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
37.13AVA-101Wet-AMDPhase 2aPhase 2a data due mid 201503/01/2015
ABIO
0.75GencaroChronic Heart FailurePhase 2b/3Phase 2b/3 to begin enrolment 1Q 201401/09/2014
ACAD
39.27PimavanserinParkinson’s disease psychosis (PDP)Phase 3NDA filing due 1Q 201502/28/2015
ACAD
39.27PimavanserinAlzheimer'sPhase 2Phase 2 initiated November 201311/15/2013
ACHN
10.87ACH-3102 and sofosbuvirHepatitis C viral infection (HCV)Phase 2100% SVR12 after 6 weeks02/12/2015
ACHN
10.87RevusiranTreatment-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
10.87ACH-3422HCV Hepatitis C Phase 1/2Phase 1 data released late Dec 2014. 3.4 log reduction after 7 days, 4.8 log reduction after 14 days12/23/2014
ACHN
10.87SovaprevirHepatitis C viral infection (HCV)Phase 2Placed on clinical hold Jul 2013.Clinical hold lifted June 201406/11/2014
ACOR
35.64DalfampridinePost stroke deficitsPhase 2b/3Annonuced Dec 15, 2015 that a Phase 3 trial has been initiated12/16/2014
ACOR
35.64CVT-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
35.64Diazepam Nasal SprayEpilepsyCRLCRL issued May 201405/04/2014
ACOR
35.64AC105Acute treatment of spinal cord injuryPhase 2Phase 2 trial initiated Sept 201309/01/2013
ACRX
9.06ARX-04Moderate-to-severe acute painPhase 3Phase 3 to be initiated 1Q 2015. Data 2H 201511/23/2014
ACRX
9.06ZalvisoPost-operative pain following open abdominal surgery and hip or knee replacement surgeryCRLCRL Jul 26 2014. NDA resubmission due 1Q 201511/12/2014
ACST
0.53CaPre (TRIFECTA trial)HypertriglyceridemiaPhase 2Phase 2 trial of CaPre (TRIFECTA trial) completed Sept 201409/30/2014
ACUR
0.75Study AP-ADF-301 (Study 301)Abuse LiabilityPhase 2Disappointing data released Aug 201308/28/2013
ADHD
7.22MDX (Metadoxine Extended Release (MG01CI))Fragile X SyndromePhase 2bPhase 2b enrolment due to be completed 1Q 2015. Data due 2Q 201502/14/2015
ADHD
7.22MDX (Metadoxine Extended Release (MG01CI))Pediatric ADHDPhase 2bPhase 2b data due 1Q 201502/14/2015
ADHD
7.22MDX (Metadoxine Extended Release (MG01CI))Adult ADHDPhase 3Phase 3 initiated March 2014. Topline data released Oct 201410/11/2014
ADMA
9.75RI-002Primary Immune Deficiency DiseasesPhase 3Phase 3 prelim data released December 2014 met endpoint. Final data due 1Q 2015. BLA filing planned for 1H 201512/05/2014
ADMP
7.11Epinephrine PFSAnaphylaxisPDUFAPDUFA estimate on or around May 29 2015. No official date given08/03/2014
ADMP
7.11APC-3000Allergic RhinitisPhase 3Phase 3 planned02/04/2014
ADMP
7.11APC-1000Asthma/COPDPhase 3Phase 3 planned02/04/2014
ADMS
17.57ADS-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
17.57NamzaricModerate to severe dementia of the Alzheimer's type.ApprovedApproved Dec 24 201412/26/2014
ADMS
17.57Amantadine Traumatic Brain InjuryPhase 2/3 Phase 2/3 planned for 201404/25/2014
ADMS
17.57AmantadineUnknownPhase 2/3Phase 2/3 planned for 201504/25/2014
AERI
29.14RhopressaGlaucomaPhase 3Phase 3 Rocket 1 trial data due mid-2Q 2015. Rocket 2 data due mid 2Q 201503/04/2015
AERI
29.14RoclatanGlaucomaPhase 3Phase 3 to be initiated 3Q 201503/04/2015
AEZS
0.78AEZS-108Cancer - Endometrial Phase 3Phase 3 trial initiated Jul 2013 under SPA, Interim analysis due 1H 201511/22/2014
AEZS
0.78Macimorelin AcetateAdult Growth Deficiency CRLCRL Nov 5 201411/08/2014
AEZS
0.78AEZS-108Metastatic Hormone-Resistant Prostate CancerPhase 2Ongoing09/01/2013
AFMD
6.00AFM13Hodgkin LymphomaPhase 2Phase 2 to be initiated early 201511/19/2014
AGEN
5.26G-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
5.26G-200Cancer - Glioblastoma (GBM) 2nd linePhase 2Enrolling 1H 201309/01/2013
AGIO
107.35AG-348Pyruvate kinase deficiencyPhase 2Phase 2 trial to be initiated 1H 201502/21/2015
AGIO
107.35AG-221Cancer - advanced solid tumorsPhase 1/2Phase 1/2 initiated Oct 201410/22/2014
AGRX
11.05TwirlaContraceptive patch Phase 3Phase 3 data due 1Q 2016. CRL issued 201311/15/2014
AKBA
10.81AKB-6548Anemia related to chronic kidney disease (CKD) who are undergoing dialysisPhase 2aPhase 2a enrolment completed Jan 2015. Data due 3Q 201501/06/2015
AKBA
10.81AKB-6548Anemia associated with chronic kidney disease (CKD)Phase 2bPhase 3 planned for 2015. 03/05/2015
ALDR
24.99Clazakizumab Psoriatic arthritis (PsA)Phase 2Phase 2 data released 4Q 2014. Further development requires partner which company is pursuing03/05/2015
ALDR
24.99ALD403 MigrainePhase 2b Phase 2b data due 2H 2015. Plans to initiate a second Phase 2b dose-ranging trial in 1H 2015 03/05/2015
ALDR
10.58Clazakizumab Rheumatoid arthritis (RA)Phase 2bPhase 2b topline data due 1H 201503/05/2015
ALDX
10.58NS2 Sjögren-Larsson Syndrome (SLS)Phase 3Phase 3 planned for 1H 2015 Data due 2H 201503/04/2015
ALDX
24.99NS2Acute anterior uveitisPhase 2Phase 2 planned for 1H 2015 Data due 2H 201503/04/2015
ALIM
4.71IluvienDiabetic macular edemaApprovedApproved Sept 26 201409/28/2014
ALIOF
115.62Selexipag - UptraviPulmonary arterial hypertension (PAH)PDUFAPDUFA Dec 22 201503/04/2015
ALIOF
115.62Macitentan (Opsumit)Pulmonary arterial hypertensionApprovedApproved Oct 18 201310/22/2013
ALKS
71.71ALKS 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
71.71Three-Month INVEGA SUSTENNA (paliperidone palmitate)SchizophreniaPDUFANDA filed approx Nov 24 2014. Priority Review. Estimated PDUFA July 24 2015. 01/26/2015
ALKS
71.71ALKS 3831SchizophreniaPhase 2Phase 2 data released Jan 2015.Met primary endpoint, equivalence to olanzapine. Pivotal trial planned for 201501/08/2015
ALKS
71.71ALKS 9070 aripiprazole lauroxilSchizophreniaPDUFAPDUFA August 22 201510/23/2014
ALKS
71.71ALKS 3831SchizophreniaPhase 2Second Phase 2 trial initiated June 2014. Data due mid 201706/03/2014
ALNY
111.33Patisiran APOLLOFamilial Amyloidotic Polyneuropathy (FAP) in Patients with ATTRPhase 3Phase 3 trial initiated Nov 2013, continues to enrol patients as of Nov 2014. Expects to complete enrolment in 201501/09/2015
ALNY
111.33RevusiranATTR in patients with familial amyloidotic cardiomyopathy (FAC)Phase 3Phase 3 ongoing. Present data in late 2015 from ongoing Phase 2 OLE study in patients with TTR cardiac amyloidosis. 01/09/2015
ALNY
111.33PatisiranFamilial Amyloidotic Polyneuropathy (FAP) in Patients with ATTRPhase 2 - open labelPhase 2 enrolment completed Sept 2013. Initial data released October 2014. Further data to be released mid 201501/09/2015
ALXA
1.96AZ-002Acute repetitive seizuresPhase 2Phase 2 initiated late Jan 201401/23/2015
ALXN
185.19Asfotase alfaHypophosphatasia (HPP)BLARolling BLA filing ongoing07/27/2014
AMAG
52.17Makena - single-dose (1 mL) vialReduce the risk of preterm birth in women with a singleton pregnancyPDUFAFDA decision due 2Q 201502/12/2015
AMAG
52.17FerahemeIron 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
159.62Talimogene laherparepvecMelanomaPDUFAPDUFA July 28 2015. Adcom meeting April 29, 201502/12/2015
AMGN
159.62BlinatumomabAcute Lymphoblastic LeukemiaPDUFAPDUFA May 19, 2015. Priority review01/28/2015
AMGN
159.62ABP 501 (adalimumab) Moderate-to-severe rheumatoid arthritisPhase 3Phase 3 data due 1Q 201501/28/2015
AMGN
159.62AMG 416Secondary hyperparathyroidismPhase 3Phase 3 data from its head-to-head study vs Sensipar due 1H 201501/28/2015
AMGN
159.62BrodalumabModerate-to-severe plaque psoriasisBLA filingBLA to be filed in 201501/28/2015
AMGN
159.62ABP 215 (bevacizumab) in the second half of 201Advanced non-small cell lung cancerPhase 3Phase 3 data due 2H 201501/28/2015
AMGN
159.62RomosozumabPostmenopausal osteoporosisPhase 3Phase 3 data due 1H 2016 01/28/2015
AMGN
159.62Corlanor (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
159.62KyprolisRelapsed multiple myeloma - patients who have received at least one prior therapysNDA filingsNDA filed on or about Jan 27 201501/28/2015
AMGN
159.62AMG 334MigrainePhase 3Phase 3 planned for 2015. 01/28/2015
AMGN
159.62EvolocumabLDL Cholesterol-Lowering Medication PDUFAPDUFA Aug. 27, 201501/26/2015
AMPE
5.81OptinaDiabetic Macula EdemaPhase 2bPhase 2b trial completed enrolment Feb 2014.Data due 2015 - possibly 1H, otherwise 2H 2015 - Read Pg 10 of 10-k for more details02/28/2015
AMPE
5.81AmpionOsteoarthritis of the KneePhase 3Data from STRUT study released Feb 2015. Data from STRIDE study due 2Q 2015.02/28/2015
AMPE
5.81ZertanePremature ejaculationPhase 3Pivotal trial pending. Will spin off Zertane into a standalone company called Vyrix Pharmaceuticals, Inc12/15/2013
AMRN
1.70Vascepa 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 201803/04/2015
ANAC
47.58AN2728Mild-to-moderate atopic dermatitisPhase 3Phase 3 data due 2H 201511/08/2014
ANAC
47.58TavaboroleOnychomycosisApprovedApproved July 8 201407/09/2014
ANAC
47.58AN2728Mild-to-moderate plaque-type psoriasisPhase 2bPromising Prelim Phase 2b data released Jun 2011. Phase 3 planning on hold04/25/2013
ANIK
40.00CingalOsteoarthritisPMAPMA filed on or about Feb 11 201502/12/2015
ANIK
40.00MonoviscOsteoarthritisApprovedApproved Feb 201402/16/2014
ANTH
5.50BlisibimodLupusPhase 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 during 2015 with final data 3Q 2016.02/12/2015
ANTH
5.50BlisibimodIgA nephropathyPhase 2Phase 2 initiated Jun 2013. Interim data pending partnership negotiations11/15/2014
ANTH
5.50Sollpura (liprotamase)Exocrine Pancreatic InsufficiencyPhase 3Phase 3 due to be initiated mid 201507/15/2014
APPY
0.56Appy1Acute 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
5.50RayVa Secondary Raynaud's PhenomenonPhase 2aPhase 2a initiated December 2014. Expects to complete trial 2015. 12/05/2014
APRI
2.49VitarosErectile DysfunctionApproved in Canada. Partner "Warner Chilcott continues to pursue the approval of the drug"04/25/2013
AQXP
10.04AQX-1125 FLAGSHIPChronic obstructive pulmonary disease (COPD)Phase 2Phase 2 enrolment completed early Feb 2015. Data due mid 201502/03/2015
AQXP
10.04AQX-1125 KINSHIPAtopic dermatitis (AD)Phase 2Phase 2 initiated late Dec 201401/01/2015
AQXP
10.04AQX-1125 LEADERSHIPBladder pain syndrome/interstitial cystitis (BPS/IC). Phase 2Phase 2 enrolment completed March 2015. Data due mid 201503/04/2015
ARDX
15.84TenapanorLate-stage chronic kidney disease (CKD) Phase 2aPhase 2a data due 2Q 201502/26/2015
ARDX
15.84TenapanorHyperphosphatemia 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
15.84TenapanorConstipation-predominant irritable bowel syndrome (IBS-C) Phase 2bData released Oct 201410/11/2014
ARGS
9.15AGS-004 HIVPhase 2bPhase 2b trial did not meet endpoint - early Jan 201501/10/2015
ARGS
9.15AGS-003 ADAPT Trial Phase 3AGS-003 Phase 3 ADAPT Trial on track to complete enrollment 1Q 201511/15/2014
ARGS
9.15AGS-003 Early stage RCC, non-clear cell mRCC, and other solid tumorsPhase 2Phase 2 trials planned for 201408/14/2014
ARIA
8.34Brigatinib - 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 mid-2016.02/21/2015
ARIA
8.34Iclusig (ponatinib) Cancer - second line chronic-phase CML (CP-CML) Phase 3Phase 2 dose ranging trial to be initiated 2H 201501/13/2015
