CTIX
2.76KevetrinCancer - variousPhase 2/3Phase 2/3 planned12/18/2014
CUR
1.59 NSI-566Amyotrophic lateral sclerosis (Lou Gehrig's)Phase 2Phase 2 data released early March 2015. A larger controlled Phase 2 trial is expected to be initiated during 201505/09/2015
CUR
1.59NSI-189DepressionPhase 2Phase 2 to be initiated 201505/09/2015
CUR
1.59NSI-566Motor deficits due to ischemic strokePhase 1/2Phase 1/2 trial initiated in China Aug/Sep 2013. First patient dosed Jan 2014. Continues to enrol patients as of March 201503/22/2015
CVM
0.72MultiklineCancer - Head and NeckPhase 3Initiated Dec 2010. Full enrolment due to be completed by 1Q 201605/09/2015
CYCC
0.83Sapacitabine (SEAMLESS)Cancer - Acute myeloid leukemiaPhase 3Noted mid-Dec 2014 that interim analysis suggests that trial will fail12/18/2014
CYCC
0.83SapacitabineCancer - Myelodysplastic syndromesPhase 2Phase 2b to be initiated 201511/12/2014
CYTK
6.09TirasemtivALSPhase 3Phase 3 to be initiated 2Q 201505/02/2015
CYTK
6.09CK-2127107Spinal muscular atrophy (SMA)Phase 2Phase 2 to be initiated 2H 201505/02/2015
CYTK
6.09Omecamtiv mecarbil ATOMIC-AHFAcute heart failurePhase 2bData released Sept 3 at EUROPEAN SOCIETY OF CARDIOLOGY CONGRESS missed primary endpoint. Expansion trial enrolment completed March 2015. Data due 2H 201503/14/2015
CYTR
3.93Aldoxorubicin with doxorubicinCancer - soft tissue sarcomas refractoryPhase 3Phase 3 initiated March 2014 under SPA, expect to complete trial enrollment by 1Q 2016. PFS data 2H 2016 05/02/2015
CYTR
3.93AldoxorubicinCancer - relapsed/refractory small cell lung cancerPhase 2bPhase 2b data due by end of 201605/02/2015
CYTR
3.93AldoxorubicinCancer - soft tissue sarcomas first linePhase 2bOverall survival data - secondary endpoint released Jan 2015 - HR 0.73 CI 0.44-1.20 - OS 16.0 months vs 14.4 (p=0.21) - not statistically significant01/23/2015
CYTR
3.93AldoxorubicinCancer - AIDS-related Kaposi’s sarcomaPhase 2Phase 2 initiated Jan 2014. Placed on partial clinical hold Nov 2014. Interim data released Jan 2015 showed 4 of 6 patients demonstrated either a partial or complete response01/09/2015
CYTR
3.93AldoxorubicinCancer - relapsed glioblastomaPhase 2Phase 2 initiated Nov 2013. Prelim data released Jan 2015 showed on CR from 1 of 12 patients, with tumor shrinkage and stable disease in some others. More data due at ASCO 201501/06/2015
CYTR
3.93BafetinibCancer - B-Cell Chronic Lymphocytic Leukemia (B-CLL)Phase 2Phase 2 proof of concept completed. Seeking partner for further development09/08/2013
CYTR
3.93BafetinibCancer - B-cell chronic lymphocytic leukemia (B-CLL)Phase 2Phase 2 proof of concept completed. Seeking partner for further development09/08/2013
CYTR
3.93TamibaroteneCancer - non-small-cell lung cancer (NSCLC)Phase 2bTerminated May 201305/09/2013
CYTX
0.67Cytori Cell Therapy Osteoarthritis of the kneePhase 2Phase 2 dosing initiated mid Feb 201502/21/2015
CYTX
0.67ECCS-50SclerodermaPivotalPivotal trial to be initiated 201501/13/2015
DARA
0.71KRN5500Pain - Neuropathic Phase 2Seeking partner for development09/08/2013
DBVT
23.76Viaskin Peanut Peanut allergyPhase 2bPhase 2b data released September 201410/25/2014
DCTH
0.86Melphalan Hepatic Delivery System (Melphalan HDS)Hepatocellular carcinoma (HCC)Phase 2Phase 2 data due 1H 201511/11/2014
DCTH
0.86Melphalan Hepatic Delivery System (Melphalan HDS)Ocular Melanoma (OM) Liver MetastasesPhase 3Phase 3 to be initiated mid 201511/06/2014
DCTH
0.86CHEMOSAT systemCancer - unresectable metastatic ocular melanoma in the liverCRLCRL Sept 13 201309/15/2013
DEPO
20.59SEFELSAHot flashesCRLCRL May 31 201306/01/2013
DERM
14.87DRM04Primary axillary hyperhidrosisPhase 2bPhase 3 to be initiated 2H 2015.05/16/2015
DERM
14.87CimziaModerate-to-severe plaque psoriasis Phase 3Phase 3 initiated Jan 2015. Data due 201705/16/2015
DERM
14.87DRM01AcnePhase 2bPhase 2b initiated April 2015. Data due 1H 201605/16/2015
DPRX
11.80LocilexMild infections of diabetic foot ulcersPhase 3Second Phase 3 under SPA initiated July 2014. Data due 2H 2015. 02/26/2015
DRRX
2.53RemoxyChronic painCRLCRL Jun 23, 2011. Expects to refile NDA in 1Q 201605/15/2015
DRRX
2.53ReldayPhase 3Phase 3 to be initiated by ZGNX in 201603/04/2015
DRRX
2.53PosidurPost-operative pain relief CRLCRL Feb 12 2014. Phase 3 planned in response to CRL03/04/2015
DSCI
6.47DSC127 Diabetic foot ulcersPhase 3Phase 3 enrollment reached midpoint May 2015. Completion end of June 2016. Data likely early 201705/20/2015
DSCO
0.82AerosurfRespiratory Distress Syndrome - ModeratePhase 2aPhase 2a data released mid May 201505/16/2015
DVAX
22.05HEPLISAVHepatitis BPhase 3CRL Feb 25 2013. Met with FDA Jun 2013. Phase 3 initiated 1Q 2014, expects that all study subjects will be enrolled by the end of 2014 and all follow-up will be completed by October 2015. Noted in March 2015 that the Data and Safety Monitoring Board had recommended the trial continue unchanged03/04/2015
DVAX
22.05AZD1419AsthmaPhase 2aAnnounced in December 2014 that a Phase 2a trial in 1H 201512/10/2014
DYAX
26.20DX-2930Hereditary angioedema (HAE) Phase 2Positive Phase 1b data released late March 2015.04/03/2015
DYAX
26.20CYRAMZA (ramucirumab)Colorectal cancerPhase 3Filing due 1H 201509/23/2014
DYAX
26.20CYRAMZA (ramucirumab)Non-small cell lung cancer (NSCLC)BLAFiling due by end of 201409/23/2014
DYAX
26.20Necitumumab - SQUIRECancer - NSCLCBLABLA filing due by end of 201409/23/2014
DYAX
26.20Anti-LINGO - RENEW trialAcute optic neuritisPhase 2Phase 2 topline data due early 201509/23/2014
DYAX
26.20Anti-LINGO - SYNERGY trialRelapsing forms of multiple sclerosisPhase 2Phase 2 topline data due 201609/23/2014
DYAX
26.20CYRAMZA (ramucirumab)Gastric CancerApprovedApproved April 201408/03/2014
DYAX
26.20Trebananib (AMG 386)OvarianPhase 3Met endpoint08/03/2014
EARS
4.91AM-101Acute inner ear tinnitusPhase 3Phase 3 topline data due early 201612/05/2014
EARS
4.91AM-111Acute inner ear hearing lossPhase 3Pivotal trial to be initiated mid 201512/05/2014
EBIO
2.92EBI-005Moderate to severe dry eye diseasePhase 3Phase 3 topline data showed endpoints not met mid May 201505/20/2015
EBIO
2.92EBI-005Moderate to severe allergic conjunctivitisPhase 2Phase 2 primary endpoint not met October 2014. Noted in mid-April 2015 that a Phase 3 trial is planned for 2H 201504/17/2015
EBS
30.43Anthrax Immune Globulin Intravenous (Human) [AIGIV] AnthraxApprovedApproved March 25 201503/27/2015
EBS
30.43BioThrax Anthrax Vaccine AdsorbedPDUFA sBLA PDUFA date estimated May 9 201501/26/2015
ECYT
6.15vintafolideCancer - ovarianPhase 3Trial stopped due to poor efficacy05/04/2014
ECYT
6.15Vintafolide (TARGET)Cancer - NSCLCPhase 2bPhase 2b topline data released March 2014. Endpoint met.03/23/2014
ECYT
6.15vintafolideCancer - folate receptor-positive triple negative breast cancerPhase 2Initiate Phase 2 2Q 201402/25/2014
EDAP
3.02 Ablatherm-HIFU (High Intensity Focused Ultrasound) Cancer - Low risk, localized prostate cancerPMAPMA submitted Feb 2013. Adcom negative vote July 30 2014. Announced early March 2015 that they intend to file a 510k submission03/10/2015
EGLT
9.06Egalet-001Abuse-Deterrent MorphinePhase 3NDA planned for submission by end of 2015 assuming positve top line results from their pivotal 60 mg bioequivalence study in 3Q 201505/09/2015
EGLT
9.06Egalet-002Moderate to severe chronic painPhase 3Phase 3 trial planned for 2Q 201505/09/2015
EGRX
64.71RTU bivalirudin liquidNDA filingNDA filing due 2Q 201511/23/2014
EGRX
64.71RyanodexMalignant hyperthermiaApprovedApproved July 22, 2014 under priority review07/24/2014
EGRX
64.71EP-3101 (bendamustine RTD) Chronic lymphocytic leukemia; Indolent non-Hodgkin's lymphomaApproved (tentative)Tentative approval July 2 2014. Teva has also received orphan drug and related pediatric exclusivity expiring in September 2015 and May 2016 for the CLL and NHL indications, respectively. 07/03/2014
ENDP
83.17XIAFLEXEdematous fibrosclerotic panniculopathy (“cellulite”)Phase 2aPhase 2b to commence 201505/16/2015
ENDP
83.17XIAFLEXAdhesive Capsulitis (“Frozen Shoulder syndrome”)Phase 2bPhase 2 trial did not meet endpoint05/16/2015
ENDP
83.17Buprenorphine Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequatePDUFAAnnounced Dec 23 2014 that they have submitted their NDA filing. Estimated PDUFA date October 23 201502/24/2015
ENDP
83.17AVEED (testosterone undecanoate) intramuscular injectionMen diagnosed with hypogonadismApprovedApproved March 6 201409/06/2013
ENTA
40.05ABT-450HCV - genotype 1ApprovedApproved December 19 201412/22/2014
ENTA
40.05ABT-493HCV Phase 2bPhase 2b initiated Sept 2014. Data due 2015.09/11/2014
ENZY
9.52VayarolHypertriglyceridemiaPhase 2Phase 3 planned12/15/2013
EPZM
19.08EPZ-6438Non-Hodgkin lymphoma - EZH2 point mutationPhase 1/2Initiated Phase 1/2 Jun 201306/14/2013
EPZM
19.08EPZ-5676Mixed lineage leukemia, or MLL-rPhase 1Phase 1 initiated Sep 201205/31/2013
ESALY
65.77FycompaPrimary generalized tonic-clonic seizures (PGTC)PDUFAsNDA filed Aug 19 2014. Estimated PDUFA Aug 19 201501/26/2015
ESALY
65.77Lenvatinib mesylate (lenvatinib)Progressive radioiodine-refractory differentiated thyroid cancerPDUFAPDUFA date under priority review of April 14, 201501/26/2015
ESPR
103.75ETC-1002-009HypercholesterolemiaPhase 2b Data released mid March 2015 - data met primary endpoint. End of Phase 2 meeting planned for 3Q 2015 with Phase to be initiated later in 201505/09/2015
ESPR
103.75ETC-1002-014Hypercholesterolemia and hypertensionPhase 2Phase 2 data due mid 201505/09/2015
ESPR
103.75ETC-1002-008HypercholesterolemiaPhase 2bPhase 2b initiation Oct 2013. Data released October 201410/11/2014
ESPR
103.75ETC-1002-007HypercholesterolemiaPhase 2aTop-line data released Sept 03 201309/04/2013
ETRM
1.12VBLOCObesityApprovedApproved Jan 14, 201501/15/2015
EVOK
5.38EVK-001Female diabetic gastroparesisPhase 3Phase 3 initiated April 2014. Enrolment due to be completed 4Q 201505/16/2015
EXAS
26.55CologuardCancer - Colorectal DNA testApprovedApproved August 201408/16/2014
EXEL
3.15Cabozantinib - (METEOR)Cancer - metastatic renal cell cancer (RCC)Phase 3Phase 3 initiated May 2013. Data due late 2Q or early 3Q 201505/02/2015
EXEL
3.15VemurafenibCancer - BRAF V600 Mutation-Positive Advanced MelanomaPDUFAPDUFA August 11, 2015 under priority review02/21/2015
EXEL
3.15CabozantinibCancer - Castration-Resistant Prostate CancerPhase 3Phase 3 COMET-2 trial did not meet endpoint December 1 201412/02/2014
EXEL
3.15XL184 cabozantinib (CELESTIAL)Cancer - advanced hepatocellular cancer (HCC)Phase 3Phase 3 initiated Sept 2013. Data due 201711/25/2014
EXEL
3.15CabozantinibCancer - EGFR Wild-Type Non-Small Cell Lung CancerPhase 2Phase 2 data released Nov 201411/05/2014
FATE
6.14ProHema Adult hematologic malignanciesPhase 2Phase 2 primary endpoint data due 2H 2015. 05/08/2015
FGEN
17.63FG-3019Duchenne muscular dystrophyPhase 2Expect to initiate Phase 2 trial in 2H 201505/16/2015
FGEN
17.63Roxadustat FG-4592Anemia in chronic kidney diseasePhase 3Phase 3 ongoing. Enrolment expected to be completed in 1H 2016. Data due 201702/01/2015
FGEN
17.63FG-3019Idiopathic pulmonary fibrosisPhase 2Phase 2 ongoing02/01/2015
FGEN
17.63FG-3019Liver fibrosisPhase 2Phase 2 ongoing in Hong Kong. Future development uncertain02/01/2015
FGEN
17.63FG-3019Pancreatic cancer Phase 2Phase 2 open-label trial ongoing02/01/2015
FLML
17.48LiquiTime ibuprofenPivotalPivotal trial planned for 2H 201505/16/2015
FLML
17.48VAZCULEP (phenylephrine hydrochloride)Clinically important hypotension resulting primarily from vasodilation in the setting of anesthesiaApprovedApproved June 30 201407/01/2014
FLML
17.48Bloxiverz (neostigmine methylsulfate)Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgeryApprovedApproved Jun 306/05/2013
FLXN
20.00FX006Osteoarthritis of the knee Phase 2bPhase 2b initiated April 2014. Placed on clinical hold Sep 2014. Hold lifted December 2014. Enrolment completed Feb 2015. Data due 4Q 2015. Phase 3 initiated Feb 2015 with data due 2016. NDA filing due 2016 assuming positive data05/09/2015
FLXN
20.00FX007Phase 2Phase 2 trial to be initiated 201404/24/2014
FOLD
11.71Migalastat HCl monotherapy (012)Fabry DiseasePhase 3NDA filing due 2H 201503/21/2015
FOLD
11.71migalastat HCl monotherapy (011)Fabry DiseasePhase 3 6 month data released Dec 2012 did not show statistical significance. 12/24 month data released April 201405/01/2014
FOMX
12.59FDX104Chemotherapy Induced RashPhase 2Phase 2 initiated Oct 201410/25/2014
FOMX
12.59FDX101RosaceaPhase 2Phase 2 to be initiated 201510/25/2014
FOMX
12.59FDX101AcnePhase 2Phase 3 to be initiated mid 201510/25/2014
FOMX
12.59FDX102ImpetigoPhase 2Phase 2 to be initiated 2H 201510/25/2014
FPRX
19.67FP-1039FGFR1Phase 1bPhase 1b initiated July 2013. Prelim data due by end of 201408/16/2014
FWP
33.05FP187Multiple sclerosisPhase 3Phase 3 planned within 12 months as of March 201503/27/2015
FWP
33.05FP187PsoriasisPhase 3Phase 3 planned within 12 months as of March 201503/27/2015
GALE
1.42NeuVax (E75) - PRESENTCancer - low-to-intermediate HER2+ breast cancerPhase 3Initiated Phase 3 Jan 2012 under SPA. Enrolment completed mid-April 2015. Interim analysis due late 2015 or early 2016. Final endpoint is currently expected to be reached in 201805/09/2015
GALE
1.42GALE-401Essential Thrombocythemia (ET)Phase 2Phase 2 initiated September 2014. Top-line data due mid 2015.03/07/2015
GALE
1.42GALE 301 -Folate Binding Protein (FBP) vaccineEndometrial and ovarian cancerPhase 2Phase 2 initiated Jan 2014. Enrolment completed June 2014. Data due mid 201503/07/2015
GALE
1.42NeuVaxCancer - HER2 3+ Breast CancerPhase 2Phase 2 initiated Nov 2014. Enrollment due to be completed 2H 201611/12/2014
GALE
1.42NeuVax in combination with HerceptinBreast cancerPhase 2bPhase 2b ongoing05/11/2014
GBIM
8.24GS-4774 - 0101 trialChronic hepatitis B infectionPhase 2Phase 2 initiated by GILD Sept 2013. 48-week results are expected to be available 1H 2015.05/16/2015
GBIM
8.24GS-4774 - 1401 trialChronic hepatitis B infectionPhase 2Phase 2 initiated by GILD in 2014. 48-week results are expected to be available mid 2016.05/16/2015
GBIM
8.24GI-6301ChordomaPhase 2Phase 2 initiated by NCI April 201505/16/2015
GBIM
8.24GI-6207Medullary thyroid cancerPhase 2Phase 2 ongoing05/16/2015
GBIM
8.24GI-4000Cancer - Non-small cell lung cancerPhase 2Phase 2b planned07/09/2014
GBIM
8.24GI-4000Cancer - colorectal cancer Phase 2Phase 2a ongoing07/09/2014
GERN
3.89ImetelstatMyelodysplastic syndromesPhase 2Phase 2 to be initiated late 201503/04/2015
GERN
3.89ImetelstatMyelofibrosisPhase 2Phase 2 clinical hold lifted Nov 2014. Phase to be initiated mid 201503/04/2015
GEVA
213.99SBC-103 Mucopolysaccharidosis IIIBPhase 1/2Phase 1/2 trial initiated late Jan 2015. Preliminary data due 2H 201502/28/2015
GEVA
213.99Sebelipase alfa (Kanuma)Late onset lysosomal acid lipase deficiency (LAL Deficiency)PDUFA PDUFA date under priority review Sept 8 201501/26/2015
GILD
109.77Elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide HIVPDUFANDA filed approx Nov 6 2014. Estimated PDUFA Nov 6 201501/26/2015
GLMD
9.35AramcholCholesterol GallstonesPhase 2aPhase 2a initiated Nov 2014. Enrolment has slowed as of May 2015. 05/16/2015
GLMD
9.35Aramchol - ARRESTNon-Alcoholic Steatohepatitis (NASH)Phase 2bInitiated Phase 2b March 2015. Interim analysis due 1H 2016. Final data due 2H 201605/16/2015
GLYC
8.54GMI-1271Acute myeloid leukemia (AMLPhase 1/2Phase 1/2 initiated May 201505/20/2015
GLYC
8.54GMI-1070 (rivipansel)Vaso-occlusive crisis of sickle cell diseasePhase 3Phase 3 to be initiated mid-201504/08/2015
GNCA
10.40GEN-003Herpes simplex virus type 2 (HSV-2) Phase 1/2Phase 2 enrolment completed early Jan 2015. Topline data released May 201505/22/2015
GNCA
10.40GEN-004Universal vaccine candidate against pneumococcusPhase 2Phase 2 trial initiated September 2014. Topline data due 4Q 201505/09/2015
GNVC
2.10CGF166Hearing lossPhase 1/2Ongoing05/09/2015
GTHP
0.10LuVivaDevice to detect cervical diseasePMANoted mid-Nov 2014 that "we also are anxiously awaiting word from the FDA on our PMA Amendment, which, based on FDA guidelines, could be received by January 24, 2015 or sooner."12/18/2014
GTXI
1.11Enobosarm Breast cancerPhase 2Phase 2 planned05/09/2015
GWPH
113.87GWP42003SchizophreniaPhase 2Phase 2 data due 2H 201505/16/2015
GWPH
113.87GWP42004Type 2 diabetesPhase 2bEstimated completion date 201605/16/2015
GWPH
113.87SativexMultiple Sclerosis (MS) spasticityPhase 3Phase 3 Special Protocol Assessment (SPA) ongoing with FDA for proposed Sativex Phase 3. trial 05/16/2015
GWPH
113.87SativexCancer painPhase 3First of three Phase 3 trials failed. Data from two additional Phase 3 cancer pain trials expected 2H 201505/16/2015
GWPH
113.87EpidiolexDravet SyndromePhase 3Top line Phase 3 data expected by the end of 201505/16/2015
GWPH
113.87EpidiolexDravet SyndromePhase 3Second Phase 3 trial initiated mid April 2015. Topline data due 1Q 201605/16/2015
GWPH
113.87EpidiolexLennox-Gastaut syndrome (LGS)Phase 3Two Phase 3 trials to be initiated 2Q 201505/16/2015
GWPH
113.87EpidiolexTuberous Sclerosis ComplexPhase 3Phase 3 to be initiated 2H 201505/16/2015
GWPH
113.87GWP42006EpilepsyPhase 2Phase 2 initiated May 2015. Data due 1H 201605/16/2015
GWPH
113.87GWP42003Ulcerative colitisPhase 2aPrelim data released 4Q 201411/23/2014
HALO
17.74PEGPH20 Cancer - pancreaticPhase 2Clinical hold lifted June 2014.Patient enrolment recommenced July 2014. Enrolment due to be completed 2H 2015. Interim data to be presented at ASCO 2015. Phase 3 to be initiated 1Q 201605/16/2015
HALO
17.74PEGPH20 in Combination with docetaxelCancer - NSCLCPhase 1bComplete enrolment 3Q 201501/13/2015
HALO
17.74PEGPH20 in combination with PD-1 InhibitorCancer - NSCLCPhase 1bPhase 1b to be initiated 2H 201501/13/2015
HALO
17.74HYQVIASubcutaneous treatment for patients with primary immunodeficiency (PI)ApprovedApproved Sept 12 201409/14/2014
HALO
17.74HTI-501CelluoitePhase 2Phase 2 data due released Jul 2013. Topline data released 1Q 201403/26/2014
HPTX
45.99RavictiHepatic encephalopathyPhase 2Phase 3 to be initiated 2H 201502/28/2015
HPTX
45.99 DiaPep277Type 1 diabetesPhase 3Trial stopped due to employee misconduct09/09/2014
HRTX
12.13HTX-019Prevention of chemotherapy-induced nausea and vomiting (CINV)NDA filing due 2H 201605/16/2015
HRTX
12.13APF530 - SustolPrevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)CRLCRL Mar 28 2013. Phase 3 data due late May 2015. Resubmission due mid 201505/09/2015
HSGX
8.32NeoCartCartilage defects in the kneePhase 3Phase 3 enrolment due to be completed 2Q 2016. Data due 2H 201705/16/2015
HTBX
6.31HS-110Cancer - NSCLC non-small cell lung cancer Phase 2Phase 2 trial initiated Sept 2014. Interim data due 2Q 2015. Second interim analysis due 4Q 2015. Enrolment to be completed 2H 2015.05/16/2015
HTBX
6.31HS-410Cancer - bladder cancerPhase 2Phase 2 initiated Oct 2014. Enrolment due to be completed 2H 2015. Data due 2H 2016. 03/29/2015
HZNP
31.90ACTIMMUNEFriedreich's Ataxia (FA)Phase 3Phase 3 to be initiated 2Q 201502/14/2015
ICPT
262.64Obeticholic acid (OCA) - REGENERATEAdult nonalcoholic steatohepatitis (NASH) patients. Phase 2FLINT trial stopped early due to strong efficacy Jan 2014. Phase 3 to be initiated 3Q 201505/20/2015
ICPT
262.64Obeticholic acid (OCA)Primary biliary cirrhosis (PBC) - POISENDA filingCompletion of NDA filing planned in 2Q 201503/21/2015
ICPT
262.64Obeticholic acid (OCA)Primary Sclerosing Cholangitis (PSC)Phase 2Phase 2 to be initiated by end of 201411/08/2014
ICPT
262.64Obeticholic acid (OCA)Portal hypertensionPhase 2Phase 2b to be initiated 2H 201401/10/2014
ICPT
262.64Obeticholic acid (OCA) - OBADIAH1Primary bile acid diarrhea (PBAD)Phase 2Phase 2b to be initiated 2H 201401/10/2014
IDRA
3.13IMO-8400Waldenström’s MacroglobulinemiaPhase 1/2Phase 1/2 data due 4Q 201505/16/2015
IDRA
3.13IMO-8400 DLBCL who harbor the MYD88 L265P mutationPhase 1/2Phase 1/2 data due 201605/16/2015
IDRA
3.13IMO-8400PsoriasisPhase 2Phase 2 initiated Jun 2013. Data released Mar 201404/25/2014
IMGN
8.93IMGN853 Cancer - ovarian cancer and relapsed endometrial cancerPhase 2Phase 2 to be initiated 2015. Phase 1b data due at ASCO 201501/31/2015
IMGN
8.93Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) - Kadcyla KRISTINE trialHER2-positive breast cancer - neo-adjuvant settingPhase 3Phase 3 enrolling01/31/2015
IMGN
8.93Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) - Kadcyla (KAITLIN) HER2-positive breast cancer - adjuvant usePhase 3Phase 3 enrolling01/31/2015
IMGN
8.93Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) - Kadcyla (KATHERINE).HER2-positive breast cancer - residual invasive diseasePhase 3Phase 3 enrolling01/31/2015
IMGN
8.93Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) - Kadcyla GATSBY trialCancer - metastatic HER2+ gastric cancer Phase 3Data due 201501/13/2015
IMGN
8.93Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) - Kadcyla - MARIANNE trialCancer - 1st-line HER2+ Metastatic Breast Cancer Phase 3Phase 3 data released Dec 18 2014. Met non-inferiority endpoint but did NOT significantly improve PFS compared to Herceptin and chemotherapy12/19/2014
IMGN
8.93SAR3419Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients (STARLYTE)Phase 2Ongoing02/02/2014
IMGN
8.93SAR3419Acute Lymphoblastic Leukemia (MYRALL)Phase 2Ongoing02/02/2014
IMMU
3.98SACITUZUMAB GOVITECANCancer - non-small cell lung cancer (NSCLC) Phase 2Phase 2 data released Feb 201502/21/2015
IMMU
3.98Clivatuzumab tetraxetanCancer - PancreaticPhase 3Phase 3 data due mid 201602/05/2015
IMMU
3.98Epratuzumab (EMBODY 2)LupusPhase 3Data due 1H 201502/05/2015
IMMU
3.98ISACTUZUMAB GOVITECAN (IMMU-132) Cancer - metastatic solid cancersPhase 2Phase 2 data released Oct 201410/30/2014
IMMU