ARIA
8.34Iclusig (ponatinib)Cancer - third line chronic-phase CML (CP-CML)Phase 2Phase 2 dose ranging trial to be initiated mid 201501/13/2015
ARIA
8.34PonatinibGastrointestinal 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
8.34Oral 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
8.34Iclusig (ponatinib) Advanced Medullary Thyroid CancerPhase 2Partial hold lifted. Ongoing10/11/2013
ARNA
4.26RalinepagPulmonary Arterial HypertensionPhase 2Phase 2 initiated mid Jan 201501/13/2015
ARNA
4.26Lorcaserin Smoking cessationPhase 2Phase 2 initiated March 2014. Data released Nov 201411/04/2014
ARQL
2.08Tivantinib (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 201503/05/2015
ARRY
8.27Binimetinib (NEMO)Cancer - NRAS melanomaPhase 3Phase 3 initiated Jul 2013. NDA filing expected 1H 201611/05/2014
ARRY
8.27Selumetinib (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
8.27Selumetinib (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
8.27ARRY 797LMNA-Related DCMPhase 2Phase 2 preliminary results from this study due by the end of 2014.08/16/2014
ARRY
8.27ARRY-520 (Filanesib)Cancer - Refractory Multiple Myeloma MMPhase 2Phase 3 to be initiated 2H 201408/16/2014
ARRY
8.27ARRY 502Asthma Phase 2aPhase 2 topline data released July 23 2013. Endpoint met. Full data released Mar 201403/04/2014
ARRY
8.27Selumetinib (AZD6244) + plus dacarbazine SUMITCancer - metastatic uveal melanoma Phase 3Phase 3 estimated primary completion date for the trial is mid-201502/05/2014
ARRY
8.27MEK162 (ARRY-162) - COLUMBUSCancer - BRAF mutant melanomaPhase 3Phase 3 initiated 2H 201311/02/2013
ARRY
8.27AMG 151 (ARRY-403) Glucokinase activatorType 2 diabetesPhase 2AMG returned rights to ARRY08/07/2013
ARRY
8.27ARRY 380Cancer - metastatic breast cancerPhase 3Phase 3 planned with ONCY08/07/2013
ARRY
8.27MEK162 (ARRY-162) - MILORecurrent low-grade serous ovarian cancer (LGSOC)Phase 3Phase 3 initiated July 201307/03/2013
ARRY
8.27ARRY 614MDSPhase 1Phase 3 decision to be made late 201304/25/2013
ARRY
8.27DanoprevirHCV Hepatitis C Phase 2Phase 3 decision to be made 201304/25/2013
ARRY
8.27ARRY 543/ ASLAN001 Cancer - HER2/EGFR inhibitor for gastric cancerPhase 2Ongoing04/25/2013
ARWR
7.91ARC-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
14.50VEN 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
ASMB
14.50VEN 308 (phenylephrin)Ileal pouch anal anastomosis, or IPAAPhase 2bPhase 2b initiation dependent on funding04/27/2013
ASND
18.09TransConGrowth hormone deficiency in childrenPhase 2Phase 2 topline data due mid 201502/01/2015
ASPX
68.97SD-809Tardive Dyskinesia (TD)Phase 2/3Phase 2b enrolment completed early Feb 2015. Topline data due mid 2015. Data from Phase 3 trial due 201602/04/2015
ASPX
68.97SD-809Huntington's disease (HD)Phase 3Phase 3 topline released Dec 16 2014 met endpoints. NDA filing due by mid 201501/13/2015
ATHX
2.90MultistemIschemic strokePhase 2Initiated 3Q 2011. Enrolment completed late Dec 2014. Initial data due April 201503/04/2015
ATHX
2.90MultistemAcute myocardial infarctionPhase 1Phase 2 planned for 201511/12/2014
ATRA
29.45PINTA 745Protein-energy wastingPhase 2Phase 2 unblinding of data due by end of 201502/28/2015
ATRS
2.78VIBEX 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
2.78OTREXUPRheumatoid arthritis (RA)ApprovedApproved Oct 14 201310/16/2013
AUXL
36.47XIAFLEXAdhesive Capsulitis (“Frozen Shoulder syndrome”)Phase 2bPhase 2b data due 1Q 201510/31/2014
AUXL
36.47AvanafilErectile dysfunctionApprovedApproved Apr 27 2012. sNDA label change also approved 17 Sept 201409/18/2014
AUXL
36.47XIAFLEXEdematous fibrosclerotic panniculopathy (“cellulite”)Phase 2aPhase 2b to commence 2Q 201508/22/2014
AUXL
36.47XIAFLEXDupuytren's ContracturePDUFAPDUFA Date Scheduled for October 20, 201402/25/2014
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
69.20BAX111Von Willebrand DiseasePDUFABLA filed about Dec 22 2014. Estimated PDFUA Dec 22 2015 01/26/2015
BAX
69.20BAX 855Hemophilia APDUFABLA filed about Dec 1 2014. Estimated PDUFA Dec 1 201501/26/2015
BAYRY
147.20BAY 81-8973Hemophilia APDUFABLA filed about Dec 17 2014. Estimated PDUFA Dec 17 201501/26/2015
BCLI
4.39NurOwn Amytrophic lateral sclerosis (ALS)Phase 2aPhase 2a data released Jan 5 2015. 11 of 12 patients experienced an improvement in the rate disease progression01/06/2015
BCRX
10.40BCX4161 - OPuS-2Hereditary angioedemaPhase 2bPhase 2b data due by end of 201501/27/2015
BCRX
10.40Peramivir - Study 303INFLUENZA ACUTE ApprovedApproved Dec 22 201412/23/2014
BCRX
10.40UlodesineGoutPhase 2bPhase 3 initiation pending partnership09/02/2013
BCRX
10.40UlodesineModerate renal impairmentPhase 2Phase 3 initiation pending partnership09/02/2013
BDSI
15.00BEMA 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
15.00Clonidine gelPainful diabetic neuropathy (PDN) Phase 3Announced that they have completed the randomization of all patients, with Phase 3 topline data due by the end of March 201512/10/2014
BDSI
15.00BEMA Buprenorphine/Naloxone (BNX) - BUNAVAILOpioid dependenceApprovedApproved June 7 201406/08/2014
BDSI
15.00BEMA BuprenorphineModerate to severe chronic pain in opioid naive subjectsPhase 3Phase 3 data released Jan 201401/24/2014
BIND
5.98 BIND-014 Cancer - KRAS mutant Non-small cell lung cancer (NSCLC)Phase 2Preliminary data due 2H 201502/05/2015
BIND
5.98 BIND-014 Cancer - Squamous histology NSCLCPhase 2Phase 2 enrolment to commence 1Q 2015, with preliminary data due 2H 201502/05/2015
BIND
5.98 BIND-014 Cancer - NSCLC broad patient populationPhase 2Phase 2 final overall survival data due in 1H 201502/05/2015
BIND
5.98 BIND-014 Cancer - Cholangiocarinoma, cervical cancer, bladder cancer and head and neck cancersPhase 2First patient enrollment in 2Q 2015 with anticipated stage 1 data in early 2016, anticipated stage 2 data readout in late 2016, and if the results of these studies are favorable, the initiation of Phase 3 pivotal studies in 2017.02/05/2015
BIND
5.98 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
1.35BIOD-531 Type 2 diabetesPhase 1Announced Dec 2014 that they intend to release Phase 1 data and initiate a Phase 2b trial in 2Q 2015 02/14/2015
BIOD
1.35BIOD-531 Type 2 diabetesPhase 2aPhase 2a data due early Jan 201501/07/2015
BIOD
1.35BIOD-123Diabetes - Type 1Phase 2Phase 2 data released Sept 201309/09/2013
BLCM
24.05BPX-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
24.05BPX-401Hematological cancers that express the CD19 antigenPhase 1/2Phase 1/2 planned 1H 201602/01/2015
BLCM
24.05BPX-601Solid tumorsPhase 1/2Phase 1/2 planned 2H 201602/01/2015
BLCM
24.05BPX-701PRAME (preferentially-expressed antigen in melanoma) -expressing melanoma, sarcomas and neuroblastomaPhase 1/2Phase 1/2 planned 2H 201502/01/2015
BLRX
2.74BL-8040Cancer - Acute myeloid leukemia (AML) Phase 2aPhase 2a enrolment began Jun 2013. Partial data released Dec 2013. Full data 2H 201512/16/2014
BLRX
2.74BL-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
2.74BL-8040Cancer - AML patients with the FLT3-ITD mutationPhase 1/2Phase 1/2 to be initiated 1Q 201512/16/2014
BLRX
2.74 BL-7010Celiac diseasePhase 1/2Efficacy trial to be initiated 2H 2015.11/06/2014
BLRX
2.74BL-8040Chronic Myeloid Leukemia Phase 1/2Phase 1/2 to be initiated late 201408/10/2014
BLRX
2.74BL-5010P Non-surgical removal of benign skin lesions.PivotalCE Mark registration trial for BL-5010P expected to begin 1H 2014; results expected 2H 201401/22/2014
BLUE
111.00LentiGlobin - HGB-206Sickle diseasePhase 1/2Most likely to have initial data 1H 2015, as per JPM estimate12/12/2014
BLUE
111.00 LentiGlobin β-ThalassemiaPhase 1/2Data presented at ASH 2014 showed that first four patients are transfusion free12/10/2014
BLUE
111.00Lenti-DChildhood cerebral adrenoleukodystrophy (CCALD)Phase 2/3Phase 2/3 trial initiated October 2013. Enrolment due to be completed 201503/06/2014
BMRN
113.50PEG-PALPhenylketonuria (PKU) Phase 3Phase 3 data due 1Q 2016.02/26/2015
BMRN
113.50Reveglucosidase alfa (BMN 701)Pompe DiseasePhase 2Data due 4Q 201502/26/2015
BMRN
113.50Talazoparib (BMN 673)Cancer -gBRCA breast cancer Phase 3Phase 3 initiated Oct 2013: Enrollment completion due 2H 201502/26/2015
BMRN
113.50BMN-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 late 2Q 201502/26/2015
BMRN
113.50BMN 190Batten DiseasePhase 1/2Phase 1/2 initiated Sep 2013. Data due 2H 201502/26/2015
BMRN
113.50Vimizim (GALNS)(MPS IVA) Morquio A SyndromeApprovedApproved Feb 14 201402/16/2014
BOTA
2.42AP611074 5% gelAnogenital wartsPhase 2bPhase 2b to be initiated 2H 201502/28/2015
BOTA
2.42VapendavirHuman rhinovirus (HRV)Phase 2bPhase 2b top-line data due mid 201603/04/2015
BOTA
2.42Laninamivir 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
38.80XIAFLEXHuman lipomasPhase 2Phase 2 enrolment due to be completed 1Q 201501/30/2015
BSTC
38.80XIAFLEXAdhesive Capsulitis (“Frozen Shoulder syndrome”)Phase 2bPhase 2b data due 1Q 201501/30/2015
BSTC
38.80XIAFLEXEdematous fibrosclerotic panniculopathy (“cellulite”)Phase 2aPhase 2b to commence 2Q 201501/30/2015
CALA
13.25CB-839Cancer - variousPhase 1Phase 2 planned for late 2015 or early 201610/25/2014
CANF
4.48CF101Psoriasis Phase 2/3Phase 2/3 topline data due by end of 1Q 201502/05/2015
CANF
4.48CF102Cancer - advanced liver cancer second linePhase 2Phase 2 first patient dosed late Dec 2014. Enrolment to be completed by end of 201501/07/2015
CANF
4.48CF101Rheumatoid arthritisPhase 3Phase 3 planned. Design of study completed late Dec 201401/01/2015
CANF
4.48CF101GlaucomaPhase 2Phase 2 data due 2Q or 3Q 201512/02/2014
CARA
10.53CR845 Uremic PruritusPhase 2Phase 2 topline data due 1H 201512/18/2014
CARA
10.53IV CR845Acute painPhase 3Phase 3 planned for early 201511/12/2014
CASI
1.63ENMD-2076Cancer - fibrolamellar carcinoma (FLC).Phase 2Plans to initiate a Phase 2 trial in 201501/19/2015
CASI
1.63ENMD-2076 Cancer - Advanced/Metastatic Soft Tissue SarcomaPhase 2Phase 2 initiated Jan 2013. Enrolling as of Nov 201401/19/2015
CASI
1.63ENMD-2076Cancer - triple-negative breast cancerPhase 2Phase 2 initiated Jul 2012. Enrolling as of Nov 201401/19/2015
CASI
1.63ENMD-2076Cancer - Ovarian Clear Cell CarcinomasPhase 2Phase 2 initiated Oct 2013. 11/02/2013
CASI
1.63MKC-1Cancer - NSCLCPhase 2Need funding to continue04/26/2013
CASI
1.63MKC-1Cancer - PancreaticPhase 2Need funding to continue04/26/2013
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
7.95CCX140Diabetic nephropathy Phase 2Phase 2 topline data released Dec 12 201412/15/2014
CCXI
7.95Vercirnon CCX282 - (SHIELD-4)Crohn's diseasePhase 3Data presented Oct 201410/21/2014
CCXI
7.95CCX168Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. Phase 2Data released December 201312/04/2013
CCXI
7.95CCX354 (GSK2941266) - (CARAT-2)Rheumatoid arthritis.Phase 2Completed05/03/2013
CCXI
7.95Vercirnon CCX282 - (SHIELD-2)Crohn's diseasePhase 3Initiated in Nov 2011.05/03/2013
CEMP