3.98Epratuzumab (EMBODY 1)LupusPhase 3Data due 1Q 201512/14/2013
IMMU
3.98VeltuzumabCancer - immune thrombocytopenic purpura - ITPPhase 2Updated Phase 1/2 data presented at ASH Dec 201312/10/2013
IMMU
3.98Veltuzumab intravenousCancer - NHL Non-Hodgkin lymphomaPhase 2Phase 3 planned, need funding09/10/2013
IMMY
8.50Impracor Topical NSAIDPain - anti-inflammatory creamPhase 3Phase 3 initiation delayed08/14/2013
IMUC
0.47ICT-107 dendritic cell vaccineGlioblastoma antigens and cancer stem cellsPhase 2bPhase 2b failed to meet primary endpoint. Phase 3 initiation due late 3Q or early 4Q 201505/13/2015
INCY
107.29Ruxolitinib - JANUS 1 and JANUS 2Cancer - PancreaticPhase 3Phase 3 data for JANUS 1 due 2016. JANUS 2 due at a later date05/03/2015
INCY
107.29BaricitinibRheumatoid arthritisPhase 3Data from first Phase 3 trial met primary endpoint December 2014 and also in February 201502/24/2015
INCY
107.29RuxolitinibBreast CancerPhase 2Data due 201602/14/2015
INCY
107.29Ruxolitinib Non-small cell lung cancerPhase 2Phase 2 data due 201602/14/2015
INCY
107.29INCB39110 and docetaxel Non-small cell lung cancerPhase 2Phase 2 underway - July 2014. Ongoing02/14/2015
INCY
107.29INCB39110 and erlotinibNon-small cell lung cancerPhase 2Phase 2 ongoing02/14/2015
INCY
107.29INCB39110 with gemcitabine and nab-paclitaxelPancreatic cancerPhase 2Phase 2 to be initiated 2H 201502/14/2015
INCY
107.29INCB24360Cancer - OvarianPhase 2Ongoing02/14/2015
INCY
107.29Jakafi (ruxolitinib) (RESPONSE)Polycythemia VeraApprovedApproved December 4 201412/05/2014
INCY
107.29Jakafi (ruxolitinib) (RELIEF)Disease-related symptoms in patients with Polycythemia VeraPhase 3Endpoint not met, mid-201407/24/2014
INCY
107.29INCB24360 in combination with ipilimumabCancer - MelanomaPhase 1/2Prelim data released at ASCo 201406/03/2014
INCY
107.29BaricitinibDiabetic nephropathyPhase 2Phase 2 initiated Aug 2012. Data due 201502/13/2014
INCY
107.29INCB18424 ruxolitinibCancer- Children with hematologic malignancies and solid tumorsPhase 1/2Ongoing05/03/2013
INCY
107.29INC280 (formerly INCB28060)Advanced hepatocellular carcinomaPhase 2Phase 2 initiated Apr 201304/30/2013
INFI
13.02Duvelisib (IPI-145) DYNAMOIndolent non-Hodgkin lymphomaPhase 2Phase 2 enrolment due to be completed 2H 201505/07/2015
INFI
13.02Duvelisib (IPI-145)Cancer - relapsed/refractory chronic lymphocytic leukemia (CLL)Phase 3Phase 3 enrolment to be completed 2H 201505/07/2015
INFI
13.02Duvelisib (IPI-145)Rheumatoid arthritisPhase 2Phase 2 failed to meet endpoint - Jan 201501/09/2015
INFI
13.02Retaspimycin Hydrochloride with everolimusCancer - NSCLCPhase 2Phase 2 enrolment completed. Does not plan to further development09/27/2013
INNL
10.95XaraColl Post-operative painPhase 3Phase 3 initiated mid May 2015. Data due 1Q 201605/16/2015
INNL
10.95CogenziaDiabetic foot ulcer infectionsPhase 3Data due mid 201605/16/2015
INO
8.36VGX-3100Cervical dysplasiaPhase 2Phase 3 to be initiated early 201605/16/2015
INSM
22.12ARIKAYCENon-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, prelim data due mid-2016 and in 2017.11/08/2014
INSM
22.12ARIKAYCEcystic fibrosisPhase 3 Phase 3 Euro data released 1 July 2013. Met endpoint but slighly inferior data to competition07/02/2013
INSV
0.14BromSite (ISV-303) Pain after cataract surgeryPhase 3NDA filing ready to file but contingent upon raising additional financing to pay the FDA filing fee of approximately $2.2 million05/16/2015
INSY
59.72Dronabinol Oral SolutionAIDS-related anorexia NDANDA to be refiled 1Q 201501/13/2015
INSY
59.72CannabidiolEpilepsyPhase 3Phase 3 to be initiated 2H 201501/13/2015
INSY
59.72SubsysAcute post-operative painPhase 3Dose ranging trial to be initiated 1H 2015, with Phase 3 to be initiated 2H 2015. Data due 2016.01/13/2015
INSY
59.72BuprenorphineAcute pain in patients undergoing a bunionectomy procedurePhase 3Phase 3 to be initiated 1H 2015. Data due 2016.01/13/2015
INSY
59.72Buprenorphine/ NaloxonePhase 3Phase 3 to be initiated 201501/13/2015
INSY
59.72OndansetronPhase 3Phase 3 to be initiated 201501/13/2015
IPXL
45.28IPX066Parkinson's ApprovedApproved Jan 8 201501/09/2015
IRWD
13.73LinaclotideChronic idiopathic constipation (CIC)Phase 3Phase 3 data due 2H 201505/06/2015
IRWD
13.73LinaclotideOpioid-induced constipation (OIC)Phase 2Phase 2 initiated Oct 2014. Data due 2H 2015.05/06/2015
IRWD
13.73LinaclotideOpioid-induced constipation (OIC)Phase 2Phase 2 initiated Oct 2014. Data due 2H 2015.05/06/2015
IRWD
13.73IW-9179GastroparesisPhase 2aPhase 2a initiated December 2014. Data due 1H 201602/14/2015
IRWD
13.73 IW-3718 Gastroesophageal reflux disease (GERD) Phase 2aPhase 2a initiated March 2014. Data released early Feb 2015 and as a result intends to initiate a Phase 2b trial02/05/2015
IRWD
13.73IW-9179Functional dyspepsiaPhase 2aEnded trial prior to completing enrolment due to various issues05/01/2014
ISIS
66.99ISIS-DMPK RxMyotonic Dystrophy Type 1 (DM1)Phase 1/2Announced Dec 16 that a Phase 1/2 trial has been initiated. Data due 201502/28/2015
ISIS
66.99ISIS-APOCIIIRxPartial lipodystrophy rapidlyPhase 3Phase 3 planned02/28/2015
ISIS
66.99ISIS-GCCRRx Type 2 diabetesPhase 2Phase 2 data due 201502/28/2015
ISIS
66.99ISIS-APO(a)RxHigh lipoprotein(a), or Lp(a)Phase 2Phase 2 initiated July 2014. Data due 201502/28/2015
ISIS
66.99ISIS-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
ISIS
66.99ISIS-SMNRxChildren with spinal muscular atrophy (SMA)Phase 3Phase 3 initiated July 2014. Additional Phase 3 study initiated Nov 201411/27/2014
ISIS
66.99PlazomicinMulti-drug resistant (MDR)Phase 3Phase 3 initiated Sept 201409/18/2014
ISIS
66.99ISIS-APOCIIIRxFamilial chylomicronemia syndrome (FCS)Phase 3Phase 3 initiated Aug 201408/29/2014
ISIS
66.99ISIS-CRPRx (ASET)Atrial fibrillationPhase 2Initiated Feb 2013. Data released 201408/17/2014
ISIS
66.99ISIS-FXIRxClotting disorders in patients undergoing knee replacement surgeryPhase 2Phase 2 data released May 201405/24/2014
ISIS
66.99OGX-427 in combination with gemcitabine and cisplatin Borealis-1Cancer - bladderPhase 2Phase 2 data due 2H 201409/12/2013
ISIS
66.99TG-1101Cancer - hepatocellular carcinoma (HCC)Phase 1/2Phase 2 initiated May 201305/07/2013
JNJ
100.82YONDELISAdvanced soft tissue sarcoma (STS)PDUFA NDA filed approx Nov 24 2014. Estimated PDUFA Nov 24 201501/26/2015
JNJ
100.82Three-Month INVEGA SUSTENNA (paliperidone palmitate)SchizophreniaPDUFANDA filed approx Nov 24 2014. Priority Review. Estimated PDUFA July 24 2015. 01/26/2015
JUNO
46.45JCAR015Relapsed/ refractory B cell acute lymphoblastic leukemiaPhase 2Phase 2 to be initiated 201503/21/2015
JUNO
46.45JCAR017Non-Hodgkin lymphoma (NHL)Phase 1/2Phase 1/2 trial planned for 201502/01/2015
JUNO
46.45JCAR017Pediatric Relapsed/ acute lymphoblastic leukemiaPhase 1/2Phase 1/2 ongoing02/01/2015
JUNO
46.45JCAR014R/R NHL or R/R ALLPhase 1/2Phase 1/2 ongoing but no plans to advance JCAR014 into registration trials02/01/2015
KBIO
0.49KB001-ACystic fibrosis (CF) patients with chronic Pseudomonas aeruginosa (Pa) lung colonizationPhase 2Phase 2 data released early January 2015 did not meet endpoint. Development discontinued01/07/2015
KBIO
0.49Pa ventilator associated pneumonia (VAP)Phase 2bPhase 2b trial to be initiated mid 201505/11/2014
KBIO
0.49KB004MDS and AMLPhase 2Phase 2 initiated Feb 2014. Top-line Data due 2Q or 3Q 201504/27/2014
KERX
10.29AuryxiaIron deficiency anemia in non-dialysis dependent CKD patientsPhase 3Phase 3 initiated 3Q 2014. Due to be completed by end of 201505/06/2015
KERX
10.29AuryxiaHyperphosphatemiaApprovedApproved Sept 5 201409/07/2014
KITE
51.21KTE-C19Relapsed/refractory diffuse large B cell lymphoma, or DLBCLPhase 1/2Phase 1/2 planned for 201507/09/2014
KMDA
4.29KamRABProphylaxis of rabies diseasePhase 3Phase 2/3 data due by mid 2015. BLA filing due 2H 201502/12/2015
KMDA
4.29Inhaled formulation of AATAATD - Alpha-1 Antitrypsin deficiencyPhase 2/3Top-line data from the pivotal Phase 2/3 clinical trial did not meet primary endpoint - May 201405/17/2014
KMDA
4.29GlassiaPediatric patients newly diagnosed with type 1 diabetesPhase 2/3Phase 2/3 initiated Mar 201403/06/2014
KPTI
26.84SelinexorCancer - Advanced Gynecologic Malignancies (SIGN Study)Phase 2Phase 2 initiated April 2014. Interim data at ASCO 201505/13/2015
KPTI
26.84SelinexorCancer - glioblastoma (KING study)Phase 2Phase 2 initiated April 2014. Interim data at ASCO 201505/13/2015
KPTI
26.84SelinexorCancer - Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2bPhase 2b initiated Dec 2014. Expects trial to be completed in two years (i.e. around end of 2016)12/12/2014
KPTI
26.84SelinexorRichter's transformation (SIRRT)Phase 2Phase 2 initiated November 201411/11/2014
KPTI
26.84SelinexorCancer - Relapsed/Refractory Acute Myeloid Leukemia (AML)Phase 2Phase 2 initiated June 25 201406/25/2014
KPTI
26.84SelinexorCancer - hormone-refractory prostate cancer (HRPC)Phase 2Phase 2 initiated June 201406/10/2014
KYTH
47.63ATX-101 Reduction of Localized Subcutaneous Fat in the Submental AreaPDUFAApproved April 29 201505/02/2015
LGND
89.17Captisol-Enabled MelphalanCancer - multiple myelomaPDUFAPDUFA October 23 201503/10/2015
LGND
89.17Captisol-enabled Delafloxacin IVABSSSIPhase 3Frist Phase 3 trial run by partner Melinta Therapeutics met endpoint. Data from second trial due 2H 201501/09/2015
LGND
89.17PromactaAplastic AnemiaApprovedApproved August 27 201408/28/2014
LGND
89.17Bazedoxifene/Conjugated Estrogens (BZA/CE), formerly known as APRELAMenopausal symptomsApprovedApproved Oct 3 201310/06/2013
LGND
89.17Captisol-enabled DelafloxacinAcute bacterial skin and skin structure infections (ABSSSI)Phase 3Phase 3 initiated by Rib-X Pharmaceuticals May 201305/15/2013
LJPC
19.67LJPC-501Catecholamine-resistant hypotension (CRH).Phase 3Phase 3 initiated late March 2015 under SPA03/27/2015
LJPC
19.67GCS-100Chronic kidney diseasePhase 2Phase 2b initiated mid March 201503/22/2015
LPCN
7.10LPCN 1111Oral testosterone productPhase 2aPhase 2b to be initiated 4Q 2015 or 1Q 201605/09/2015
LPCN
7.10LPCN 1021Men with low testosterone (Low T)Phase 3Phase 3 data due mid 2015. NDA filing due 2H 201505/02/2015
LPTN
0.30iSONEPWet-AMDPhase 2Reported Dec 2 2014 that Phase 2 enrolment has been completed. Data due 2Q 201503/25/2015
LPTN
0.30ASONEPRenal cell carcinoma (RCC)Phase 2aPhase 2a failed to meet primary endpoint late March 201503/25/2015
LXRX
7.40LX1032 Telotristat etiprateCarcinoid SyndromePhase 3Phase 3 topline data due 3Q 201505/02/2015
LXRX
7.40LX4211Type 1 DiabetesPhase 3Phase 3 screening commenced late March 201503/27/2015
LXRX
7.40LX1032 Telotristat etiprateUlcerative colitisPhase 2Ongoing05/11/2013
MACK
12.25MM-141Cancer - front line pancreatic cancerPhase 2Phase 2 initiated May 201505/06/2015
MACK
12.25MM-398 NAPOLI-1Cancer - second line pancreaticPhase 3Rolling NDA completed on or about April 27 2015. Priority review requested04/29/2015
MACK
12.25MM-111Cancer - second line HER2+ gastric cancerPhase 2Development stopped due to poor trial data released late Feb 201502/28/2015
MACK
12.25MM-398Cancer - front-line pancreatic cancerPhase 2Phase 2 to be initiated 201502/28/2015
MACK
12.25MM-121Cancer - Heregulin Positive Non-Small Cell Lung CancerPhase 2Phase 2 initiated mid Feb 201502/21/2015
MACK
12.25MM-302 HERMIONECancer - HER2-positive locally advanced or metastatic breast cancerPhase 2Phase 2 initiated August 201408/14/2014
MACK
12.25MM-121 Cancer - triple negative breast cancer cohort in the neoadjuvant settingPhase 2Phase 2 data released June 201406/22/2014
MACK
12.25MM-151CancerPhase 2Phase 2 to be initiated 201405/04/2014
MACK
12.25MM-121 Cancer -hormone receptor positive breast cancerPhase 2Data released Nov 201311/27/2013
MACK
12.25MM-121Cancer - ovarianPhase 2Missed endpoint Oct 201311/02/2013
MCUR
11.50CureXcellDiabetic Foot UlcersPhase 3Phase 3 data due October 201505/15/2015
MCUR
11.50CureXcellVenous Leg Ulcers Phase 3Phase 3 final data 1H 201605/15/2015
MDCO
27.11RAPLIXAHemostasisPDUFAApproved April 30 201505/02/2015
MDCO
27.11IONSYSAcute postoperative painApprovedApproved April 30 201505/02/2015
MDCO
27.11CangrelorReduction of thrombotic cardiovascular events including stent thrombosis in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI)Advisory Committee MeetingCardiovascular and Renal Drugs Advisory Committee met on April 15, 2015. Voted voted 9 - 2 in favour with one abstention04/17/2015
MDCO
27.11CARBAVANCESerious Bacterial Infections Due to Gram-Negative BacteriaPhase 3Phase 3 initiated Nov 2014. Data due 201611/06/2014
MDCO
27.11OritavancinABSSSIPDUFAApproved August 6 2014 under priority review08/10/2014
MDCO
27.11Angiomax (bivalirudin) Peripheral endovascular intervention (PEI)Phase 3Phase 3 enrolment commenced Oct 201310/11/2013
MDGN
7.10Erythropoietin ("EPO") therapy delivered via EPODURE BiopumpAnemiaPhase 2Phase 1/2 trial commenced enrolment Jun 2014. Initial data released Oct 15 201410/19/2014
MDVN
128.32Enzalutamide cf Bicalutamide STRIVE trialCancer - prostate enrolling both metastatic and non-metastatic patientsPhase 2Phase 2 data released early April 2015. HR = 0.24. Median PFS 19.4 months for Enzalutamide v 5.7 months for Bicalutamide04/03/2015
MDVN
128.32MDV3100 cf Bicalutamide TERRAIN trial Cancer - prostate enrolling only metastaticPhase 2Met primary endpoint late Jan 2015. HR 0.44, Median PFS 15.7 months for enzalutamide compared to 5.8 months for bicalutamide01/23/2015
MDVN
128.32XTANDICancer - mCRPC who have not received chemotherapyApprovedApproved Sept 10 201409/11/2014
MDVN
128.32Enzalutamide Androgen receptor positive, triple-negative breast cancerPhase 2Phase 2 initiated June 2013. Enrolment continues as of May 201405/11/2014
MDVN
128.32EnzalutamideAdvanced Breast Cancer That Is Estrogen or Progesterone Receptor Positive and HER2 NormalPhase 2Phase 2 initiated Dec 2013. Enrolment continues as of May 201405/11/2014
MDVN
128.32 Enzalutamide PROSPERNon-Metastatic Castration-Resistant Prostate CancerPhase 3Phase 3 initiated Nov 2013. Enrolment ongoing as of May 2014a05/11/2014
MDVN
128.32MDV3100 enzalutamide PREVAILCancer - advanced prostate cancer who have not previously been treated with chemotherapyPhase 3Endpoints met October 2013. Final results released Jan 201401/29/2014
MDWD
5.04NexoBridSevere burnsPhase 3Phase 3 initiated mid April 2015. Data due 1H 201705/06/2015
MDWD
5.04EscharEx Chronic and other hard-to-heal woundsPhase 2Phase 2 data due 2H 2015 (Israel)05/24/2014
MEIP
1.81Pracinostat in combination with Vidaza First line intermediate-2 or high-risk Myelodysplastic SyndromePhase 2Phase 2 topline data released late March 2015 did not meet primary endpoint03/24/2015
MEIP
1.81Pracinostat in combination with VidazaElderly patients with newly diagnosed acute myeloid leukemia (AML)Phase 2Preliminary data from this open-label trial was released at ASH December 2014. Phase 3 is planned12/10/2014
MEIP
1.81Pracinostat and Vidaza or DacogenMyelodysplastic SyndromePhase 2Ongoing11/13/2014
MGNX
32.04Margetuximab SOPHIA studyCancer - metastatic breast cancerPhase 3Phase 3 to commence 3Q 201505/07/2015
MGNX
32.04MGA271CancerPhase 2Phase 2 to be initiated 201511/12/2014
MNKD
4.82AFREZZA Type 1/2 diabetesApprovedApproved June 27 201406/28/2014
MNOV
3.96MN-166Progressive multiple sclerosis (progressive MS).Phase 2bEnrolment completed May 2015. 05/09/2015
MNOV
3.96MN-166Amyotrophic lateral sclerosis (ALS)Phase 2Announced mid-February 2015 that 30 of the 60 subjects planned for participation have been enrolled02/21/2015
MNOV
3.96MN-166Opioid dependence Phase 2Phase 2 interim data released August 201408/19/2014
MNOV
3.96MN-001NASH (nonalcoholic steatohepatitis)Phase 2Phase 2 planned01/15/2014
MNTA
19.39Generic CopaxoneMultiple sclerosisApprovedFiled 2007. Approved April 16 201504/17/2015
MNTA
19.39Necuparanib in combination with AbraxaneCancer - advanced metastatic pancreatic cancerPhase 1/2Initiated Phase 1/2 proof of concept trial Jul 2012. Data from Part A of trial released Oct 2014. Further data due mid 201502/21/2015
MRNS
8.17GanaxoloneFemale children with EpilepsyPhase 2Phase 2 initiated early Feb 2015. Data due 2H 201505/15/2015
MRNS
8.17GanaxoloneFragile X SyndromePhase 2Phase 2 data due 201505/15/2015
MRNS
8.17GanaxoloneEpilepsyPhase 3Phase 3 top-line data due 1Q 201603/14/2015
MSTX
0.49ANX-188 - VepoloxamerSickle cell diseasePhase 3Phase 3 initiated Jan 2013. Expect to complete enrolment 4Q 2015. Top-line data due 1Q 201605/16/2015
MSTX
0.49ANX-188 - VepoloxamerHeart Failure Phase 2Phase 2 to be initiated 3Q 201503/25/2015
MSTX
0.49AIR001Heart failure with preserved ejection fraction (HFpEF)Phase 2Phase 2 initiated early Feb 201502/05/2015
MSTX
0.49ANX-188 - VepoloxamerAcute limb ischemia (ALI)Phase 2Initiated Phase 2 March 2014. Expect to complete enrolment 2H 201611/03/2014
MSTX
0.49AIR001 Pulmonary Hypertension Phase 2Phase 2 prelim data released Sept 201409/09/2014
NAVB
1.30LymphoseekHead and Neck CancerApprovedApproved Jun 13 201406/14/2014
NAVB
1.30NAV4694Predicting Progression to Alzheimer's Disease (AD) in Subjects With Mild Cognitive Impairment (MCI)Phase 2Phase 2 initiated Mar 2013. Initial data released Feb 2014. Data due 4Q 2016. 02/07/2014
NAVB
1.30NAV5001 Imaging Agent for Parkinson’s DiseasePhase 3Phase 3 initiated Dec 201312/08/2013
NBIX
42.30Elagolix Uterine FibroidsPhase 2bPhase 2b initiated Mar 2013. Ongoing as of Feb 2014. Data due 2H 2015.05/02/2015
NBIX
42.30VMAT2 NBI-98854 - Kinect 3Tardive dyskinesiaPhase 3Phase 3 initiated Oct 2014. Data due 2H 201505/02/2015
NBIX
42.30Elagolix EndometriosisPhase 3First Phase 3 trial met both co-primary endpoints - Jan 2015. Data from second Phase 3 trial due towards the end of 201505/02/2015
NBIX
42.30NBI-77860Classic congenital adrenal hyperplasia (CAH) Phase 1/2Announced Dec 10 2014 that a Phase 1/2 trial in patients with CAH had been initiated12/11/2014
NBS
2.66NBS20Recurrent metastatic melanoma Phase 3Phase 3 initiated late April 201505/02/2015
NBS
2.66NBS10 - PreSERVE trialAcute myocardial infarctionPhase 2Phase 2 one-year data eleased March 201503/07/2015
NBS
2.66AMR-001Left ventricular dysfunction following acute ST segment elevation myocardial infarction (STEMI)Phase 2Phase 2 data released Nov 201411/23/2014
NBY
0.70Auriclosene (NVC-422)Viral conjunctivitisPhase 2bData released August 2014. Endpoints not met08/21/2014
NBY
0.70Auriclosene (NVC-422)Impetigo skin infection studyPhase 2bFailed to meet endpoint Nov 2013. Plans to reinitiate trial in 201412/20/2013
NBY
0.70Auriclosene (NVC-422)Urine infectionPhase 2Phase 2 Topline Data released 3Q08/06/2013
NDRM
13.47ND0612HSevere Parkinson's DiseasePhase 2US Phase 2 planned for 2H 201604/03/2015
NDRM
13.47ND0612LModerate Parkinson's DiseasePhase 3Phase 3 planned for 2H 201504/03/2015
NEOT
6.00LIPO-202Reduction of central abdominal bulging due to subcutaneous fat in non-obese patientsPhase 3Phase 3 initiated mid-April 2015. Topline data due by end of 201504/15/2015
NERV
5.03MIN-101SchizophreniaPhase 2bPhase 2b trial to be initiated in Europe 2Q 2015. Data due 2Q 201605/09/2015
NERV
5.03MIN-202Primary insomniaPhase 2Phase 2 trial to be initiated mid 201505/09/2015
NERV
5.03MIN-117Major Depressive DisorderPhase 2aPhase 2 trial to be initiated in Europe 2Q 201505/09/2015
NKTR
11.53Etirinotecan pegol NKTR-102 (BEACON)Cancer - Metastatic Breast CancerPhase 3Phase 3 topline data mid March 2015 did not reach primary endpoint03/21/2015
NKTR
11.53NKTR-181Chronic painPhase 3Missed endpoint Sept 2013 but Phase 3 initiated late Feb 201502/26/2015
NKTR
11.53 BAX 855 Hemophilia ABLACompany announced Dec 2 2014 that BAX has submitted their BLA12/02/2014
NKTR
11.53FovistaWet-AMDPhase 3Phase 3 initial topline data due 201611/25/2014
NKTR
11.53NaloxegolOpioid-induced constipation (OIC)ApprovedApproved Sept 16 201409/17/2014
NKTR
11.53Etirinotecan pegol NKTR-102Cancer - gliomaPhase 2Phase 2 data released at ASCO 201406/02/2014
NKTR
11.53Inhaled Amikacin Solution (BAY41-6551T)Gram-Negative Pneumonia (INHALE 1)Phase 3Phase 3 data due 1H 201504/27/2014
NKTR
11.53Etirinotecan pegol NKTR-102Cancer - relapsed or refractory Small-Cell Lung Cancer (SCLC)Phase 2Phase 2 initiated Oct 201310/25/2013
NKTR
11.53Etirinotecan pegol NKTR-102Cancer - ovarianPhase 2Completed Dec 2012. Considering future development09/18/2013
NLNK
41.74HyperAcute Pancreas - IMPRESSSurgically resected pancreatic cancerPhase 3Enrloment completed Sept 2013. First of two interim analyses completed March 2014. Trial to continue as planned. Second analysis May 2015 - trial to continue as planned05/16/2015
NLNK
41.74HyperAcute Pancreas - PILLARPancreatic cancerPhase 3Phase 3 enrolment to be completed 2H 201502/28/2015
NLNK
41.74HyperAcute LungCancer - NSCLCPhase 2b/3Initiated Phase 2b/3 Oct 2012, ongoing as of March 2014. Update to be given 2H 201502/28/2015
NLNK
41.74HyperAcute Melanoma - dorgenmeltucel-LCancer - melanomaPhase 1b/2Planning03/12/2014
NLNK
41.74Indoximod in combination with docetaxelCancer - breastPhase 2Phase 2 initiated Apr 2013. Ongoing as of March 201403/12/2014
NLNK
41.74Sipuleucel-T (PROVENGE®) plus indoximod (D-1MT/NLG8189) Asymptomatic or minimally symptomatic metastatic hormone refractory prostate cancerriglPhase 2Phase 2 initiated Sep 2012. Ongoing as of March 201403/12/2014
NRX
7.30PyridorinDiabetic nephropathyPhase 3Phase 3 initiated June 2014. Enrolment due to be half complete by 1Q 201508/12/2014
NSPR
0.23MGuardSTEMI - ST segment elevation myocardial infarctionInvestigational Device Exemption (IDE) support trialMaster 12-month data due 4Q 201308/18/2013
NSPR
0.23MGuardSTEMI - ST segment elevation myocardial infarctionInvestigational Device Exemption (IDE) support trialMaster 2 enrolment due to be completed 3Q 2014. Data due 4Q 201508/18/2013