33.45Taksta CEM-102Prosthetic joint infection (PJI) Phase 2Plans to initiate Phase 3 trial in 201502/26/2015
CEMP
33.45SolithromycinNASHPhase 2Phase 2 to be initiated 201502/26/2015
CEMP
33.45SolithromycinCOPDPhase 2Phase 2 to be initiated 201502/26/2015
CEMP
33.45CEM-101 (solithromycin )CAPBPhase 3Phase 3 data released early Jan 2015 met the primary objective of statistical non-inferiority 01/06/2015
CEMP
33.45CEM-101 (solithromycin )Uncomplicated urogenital gonococcal infectionsPhase 3Phase 3 initiated August 201408/16/2014
CERS
4.43INTERCEPT PlateletsApprovedPMA approved Dec 18 201412/19/2014
CERS
4.43INTERCEPT B123PlasmaApprovedPMA approved Dec 16 201412/18/2014
CERS
4.43INTERCEPT Acute and Chronic AnemiaPhase 3Phase 3 Eruopean trials initiated 201306/12/2013
CERU
8.14CRLX301Cancer - solid tumoursPhase 2Phase 2 patient dosing initiated mid Dec 201412/18/2014
CERU
8.14CRLX101 in Combination with Chemotherapy and Radiation Rectal CancerPhase 1b/2Data due 1Q 201511/15/2014
CERU
8.14CRLX101, in combination with AvastinCancer - relapsed ovarianPhase 2Data due 1Q 201511/15/2014
CERU
8.14CRLX101, in combination with AvastinCancer - Relapsed Renal Cell CarcinomaPhase 2Data due by end of 201511/15/2014
CERU
8.14CRLX101 and XelodaNeoadjuvant Rectal CancerPhase 1b/2Ongoing04/25/2014
CHRS
30.48CHS-1420Psoriasis or rheumatoid arthritisPhase 3Phase 3 planned for 1H 2015 in either psoriasis or rheumatoid arthritis02/01/2015
CHRS
30.48CHS-0214Rheumatoid arthritis Phase 3Phase 3 European trial ongoing02/01/2015
CHRS
30.48CHS-0214PsoriasisPhase 3Phase 3 European trial ongoing02/01/2015
CLDN
21.49MYDICAR - CUPID 2 TrialIschemic or dilated cardiomyopathyPhase 2bPhase 2b data due April 201511/13/2014
CLDN
21.49MYDICAREnd-stage renal disease (ESRD)Phase 2aPhase 2a trial possibly going to be initiated 201511/13/2014
CLDX
29.90CDX-110 rindopepimut - ACT IVCancer- glioblastoma multiforme (GBM) front linePhase 3Initiated Phase 3 Dec 2011. First interim analysis due mid 201502/26/2015
CLDX
29.90Glemba Cancer - metastatic triple negative breast cancers that overexpress gpNMBPhase 2bPhase 2b enrolment to continue through to 201602/26/2015
CLDX
29.90Glembatumumab vedotinCancer - melanomaPhase 2Phase 2 initiated December 201412/05/2014
CLDX
29.90CDX-110 (rindopepimut) in combination with Avastin - ReACTCancer- glioblastoma multiforme (GBM) refractoryPhase 2Phase 2 inteirm data released Nov 201411/19/2014
CLDX
29.90CDX-011 EMERGECancer - Metastatic breastPhase 2bPrelim data released May 23 2012. Updated data released Dec 2012. Phase 3 trial initiated Dec 201303/04/2014
CLSN
2.85ThermoDoxCancer - Hepatocellular carcinoma - liver cancerPhase 3Failed to meet primary endpoint. New Phase 3 be initiated Sept 201409/03/2014
CLSN
2.85ThermoDoxRecurrent Chest Wall Breast Cancer (RCWBC)Phase 2Phase 2 interim data released Feb and July 201407/27/2014
CLVS
79.95Rociletinib Cancer - 2nd line T790M+ NSCLC Phase 2/3NDA filing due mid 201502/26/2015
CLVS
79.95Rucaparib ARIEL2Cancer - ovarian second linePhase 2Phase 2 dosing initiated Oct 2013. Interim data released November 2014. Enrolment due to be completed early 201511/22/2014
CLVS
79.95LucitanibCancer - breastPhase 2Phase 2 dosing initiated Oct 201410/25/2014
CLVS
79.95Rucaparib RUCAPANCCancer - pancreaticPhase 2Phase 2 initiated June 201406/17/2014
CLVS
79.95Rucaparib ARIEL3 Cancer - ovarian second linePivotalPivotal trial initiated late 201302/28/2014
CMRX
41.18SUPPRESS trial of CMX001 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 201602/28/2015
CMRX
41.18CMX001AdV diseasePhase 2Phase 2 top line data released Aug 201308/15/2013
CNAT
6.63Emricasan Acute-on-Chronic Liver Failure (ACLF) Phase 2Phase 2 topline data released Jan 201501/09/2015
CNAT
6.63EmricasanPortal Hypertension Phase 2Phase 2 data due 3Q 201501/09/2015
CNAT
6.63EmricasanNon-alcoholic steatohepatitis (NASH)Phase 2Phase 2 trial initiated Mar 2014. Topline data due 1Q 201501/09/2015
CNAT
6.63EmricasanLiver CirrhosisPhase 2Phase 2 topline data due 2H 201501/09/2015
CNAT
6.63EmricasanLiver 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 1H 2015.01/09/2015
CNAT
6.63EmricasanSevere alcoholic hepatitisPhase 2Phase 2 initiated Sept 201309/22/2013
CNCE
14.39CTP-499 Diabetic Kidney DiseasePhase 2Phase 3 planned. Needs partner11/13/2014
CNCE
14.39AVP-786 Neurologic and Psychiatric DisordersPhase 2Phase 2 initiated August 201408/27/2014
CNDO
3.25TSO - (CNDO-201) (TRUST-I)Crohn’s diseasePhase 2Phase 2 endpoint not met Oct 201310/15/2013
CNDO
3.25TSO - (CNDO-201)Ulcerative colitisPhase 2Phase 2 initiated Sep 201309/15/2013
CORI
6.94MicroCor hPTH(1-34) OsteoporosisPhase 2Phase 2 planned for 201405/17/2014
CORI
6.94AG200-15ContraceptivePhase 3Additional Phase 3 planned following rejection of NDA04/25/2014
CORI
6.94Corplex Tamsulosin Benign prostatic hyperplasiaPhase 2Phase 2 planned 1H 201504/25/2014
CORT
3.62Corlux - KorlymCancer - triple-negative breast cancerPhase 1/2Phase 1/2 data due 201503/05/2015
CPIX
6.75Hepatoren HRSPhase 2Ongoing04/25/2013
CPRX
3.92Firdapse Lambert-Easton Myasthenic Syndrome (LEMS)Phase 3Rolling NDA to be completed 3Q 201502/03/2015
CPXX
2.65CPX-351 Secondary AMLPhase 3Phase 3 initial induction response rate analysis due 2Q 2015. Overall survival data due 1Q 2016. 02/04/2015
CPXX
2.65CPX-351 Adult patients with hematologic malignanciesPhase 2Phase 2 pharmacokinetic and pharmacodynamics study is also ongoing02/04/2015
CRIS
3.26CUDC-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
3.26Erivedge (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
9.76Vernakalant IV Atrial fibrillationPhase 3Phase 3 placed on clinical hold Oct 2010 due to patient death07/07/2014
CSII
37.59Orbital atherectomy systemCalcified coronary arteriesPMAPMA approved Oct 22 201310/23/2013
CTIC
2.59OPAXIOOvarian cancerPhase 3Phase 3 second of four analyses completed early Feb 2014. Trial to continue as planned02/04/2015
CTIC
2.59TosedostatCancer - 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
2.59Pacritinib -PERSIST-1MyelofibrosisPhase 3Topline data due late 1Q 2015, with NDA filing late 2015. A second planned Phase 3 trial was initiated in March 2014 with enrolment due to be completed in mid-201501/08/2015
CTIC
2.59OpaxioCancer - OvarianPhase 3Enrolment completed Jan 201401/29/2014
CTIC
2.59OpaxioCancer - glioblastoma multiformePhase 2Ongoing12/07/2013
CTIC
2.59OpaxioCancer - head and neck cancerPhase 1/2Ongoing12/07/2013
CTIC
2.59PacritinibMyelofibrosisPhase 3Second Phase 3 trial (PERSIST-2) is planned to initiate in 4Q 2013. 10/08/2013
CTIC
2.59BrostallicinCancer - breastPhase 2Interim data released Dec 2012. Final data released ASCO 201306/03/2013
CTIC
2.59PixantroneCancer - Relapsed/refractory diffuse large B-cell lymphoma ("DLBCL")PivotalInitiated Mar 2011. Ongoing04/25/2013
CTIC
2.59PixantroneCancer - Non-Hodgkin lymphomaCRLNDA withdrawn Jan 2012. Not planning to resubmit NDA as of early 2013, but may evaluate a possible resubmission strategy based on the data generated from the ongoing PIX306 clinical trial04/25/2013
CTIX
3.63CellceutixPlacque psoriasisPhase 2Given green light in November 2014 to initiate a Phase 2 trial12/18/2014
CTIX
3.63BrilacidinOral mucositisPhase 2Phase 2 trial to be initiated Dec 201412/18/2014
CTIX
3.63BrilacidinAcute 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
3.63KevetrinCancer - variousPhase 2/3Phase 2/3 planned12/18/2014
CUR
3.71 NSI-566Amyotrophic lateral sclerosis (Lou Gehrig's)Phase 2Phase 2 data are due LATE 1Q or EARLY 2Q 2015 according to Jan 2015 presentation. 01/16/2015
CUR
3.71NSI-189DepressionPhase 2Phase 2 to be initiated 2Q 201511/08/2014
CUR
3.71NSI-566Motor deficits due to ischemic strokePhase 1/2Phase 1/2 trial initiated in China Aug/Sep 2013. First patient dosed Jan 201401/14/2014
CVM
1.14MultiklineCancer - Head and NeckPhase 3Initiated Dec 2010, enrolling. 117 patients enrolled as of Apr 2013. 146 patients as of Feb 2014. 352 patients as of end of Jan 2015. 377 as of March 2015. Full enrolment due to be completed by end of 201503/04/2015
CYCC
1.04Sapacitabine (SEAMLESS)Cancer - Acute myeloid leukemiaPhase 3Noted mid-Dec 2014 that interim analysis suggests that trial will fail12/18/2014
CYCC
1.04SapacitabineCancer - Myelodysplastic syndromesPhase 2Phase 2b to be initiated 201511/12/2014
CYCC
1.04SapacitabineCancer - NSCLCPhase 2Ongoing04/26/2013
CYTK
7.98TirasemtivALSPhase 3Phase 3 to be initiated 2Q 201502/14/2015
CYTK
7.98CK-2127107Spinal muscular atrophy (SMA)Phase 2Phase 2 to be initiated 2H 201502/14/2015
CYTK
7.98Omecamtiv mecarbil ATOMIC-AHFAcute heart failurePhase 2bData released Sept 3 at EUROPEAN SOCIETY OF CARDIOLOGY CONGRESS missed primary endpoint09/03/2013
CYTR
3.28AldoxorubicinCancer - 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
3.28Aldoxorubicin with doxorubicinCancer - soft tissue sarcomas refractoryPhase 3Phase 3 initiated March 2014 under SPA, expect to complete trial enrollment in 2H 2015. Unblind data by mid-2016 01/21/2015
CYTR
3.28AldoxorubicinCancer - AIDS-related Kaposi’s sarcomaPhase 2Phase 2 initiated Jan 2014. Prelim data due 2Q 2015. 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
3.28AldoxorubicinCancer - 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
3.28AldoxorubicinCancer - SCLCPhase 2bPhase 2b to be initiated Sept 201410/01/2014
CYTR
3.28BafetinibCancer - B-Cell Chronic Lymphocytic Leukemia (B-CLL)Phase 2Phase 2 proof of concept completed. Seeking partner for further development09/08/2013
CYTR
3.28BafetinibCancer - B-cell chronic lymphocytic leukemia (B-CLL)Phase 2Phase 2 proof of concept completed. Seeking partner for further development09/08/2013
CYTR
3.28TamibaroteneCancer - non-small-cell lung cancer (NSCLC)Phase 2bTerminated May 201305/09/2013
CYTR
3.28INNO-206 aldoxorubicinCancer Phase 2Phase 2 clinical trial with INNO-206 for pancreatic cancer initiated Apr 2012. No objective responses to date04/26/2013
CYTR
3.28TamibaroteneCancer - Acute promyelocytic leukemia Phase 2Phase 2 SPA obtained but not currently open04/26/2013
CYTX
1.14Cytori Cell Therapy Osteoarthritis of the kneePhase 2Phase 2 dosing initiated mid Feb 201502/21/2015
CYTX
1.14ECCS-50SclerodermaPivotalPivotal trial to be initiated 201501/13/2015
DARA
0.82KRN5500Pain - Neuropathic Phase 2Seeking partner for development09/08/2013
DBVT
21.20Viaskin Peanut Peanut allergyPhase 2bPhase 2b data released September 201410/25/2014
DCTH
1.14Melphalan Hepatic Delivery System (Melphalan HDS)Hepatocellular carcinoma (HCC)Phase 2Phase 2 data due 1H 201511/11/2014
DCTH
1.14Melphalan Hepatic Delivery System (Melphalan HDS)Ocular Melanoma (OM) Liver MetastasesPhase 3Phase 3 to be initiated mid 201511/06/2014
DCTH
1.14CHEMOSAT systemCancer - unresectable metastatic ocular melanoma in the liverCRLCRL Sept 13 201309/15/2013
DEPO
24.25SEFELSAHot flashesCRLCRL May 31 201306/01/2013
DERM