NVAX
8.89RSV F VaccineRespiratory Syncytial Virus (RSV) in women in their third trimester of pregnancyPhase 2Phase 2 initiated Sept 201409/18/2014
NVAX
8.89RSV vaccineRespiratory Syncytial Virus (RSV) in women of childbearing age.Phase 2Phase 2 topline data released April 201404/29/2014
NVAX
8.89Seasonal Influenza VaccineSeasonal FluPhase 2Further Phase 2 trials planned09/18/2013
NWBO
7.85DCVaxCancer - Glioblastoma multiforme (GBM) brain cancerPhase 3First trigger for interim analysis hit. Topline data due 1H 2015 as per Jan 2014 conference. However, trial design was altered in Aug 2014. No timeline update in PR08/17/2014
NWBO
7.85DCVaxCancer - inoperable solid tumor cancersPhase 1/2Initial data released May 2014. Phase 2 portion planned07/17/2014
NYMX
1.54NX-1207Cancer - low grade localized prostatePhase 2Phase 2 data released April 201405/01/2014
OCAT
6.90Retinal pigment epithelium cells Stargardt’s diseasePhase 2Pivotal trial planned03/02/2015
OCAT
6.90Retinal pigment epithelium cellsAge-related macular degenerationPhase 2Phase 2 trial planned03/02/2015
OCRX
3.66OCR-002 (IV)Hepatic encephalopathyPhase 2bPhase 2b trial to be completed 2H 201605/02/2015
OCRX
3.66OCR-002 Cirrhosis and upper gastrointestinal bleedingPhase 2aPhase 2a preliminary data released mid-Feb 201502/21/2015
OCUL
23.60OTX-DP Ocular inflammation and pain following cataract surgeryPhase 3Primary efficacy endpoint for pain met; primary efficacy endpoint for inflammatory cells not attained. NDA to be filed 2H 2015 for post-surgical ocular pain indication only. Phase 3 trial to be initiated in order to file a potential sNDA to include treatment of post-operative ocular inflammation05/16/2015
OCUL
23.60OTX-DPGlaucoma and ocular hypertensionPhase 2bPhase 2b initiated November 2014. Data due 4Q 201604/08/2015
OCUL
23.60OTX-DPAllergic conjunctivitisPhase 2Phase 3 to be initiated mid 201503/11/2015
OCUL
23.60OTX-DPDry Eye DiseasePhase 2Phase 2 enrolment commenced mid Jan 201501/22/2015
OGXI
2.16Custirsen in combination with Jevtana (cabazitaxel)-AFFINITYCancer - castrate-resistant prostate second-linePhase 3Initiated 2nd Phase 3 trial Aug 2012. Enrolment completed Sept 2014. Data due late 2015 or early 201605/16/2015
OGXI
2.16OGX-427 Borealis-2Cancer - advanced or metastatic bladder cancerPhase 2Phase 2 initiated Apr 2013. Completion of enrolment due late 201505/16/2015
OGXI
2.16Custirsen ENSPIRITCancer - NSCLCPhase 3Phase 3 initiated Oct 2012. First interim analysis released August 2014, second interim futility analysis expected in mid-2015. Data due 2H 201605/16/2015
OGXI
2.16OGX-427 in Combination with ABRAXANE plus Gemcitabine - Rainier TrialMetastatic Pancreatic CancerPhase 2Data due late 2015/early 201603/29/2015
OGXI
2.16OGX-427 and carboplatin and pemetrexed - SpruceTrialNon-squamous, non-small cell lung cancer (NSCLC)Phase 2Phase 2 data due mid 201603/29/2015
OGXI
2.16OGX-427 in combination with gemcitabine and cisplatin Borealis-1Cancer - bladderPhase 2Released Phase 2 data mid Dec 201412/22/2014
OGXI
2.16OGX-427 plus gemcitabine and carboplatin - Cedar TrialNon-squamous, non-small cell lung cancer (NSCLC)Phase 2Phase 2 open label initiated July 201407/02/2014
OGXI
2.16OGX-427 with PrednisoneCancer - chemotherapy-naive patients with metastatic CRPCPhase 2Phase 2 ongoing11/09/2013
OHRP
2.71Squalamine Eye DropsNeovascular (Wet) Age-related Macular Degeneration (AMD)Phase 2Topline data released late March 2015 failed to show statistical significance in overall population. Phase 3 to be initiated 2H 201505/13/2015
OHRP
2.71OHR-005Diabetic macular edema (DME)Phase 2Phase 2 initiated May 201405/10/2014
OHRP
2.71OHR/AVR118Cancer cachexia.Phase 2Phase 2 data presented Dec 201312/27/2013
OMER
20.79OMS721 Thrombotic microangiopathies (TMAs)Phase 2Phase 2 dosing completed mid Feb 201502/21/2015
OMER
20.79OMER824Huntington diseasePhase 2Phase 2 initiated Feb 2014. Trial placed on hold due to preclinical concerns10/22/2014
OMER
20.79OmidriaCataract surgeryApprovedApproved June 2 201406/03/2014
OMER
20.79OMER824SchizophreniaPhase 2Phase 2 initiated Sept 2013. Data released Jan 201401/30/2014
ONCE
9.37SPK-RPE65Inherited retinal dystrophiesPhase 3Phase 3 data due 2H 201503/21/2015
ONCE
9.37SPK-CHMChoroideremia Phase 1/2Phase 1/2 dosing commenced 1Q 201503/21/2015
ONCY
0.70REOLYSIN Cancer - metastatic colorectal cancerPhase 2Phase 2 enrolment completed mid Feb 201502/21/2015
ONCY
0.70REOLYSIN - intravenous with gemcitabineCancer - PancreaticPhase 2Data released Aug 201409/17/2014
ONCY
0.70REOLYSIN in Combination with Paclitaxel and CarboplatinCancer - Metastatic Pancreatic CancerPhase 2Enrolment completed July 201407/09/2014
ONCY
0.70 REOLYSIN with paclitaxel & carboplatinCancer - Head and NeckPhase 2Data released Apr 2014. Phase 3 planned04/10/2014
ONCY
0.70Intravenous REOLYSIN with paclitaxel & carboplatinCancer - squamous cell carcinoma of the lung (SCCLC)Phase 2Final data released Sept 201309/10/2013
ONCY
0.70Intravenous REOLYSIN in combination with paclitaxel and carboplatinCancer - metastatic melanomaPhase 2Prelim data released May 201305/23/2013
ONTX
2.77Oral Rigosertib and azacitidine 09-08 trialCancer - MDS and AMLPhase 2Phase 2 enrolment due to be completed 2H 201505/16/2015
ONTX
2.77Oral Rigosertib and azacitidine 09-07 trialCancer - Lower-Risk MDS (LR-MDS)Phase 2Phase 2 data due 2H 201505/16/2015
ONTX
2.77RigosertibCancer - MDS high riskPhase 3Original Phase 3 trial did not meet endpoint in Feb 2014. However, the company announced in Feb 2015 that following "subgroup analyses" and lack of current treatment options that they intend to initiate a Phase 3 trial in 2H 201505/16/2015
ONTX
2.77RigosertibCancer - relapsed or metastatic head and neck cancersPhase 2Initiated mid-201309/22/2013
ONTY
3.49PX-866Cancer - glioblastomaPhase 2Phase 2 data due at ASCO05/18/2013
OPHT
52.12FovistaWet-AMDPhase 3Phase 3 initial topline data due late 201605/16/2015
OPHT
52.12ZimuraGeographic atrophyPhase 2/3Phase 2/3 trial to be initiated late 2H 201505/16/2015
OPK
17.73CTAP101 Capsules - (Rayaldy)Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) and vitamin D insufficiencyNDANDA filng due May 201505/13/2015
OPK
17.73Neurokinin-1 (“NK-1”) - Rolapitant (partnered with TSRO)Prevention of chemotherapy induced nausea and vomiting, or CINV PDUFAPDUFA Sept 5 201505/02/2015
OPK
17.73hGH-CTPChildren - growth hormone deficiencyPhase 3End of Phase 2 Meeting for hGH-CTP for Pediatric GHD Scheduled for 1Q 201503/02/2015
OPK
17.73hGH-CTPAdults - growth hormone deficiencyPhase 3Initiated Phase 3 Jun 2013. Ongoing as of Feb 201503/02/2015
OPK
17.73Factor VIIa-CTPHemophiliaPhase 2Intend to initiate Phase 2 in 201503/02/2015
OPK
17.73Fermagate Tabletshyperphosphatemia in CKD patients on chronic hemodialysisPhase 3Phase 3 data due 1H 201709/12/2013
OPRN
CabalettaOculopharyngeal Muscular DystrophyPhase 2/3Phase 2/3 ongoing10/25/2014
OPXA
0.38Tovaxin (Tcelna)Secondary Progressive MS (SPMS)Phase 2bPhase 2b initiated Sept 2012. 100 patients enrolled as of Nov 2013. Top-line data 2H 201611/25/2014
OPXA
0.38Tovaxin (Tcelna)Relapsing Remitting MS (RRMS)Phase 2bFurther development pending funding09/18/2013
OREX
4.95ContraveObesityApprovedApproved September 11 2014. CV outcomes trial terminated May 2015. New safety trial to be initiated later in 2015. Due to be completed in 2022.05/16/2015
ORPN
5.78CabalettaOculopharyngeal Muscular DystrophyPhase 2/3Phase 2/3 HOPEMD trial - US part of trial expected to commence 3Q 201505/20/2015
OSIR
18.15GrafixDiabetic Foot UlcersData released Aug 201308/14/2013
OTIC
24.46OTO-104 Ménière's diseasePhase 2bPhase 2b data released May 2015 did not meet primary endpoint05/22/2015
OTIC
24.46AuriProPediatric patients with acute otitis media with tympanostomy tubes (AOMT)Phase 2Phase 2 label expansion trial initiated late March 2015. Enrolment completed May 2015.05/09/2015
OTIC
24.46AuriProEar Tube Placement SurgeryNDA filingAnnounced April 28 2015 that FDA accpeted their NDA filing 04/29/2015
OXGN
1.38FosbretabulinCancer - gastrointestinal neuroendocrine tumorsPhase 2Phase 2 initiated Sept 2014. Enrolment due to be completed 201503/21/2015
OXGN
1.38Fosbretabulin Combined With Pazopanib Cancer - Recurrent Ovarian CancerPhase 1/2Phase 1/2 initiated Oct 201410/11/2014
OXGN
1.38ZYBRESTATCancer - OvarianPhase 2Met primary endpoint March 2014. Further data to be presented at the International Gynecologic Cancer Society meeting from November 8 201408/10/2014
PBMD
2.97CAN-004Cancer - ovarianPhase 2Phase 2 commenced April 201404/29/2014
PBMD
2.97CVacCancer - ovarianPhase 3Phase 3 initiated Jan 2012. Enrolment halted Sept 201309/19/2013
PBMD
2.97CVacCancer - resectable pancreatic cancer, metastatic colorectal cancer, and triple-negative breast cancerPhase 2Phase 2 trials planned06/25/2013
PBYI
198.52PB272 - NEfERTT trialHER2-positive breast cancer first linePhase 2Phase 2 data to be presented and published mid 201505/16/2015
PBYI
198.52PB272 Neoadjuvant treatment for patients with HER2-positive breast cancer (NSABP FB-7)Phase 2Phase 2 due to be completed 1H 201505/16/2015
PBYI
198.52PB272 plus temsirolimusFourth line HER2-positive metastatic breast cancerPhase 3Phase 3 initiation due 2H 201505/16/2015
PBYI
198.52PB272HER2 non-amplified breast cancer that has a HER2 mutationPhase 2Phase 2 data due 2H 201505/16/2015
PBYI
198.52PB272 HER2+ MBC that has metastasized to the brainPhase 2Phase 2 data potentially due 2H 201505/16/2015
PBYI
198.52Neratinib monotherapy with high dose loperamide prophylaxisExtended adjuvant treatment of early stage HER2-positive breast cancerPhase 2Phase 2 to be initiated 1Q 201503/07/2015
PBYI
198.52PB272 ExteNET trial Extended adjuvant HER2-positive early stage breast cancerPhase 3NDA filing delayed due to 1Q 2016 following FDA request for data from preclinical carcinogenicity studies 12/03/2014
PBYI
198.52PB272 HER2 mutated non-small cell lung cancerPhase 2Phase 2 initial data released 201409/30/2014
PBYI
PB272Third line HER2+ MBC Phase 3Phase 3 initiated June 201307/01/2014
PCRX
77.02EXPARELSingle-dose injection femoral nerve block for total knee arthroplasty surgeryCRLPDUFA CRL March 2 2015.03/04/2015
PCYC
261.25IMBRUVICA RESONATE -2Cancer - newly diagnosed elderly CLL/SLL patientsPhase 3Phase 3 data due mid 201505/03/2015
PCYC
261.25BRILLIANCE (CLL3002) - IMBRUVICA R/R CLL/SLLPhase 3Phase 3 continues to enrol as of late April 201505/03/2015
PCYC
261.25RAY (MCL3001) IMBRUVICAR/R Mantle Cell Lymphoma (MCL)Phase 3Phase 3 data due 1H 201505/03/2015
PCYC
261.25IMBRUVICA in combination with bendamustine and rituximab - HELIOS (CLL3001)Cancer - Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL/SLL)Phase 3Phase 3 interim analysis due 1H 201502/21/2015
PCYC
261.25IMBRUVICAMarginal Zone Lymphoma (MZL)Phase 2Phase 2 initiated 4Q 2013. Ongoing02/21/2015