16.23DRM04Primary axillary hyperhidrosisPhase 2bPhase 3 to be initiated 2H 2015 following Phase 2b data released early Feb 2015. Company noted that the Phase 2b trial was not powered to demonstrate statistical significance02/06/2015
DERM
16.23CimziaModerate-to-severe plaque psoriasis Phase 3Phase 3 initiated Jan 2015. Data due 201701/08/2015
DERM
16.23DRM01AcnePhase 2aPhase 2b to be initiated 1H 201511/13/2014
DPRX
13.68LocilexMild infections of diabetic foot ulcersPhase 3Second Phase 3 under SPA initiated July 2014. Data due 2H 2015. 02/26/2015
DRRX
1.37RemoxyChronic painCRLCRL Jun 23, 2011. PFE announced they will return rights to PTIE in late Oct 2014. PTIE expects to report a target date for the potential re-filing of the REMOXY NDA following return of rights.02/21/2015
DRRX
1.37ReldayPhase 3Phase 3 to be initiated by ZGNX in 201603/04/2015
DRRX
1.37PosidurPost-operative pain relief CRLCRL Feb 12 2014. Phase 3 planned in response to CRL03/04/2015
DSCI
7.76DSC127 Diabetic foot ulcersPhase 3Phase 3 to be completed 2H 201611/24/2014
DSCO
1.73AerosurfRespiratory Distress Syndrome - ModeratePhase 2aPhase 2a data due 1Q 201511/08/2014
DSCO
1.73Surfaxin LS - lyophilized dosage form of SURFAXINNeonatal RDSPhase 2 Talks with FDA regarding further development 04/26/2013
DVAX
21.65AZD1419AsthmaPhase 2aAnnounced in December 2014 that a Phase 2a trial in 1H 201512/10/2014
DVAX
21.65HEPLISAVHepatitis 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
DYAX
15.59DX-2930Hereditary angioedema (HAE) Phase 2Phase 2 to be initiated 2H 201502/26/2015
DYAX
15.59CYRAMZA (ramucirumab)Colorectal cancerPhase 3Filing due 1H 201509/23/2014
DYAX
15.59CYRAMZA (ramucirumab)Non-small cell lung cancer (NSCLC)BLAFiling due by end of 201409/23/2014
DYAX
15.59Necitumumab - SQUIRECancer - NSCLCBLABLA filing due by end of 201409/23/2014
DYAX
15.59Anti-LINGO - RENEW trialAcute optic neuritisPhase 2Phase 2 topline data due early 201509/23/2014
DYAX
15.59Anti-LINGO - SYNERGY trialRelapsing forms of multiple sclerosisPhase 2Phase 2 topline data due 201609/23/2014
DYAX
15.59CYRAMZA (ramucirumab)Gastric CancerApprovedApproved April 201408/03/2014
DYAX
15.59Trebananib (AMG 386)OvarianPhase 3Met endpoint08/03/2014
EARS
5.86AM-101Acute inner ear tinnitusPhase 3Phase 3 topline data due early 201612/05/2014
EARS
5.86AM-111Acute inner ear hearing lossPhase 3Pivotal trial to be initiated mid 201512/05/2014
EBS
29.48Anthrax Immune Globulin Intravenous (Human) [AIGIV] AnthraxPDUFA BLA filed early August 2014. Estimated PDUFA Aug 7 201501/26/2015
EBS
29.48BioThrax Anthrax Vaccine AdsorbedPDUFA sBLA PDUFA date estimated May 9 201501/26/2015
ECYT
6.30vintafolideCancer - ovarianPhase 3Trial stopped due to poor efficacy05/04/2014
ECYT
6.30Vintafolide (TARGET)Cancer - NSCLCPhase 2bPhase 2b topline data released March 2014. Endpoint met.03/23/2014
ECYT
6.30vintafolideCancer - folate receptor-positive triple negative breast cancerPhase 2Initiate Phase 2 2Q 201402/25/2014
EDAP
3.97 Ablatherm-HIFU (High Intensity Focused Ultrasound) Cancer - Low risk, localized prostate cancerPMAPMA submitted Feb 2013. Adcom negative vote July 30 201408/03/2014
EGLT
14.97Egalet-001Abuse-Deterrent MorphineBioequivalence StudiesPhase 3 to commence 1Q 2015. NDA planned for mid-2016.11/13/2014
EGLT
14.97Egalet-002Moderate to severe chronic painPhase 3Phase 3 trial planned for 1Q 201511/13/2014
EGRX
38.18RTU bivalirudin liquidNDA filingNDA filing due 2Q 201511/23/2014
EGRX
38.18RyanodexMalignant hyperthermiaApprovedApproved July 22, 2014 under priority review07/24/2014
EGRX
38.18EP-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
87.84Buprenorphine 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
87.84AVEED (testosterone undecanoate) intramuscular injectionMen diagnosed with hypogonadismApprovedApproved March 6 201409/06/2013
ENTA
35.09ABT-450HCV - genotype 1ApprovedApproved December 19 201412/22/2014
ENTA
35.09ABT-493HCV Phase 2bPhase 2b initiated Sept 2014. Data due 2015.09/11/2014
ENZY
7.43VayarolHypertriglyceridemiaPhase 2Phase 3 planned12/15/2013
EPZM
24.20EPZ-6438Non-Hodgkin lymphoma - EZH2 point mutationPhase 1/2Initiated Phase 1/2 Jun 201306/14/2013
EPZM
24.20EPZ-5676Mixed lineage leukemia, or MLL-rPhase 1Phase 1 initiated Sep 201205/31/2013
ESALY
56.21FycompaPrimary generalized tonic-clonic seizures (PGTC)PDUFAsNDA filed Aug 19 2014. Estimated PDUFA Aug 19 201501/26/2015
ESALY
56.21Lenvatinib mesylate (lenvatinib)Progressive radioiodine-refractory differentiated thyroid cancerPDUFAPDUFA date under priority review of April 14, 201501/26/2015
ESPR
63.21ETC-1002-009HypercholesterolemiaPhase 2b Data due March 201511/23/2014
ESPR
63.21ETC-1002-014Hypercholesterolemia and hypertensionPhase 2Phase 2 data due 2Q 201511/23/2014
ESPR
63.21ETC-1002-008HypercholesterolemiaPhase 2bPhase 2b initiation Oct 2013. Data released October 201410/11/2014
ESPR
63.21ETC-1002-007HypercholesterolemiaPhase 2aTop-line data released Sept 03 201309/04/2013
ETRM
1.14VBLOCObesityApprovedApproved Jan 14, 201501/15/2015
EVOK
6.00EVK-001Female diabetic gastroparesisPhase 3Phase 3 initiated April 2014. Enrolment due to be completed 2H 2015, slower than initially expected02/03/2015
EXAS
21.83CologuardCancer - Colorectal DNA testApprovedApproved August 201408/16/2014
EXEL
3.10Cabozantinib - (METEOR)Cancer - metastatic renal cell cancer (RCC)Phase 3Phase 3 initiated May 2013. Enrollement due to be completed 2014. Data due 2Q 201502/26/2015
EXEL
3.10VemurafenibCancer - BRAF V600 Mutation-Positive Advanced MelanomaPDUFAPDUFA August 11, 2015 under priority review02/21/2015
EXEL
3.10CabozantinibCancer - Castration-Resistant Prostate CancerPhase 3Phase 3 COMET-2 trial did not meet endpoint December 1 201412/02/2014
EXEL
3.10XL184 cabozantinib (CELESTIAL)Cancer - advanced hepatocellular cancer (HCC)Phase 3Phase 3 initiated Sept 2013. Data due 201711/25/2014
EXEL
3.10CabozantinibCancer - EGFR Wild-Type Non-Small Cell Lung CancerPhase 2Phase 2 data released Nov 201411/05/2014
EXEL
3.10Cabozantinib Plus AbirateroneChemotherapy-Naïve Patients with Metastatic Castration-Resistant Prostate CancerPhase 2Phase 2 initiated Dec 201312/03/2013
FATE
5.01ProHema Adult hematologic malignanciesPhase 2Phase 2 data due mid-2015. 01/13/2015
FGEN
30.57Roxadustat FG-4592Anemia in chronic kidney diseasePhase 3Phase 3 ongoing. Enrolment expected to be completed in 1H 2016. Data due 201702/01/2015
FGEN
30.57FG-3019Idiopathic pulmonary fibrosisPhase 2Phase 2 ongoing02/01/2015
FGEN
30.57FG-3019Liver fibrosisPhase 2Phase 2 ongoing in Hong Kong. Future development uncertain02/01/2015
FGEN
30.57FG-3019Pancreatic cancer Phase 2Phase 2 open-label trial ongoing02/01/2015
FLML
16.00VAZCULEP (phenylephrine hydrochloride)Clinically important hypotension resulting primarily from vasodilation in the setting of anesthesiaApprovedApproved June 30 201407/01/2014
FLML
16.00Bloxiverz (neostigmine methylsulfate)Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgeryApprovedApproved Jun 306/05/2013
FLXN
25.07FX006Osteoarthritis 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 data02/26/2015
FLXN
25.07FX007Phase 2Phase 2 trial to be initiated 201404/24/2014
FOLD
8.62Migalastat HCl monotherapy (012)Fabry DiseasePhase 3Phase 3 data released August 2014. Endpoints met. Announced on December 11 that they intend to meet with the FDA during 1Q 2015 to discuss their possible NDA filing12/12/2014
FOLD
8.62migalastat 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
9.18FDX104Chemotherapy Induced RashPhase 2Phase 2 initiated Oct 201410/25/2014
FOMX
9.18FDX101RosaceaPhase 2Phase 2 to be initiated 201510/25/2014
FOMX
9.18FDX101AcnePhase 2Phase 3 to be initiated mid 201510/25/2014
FOMX
9.18FDX102ImpetigoPhase 2Phase 2 to be initiated 2H 201510/25/2014
FPRX
25.92FP-1039FGFR1Phase 1bPhase 1b initiated July 2013. Prelim data due by end of 201408/16/2014
FWP
23.38FP187Multiple sclerosisPhase 3Phase 3 planned10/25/2014
FWP
23.38FP187PsoriasisPhase 3Phase 3 planned for early 201510/25/2014
GALE
2.04NeuVax (E75) - PRESENTCancer - low-to-intermediate HER2+ breast cancerPhase 3Initiated Phase 3 Jan 2012 under SPA. Enrolment due to be completed near end of 1Q 2015. Final endpoint is currently expected to be reached in 201802/12/2015
GALE
2.04GALE-401Essential Thrombocythemia (ET)Phase 2Phase 2 initiated September 2014. Top-line data due mid 2015.11/19/2014
GALE
2.04NeuVaxCancer - HER2 3+ Breast CancerPhase 2Phase 2 initiated Nov 2014. Enrollment due to be completed 2H 201611/12/2014
GALE
2.04NeuVax in combination with HerceptinBreast cancerPhase 2bPhase 2b ongoing05/11/2014
GALE
2.04GALE 301 -Folate Binding Protein (FBP) vaccineEndometrial and ovarian cancerPhase 2Phase 2 initiated Jan 2014. Enrolment completed June 2014. Data due mid 201503/18/2014
GBIM
7.01GS-4774Chronic hepatitis B infectionPhase 2Phase 2 initiated by GILD Sept 201307/09/2014
GBIM
7.01GI-6207Medullary thyroid cancerPhase 2Phase 2 ongoing07/09/2014
GBIM
7.01GI-4000Cancer - Non-small cell lung cancerPhase 2Phase 2b planned07/09/2014
GBIM
7.01GI-4000Cancer - colorectal cancer Phase 2Phase 2a ongoing07/09/2014
GERN
3.58ImetelstatMyelodysplastic syndromesPhase 2Phase 2 to be initiated late 201503/04/2015
GERN
3.58ImetelstatMyelofibrosisPhase 2Phase 2 clinical hold lifted Nov 2014. Phase to be initiated mid 201503/04/2015
GEVA
101.50SBC-103 Mucopolysaccharidosis IIIBPhase 1/2Phase 1/2 trial initiated late Jan 2015. Preliminary data due 2H 201502/28/2015
GEVA
101.50Sebelipase alfa (Kanuma)Late onset lysosomal acid lipase deficiency (LAL Deficiency)PDUFA PDUFA date under priority review Sept 8 201501/26/2015
GILD
103.79Elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide HIVPDUFANDA filed approx Nov 6 2014. Estimated PDUFA Nov 6 201501/26/2015
GLMD
8.89AramcholNon-Alcoholic Steatohepatitis (NASH)Phase 2bInitiate Phase 2b 4Q 2014. Interim analysis due 2H 2015. Final data due 2H 201612/02/2014
GLMD
8.89AramcholCholesterol GallstonesPhase 2aPhase 2a initiated Nov 2014, data due 1H 201511/15/2014
GLYC
8.17GMI-1070 (rivipansel)Vaso-occlusive crisis of sickle cell diseasePhase 3Phase 3 planned 09/28/2014
GNCA
8.51GEN-003Herpes simplex virus type 2 (HSV-2) Phase 1/2Phase 2 enrolment completed early Jan 2015. Topline data due late 2Q 201502/14/2015
GNCA
8.51GEN-004Universal vaccine candidate against pneumococcusPhase 2Phase 2 trial initiated September 2014. Topline data due 4Q 201502/14/2015
GTHP
0.20LuVivaDevice 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
0.81GTx-758 CapesarisCancer - ProstatePhase 2Placed on clinical hold. Hold lifted May 2012. Phase 2 trial continued on LOWER doses. Ongoing. Prelim data released Jan 2014. Data due 2Q 201511/11/2014
GTXI
0.81Ostarine (Enobosarm (GTx-024))ER Positive Metastatic Breast CancerPhase 2Phase 2 initiated Apr 2013. Enrolling. Prelim Data due late 2Q 2014 at ASCO05/12/2014
GWPH
82.89GWP42006EpilepsyPhase 2Phase 2 to be initiated 1Q 201502/05/2015