PCYC
261.25IMBRUVICA in combination with bendamustine and rituximab - SHINE (MCL3002)Cancer - newly diagnosed MCLPhase 3Janssen plans to enroll 520 patients02/21/2015
PCYC
261.25IMBRUVICA - ILLUMINATER/R CLL/SLLPhase 3Phase 3 initiated 4Q 201402/21/2015
PCYC
261.25IMBRUVICACancer - relapsed or refractory follicular lymphomaPhase 2Phase 2 ongoing02/21/2015
PCYC
261.25IMBRUVICAWaldenström’s MacroglobulinemiaApprovedApproved Jan 29, 201501/31/2015
PCYC
261.25IMBRUVICA RESONATE™-17Deletion 17pPhase 2Phase 2 released at ASH 201511/23/2014
PCYC
261.25IMBRUVICACancer - relapsed/refractory multiple myeloma (MM)Phase 1/2bData released at ASH 201408/03/2014
PCYC
261.25IMBRUVICA RESONATECancer - Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL/SLL)ApprovedApproved July 29 201408/03/2014
PCYC
261.25IMBRUVICA Cancer - Chronic Lymphocytic Leukemia Who Have Received at Least One Prior TherapyApprovedApproved Feb 12 201402/13/2014
PCYC
261.25IMBRUVICA Cancer - relapsed or refractory MCL mantle cell lymphomaApprovedApproved Nov 13 201308/31/2013
PFE
34.11PalbociclibFirst-Line Therapy in Combination with Letrozole for ER+, HER2- Advanced Breast CancerPDUFAPDUFA date under priority review of April 13 201501/26/2015
PFNX
18.00PF582Biosimilar candidate to Lucentis for retinal diseasesPhase 1/2Phase 1/2 interim data due 1Q 2015. Phase 3 to be initiated 201605/16/2015
PGNX
5.19AzedraPheochromocytomaPhase 2bPivotal Phase 2 trial resumed January 2015 following suspension of trial in 2010 due to lack of funding. Noted early May 2015 that enrolment is due to be completed by end of 201505/07/2015
PGNX
5.19Subcutaneous RELISTORchronic painApprovedApproved September 29 201410/01/2014
PGNX
5.19PSMA ADCCancer - metastatic castrate resistant prostate cancer (mCRPC).Phase 2Abstract released at American Society of Clinical Oncology's 2014 Genitourinary Cancers Symposium Meeting in San Francisco in January 28 2014.01/29/2014
PLX
2.16PRX-102Fabry diseasePhase 1/2Phase 1/2 enrolment completed early Feb 2015. Interim data due 3Q 2015. Full data due 4Q 2015. Phase 3 trial to be initiated early 201605/09/2015
POZN
6.58PA32540 and PA8140Cardiovascular patients at risk for developing aspirin-associated gastric ulcersCRLCRL Apr 25 2014. Further CRL issued Dec 17 2014 - due to deficiencies with facility. Active ingredient supplier has informed POZEN that they received a warning letter relating to the Form 483 inspection deficiencies12/18/2014
PPHM
1.30BavituximabCancer - Refractory NSCLCPhase 3Interim data released Sept 2012 reported to be faulty. Phase 3 SUNRISE trial initiated Dec 2013. Enrolment due to be completed by end of 201503/14/2015
PPHM
1.30Bavituximab plus carboplatin and paclitaxelCancer - front-line NSCLCPhase 2PFS disappointing data released Mar 2013. OS data showed not statistical meaningful improvement. Will not pursue Phase 306/28/2013
PRAN
1.28PBT-2Alzheimer'sPhase 2Phase 2 endpoint not met04/01/2014
PRAN
1.28PBT-2Huntington's DiseasePhase 2Data released Feb 201402/19/2014
PRTA
33.91NEOD001AL AmyloidosisPhase 3Phase 1/2 postive data released December 2 2014. Phase 3 initiated.12/03/2014
PRTK
30.95OmadacyclineAcute bacterial skin and skin structure infections (ABSSSI)Phase 3Phase 3 topline data due 3Q 201604/03/2015
PRTK
30.95OmadacyclineCommunity-acquired bacterial pneumonia (CABP)Phase 3Phase 3 initiation due late 201504/03/2015
PRTO
15.51PRT-201 Chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF)Phase 3Phase 3 initiated July 2014. Data due 1Q 201705/16/2015
PSDV
3.94MedidurPosterior uveitisPhase 3Enrolment completed late March 2015. Data due 2H 201605/09/2015
PSDV
3.94IluvienDiabetic macular edemaApprovedApproved Sept 26 201409/28/2014
PSTI
2.80PLX-PAD Muscle injuryPhase 1/2Phase 1/2 data released Jan 21 201401/22/2014
PSTI
2.80PLX-PAD (stem cells)Intermittent claudication, or ICPhase 2Phase 2 put on clinical hold Jun 2013. Lifted Sept 201309/17/2013
PTCT
54.53Ataluren Duchenne muscular dystrophy caused by nonsense mutations (nmDMD)Phase 3Top-line data due 4Q 2015. Rolling NDA filing commenced late Dec 201402/28/2015
PTCT
54.53Spinal Muscular Atrophy (SMAPhase 1/2Phase 1/2 initiated November 201411/22/2014
PTCT
54.53Ataluren Nonsense mutation cystic fibrosisPhase 3Phase 3 initiated July 2014. Data due 2H 201611/08/2014
PTIE
2.00RemoxyChronic painCRLCRL Jun 23, 2011. Expects to refile NDA in 1Q 201605/15/2015
PTIE
2.00ORADUR-HydromorphonePhase 3Phase 3 to be initiated 201508/09/2014
PTLA
38.54Andexanet alfaFactor Xa inhibitor reversal agentPhase 3Phase 3 first part of study met primary endpoint Jan 2015. Data from second part released April 2015 also positive. BLA to be filed by late 2015 05/07/2015
PTLA
38.54Betrixaban (The APEX Study)Venous thromboembolism (VTE) PreventionPhase 3Complete patient enrollment in APEX by the end of 2015. Data due early 201605/07/2015
PTLA
38.54Cerdulatinib (PRT2070)Refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia.Phase 1/2 Ongoing11/12/2014
PTN
0.86Bremelanotidefemale sexual dysfunction (FSD)Phase 3Phase 3 initiated Dec 2014. Enrolment to be completed by end of 2015. Top-line data due mid-201605/16/2015
PTN
0.86PL-3994Heart failurePhase 2aPhase 2a to be initiated 1H 201509/10/2014
PTN
0.86PL-3994Acute exacerbations of asthmaPhase 2aCompleted04/28/2013
PTX
6.28TREXIMETAdolescent migraine patientsApprovedApproved May 15 201505/16/2015
PVCT
0.78PV-10Cancer - MelanomaPhase 3Phase 3 initiated mid-April 2015.04/17/2015
PVCT
0.78PH-10Cancer - PsoriasisPhase 2Phase 2 enrolling04/08/2015
QLTI
3.73QLT091001Impaired Dark Adaptation (IDA)Phase 2aPhase 2a data released December 201412/07/2014
QLTI
3.73punctal plug drug deliveryGlaucomaPhase 2Sold to Mati04/28/2013
QRXPY
0.05MOXDUOModerate to severe acute painCRLCRL Aug 2013. New PDUFA May 25 2014. New CRL May 27 201405/28/2014
QURE
26.93AAV5 Gene therapyhemophilia BPhase 1/2Phase 1/2 to be initiated early 2015 with interim data due mid 201512/02/2014
RARE
82.64rhGUS Mucopolysaccharidosis 7 (MPS 7) Phase 3Announced Dec 15 that a Phase 3 trial has been initiated. Data due 1H 2016.05/15/2015
RARE
82.64KRN23X-Linked Hypophosphatemia (XLH)Phase 2Phase 2 preliminary data for pediatric patients due 2Q 201505/13/2015
RARE
82.64KRN23Tumor-induced osteomalacia (TIO)Phase 2Interim data due late 2015 or early 201605/13/2015
RARE
82.64Triheptanoin Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD)Phase 2Phase 2 initiated February 2014. Data due 2H 201503/27/2015
RARE
82.64TriheptanoinGlucose Transporter Type-1 Deficiency Syndrome (Glut1 DS)Phase 2Phase 2 initiated March 2014. Data due 2H 201503/27/2015
RCPT
164.82RPC1063 ozanimod Ulcerative Colitis (UC) Phase 2Phase 2 top-line data met endpoints - Oct 2014. Phase 3 planned for 201505/06/2015
RCPT
164.82RPC4046 Eosiniphilic EsophagitisPhase 2Phase 2 topline data due 1H 201605/06/2015
RCPT
164.82RPC1063 ozanimodChron's diseasePhase 2Phase 2 planned for 201505/06/2015
RCPT
164.82RPC1063 ozanimod -RADIANCERelapsing Multiple Sclerosis (RMS). Phase 3Phase 2 Top-line data released June 2014. Phase 3 is ongoing.03/04/2015
RCPT
164.82RPC1063 - SUNBEAMRelapsing Multiple Sclerosis (RMS).Phase 3Phase 3 trial initiated Dec 2014. Expects to complete Phase 3 program in 201712/23/2014
RDUS
48.90Abaloparatide-SCOsteoporosisPhase 3Phase 3 top-line released late December 2014 - met endpoint. Data from ACTIVExtend extension trial due 2Q 2015. NDA filing due 2H 201505/07/2015
RDUS
48.90RAD1901 SERM for vasomotor symptomsPhase 2bPhase 2b due to be initiated 2H 201503/11/2015
RDUS
48.90Abaloparatide-TD (patch)OsteoporosisPhase 2Phase 2 complete07/09/2014
RGDO
#N/ACenicriviroc (CVC) - CENTAUR trialNon-alcoholic steatohepatitis (NASH)Phase 2bFollowing merger announcement with Tobira Therapeutics in mid-Jan 2015, Phase 2b NASH data are due in 2Q 201601/15/2015
RGDO
#N/AREGULATE-PCI - REG1percutaneous coronary intervention (PCI)Phase 3Trial halted due to safety concerns - Aug 201408/26/2014
RGLS
12.90RG-101 HCVPhase 2Phase 2 to be initiated 2Q 201502/21/2015
RIGL
3.50Fostamatinib Immune Thrombocytopenic Purpura (ITP)Phase 3Phase 3 initiated July 2014. Data from two trials due mid 201605/08/2015
RIGL
3.50FostamatinibIgA nephropathyPhase 2Phase 2 data due early 201601/10/2015
RIGL
3.50R348Chronic dry eye disease - as a result of patients with acute or chronic graft vs. host disease (GvHD)Phase 2Phase 2 data due mid 201601/10/2015
RLYP
33.76Patiromer for Oral Suspension (Patiromer FOS)HyperkalemiaPDUFAPDUFA October 21 201501/06/2015
RMTI
10.29Soluble Ferric PyrophosphateIron deficiencyApprovedApproved Jan 26 201501/27/2015
RNN
0.71ArchexinCancer - metastatic renal cell carcinoma (RCC)Phase 2Phase 2 initiation Jan 2014. Initial phase to be completed late 201404/11/2014
RPRX
7.61Androxal Secondary hypogonadismPDUFAPDUFA date November 30 2015. FDA plans to schedule Advisory Committee Meeting. Date TBA.04/17/2015
RPRX
7.61ProellexUterine fibroids (vaginal treatment)Phase 2bPhase 2b initiated Dec 201401/01/2015
RPRX
7.61ProellexUterine fibroids (oral treatment)Phase 2bPhase 2b initiated Dec 201401/01/2015
RPTP
11.78RP 103Non-alcoholic fatty liver disease (NAFLD) in childrenPhase 2bPhase 2b initiated Jun 2012. Enrolment target hit Jan 2014. Data due 2H 201505/08/2015
RPTP
11.78RP 103Mitochondrial disorders including Leigh syndromePhase 2Phase 2 data due 201505/08/2015
RPTP
11.78RP 103Huntington's DiseasePhase 2Topline Phase 2/3 data released Feb 2014 02/21/2014
RPTP
11.78PROCYSBICystinosisApprovedApproved08/09/2013
RTGN
4.07RUT58-60Prevention of infection post abdominal surgeryPhase 1/2Phase 1/2 enrolling as of Feb 201504/07/2015
RTRX
26.87Sparsentan (DUET) Focal segmental glomerulosclerosis (FSGS)Phase 2/3Enrolment due to be completed by end of 201505/15/2015
RTRX
26.87CholbamRare Bile Acid Synthesis Disorders ApprovedApproved Mar 18 201503/21/2015
RVNC
25.47RT001 - BELMONTLateral canthal lines (crow’s feet lines)Phase 2Phase 2 enrolment complete05/16/2015
RVNC
25.47RT001 HyperhidrosisPhase 2Phase 2 planned for 2015. Preliminary data due 2H 201505/16/2015
RVNC
25.47RT002Moderate to severe glabellar (frown) linesPhase 2Phase 2 initiated January 2015. Data due late 201503/04/2015
RVX
17.02RVX-208 Pre-diabetes mellitus Phase 2Phase 2 initiated Oct 2012, data released mid 201408/10/2014
RXDX
9.62RXDX-101Cancer - solid tumorsPhase 1/2Phase 1/2 trial initiated July 201407/22/2014
RXII
0.47 (RXI-109-1401)Recurrence of keloids after keloid revision surgeryPhase 2aPhase 2 initiated April 2014. Enrolment complete. Data collection ongoing as of May 201505/16/2015
RXII
0.47(RXI-109-1301)Anti-scarringPhase 2Phase 2 initiated November 2013. First data released Sept 2014. Announced completion of enrolment Dec 17 201412/18/2014
RXII
0.47RXI-109-1402Suppressing recurrence of hypertrophic scars after bilateral scar revision surgery in the breast areaPhase 2Phase 2 initiated July 201404/25/2014