GWPH
82.89EpidiolexLennox-Gastaut syndrome (LGS)Phase 3Two Phase 3 trials to be initiated end of 1Q 2015 with data from at least one of the two trials due by the end of 201502/05/2015
GWPH
82.89EpidiolexDravet SyndromePhase 2/3Top line Phase 3 data expected by the end of 201502/05/2015
GWPH
82.89SativexCancer painPhase 3First of three Phase 3 trials failed. Data from two additional Phase 3 cancer pain trials expected 2H 201502/05/2015
GWPH
82.89GWP42004Type 2 diabetesPhase 2bEstimated completion date 201602/05/2015
GWPH
82.89GWP42003SchizophreniaPhase 2Phase 2 data due 2H 201502/05/2015
GWPH
82.89SativexMultiple Sclerosis (MS) spasticityPhase 3Phase 3 Special Protocol Assessment (SPA) ongoing with FDA for proposed Sativex Phase 3. Expects response from FDA during 1Q 2015 trial 02/05/2015
GWPH
82.89GWP42003Ulcerative colitis.Phase 2aPrelim data released 4Q 201411/23/2014
HALO
15.45PEGPH20 Cancer - pancreaticPhase 2Clinical hold lifted June 2014.Patient enrolment recommenced July 2014. Enrolment due to be completed 2H 201501/13/2015
HALO
15.45PEGPH20 in Combination with docetaxelCancer - NSCLCPhase 1bComplete enrolment 3Q 201501/13/2015
HALO
15.45HYQVIASubcutaneous treatment for patients with primary immunodeficiency (PI)ApprovedApproved Sept 12 201409/14/2014
HALO
15.45HTI-501CelluoitePhase 2Phase 2 data due released Jul 2013. Topline data released 1Q 201403/26/2014
HALO
15.45PEGPH20 in combination with modified FOLFIRINOX chemotherapy (mFOLFIRINOX)Cancer - pancreaticPhase 1/2Phase 1/2 initiated Oct 201301/14/2014
HPTX
29.90RavictiHepatic encephalopathyPhase 2Phase 3 to be initiated 2H 201502/28/2015
HPTX
29.90 DiaPep277Type 1 diabetesPhase 3Trial stopped due to employee misconduct09/09/2014
HRTX
14.64APF530 - SustolPrevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)CRLCRL Mar 28 2013. Refile 201511/08/2014
HSGX
10.43NeoCartCartilage defects in the kneePhase 3Phase 3 enrolment due to be completed 2Q 2016. Data due 2H 201702/28/2015
HTBX
6.73HS-410Cancer - bladder cancerPhase 2Phase 2 initiated Oct 2014. Enrolment due to be completed 2H 2015. Data due 2H 2016. Phase 1 interim data due 1H 201502/03/2015
HTBX
6.73HS-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 2015.02/03/2015
HZNP
20.79ACTIMMUNEFriedreich's Ataxia (FA)Phase 3Phase 3 to be initiated 2Q 201502/14/2015
ICPT
261.49Obeticholic acid (OCA)Adult nonalcoholic steatohepatitis (NASH) patients. Phase 2FLINT trial stopped early due to strong efficacy Jan 2014. Phase 3 to be initiated 1H 201501/13/2015
ICPT
261.49Obeticholic acid (OCA)Primary biliary cirrhosis (PBC) - POISENDA filingCompletion of NDA filing planned in 1H 201501/13/2015
ICPT
261.49Obeticholic acid (OCA)Primary Sclerosing Cholangitis (PSC)Phase 2Phase 2 to be initiated by end of 201411/08/2014
ICPT
261.49Obeticholic acid (OCA)Portal hypertensionPhase 2Phase 2b to be initiated 2H 201401/10/2014
ICPT
261.49Obeticholic acid (OCA) - OBADIAH1Primary bile acid diarrhea (PBAD)Phase 2Phase 2b to be initiated 2H 201401/10/2014
IDRA
4.78 IM0-8400 DLBCL who harbor the MYD88 L265P mutationPhase 1/2Phase 1/2 to be initiated 2H 201405/17/2014
IDRA
4.78IMO-8400PsoriasisPhase 2Phase 2 initiated Jun 2013. Data released Mar 201404/25/2014
IDRA
4.78IMO-8400Waldenström’s MacroglobulinemiaPhase 1/2Phase 1/2 enrolment initiated Dec 201312/05/2013
IMGN
7.92IMGN853 Cancer - ovarian cancer and relapsed endometrial cancerPhase 2Phase 2 to be initiated 2015. Phase 1b data due at ASCO 201501/31/2015
IMGN
7.92Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) - Kadcyla KRISTINE trialHER2-positive breast cancer - neo-adjuvant settingPhase 3Phase 3 enrolling01/31/2015
IMGN
7.92Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) - Kadcyla (KAITLIN) HER2-positive breast cancer - adjuvant usePhase 3Phase 3 enrolling01/31/2015
IMGN
7.92Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) - Kadcyla (KATHERINE).HER2-positive breast cancer - residual invasive diseasePhase 3Phase 3 enrolling01/31/2015
IMGN
7.92Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) - Kadcyla GATSBY trialCancer - metastatic HER2+ gastric cancer Phase 3Data due 201501/13/2015
IMGN
7.92Trastuzumab 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
7.92SAR3419Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients (STARLYTE)Phase 2Ongoing02/02/2014
IMGN
7.92SAR3419Acute Lymphoblastic Leukemia (MYRALL)Phase 2Ongoing02/02/2014
IMMU
4.30SACITUZUMAB GOVITECANCancer - non-small cell lung cancer (NSCLC) Phase 2Phase 2 data released Feb 201502/21/2015
IMMU
4.30Clivatuzumab tetraxetanCancer - PancreaticPhase 3Phase 3 data due mid 201602/05/2015
IMMU
4.30Epratuzumab (EMBODY 2)LupusPhase 3Data due 1H 201502/05/2015
IMMU
4.30ISACTUZUMAB GOVITECAN (IMMU-132) Cancer - metastatic solid cancersPhase 2Phase 2 data released Oct 201410/30/2014
IMMU
4.30Epratuzumab (EMBODY 1)LupusPhase 3Data due 1Q 201512/14/2013
IMMU
4.30VeltuzumabCancer - immune thrombocytopenic purpura - ITPPhase 2Updated Phase 1/2 data presented at ASH Dec 201312/10/2013
IMMU
4.30Veltuzumab intravenousCancer - NHL Non-Hodgkin lymphomaPhase 2Phase 3 planned, need funding09/10/2013
IMMU
4.30EpratuzumabCancer - ALLPhase 2Phase 2 initial data presented at ASH 201204/26/2013
IMMU
4.30Epratuzumab in combination with chemotherapy in pediatric patients Cancer - ALLPhase 3Phase 3 planned04/26/2013
IMMY
7.66Impracor Topical NSAIDPain - anti-inflammatory creamPhase 3Phase 3 initiation delayed08/14/2013
IMUC
0.60ICT-107 dendritic cell vaccineGlioblastoma antigens and cancer stem cellsPhase 2bPhase 2b failed to meet primary endpoint. Plans to meet FDA in 2014. Possible Phase 3 initiation mid 201509/21/2014
IMUC
0.60ICT-140Recurrent ovarian cancerPhase 2aPhase 2 planned for 3Q 201403/15/2014
INCY
92.00BaricitinibRheumatoid arthritisPhase 3Data from first Phase 3 trial met primary endpoint December 2014 and also in February 201502/24/2015
INCY
92.00RuxolitinibBreast CancerPhase 2Data due 201602/14/2015
INCY
92.00Ruxolitinib - JANUS 1 and JANUS 2Cancer - PancreaticPhase 3Phase 3 data due 201602/14/2015
INCY
92.00Ruxolitinib Non-small cell lung cancerPhase 2Phase 2 data due 201602/14/2015
INCY
92.00INCB39110 and docetaxel Non-small cell lung cancerPhase 2Phase 2 underway - July 2014. Ongoing02/14/2015
INCY
92.00INCB39110 and erlotinibNon-small cell lung cancerPhase 2Phase 2 ongoing02/14/2015
INCY
92.00INCB39110 with gemcitabine and nab-paclitaxelPancreatic cancerPhase 2Phase 2 to be initiated 2H 201502/14/2015
INCY
92.00INCB24360Cancer - OvarianPhase 2Ongoing02/14/2015
INCY
92.00Jakafi (ruxolitinib) (RESPONSE)Polycythemia VeraApprovedApproved December 4 201412/05/2014
INCY
92.00Jakafi (ruxolitinib) (RELIEF)Disease-related symptoms in patients with Polycythemia VeraPhase 3Endpoint not met, mid-201407/24/2014
INCY
92.00INCB24360 in combination with ipilimumabCancer - MelanomaPhase 1/2Prelim data released at ASCo 201406/03/2014
INCY
92.00BaricitinibDiabetic nephropathyPhase 2Phase 2 initiated Aug 2012. Data due 201502/13/2014
INCY
92.00INCB18424 ruxolitinibCancer- Children with hematologic malignancies and solid tumorsPhase 1/2Ongoing05/03/2013
INCY
92.00INC280 (formerly INCB28060)Advanced hepatocellular carcinomaPhase 2Phase 2 initiated Apr 201304/30/2013
INFI
16.58Duvelisib (IPI-145) DYNAMOIndolent non-Hodgkin lymphomaPhase 2Phase 2 topline data due 2H 201502/26/2015
INFI
16.58Duvelisib (IPI-145)Cancer - relapsed/refractory chronic lymphocytic leukemia (CLL)Phase 3Phase 3 enrolment to be completed 2H 201502/26/2015
INFI
16.58Duvelisib (IPI-145)Rheumatoid arthritisPhase 2Phase 2 failed to meet endpoint - Jan 201501/09/2015
INFI
16.58Retaspimycin Hydrochloride with everolimusCancer - NSCLCPhase 2Phase 2 enrolment completed. Does not plan to further development09/27/2013
INNL
8.40XaraColl Post-operative painPhase 3Phase 3 to be initiated 1H 201511/15/2014
INNL
8.40CogenziaDiabetic foot ulcer infectionsPhase 3Phase 3 to be initiated 2H 2014. Data due late 201510/25/2014
INO
7.61VGX-3100Cervical dysplasiaPhase 2Phase 3 to be initiated early 201611/11/2014
INSM
20.08ARIKAYCENon-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
20.08ARIKAYCEcystic fibrosisPhase 3 Phase 3 Euro data released 1 July 2013. Met endpoint but slighly inferior data to competition07/02/2013
INSV
0.19BromSite (ISV-303) Pain after cataract surgeryPhase 3NDA filing due 1Q 201502/21/2015
INSY
57.97Dronabinol Oral SolutionAIDS-related anorexia NDANDA to be refiled 1Q 201501/13/2015
INSY
57.97CannabidiolEpilepsyPhase 3Phase 3 to be initiated 2H 201501/13/2015
INSY
57.97SubsysAcute 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
57.97BuprenorphineAcute pain in patients undergoing a bunionectomy procedurePhase 3Phase 3 to be initiated 1H 2015. Data due 2016.01/13/2015
INSY
57.97Buprenorphine/ NaloxonePhase 3Phase 3 to be initiated 201501/13/2015
INSY
57.97OndansetronPhase 3Phase 3 to be initiated 201501/13/2015
IPXL
40.12IPX066Parkinson's ApprovedApproved Jan 8 201501/09/2015
IRWD
15.85IW-9179GastroparesisPhase 2aPhase 2a initiated December 2014. Data due 1H 201602/14/2015
IRWD
15.85LinaclotideChronic idiopathic constipation (CIC)Phase 3Phase 3 data due 201602/14/2015
IRWD
15.85LinaclotideOpioid-induced constipation (OIC)Phase 2Phase 2 initiated Oct 2014. Data due 2H 2015.02/14/2015
IRWD
15.85 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
15.85IW-9179Functional dyspepsiaPhase 2aEnded trial prior to completing enrolment due to various issues05/01/2014
ISIS
71.80ISIS-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
71.80ISIS-APOCIIIRxPartial lipodystrophy rapidlyPhase 3Phase 3 planned02/28/2015
ISIS
71.80ISIS-GCCRRx Type 2 diabetesPhase 2Phase 2 data due 201502/28/2015
ISIS
71.80ISIS-APO(a)RxHigh lipoprotein(a), or Lp(a)Phase 2Phase 2 initiated July 2014. Data due 201502/28/2015
ISIS
71.80ISIS-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
71.80ISIS-SMNRxChildren with spinal muscular atrophy (SMA)Phase 3Phase 3 initiated July 2014. Additional Phase 3 study initiated Nov 201411/27/2014
ISIS
71.80PlazomicinMulti-drug resistant (MDR)Phase 3Phase 3 initiated Sept 201409/18/2014
ISIS
71.80ISIS-APOCIIIRxFamilial chylomicronemia syndrome (FCS)Phase 3Phase 3 initiated Aug 201408/29/2014
ISIS
71.80ISIS-CRPRx (ASET)Atrial fibrillationPhase 2Initiated Feb 2013. Data released 201408/17/2014
ISIS
71.80ISIS-FXIRxClotting disorders in patients undergoing knee replacement surgeryPhase 2Phase 2 data released May 201405/24/2014
ISIS
71.80OGX-427 in combination with gemcitabine and cisplatin Borealis-1Cancer - bladderPhase 2Phase 2 data due 2H 201409/12/2013
ISIS
71.80TG-1101Cancer - hepatocellular carcinoma (HCC)Phase 1/2Phase 2 initiated May 201305/07/2013
JNJ
102.52YONDELISAdvanced soft tissue sarcoma (STS)PDUFA NDA filed approx Nov 24 2014. Estimated PDUFA Nov 24 201501/26/2015
JNJ
102.52Three-Month INVEGA SUSTENNA (paliperidone palmitate)SchizophreniaPDUFANDA filed approx Nov 24 2014. Priority Review. Estimated PDUFA July 24 2015. 01/26/2015
JUNO
53.03JCAR015Relapsed/ refractory B cell acute lymphoblastic leukemiaPhase 2Phase 2 to be initiated mid-201502/01/2015
JUNO
53.03JCAR017Relapsed/refractory B cell non-Hodgkin’s lymphomaPhase 1/2Phase 1/2 trial planned for 201502/01/2015
JUNO
53.03JCAR017Pediatric Relapsed/ acute lymphoblastic leukemiaPhase 1/2Phase 1/2 ongoing02/01/2015
JUNO
53.03JCAR014R/R NHL or R/R ALLPhase 1/2Phase 1/2 ongoing but no plans to advance JCAR014 into registration trials02/01/2015
KBIO
0.69KB001-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
0.69Pa ventilator associated pneumonia (VAP)Phase 2bPhase 2b trial to be initiated mid 201505/11/2014
KBIO
0.69KB004MDS and AMLPhase 2Phase 2 initiated Feb 2014. Top-line Data due 2Q or 3Q 201504/27/2014
KERX
13.28AuryxiaIron deficiency anemia in non-dialysis dependent CKD patientsPhase 3Phase 3 initiated 3Q 2014. Due to be completed by end of 201502/28/2015
KERX
13.28AuryxiaHyperphosphatemiaApprovedApproved Sept 5 201409/07/2014
KITE
65.29KTE-C19Relapsed/refractory diffuse large B cell lymphoma, or DLBCLPhase 1/2Phase 1/2 planned for 201507/09/2014
KMDA
4.79KamRABProphylaxis of rabies diseasePhase 3Phase 2/3 data due by mid 2015. BLA filing due 2H 201502/12/2015
KMDA
4.79Inhaled 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
4.79GlassiaPediatric patients newly diagnosed with type 1 diabetesPhase 2/3Phase 2/3 initiated Mar 201403/06/2014
KPTI
28.00SelinexorCancer - 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
28.00SelinexorRichter's transformation (SIRRT)Phase 2Phase 2 initiated November 201411/11/2014
KPTI
28.00SelinexorCancer - Relapsed/Refractory Acute Myeloid Leukemia (AML)Phase 2Phase 2 initiated June 25 201406/25/2014
KPTI
28.00SelinexorCancer - hormone-refractory prostate cancer (HRPC)Phase 2Phase 2 initiated June 201406/10/2014
KPTI
28.00SelinexorCancer - glioblastoma following treatment with radiation and temozolomide.Phase 2Phase 2 initiated April 201405/01/2014
KPTI
28.00SelinexorCancer - Advanced Gynecologic Malignancies (SIGN Study)Phase 2Phase 2 initiated April 201404/25/2014
KYTH
49.88ATX-101 Reduction of Localized Subcutaneous Fat in the Submental AreaPDUFAPDUFA May 13 2015. Advisory Committee Meeting March 9 201501/25/2015
LGND
69.37Captisol-enabled Delafloxacin IVABSSSIPhase 3Frist Phase 3 trial run by partner Melinta Therapeutics met endpoint. Data from second trial due 2H 201501/09/2015
LGND
69.37Captisol-Enabled MelphalanCancer - multiple myelomaNDA filingAnnounced Dec 26, 2014 that a NDA fiing has been made by partner SPPI 12/27/2014
LGND
69.37PromactaAplastic AnemiaApprovedApproved August 27 201408/28/2014
LGND
69.37Bazedoxifene/Conjugated Estrogens (BZA/CE), formerly known as APRELAMenopausal symptomsApprovedApproved Oct 3 201310/06/2013
LGND
69.37Captisol-enabled DelafloxacinAcute bacterial skin and skin structure infections (ABSSSI)Phase 3Phase 3 initiated by Rib-X Pharmaceuticals May 201305/15/2013
LGND
69.37Merck Captisol ProgramUndisclosedPhase 3Expect Merck to potentially file a 505(b)(2) in 201304/27/2013
LGND
69.37Captisol-enabled Clopidogrel - MDCO-157Phase 3Phase 3 planned by MDCO04/27/2013
LGND
69.37DinaciclibRefractory chronic lymphocytic leukemia (CLL)Phase 2b/3Phase 2b/3 trial initiated Oct 201204/27/2013
LGND
69.37MEDI-528Asthma Phase 2Ongoing04/27/2013
LGND
69.37PromactaOncology-related thrombocytopenia in patients with solid tumors, Myelodysplastic Syndrome (MDS), or Secondary Acute Myeloid Leukemia (AML) after MDSPhase 2Ongoing04/27/2013
LGND
69.37MK-8931Mild-to-moderate Alzheimer's diseasePhase 2/3Phase 2/3 initiated by Merck in Dec 201204/27/2013
LGND
69.37Captisol-enabled Carbamazepine-IVAcute seizure disorderPhase 3Phase 3 ongoing04/27/2013
LGND
69.37LGD-4033Muscle wasting associated with cancer (cachexia), acute rehabilitation (e.g. hip fracture), and acute illness.Phase 2Phase 2 pending04/27/2013
LJPC
21.39LJPC-501Catecholamine-resistant hypotension (CRH).Phase 3Phase 3 to commence 1Q 2015 under SPA02/12/2015
LJPC
21.39GCS-100Chronic kidney diseasePhase 2Phase 2b to commence 1Q 201511/13/2014
LPCN
8.20LPCN 1021Men with low testosterone (Low T)Phase 3NDA filing due 2H 201512/16/2014
LPCN
8.20LPCN 1111Oral testosterone productPhase 2aPhase 2b to be initiated 1Q 201511/11/2014
LPTN
2.93iSONEPWet-AMDPhase 2Reported Dec 2 2014 that Phase 2 enrolment has been completed. Data due 2Q 201512/03/2014
LPTN
2.93ASONEPRenal cell carcinoma (RCC)Phase 2aPhase 2a initiated dosing May 23 2013. Interim data reported July 201407/27/2014
LXRX
1.13LX4211Type 1 DiabetesPhase 3Phase 3 planned for early 201511/05/2014
LXRX
1.13LX1032 Telotristat etiprateCarcinoid SyndromePhase 3Phase 3 initiated Sep 2012. Enrolment due to be completed by end of 201405/12/2014
LXRX
1.13LX1032 Telotristat etiprateUlcerative colitisPhase 2Ongoing05/11/2013
LXRX
1.13LX2931RA + autoimmune diseasesPhase 2Phase 2 Data did not achieve statistical significance 201004/27/2013
MACK
12.29MM-111Cancer - second line HER2+ gastric cancerPhase 2Development stopped due to poor trial data released late Feb 201502/28/2015
MACK
12.29MM-398 NAPOLI-1Cancer - second line pancreaticPhase 3NDA filng due late 1Q or early 2Q 201502/28/2015
MACK
12.29MM-141Cancer - front line pancreatic cancerPhase 2Phase 2 to be initiated 201502/28/2015
MACK
12.29MM-398Cancer - front-line pancreatic cancerPhase 2Phase 2 to be initiated 201502/28/2015
MACK
12.29MM-121Cancer - Heregulin Positive Non-Small Cell Lung CancerPhase 2Phase 2 initiated mid Feb 201502/21/2015
MACK
12.29MM-302 HERMIONECancer - HER2-positive locally advanced or metastatic breast cancerPhase 2Phase 2 initiated August 201408/14/2014
MACK
12.29MM-121 Cancer - triple negative breast cancer cohort in the neoadjuvant settingPhase 2Phase 2 data released June 201406/22/2014
MACK
12.29MM-151CancerPhase 2Phase 2 to be initiated 201405/04/2014
MACK
12.29MM-121 Cancer -hormone receptor positive breast cancerPhase 2Data released Nov 201311/27/2013
MACK
12.29MM-121Cancer - ovarianPhase 2Missed endpoint Oct 201311/02/2013
MACK
12.29MM-398Cancer - ColorectalPhase 2Ongoing04/27/2013
MCUR
9.48CureXcellDiabetic Foot UlcersPhase 3Phase 3 data due 2H 201511/04/2014
MCUR
9.48CureXcellVenous Leg Ulcers Phase 3Phase 3 initial data due 2H 2015. Final data 2H 201611/04/2014
MDCO
29.82CangrelorReduction 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 will meet on April 15, 201502/28/2015
MDCO
29.82CARBAVANCESerious Bacterial Infections Due to Gram-Negative BacteriaPhase 3Phase 3 initiated Nov 2014. Data due 201611/06/2014
MDCO
29.82OritavancinABSSSIPDUFAApproved August 6 2014 under priority review08/10/2014
MDCO
29.82FibrocapsHemostasisPDUFAPDUFA extended to April 30 201503/04/2015
MDCO
29.82IONSYSAcute postoperative painsNDAsNDA to be filed 1H 201403/18/2014
MDCO
29.82Angiomax (bivalirudin) Peripheral endovascular intervention (PEI)Phase 3Phase 3 enrolment commenced Oct 201310/11/2013
MDGN
8.20Erythropoietin ("EPO") therapy delivered via EPODURE BiopumpAnemiaPhase 2Phase 1/2 trial commenced enrolment Jun 2014. Initial data released Oct 15 201410/19/2014
MDVN
126.93MDV3100 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
126.93XTANDICancer - mCRPC who have not received chemotherapyApprovedApproved Sept 10 201409/11/2014
MDVN
126.93Enzalutamide Androgen receptor positive, triple-negative breast cancerPhase 2Phase 2 initiated June 2013. Enrolment continues as of May 201405/11/2014
MDVN
126.93EnzalutamideAdvanced 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
126.93MDV3100 cf Bicalutamide STRIVE trialCancer - prostate enrolling both metastatic and non-metastatic patientsPhase 2Completed enrolment March 201405/11/2014
MDVN
126.93 Enzalutamide PROSPERNon-Metastatic Castration-Resistant Prostate CancerPhase 3Phase 3 initiated Nov 2013. Enrolment ongoing as of May 201405/11/2014
MDVN
126.93MDV3100 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
8.01NexoBridSevere burnsPhase 3Phase 3 planned 201502/14/2015
MDWD
8.01EscharEx Chronic and other hard-to-heal woundsPhase 2Phase 2 data due 2H 2015 (Israel)05/24/2014
MEIP
5.67Pracinostat 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
5.67Pracinostat in combination with Vidaza First line intermediate-2 or high-risk Myelodysplastic SyndromePhase 2Phase 2 topline data expected March 201512/10/2014
MEIP
5.67Pracinostat and Vidaza or DacogenMyelodysplastic SyndromePhase 2Ongoing11/13/2014
MGNX
35.50Margetuximab SOPHIA studyCancer - metastatic breast cancerPhase 3Phase 3 to commence 3Q 201503/04/2015
MGNX
35.50MGA271CancerPhase 2Phase 2 to be initiated 201511/12/2014
MNKD
5.76AFREZZA Type 1/2 diabetesApprovedApproved June 27 201406/28/2014
MNOV
3.59MN-166Amyotrophic lateral sclerosis (ALS)Phase 2Announced mid-February 2015 that 30 of the 60 subjects planned for participation have been enrolled02/21/2015
MNOV
3.59MN-166Opioid dependence Phase 2Phase 2 interim data released August 201408/19/2014
MNOV
3.59MN-001NASH (nonalcoholic steatohepatitis)Phase 2Phase 2 planned01/15/2014
MNOV
3.59MN-166Progressive multiple sclerosis (progressive MS).Phase 2bPh2b initiated Jul 2013. Data due 201607/21/2013
MNOV
3.59MN-166Chronic medication overuse headache (MOH) painPhase 2Phase 2 to be completed mid 201304/27/2013
MNTA
14.88Necuparanib 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
MNTA
14.88Generic CopaxoneMultiple sclerosisaNDAFiled 2007. FDA still reviewing05/01/2013
MRNS
10.50GanaxoloneFemale children with EpilepsyPhase 2Phase 2 initiated early Feb 201502/04/2015
MRNS
10.50GanaxoloneEpilepsyPhase 3Phase 3 top-line data due 1H 201511/15/2014
MRNS
10.50GanaxoloneFragile X SyndromePhase 2Phase 2 top-line data due mid-201511/15/2014
MSTX
0.55AIR001Heart failure with preserved ejection fraction (HFpEF)Phase 2Phase 2 initiated early Feb 201502/05/2015
MSTX
0.55ANX-188Sickle cell diseasePhase 3Phase 3 initiated Jan 2013. Expect to complete enrolment 4Q 2015. Top-line data due 1Q 201601/06/2015
MSTX
0.55ANX-188Acute limb ischemia (ALI)Phase 2Initiated Phase 2 March 2014. Expect to complete enrolment 2H 201611/03/2014
MSTX
0.55MST-188 Heart Failure Phase 2Phase 2 to be initiated 2H 2014. Interim data due 2H 201511/03/2014
MSTX
0.55AIR001 Pulmonary Hypertension Phase 2Phase 2 prelim data released Sept 201409/09/2014
NAVB
1.72LymphoseekHead and Neck CancerApprovedApproved Jun 13 201406/14/2014
NAVB
1.72NAV4694Predicting 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
1.72NAV5001 Imaging Agent for Parkinson’s DiseasePhase 3Phase 3 initiated Dec 201312/08/2013
NBIX
41.98Elagolix Uterine FibroidsPhase 2bPhase 2b initiated Mar 2013. Ongoing as of Feb 2014. Data due 2H 2015.02/12/2015
NBIX
41.98VMAT2 NBI-98854 - Kinect 3Tardive dyskinesiaPhase 3Phase 3 initiated Oct 2014. Data due 2H 201502/12/2015
NBIX