SAGE
71.00SAGE-547Postpartum DepressionPhase 2aPhase 2a data due mid 201505/16/2015
SAGE
71.00SAGE-547Essential tremorPhase 2Phase 2 data due mid 201505/16/2015
SAGE
71.00SAGE-547SRSEPhase 1/2Phase 3 trial to be initiated mid-201505/16/2015
SCMP
15.80CobiprostoneOral MucositisPhase 2Phase 2 to be initiated 1H 201505/07/2015
SCMP
15.80Cobiprostone Non-erosive reflux disease (NERD)Phase 2Phase 2 dosing commenced February 201503/05/2015
SCMP
15.80SPI-017Management of symptoms associated with severe lumbar spinal stenosis.Phase 2aCompleted Phase 2a Dec 2013. Additional Phase 2a trials planned for late 201401/14/2014
SCMP
15.80LubiprostonePediatric functional constipationPhase 3Phase 3 initiated Dec 2013, with data due early 201612/18/2013
SCYX
8.78SCY-078Serious and life-threatening invasive fungal infectionsPhase 2Phase 2 topline data due 1H 201605/16/2015
SGEN
42.81ADCETRIS in combination with chemotherapy ECHELON-1 Frontline Hodgkin lymphomaPhase 3Phase 3 data due 2017 or 201805/03/2015
SGEN
42.81ADCETRIS in combination with chemotherapy - ECHELON-2Cancer - frontline CD30-positive mature T-cell lymphomas Phase 3Phase 3 data due 2017 or 201805/03/2015
SGEN
42.81ADCETRISCancer - ALCANZA trial for relapsed CD30-positive cutaneous T-cell lymphomaPhase 3Phase 3 data due 201605/03/2015
SGEN
42.81ADCETRIS - AETHERACancer - post-transplant Hodgkin lymphoma (HL) patientsPDUFAPDUFA August 18, 2015 under priority review04/22/2015
SGEN
42.81ADCETRIS in combination with bendamustineCancer - second-line HLPhase 1/2Phase 1/2 initiated Jun 201305/08/2013
SGMO
12.46SB-BCLmR-HSPCbeta-thalassemiaPhase 1/2Phase 1/2 to be initiated in 201502/12/2015
SGMO
12.46SB-728-1401HIV/AIDSPhase 2Phase 2 data due by the end of 201501/13/2015
SGMO
12.46CERE-110 Alzheimer's DiseasePhase 2Phase 2 data due 201511/24/2014
SGMO
12.46SB-728-902HIV/AIDSPhase 2Data presented Dec 201312/07/2013
SGMO
12.46SB-728-1101HIV/AIDSPhase 2Data presented Dec 201312/07/2013
SGYP
4.44PlecanatideConstipation-predominant irritable bowel syndrome (IBS-C).Phase 3Phase 3 data due 4Q 2015. Second Phase 3 trial to be initiated 1H 2016 with data due 2H 201605/13/2015
SGYP
4.44PlecanatideChronic idiopathic constipation (CIC)Phase 3Enrolment from first and second Phase 3 trials completed Jan 2015. Topline data from first trial due 2Q 2015. Topline data from second trial due 3Q 201505/13/2015
SGYP
4.44SP-333Opioid-induced constipation (OIC)Phase 2Phase 2 initiated Oct 2013. Enrollment completed July 2014. Data released Nov 201411/22/2014
SHPG
256.16LifitegrastDry eye disease in adultsPDUFA Priority ReviewPDUFA date under priority review of October 25, 201504/10/2015
SLXP
172.81RELISTOR (methylnaltrexone bromide) - subcutaneous useOpioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain.ApprovedApproved September 29 201410/01/2014
SLXP
172.81Budesonide foamModerate ulcerative proctitis or proctosigmoiditis ApprovedTentative approval granted September 15 2014 pending patent issues09/16/2014
SLXP
172.81XIFAXANIrritable bowel syndrome with diarrhea (IBS-D)NDAFiled response to CRL Aug 29 201409/03/2014
SLXP
172.81RUCONESTHereditary angioedema (HAE)ApprovedApproved July 16, 201407/17/2014
SLXP
172.81EIR rifaximin Crohn’s diseasePhase 3Phase 3 due to be initiated 2H 201305/11/2013
SNSS
2.39VoreloxinCancer - Acute myeloid leukemia AMLPhase 3Endpoint not met Oct 201410/11/2014
SNSS
2.39Vosaroxin in combination with decitabineOlder patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS)Phase 2Phase 2 updated due at American Association for Cancer Research Annual Meeting 2014 (AACR) on April 803/07/2014
SNSS
2.39VoreloxinAdult patients with previously treated intermediate-2 or high-risk myelodysplastic syndrome (MDS)Phase 1/2Phase 1/2 initiated Oct 201310/29/2013
SNSS
2.39VoreloxinCancer - newly diagnosed elderly acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) Phase 2/3First two planned interim assessments of the LI-1 trial due 201305/10/2013
SNTA
2.22STA-9090 Ganetespib - GALAXY-2Cancer - NSCLCPhase 3Phase 3 trial initiated Apr 2013 with first analysis due 2H 2015, second analysis due 1H 201605/09/2015
SNTA
2.22Ganetespib AML-19 trialCancer - AMLPhase 2/3Phase 3 to be initiated 1H 201503/14/2015
SNTA
2.22Ganetespib AML-LI trialCancer - AMLPhase 2/3Phase 3 ongoing03/14/2015
SNTA
2.22Ganetespib and paclitaxelCancer - ovarianPhase 2Phase 2 initiation due 2H 201503/14/2015
SNTA
2.22Ganetespib - I-SPY 2 TRIAL Cancer - breastPhase 2Phase 2 initiated Oct 201410/30/2014
SNTA
2.22Ganetespib AML-18 trialCancer - AMLPhase 2/3Initiated in 4Q 201408/10/2014
SNY
49.29PraluentHypercholesterolemiaPDUFAPDUFA priority review date July 24 201501/26/2015
SPHS
0.88PRX302Localized low to intermediate risk prostate cancerPhase 2Phase 2 planned for 1H 201505/16/2015
SPHS
0.88PRX302Benign prostatic hyperplasia Phase 3Dec 15 2015, Independent Data Monitoring Committee (IDMC) reported that a predefined efficacy threshold following treatment was not achieved12/16/2014
SPPI
6.24SPI-2012 (also referred to as "LAPS-GCSF")Chemotherapy-Induced NeutropeniaPhase 2Phase 3 likely to be initiated in 201505/08/2015
SPPI
6.24ApaziquoneCancer - BladderPhase 3Failed to meet primary endpoint in Phase 3 trial - Apr 2012. NDA to be filed 201503/14/2015
SPPI
6.24Captisol-Enabled MelphalanConditioning treatment prior to autologous stem cell transplant for patients with multiple myelomaPDUFAPDUFA October 23 201503/10/2015
SPPI
6.24BelinostatCancer - Peripheral T-Cell LymphomaApprovedApproved July 3 201407/04/2014
SPPI
6.24ZevalinDiffuse Large B-Cell Lymphoma (DLBCL)Phase 3Phase 3 initiated Sep 201205/13/2013
SRNE
12.91CynviloqCancerBioequivalence trialData analysis suggests that Cynviloq meets the bioequivalence (BE) criteria for both total and unbound paclitaxel05/16/2015
SRPT
26.71EteplirsenDuchenne muscular dystrophyNDARolling NDA to be completed by mid 201505/20/2015
SSH
4.12C-Pulse Heart Assist System - COUNTER HFModerate to severe heart failurePivotal Announced early March that enrolment paused due to safety concerns. Resumed late May 201505/27/2015
SSH
4.12C-Pulse Heart Assist System - OPTIONS HF study Moderate to severe heart failure
STEM
0.68HuCNS-SC cellsSpinal cord injury Phase 2Phase 2 trial initiated Oct 2014. Enrolment of first cohort completed mid-April 2015. Interim 6 month data due later in 201504/17/2015
STEM
0.68HuCNS-SC cellsAge-Related Macular DegenerationPhase 1/2Final data to be released mid 201503/22/2015
STML
12.71SL-701Cancer - blastic plasmacytoid dendritic cell neoplasm (BPDCN)Phase 2b pivotalPhase 2b planned04/27/2013
STML
12.71SL-701Cancer- adult relapsed or refractory acute myeloid leukemia (AML) Phase 2bPhase 2b planned04/27/2013
STML
12.71SL-701Cancer - malignant gliomaPhase 2bPhase 2b planned04/27/2013
STML
12.71SL-701Cancer - second line glioblastoma (GBM)Phase 2bPhase 2b planned04/27/2013
SUPN
13.20SPN-812ADHDPhase 2bPhase 2b due to commence 2H 201511/12/2014
SUPN
13.20SPN-810Impulsive Aggression in ADHDPhase 2bPhase 3 due to commence 2H 201511/12/2014
SUPN
13.20Trokendi XR SPN-538EpilepsyApprovedApproved Aug 19 201308/22/2013
SYN
1.87TrimestaRelapsing-remitting MS in womenPhase 2Phase 2 data due 2Q 201505/13/2015
SYN
1.87 SYN-004C. difficile InfectionPhase 2bPhase 2b to be initiated 2H 2015 with data due 2H 201505/13/2015
SYN
1.87SYN-004Constipation-Predominant Irritable Bowel Syndrome (C-IBS)Phase 2Phase 2 to commence 2Q 2015 with data due 2H 201505/13/2015
SYN
1.87FlupirtineFibromyalgiaPhase 2Pending. Partner Meda has received the go-ahead from the FDA to conduct a Phase 2 proof of concept trial04/27/2013
TBPH
14.17Velusetrag (TD-5108)GastroparesisPhase 2Phase 2 initiated mid March 201503/14/2015
TBPH
14.17TD-4208COPDPhase 3Phase 3 to be initiated later in 201503/11/2015
TBPH
14.17TelavancinStaphylococcus aureus bacteremiaPhase 3Phase 3 first patient enrolled late February 201502/26/2015
TCON
10.99TRC105 Renal Cell CarcinomaPhase 2Phase 2 initiated Dec 2014. Phase 2 data due early to mid 201602/01/2015
TCON
10.99TRC105Soft tissue sarcomasPhase 1b/2Phase 1b data due mid 2015. Phase 2 data due late 201502/01/2015
TCON
10.99TRC105Hepatocellular carcinomaPhase 1b/2Phase 1b/2 initiated Dec 2014. Phase 1b data due early 2015. Phase 2 data due early to mid 201602/01/2015
TCON
10.99TRC105GlioblastomaPhase 2Phase 2 data due early to mid 201602/01/2015
TCON
10.99TRC105Breast CancerPhase 2Phase 2 planned for 2015. Data due mid to late 201602/01/2015
TGTX
15.95TG-1101 and TGR-1202Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin's Lymphoma (NHL)Phase 3Phase 3 trials planned for 1H and 2H 201501/16/2015
TGTX
15.95TG-1101 and IMBRUVICA (GENUINE trial)Chronic Lymphocytic Leukemia (CLL) Phase 3Phase 3 open for enrolment as of mid Jan 201501/16/2015
TGTX
15.95Ublituximab TG-1101Relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) Phase 1/2Phase 1/2 trial initiated Sep 2012. Data at ASH Dec 2013 and at ASCO 201306/05/2013
THLD
3.87Evofosfamide MAESTROCancer - PancreaticPhase 3Number of protocol-specified events may be reached 2H 2015, with data available shortly after05/02/2015
THLD
3.87EvofosfamideCancer - soft tissue sarcoma (406 trial)Phase 3Number of protocol-specified events may be reached 2H 2015, with data available shortly after03/04/2015
THLD
3.87TH-4000Cancer - EGFR-positive, T790M-negative non-small cell lung cancerPhase 2Phase 2 to be initiated 1H 201503/04/2015
THLD
3.87TH-302Cancer - multiple myeloma Phase 1/2Initiated dosing in final part of trial July 2014. Initial data presented at ASH 201412/07/2014
THLD
3.87EvofosfamideCancer - glioblastoma (GBM)Phase 1/2Phase 1/2 interim data released Nov 201411/19/2014
THLD
3.87EvofosfamideCancer - second line NSCLCPhase 2Phase 2 initiated July 201407/02/2014
THRX
16.62TD-4208Chronic obstructive pulmonary disease (COPDPhase 2bPhase 3 to be initiated 201505/09/2015
THRX
16.62TelavancinStaphylococcus aureus bacteremiaPhase 3Phase 3 enrolling as of May 201505/09/2015
THRX
16.62Velusetrag GastroparesisPhase 3Phase 3 enrolling as of May 201505/09/2015
THRX
16.62BREO ELLIPTAAsthmaApprovedApproved April 30 2015. 05/02/2015
THRX
16.62TD-9855FibromyalgiaPhase 2Phase 2 data released April 201405/01/2014
TKAI
10.81GaleteroneCancer - castration-resistant prostate cancer (CRPC)Phase 2Phase 3 to be initiated 2Q 201505/16/2015
TKMR
13.55TKM-PLK1Gastrointestinal Neuroendocrine Tumors (GI-NET) Phase 1/2Final data due mid-201503/14/2015
TKMR
13.55TKM-Ebola-GuineaEbola Phase 2Phase 2 trial initiated in Sierra Leone mid March 2015. Data due 2H 201503/14/2015
TKMR
13.55ALN-TTR02 - patisiranFamilial Amyloidotic Polyneuropathy (FAP) in Patients with ATTRPhase 2 - open labelPhase 2 enrolment completed Sept 2013. Initial data due October 2014. Partnered with ALNY08/17/2014
TKMR
13.55TKM-PLK1Adrenocortical Carcinoma (ACC)Phase 1/2Enrolling as of June 2014. Interim data due 2H 201407/22/2014