41.98Elagolix EndometriosisPhase 3First Phase 3 trial met both co-primary endpoints - Jan 2015. Data from second Phase 3 trial due towards the end of 201501/09/2015
NBIX
41.98NBI-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
3.97AMR-001Left ventricular dysfunction following acute ST segment elevation myocardial infarction (STEMI)Phase 2Phase 2 data released Nov 201411/23/2014
NBY
0.53Auriclosene (NVC-422)Viral conjunctivitisPhase 2bData released August 2014. Endpoints not met08/21/2014
NBY
0.53Auriclosene (NVC-422)Impetigo skin infection studyPhase 2bFailed to meet endpoint Nov 2013. Plans to reinitiate trial in 201412/20/2013
NBY
0.53Auriclosene (NVC-422)Urine infectionPhase 2Phase 2 Topline Data released 3Q08/06/2013
NDRM
13.80ND0612HSevere Parkinson's DiseasePhase 3US Phase 3 planned for 1H 201602/01/2015
NDRM
13.80ND0612LModerate Parkinson's DiseasePhase 3Phase 3 planned for 201502/01/2015
NEOT
7.15LIPO-202Reduction of central abdominal bulging due to subcutaneous fat in non-obese patientsPhase 3Phase 3 planned 1H 2015. Topline data due by end of 201502/01/2015
NERV
5.43MIN-101SchizophreniaPhase 2bPhase 2b trial to be initiated in 1H 201512/05/2014
NKTR
13.44Etirinotecan pegol NKTR-102 (BEACON)Cancer - Metastatic Breast CancerPhase 3Maintained gudiance on Dec 11, 2014 that they expect Phase 3 topline data due March 201502/26/2015
NKTR
13.44NKTR-181Chronic painPhase 3Missed endpoint Sept 2013 but Phase 3 initiated late Feb 201502/26/2015
NKTR
13.44 BAX 855 Hemophilia ABLACompany announced Dec 2 2014 that BAX has submitted their BLA12/02/2014
NKTR
13.44FovistaWet-AMDPhase 3Phase 3 initial topline data due 201611/25/2014
NKTR
13.44NaloxegolOpioid-induced constipation (OIC)ApprovedApproved Sept 16 201409/17/2014
NKTR
13.44Etirinotecan pegol NKTR-102Cancer - gliomaPhase 2Phase 2 data released at ASCO 201406/02/2014
NKTR
13.44Inhaled Amikacin Solution (BAY41-6551T)Gram-Negative Pneumonia (INHALE 1)Phase 3Phase 3 data due 1H 201504/27/2014
NKTR
13.44Etirinotecan pegol NKTR-102Cancer - relapsed or refractory Small-Cell Lung Cancer (SCLC)Phase 2Phase 2 initiated Oct 201310/25/2013
NKTR
13.44Etirinotecan pegol NKTR-102Cancer - ovarianPhase 2Completed Dec 2012. Considering future development09/18/2013
NKTR
13.44Etirinotecan pegol NKTR-102Cancer - colorectalPhase 2Enroling04/27/2013
NKTR
13.44Cipro DPI (Cipro Dry Powder Inhaler)Non-cystic fibrosis bronchiectasisPhase 3In Aug 2012, Bayer initiated a global Phase 3 program called RESPIRE. Data due mid-2015 as per JPM conference slides 2014.04/27/2013
NLNK
49.94HyperAcute Pancreas - IMPRESSSurgically resected pancreatic cancerPhase 3Enrloment completed Sept 2013. First of two interim analyses completed March 2014. Trial to continue as planned. Second analysis due 1Q or 2Q 201502/28/2015
NLNK
49.94HyperAcute Pancreas - PILLARPancreatic cancerPhase 3Phase 3 enrolment to be completed 2H 201502/28/2015
NLNK
49.94HyperAcute LungCancer - NSCLCPhase 2b/3Initiated Phase 2b/3 Oct 2012, ongoing as of March 2014. Update to be given 2H 201502/28/2015
NLNK
49.94HyperAcute Melanoma - dorgenmeltucel-LCancer - melanomaPhase 1b/2Planning03/12/2014
NLNK
49.94Indoximod in combination with docetaxelCancer - breastPhase 2Phase 2 initiated Apr 2013. Ongoing as of March 201403/12/2014
NLNK
49.94Sipuleucel-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
NPSP
0.00NatparaHypoparathyroidismApprovedApproved Jan 23 2015 01/25/2015
NPSP
0.00NPSP795 Autosomal dominant hypocalcemia or ADHPhase 2Phase 2 initiated August 2014. Preliminary top-line data due early 201511/23/2014
NPSP
0.00GATTEXShort Bowel Syndrome - seeking additions to labelApprovedApproved June 201407/01/2014
NRX
7.92PyridorinDiabetic nephropathyPhase 3Phase 3 initiated June 2014. Enrolment due to be half complete by 1Q 201508/12/2014
NSPR
0.28MGuardSTEMI - ST segment elevation myocardial infarctionInvestigational Device Exemption (IDE) support trialMaster 12-month data due 4Q 201308/18/2013
NSPR
0.28MGuardSTEMI - 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
8.91RSV F VaccineRespiratory Syncytial Virus (RSV) in women in their third trimester of pregnancyPhase 2Phase 2 initiated Sept 201409/18/2014
NVAX
8.91RSV vaccineRespiratory Syncytial Virus (RSV) in women of childbearing age.Phase 2Phase 2 topline data released April 201404/29/2014
NVAX
8.91Seasonal Influenza VaccineSeasonal FluPhase 2Further Phase 2 trials planned09/18/2013
NVGN
3.05Intravenous ME-143Cancer - triple-negative breast cancerPhase 2Phase 2 enrolling04/27/2013
NWBO
7.34DCVaxCancer - 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
7.34DCVaxCancer - inoperable solid tumor cancersPhase 1/2Initial data released May 2014. Phase 2 portion planned07/17/2014
NYMX
0.62NX-1207Cancer - low grade localized prostatePhase 2Phase 2 data released April 201405/01/2014
OCAT
6.65Retinal pigment epithelium cells Stargardt’s diseasePhase 2Pivotal trial planned03/02/2015
OCAT
6.65Retinal pigment epithelium cellsAge-related macular degenerationPhase 2Phase 2 trial planned03/02/2015
OCRX
4.96OCR-002 Cirrhosis and upper gastrointestinal bleedingPhase 2aPhase 2a preliminary data released mid-Feb 201502/21/2015
OCRX
4.96OCR-002 (IV)Hepatic encephalopathyPhase 2bPhase 2b enrolment to be completed mid-201511/15/2014
OCUL
39.39OTX-DPDry Eye DiseasePhase 2Phase 2 enrolment commenced mid Jan 201501/22/2015
OCUL
39.39OTX-DP Ocular inflammation and pain following cataract surgeryPhase 3Phase 3 data due 1Q 201511/13/2014
OCUL
39.39OTX-DPGlaucoma and ocular hypertensionPhase 2bPhase 2b initiated November 201411/13/2014
OCUL
39.39OTX-DPAllergic conjunctivitisPhase 2Phase 2 data released November 201411/13/2014
OGXI
2.61Custirsen 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 201601/19/2015
OGXI
2.61OGX-427 in combination with gemcitabine and cisplatin Borealis-1Cancer - bladderPhase 2Released Phase 2 data mid Dec 201412/22/2014
OGXI
2.61OGX-427 in Combination with ABRAXANE plus Gemcitabine - Rainier TrialMetastatic Pancreatic CancerPhase 2Announced Dec 16 2014 that enrolment has been completed in their Phase 2 trial12/18/2014
OGXI
2.61Custirsen ENSPIRITCancer - NSCLCPhase 3Phase 3 initiated Oct 2012. First interim analysis released August 2014. Trial to continue as planned.08/22/2014
OGXI
2.61OGX-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
2.61OGX-427 with PrednisoneCancer - chemotherapy-naive patients with metastatic CRPCPhase 2Phase 2 ongoing11/09/2013
OGXI
2.61OGX-427 and carboplatin and pemetrexed - SpruceTrialNon-squamous, non-small cell lung cancer (NSCLC)Phase 2Phase 2 enrolment commenced Jul 201308/01/2013
OGXI
2.61OGX-427 Borealis-2Cancer - advanced or metastatic bladder cancerPhase 2Phase 2 initiated Apr 201305/01/2013
OHRP
11.48Squalamine Eye DropsNeovascular (Wet) Age-related Macular Degeneration (AMD)Phase 2Phase 2 interim data released June 24 2014. Topline data due 1Q 2015. Phase 3 to be initiated before end of 1H 201502/12/2015
OHRP
11.48OHR-005Diabetic macular edema (DME)Phase 2Phase 2 initiated May 201405/10/2014
OHRP
11.48OHR/AVR118Cancer cachexia.Phase 2Phase 2 data presented Dec 201312/27/2013
OMER
27.00OMS721 Thrombotic microangiopathies (TMAs)Phase 2Phase 2 dosing completed mid Feb 201502/21/2015
OMER
27.00OMER824Huntington diseasePhase 2Phase 2 initiated Feb 2014. Trial placed on hold due to preclinical concerns10/22/2014
OMER
27.00OmidriaCataract surgeryApprovedApproved June 2 201406/03/2014
OMER
27.00OMER824SchizophreniaPhase 2Phase 2 initiated Sept 2013. Data released Jan 201401/30/2014
OMER
27.00OMS201UrologyPhase 2Phase 2 planning. Company have no plans for 2013, but will resume when they have adequate resources 04/27/2013
ONCE
10.50SPK-RPE65Inherited retinal dystrophiesPhase 3Phase 3 data due 2H 201502/01/2015
ONCE
10.50SPK-CHMChoroideremia Phase 1/2Phase 1/2 dosing to commence 1Q 201502/01/2015
ONCY
1.04REOLYSIN Cancer - metastatic colorectal cancerPhase 2Phase 2 enrolment completed mid Feb 201502/21/2015
ONCY
1.04REOLYSIN - intravenous with gemcitabineCancer - PancreaticPhase 2Data released Aug 201409/17/2014
ONCY
1.04REOLYSIN in Combination with Paclitaxel and CarboplatinCancer - Metastatic Pancreatic CancerPhase 2Enrolment completed July 201407/09/2014
ONCY
1.04 REOLYSIN with paclitaxel & carboplatinCancer - Head and NeckPhase 2Data released Apr 2014. Phase 3 planned04/10/2014
ONCY
1.04Intravenous REOLYSIN with paclitaxel & carboplatinCancer - squamous cell carcinoma of the lung (SCCLC)Phase 2Final data released Sept 201309/10/2013
ONCY
1.04Intravenous REOLYSIN in combination with paclitaxel and carboplatinCancer - metastatic melanomaPhase 2Prelim data released May 201305/23/2013
ONCY
1.04Intravenous Administration of REOLYSIN in combination with paclitaxel and carboplatinNon-small cell lung with K-RAS or EGFR-activated tumoursPhase 2Ongoing04/27/2013
ONCY
1.04REOLYSIN with paclitaxel Cancer - ovarian, fallopian tube or primary peritonealPhase 2Ongoing04/27/2013
ONTX
2.26RigosertibCancer - 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 2015 in patients after failure of treatment with Hypomethylating Agents02/03/2015
ONTX
2.26Oral RigosertibCancer - MDS low riskPhase 3Announced early Feb 2015 that partner Baxter had decided NOT to pursue additional trials02/03/2015
ONTX
2.26RigosertibCancer - relapsed or metastatic head and neck cancersPhase 2Initiated mid-201309/22/2013
ONTY
1.61PX-866Cancer - glioblastomaPhase 2Phase 2 data due at ASCO05/18/2013
OPHT
54.00FovistaWet-AMDPhase 3Phase 3 initial topline data due 201602/24/2015
OPHT
54.00ZimuraGeographic atrophyPhase 2/3Phase 2/3 trial to be initiated late 2H 201502/24/2015
OPK
14.37Neurokinin-1 (“NK-1”) - Rolapitant (partnered with TSRO)Prevention of chemotherapy induced nausea and vomiting, or CINV PDUFANDA filed early Sept 2014. Estimated PDUFA Sept 8 201501/26/2015
OPK
14.37CTAP101 Capsules - (Rayaldy)Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) and vitamin D insufficiencyNDANDA filng due 1Q 201503/02/2015
OPK
14.37hGH-CTPChildren - growth hormone deficiencyPhase 3End of Phase 2 Meeting for hGH-CTP for Pediatric GHD Scheduled for 1Q 201503/02/2015
OPK
14.37Fermagate Tabletshyperphosphatemia in CKD patients on chronic hemodialysisPhase 3Phase 3 data due 1H 201709/12/2013
OPK
14.37hGH-CTPAdults - growth hormone deficiencyPhase 3Initiated Phase 3 Jun 2013. Ongoing as of Feb 201503/02/2015
OPK
14.37Factor VIIa-CTPHemophiliaPhase 2Intend to initiate Phase 2 in 201503/02/2015
OPRN
CabalettaOculopharyngeal Muscular DystrophyPhase 2/3Phase 2/3 ongoing10/25/2014
OPXA
0.83Tovaxin (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
0.83Tovaxin (Tcelna)Relapsing Remitting MS (RRMS)Phase 2bFurther development pending funding09/18/2013
OREX
7.99ContraveObesityApprovedApproved September 11 201409/11/2014
OREX
7.99EmpaticEpilepsyPhase 2bPhase 3 planned. Needs partner04/27/2013
ORPN