TKMR
13.55ALN-TTR02 - patisiran APOLLOFamilial Amyloidotic Polyneuropathy (FAP) in Patients with ATTRPhase 3Phase 3 trial initiated Nov 2013, continues to enrol patients as of Jan 2014. Partnered with ALNY07/07/2014
TLOG
2.31BirinapantCancer - 3rd line ovarianPhase 1/2Phase 1/2 trial to be completed at lower doses - announced Dec 16 2014. Data due 201502/28/2015
TLOG
2.31BirinapantMyelodysplastic syndromes, or MDSPhase 2Phase 2 data due mid 201502/28/2015
TLOG
2.31BirinapantCancer - acute myelogenous leukemia or AMLPhase 1/2Data due 201502/28/2015
TLOG
2.31SHAPECancer - Cutaneous T-Cell LymphomaPhase 2Phase 2 trial initiated mid-Dec 2014. Data due 201512/19/2014
TNXP
6.95TNX-102 SL Fibromyalgia Phase 2b/3Endpoint not met - Sept 2014. Phase 3 initiated May 2015. Data due 2H 201605/16/2015
TNXP
6.95TNX-201Episodic tension-type headachePhase 2Phase 2 to be initiated 2Q 2015. Data due 4Q 2015.05/13/2015
TNXP
6.95TNX-102 SL PTSD - for the treatment of post-traumatic stress disorderPhase 2Phase 2 trial initiated mid Jan 201501/16/2015
TRGT
2.73TC-6499 Diabetic GastroparesisPhase 1/2Topline data released mid-April 2015 did not meet endpoint04/17/2015
TRLPF
0.53TEFINAFemale Orgasmic DisorderPhase 2Phase 3 planned05/07/2015
TRLPF
0.53CompleoTRTTestosterone deficiency in menApprovedApproved May 201405/29/2014
TRVN
6.77TRV130 Moderate to severe acute painPhase 2bTopline data due 3Q 201505/09/2015
TRVN
6.77TRV027 - BLAST-AHFAcute heart failurePhase 2bTopline data due 1H 201605/09/2015
TSRO
56.14Niraparib - BRAVOCancer - breastPhase 3Phase 3 initiated 1Q 2014.Ongoing05/02/2015
TSRO
56.14Niraparib - NOVA (Niraparib Ovarian) Cancer - ovarianPhase 3Phase 3 data due 4Q 2015.05/02/2015
TSRO
56.14RolapitantPrevention of chemotherapy induced nausea and vomiting, or CINV in HEC patientsPDUFAPDUFA Sept 5 201505/02/2015
TSRO
56.14TSR-011Cancer - NSCLCPhase 1/2Phase 2 dosing to be finalised by end of 201307/26/2013
TTHI
7.25TT401 (LY2944876)Type 2 diabetesPhase 2Phase 2 initiated May 2014. Data due 4Q 201505/16/2015
TTHI
7.25ELND005Alzheimer's DiseasePhase 2Reported March 2015 that Phase 2 enrolment has been completed with data due early summer 201505/16/2015
TTHI
7.25ELND005Bipolar I Disorder (BPD 1)Phase 2Phase 2 data released Nov 2014 - development terminated02/12/2015
TTHI
7.25ELND005-DS201Down syndromePhase 2Phase 2 initiated Sept 201309/05/2013
TTNP
0.79ProbuphineOpioid dependencePhase 3New Phase 3 trial initiated July 2014, data due 2Q 2015. NDA due late 2015.05/16/2015
TTPH
42.69Eravacycline (TP-434)cUTI - complicated urinary tract infectionsPhase 3Top-line data due 3Q 201505/07/2015
TTPH
42.69Eravacycline (TP-434)cIAI (complicated intra-abdominal infections)Phase 3Announced Dec 17, 2014 that their Phase 3 trial met endpoints, with NDA filing due by end of 201503/07/2015
UTHR
182.50Oral treprostinilPulmonary arterial hypertension (PAH)ApprovedApproved Dec 20 201312/21/2013
VBLT
7.35VB-111Cancer - recurrent glioblastoma, or rGBMPhase 2Phase 3 to be initiated mid 201505/16/2015
VBLT
7.35VB-201Ulcerative colitisPhase 2Phase 2 failed to meet endpoints - Feb 2015 data02/21/2015
VBLT
7.35VB-201Psoriasis Phase 2Phase 2 failed to meet endpoints - Feb 2015 data02/21/2015
VCEL
3.10ixmyelocel-TStem cells - Dilated Cardiomyopathy Phase 2bCommenced enrolment Phase 2b Apr 2013. Enrolment completed Jan 2015. Topline data due towards the end of 1Q 201601/31/2015
VICL
0.92Vaxfectin-formulated therapeutic vaccineHerpesPhase 1/2Data due by mid 201505/09/2015
VICL
0.92ASP0113Hematopoietic cell transplantPhase 3Initiated Phase 3 Jun 2013. Enrollment due to be completed end of 201505/09/2015
VICL
0.92ASP0113solid organ transplant (SOT)Phase 2Initiated Phase 2 Dec 2013. Enrolment due to be completed 2Q 201505/09/2015
VNDA
10.24VLY-686 (tradipitant)Chronic pruritusPhase 2Phase 2 data released March 2015 FAIL - no statistical difference from placebo. Further Phase 2 trial planned 4Q 201505/07/2015
VNDA
10.24TasimelteonInsomniaApprovedApproved Jan 31 2014. 02/02/2014
VRTX
122.63Lumacaftor and ivacaftorCystic fibrosis (CF) ages 12 and older who have two copies of the F508del mutation PDUFAPDUFA date July 5 2015 for the combination of lumacaftor and ivacaftor in people with CF ages 12 and older who have two copies of the F508del mutation - priority review. Adcom meeting May 12, 2015 voted 12-1 in favour.05/16/2015
VRTX
122.63VX-661Cystic fibrosis with 1 or 2 copies of the F508del mutationPhase 2bPhase 2b data released late March 2015 showed a 3% improvement in lung function compared with 1% of placebo03/24/2015
VRTX
122.63Vacaftor 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
235.31EfinaconazoleOnychomycosisPDUFACRL May 28 201305/29/2013
VRX
235.31LuliconazoleTinea cruris, pedis and corporisPDUFAPDUFA date Dec 11 201304/27/2013
VSAR
14.62VRS-317Growth hormone deficiency, or GHD - pediatricPhase 3Phase 3 initiated early Jan 2015. Interim 6 month height velocity analysis by late 2016 and top line data on the 12 month height velocity primary endpoint is expected in mid 2017. Delay due to clinical hold05/07/2015
VSAR
14.62VRS-317Growth hormone deficiency, or GHD - adultPhase 2/3Phase 2/3 to be initiated in 2H 2015.02/14/2015
VSTM
8.62VS-6063Mesothelioma prior to surgeryPhase 2Phase 2 interim analysis due 3Q 201505/16/2015
VSTM
8.62VS-6063KRAS-mutated NSCLCPhase 2Phase 2 data due 2H 201505/13/2015
VTAE
12.26VTP-34072Type 2 DiabetesPhase 2Phase 2 initiated July 2014. Data due 2Q 201505/16/2015
VTL
21.15ELAD (VTI-208)Alcohol-induced liver decompensation, or AILDPhase 3Phase 3 initiated 2013. Prelim data due 3Q 201505/16/2015
VTL
21.15ELAD (VTI-210)Severe acute alcoholic hepatitisPhase 3Phase 3 data due early 201705/16/2015
VTL
21.15ELAD (VTI-212)Fulminant hepatic failure, or FHF, or surgery-induced acute liver failure, or SILFPhase 2/3Phase data due 201605/16/2015
VVUS
2.47AvanafilErectile dysfunctionApprovedApproved Apr 27 2012. sNDA label change also approved 17 Sept 201409/18/2014
XENE
12.35TV-45070OsteoarthritisPhase 2bPhase 2b data due 3Q 201505/16/2015
XENE
12.35TV-45070Postherpetic neuralgiaPhase 2b Phase 2b initiated late March 2015. Data due 2H 201605/16/2015
XENE
12.35XEN801AcnePhase 1/2Phase 2 to be initiated 2H 2015 pending positive Phase 1 data02/01/2015
XENT
23.56Steroid eluting implantIn-office treatment of patients with recurrent disease due to polypsPhase 3Phase initiated late Dec 2014. Enrolment to be completed late 201601/01/2015
XLRN
33.39LuspaterceptMyelodysplastic syndromes (MDS)Phase 2Phase 3 to be initiated 201505/09/2015
XLRN
33.39Luspatercept b -thalassemiaPhase 2Phase 3 to be initiated 201505/09/2015
XLRN
33.39DalanterceptRenal Cell CarcinomaPhase 2Phase 2 data due at ASCO 201503/04/2015
XLRN
33.39LuspaterceptEnd stage renal disease (ESRD) Phase 2bPhase 2b to be initiated 201501/13/2015
XLRN
33.39DalanterceptHead and neck cancerPhase 2Phase 2 interim data due at ASCO 201402/27/2014
XLRN
33.39DalanterceptLiver cancerPhase 2aPhase 2a to be initiated 1Q or 2Q 201402/27/2014
XLRN
33.39Luspatercept Multiple myelomaPhase 2Phase 2 ongoing09/22/2013
XLRN
33.39Luspatercept Diamond-Blackfan anemia Phase 2Phase 2 ongoing09/22/2013
XLRN
33.39LuspaterceptMyelofibrosisPhase 2Phase 2 ongoing09/22/2013
XNCR
17.23XmAb5871Moderate to severe rheumatoid arthritisPhase 2aPhase 2 data released late Jan 2015. The company have already stated (Oct 2014) that they do not plan on starting a Phase 2b rheumatoid arthritis trial in 201511/12/2014
XNCR
17.23MOR208 (XmAb5574)B-cell acute lymphoblastic leukemia (B-ALL) Phase 2Phase 2 initiated 2Q 201304/23/2014
XNCR
17.23MOR208 (XmAb5574)Non-Hodgkin lymphoma (NHL)Phase 2Phase 2 initiated 2Q 201304/23/2014
XNPT
6.05XP23829Moderate-to-severe plaque psoriasisPhase 2Phase 2 topline data due 3Q 201505/07/2015
XNPT
6.05XP23829Relapsing forms of multiple sclerosis (MS)Phase 3 planned01/13/2015
XNPT
6.05XP21279Parkinson's DiseasePhase 2bData released Dec 2011, no statistical improvement over Sinemet. However Phase 3 planned dependent on funding04/27/2013
XOMA
3.36XOMA 052 Gevokizumab EYEGUARD-BBehcet's uveitisPhase 3Waiting on final exacerbation to occur. Data will be released 6 weeks following final exacerbation. 05/08/2015
XOMA
3.36XOMA 052 GevokizumabDiabetic NephropathyPhase 2Phase 2 initiated late March 201504/03/2015
XOMA
3.36XOMA 052 Gevokizumab EYEGUARD-ANon-Infectious Uveitis (Active)Phase 3Data due 201511/27/2014
XOMA
3.36XOMA 052 Gevokizumab EYEGUARD-C Non-Infectious Uveitis ( Controlled )Phase 3Data due 201511/27/2014
XOMA
3.36XOMA 052 gevokizumabPyoderma GangrenosumPhase 2Initiated Phase 3 trial November 201411/05/2014
XOMA
3.36XOMA 052 GevokizumabErosive osteoarthritis of the handPhase 2Phase 2 prelim data released Oct 2013. Not pursuing futre development03/06/2014
XOMA
3.36XOMA 052 gevokizumabType 1 DiabetesPhase 205/04/2013
XOMA
3.36XOMA 052 GevokizumabNeutrophilic Dermatoses and Schnitzler syndromePhase 3Phase 3 planned in one or more of Neutrophilic Dermatoses and Schnitzler syndrome. Will meet with FDA in 201304/27/2013
XOMA
3.36XOMA 052 GevokizumabModerate to Severe Acne VulgarisPhase 2Initiated Phase 2 Dec 2011. Topline Data released Jan 2013. Phase 3 planned04/27/2013
XON
41.58Ad-IL-12CancerPhase 2Updated data released at AACR Tumor Immunology and Immunotherapy Meeting December 201412/05/2014
ZFGN
31.63BeloranibPrader-Willi Syndrome (PWS)Phase 3First of two Phase 3 trials to initiated Oct 2014. Initial data due early 1Q 201605/16/2015
ZFGN
31.63BeloranibSevere obesity Phase 2bPhase 2b data due late 2015 or very early 201605/16/2015
ZFGN
31.63BeloranibHypothalamic injury-associated obesity (HIAO)Phase 2aPhase 2a to completed Jan 201503/11/2015
ZGNX
1.39ZX008Dravet syndromPhase 3Phase 3 planned for 3Q 201505/16/2015
ZGNX
1.39 Abuse deterrent formulations of Zohydro ERModerate to severe painApprovedApproved January 30 201501/31/2015
ZGNX
1.39Zohydro ERModerate to severe painApprovedApproved Oct 25 201310/26/2013
ZIOP
9.14Ad-RTS-hIL-12 + veledimex Cancer - breastPhase 1b/2Phase 1b/2 trial to be initiated in 201502/28/2015
ZIOP
9.14IL-12Cancer - breastPhase 2Updated data released at AACR Tumor Immunology and Immunotherapy Meeting December 201405/12/2014
ZIOP
9.14IL-12Cancer - melanomaPhase 2Updated data released at AACR Tumor Immunology and Immunotherapy Meeting December 201405/12/2014
ZSAN
9.37Daily ZP-PTHOsteoporosisPhase 3Phase 3 planned05/16/2015
ZSAN
9.37ZP-GlucagonSevere hypoglycemiaPhase 2Phase 2 to be completed 3Q 201505/16/2015
ZSAN
9.37ZP-TriptanMigrainePhase 2Phase 2 to be initiated 2H 201502/01/2015
ZSPH
58.90ZS-9HyperkalemiaPhase 3NDA filed on or about May 26 201505/27/2015

About the author

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

18 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

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