7.23CabalettaOculopharyngeal Muscular DystrophyPhase 2/3Phase 2/3 HOPEMD trial - randomization of Israeli patients has begun; patients are being enrolled into the first six-month phase in Canada; US trial requires IND filing, estimate 1Q 201501/10/2015
OSIR
17.02GrafixDiabetic Foot UlcersData released Aug 201308/14/2013
OSIR
17.02ProchymalCrohn’s diseasePhase 3Enrollment re-started May '10.Ongoing04/27/2013
OSIR
17.02ProchymalAcute myocardial infarctionPhase 2Interim data released Jul 2012. Trial extended for further four years04/27/2013
OTIC
36.24AuriProEar Tube Placement SurgeryNDA filingNDA filed on or about Feb 26 201502/28/2015
OTIC
36.24OTO-104 Ménière's diseasePhase 2bPhase 2b data due 2Q 201501/09/2015
OXGN
1.84Fosbretabulin Combined With Pazopanib Cancer - Recurrent Ovarian CancerPhase 1/2Phase 1/2 initiated Oct 201410/11/2014
OXGN
1.84FosbretabulinCancer - gastrointestinal neuroendocrine tumorsPhase 2Phase 2 initiated Sept 201409/18/2014
OXGN
1.84ZYBRESTATCancer - 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
0.84CAN-004Cancer - ovarianPhase 2Phase 2 commenced April 201404/29/2014
PBMD
0.84CVacCancer - ovarianPhase 3Phase 3 initiated Jan 2012. Enrolment halted Sept 201309/19/2013
PBMD
0.84CVacCancer - resectable pancreatic cancer, metastatic colorectal cancer, and triple-negative breast cancerPhase 2Phase 2 trials planned06/25/2013
PBYI
237.76PB272Extended 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
237.76PB272 HER2-positive breast cancer first linePhase 2Phase 2 failed to meet endpoint, Nov 2014.11/15/2014
PBYI
237.76PB272 Neoadjuvant treatment for patients with HER2-positive breast cancer (NSABP FB-7)Phase 2Phase 2 data due 4Q 201411/12/2014
PBYI
237.76PB272 in combination with toriselFourth line HER2-positive metastatic breast cancerPhase 2Phase 2 additional data due 2H 2014. Phase 3 initiation due 201511/12/2014
PBYI
237.76PB272HER2-negative breast cancer patients who have a HER2 mutationPhase 2Data due 201511/12/2014
PBYI
237.76PB272 HER2+ MBC that has metastasized to the brainPhase 2Data due 201511/12/2014
PBYI
237.76PB272 HER2 mutated non-small cell lung cancerPhase 2Phase 2 initial data released 201409/30/2014
PBYI
237.76PB272Third line HER2+ MBC Phase 3Phase 3 initiated June 201307/01/2014
PCRX
98.54EXPARELSingle-dose injection femoral nerve block for total knee arthroplasty surgeryCRLPDUFA CRL March 2 2015.03/04/2015
PCYC
254.27IMBRUVICA RESONATE -2Cancer - newly diagnosed elderly CLL/SLL patientsPhase 3Phase 3 data due 2H 201502/21/2015
PCYC
254.27IMBRUVICA 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
254.27IMBRUVICAMarginal Zone Lymphoma (MZL)Phase 2Phase 2 initiated 4Q 2013. Ongoing02/21/2015
PCYC
254.27IMBRUVICA in combination with bendamustine and rituximab - SHINE (MCL3002)Cancer - newly diagnosed MCLPhase 3Janssen plans to enroll 520 patients02/21/2015
PCYC
254.27IMBRUVICA - ILLUMINATER/R CLL/SLLPhase 3Phase 3 initiated 4Q 201402/21/2015
PCYC
254.27IMBRUVICACancer - relapsed or refractory follicular lymphomaPhase 2Phase 2 ongoing02/21/2015
PCYC
254.27IMBRUVICAWaldenström’s MacroglobulinemiaApprovedApproved Jan 29, 201501/31/2015
PCYC
254.27IMBRUVICA RESONATE™-17Deletion 17pPhase 2Phase 2 released at ASH 201511/23/2014
PCYC
254.27IMBRUVICACancer - relapsed/refractory multiple myeloma (MM)Phase 1/2bData released at ASH 201408/03/2014
PCYC
254.27IMBRUVICA RESONATECancer - Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL/SLL)ApprovedApproved July 29 201408/03/2014
PCYC
254.27IMBRUVICA Cancer - Chronic Lymphocytic Leukemia Who Have Received at Least One Prior TherapyApprovedApproved Feb 12 201402/13/2014
PCYC
254.27IMBRUVICA Cancer - relapsed or refractory MCL mantle cell lymphomaApprovedApproved Nov 13 201308/31/2013
PFE
34.51PalbociclibFirst-Line Therapy in Combination with Letrozole for ER+, HER2- Advanced Breast CancerPDUFAPDUFA date under priority review of April 13 201501/26/2015
PFNX
14.24PF582Biosimilar candidate to Lucentis for retinal diseasesPhase 1/2Phase 1/2 interim data due 1Q 2015. Phase 3 to be initiated mid 201511/15/2014
PGNX
6.93AzedraPheochromocytomaPhase 2bPivotal Phase 2 trial resumed January 2015 following suspension of trial in 2010 due to lack of funding01/25/2015
PGNX
6.93Subcutaneous RELISTORchronic painApprovedApproved September 29 201410/01/2014
PGNX
6.93PSMA 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
PGNX
6.93Oral RelistorChronic, Non-Cancer Pain Subjects with Opioid-Induced ConstipationPhase 3Phase 3 completed. Further progress on hold04/27/2013
PLX
1.87PRX-102Fabry diseasePhase 1/2Phase 1/2 enrolment completed early Feb 2015. Interim data due 3Q 2015. Full data due 4Q 201502/03/2015
POZN
7.33PA32540 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. Intends to schedule a Type A meeting with FDA to address issues12/18/2014
PPHM
1.54BavituximabCancer - Refractory NSCLCPhase 3Interim data released Sept 2012 reported to be faulty. Phase 3 SUNRISE trial initiated Dec 201312/31/2013
PPHM
1.54Bavituximab 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
PPHM
1.54BavituximabCancer - LiverPhase 2Phase 2 part of trial is enrolling04/27/2013
PRAN
1.13PBT-2Alzheimer'sPhase 2Phase 2 endpoint not met04/01/2014
PRAN
1.13PBT-2Huntington's DiseasePhase 2Data released Feb 201402/19/2014
PRTA
26.26NEOD001AL AmyloidosisPhase 3Phase 1/2 postive data released December 2 2014. Phase 3 initiated.12/03/2014
PRTO
10.44PRT-201 Chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF)Phase 3Phase 3 initiated July 2014. Data due 1Q 201711/27/2014
PSDV
4.50IluvienDiabetic macular edemaApprovedApproved Sept 26 201409/28/2014
PSDV
4.50Injectable sustained-release micro-insertPosterior uveitisPhase 3Pivotal trial initiated Jul 2013 (first of two Phase 3 trials)07/02/2013
PSTI
3.20PLX-PAD Muscle injuryPhase 1/2Phase 1/2 data released Jan 21 201401/22/2014
PSTI
3.20PLX-PAD (stem cells)Intermittent claudication, or ICPhase 2Phase 2 put on clinical hold Jun 2013. Lifted Sept 201309/17/2013
PSTI
3.20PLX-PAD (stem cells)Pulmonary Arterial Hypertension (PAH) Phase 1Phase 1 planned04/27/2013
PTCT
72.26Ataluren 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
72.26Spinal Muscular Atrophy (SMAPhase 1/2Phase 1/2 initiated November 201411/22/2014
PTCT
72.26Ataluren Nonsense mutation cystic fibrosisPhase 3Phase 3 initiated July 2014. Data due 2H 201611/08/2014
PTIE
1.84RemoxyChronic painCRLCRL Jun 23, 2011. PFE announced they will return rights to PTIE in late Oct 2014. PTIE expects to report a target date for the potential re-filing of the REMOXY NDA following return of rights.02/21/2015
PTIE
1.84ORADUR-HydromorphonePhase 3Phase 3 to be initiated 201508/09/2014
PTLA
41.84Betrixaban (The APEX Study)Venous thromboembolism (VTE) PreventionPhase 3Complete patient enrollment in APEX by the end of 2015. Data due early 201602/06/2015
PTLA
41.84Andexanet alfaFactor Xa inhibitor reversal agentPhase 3Phase 3 first part of study met primary endpoint Jan 2015. Data from second part due mid-2015. BLA to be filed by late 201503/04/2015
PTLA
41.84Cerdulatinib (PRT2070)Refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia.Phase 1/2 Ongoing11/12/2014
PTN
1.18Bremelanotidefemale sexual dysfunction (FSD)Phase 3Phase 3 initiated Dec 2014. Enrolment to be completed by end of 2015. Top-line data due mid-201602/14/2015
PTN
1.18PL-3994Heart failurePhase 2aPhase 2a to be initiated 1H 201509/10/2014
PTN
1.18PL-3994Acute exacerbations of asthmaPhase 2aCompleted04/28/2013
PTX
11.66TREXIMETAdolescent migraine patientsPDUFAsNDA filed Nov 14 2014. Granted priority review. Estimated PDUFA May 14 201502/05/2015
QLTI
4.04QLT091001Impaired Dark Adaptation (IDA)Phase 2aPhase 2a data released December 201412/07/2014
QLTI
4.04punctal plug drug deliveryGlaucomaPhase 2Sold to Mati04/28/2013
QRXPY
0.04MOXDUOModerate to severe acute painCRLCRL Aug 2013. New PDUFA May 25 2014. New CRL May 27 201405/28/2014
QURE
23.60AAV5 Gene therapyhemophilia BPhase 1/2Phase 1/2 to be initiated early 2015 with interim data due mid 201512/02/2014
RARE
58.22KRN23Tumor-induced osteomalacia (TIO)Phase 2Phase 2 to be initiated 1H 201501/07/2015
RARE
58.22rhGUS Mucopolysaccharidosis 7 (MPS 7) Phase 3Announced Dec 15 that a Phase 3 trial has been initiated. Data due 1H 2016.12/16/2014
RARE
58.22Triheptanoin Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD)Phase 2Phase 2 initiated February 2014. Data due 201511/11/2014
RARE
58.22TriheptanoinGlucose Transporter Type-1 Deficiency Syndrome (Glut1 DS)Phase 2Phase 2 initiated March 2014. Data due 201511/11/2014
RARE
58.22KRN23X-linked Hypophosphatemia (XLH)Phase 2Phase 2 initiated July 2014. Interim data due 2015.11/11/2014
RCPT
142.64RPC1063 - SUNBEAMRelapsing Multiple Sclerosis (RMS).Phase 3Phase 3 trial initiated Dec 2014. Expects to complete Phase 3 program in 201712/23/2014
RCPT
142.64RPC1063 -RADIANCERelapsing Multiple Sclerosis (RMS). Phase 3Phase 2 Top-line data released June 2014. Phase 3 is ongoing.03/04/2015
RCPT
142.64RPC1063Ulcerative Colitis (UC) Phase 2Phase 2 top-line data met endpoints - Oct 2014. Phase 3 planned for 201503/04/2015
RCPT
142.64RPC4046 Eosiniphilic EsophagitisPhase 2Phase 2 topline data due 1H 201603/04/2015
RCPT
142.64RPC1063Chron's diseasePhase 2Phase 2 planned for 201503/04/2015
RDUS
45.94Abaloparatide-SCOsteoporosisPhase 3Phase 3 top-line released late December 2014 - met endpoint. Data from ACTIVExtend extension trial due 2Q 2015. NDA filing due 2H 201501/31/2015
RDUS
45.94RAD1901 Vasomotor symptoms such as hot flashesPhase 2Phase 2 complete07/09/2014
RDUS
45.94Abaloparatide-TD (patch)OsteoporosisPhase 2Phase 2 complete07/09/2014
RGDO
1.32Cenicriviroc (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
1.32REGULATE-PCI - REG1percutaneous coronary intervention (PCI)Phase 3Trial halted due to safety concerns - Aug 201408/26/2014
RGLS
20.49RG-101 HCVPhase 2Phase 2 to be initiated 2Q 201502/21/2015
RIGL
3.20Fostamatinib Immune Thrombocytopenic Purpura (ITP)Phase 3Phase 3 initiated July 2014. Data from first of two trials due 1Q 201603/04/2015
RIGL
3.20FostamatinibIgA nephropathyPhase 2Phase 2 data due early 201601/10/2015
RIGL
3.20R348Chronic dry eye disease - as a result of patients with acute or chronic graft vs. host disease (GvHD)Phase 2Phase 2 data due 1Q 201601/10/2015
RLYP
42.02Patiromer for Oral Suspension (Patiromer FOS)HyperkalemiaPDUFAPDUFA October 21 201501/06/2015
RMTI
10.40Soluble Ferric PyrophosphateIron deficiencyApprovedApproved Jan 26 201501/27/2015
RNA
18.65DrisapersenDuchenne Muscular Dystrophy (DMD)NDA filingPhase 3 endpoint not met Sept 2013. NDA filing commenced Oct 201410/11/2014
RNA
18.65 PRO053DMDPhase 1/2Phase 1/2 initiated Jun 2013. Data due 1H 201508/16/2014
RNA
18.65PRO044Duchenne Muscular Dystrophy (DMD) patients with a mutation around location 44 in the DNA for the dystrophin proteinPlacebo trial to commence 201508/16/2014
RNN
0.77ArchexinCancer - metastatic renal cell carcinoma (RCC)Phase 2Phase 2 initiation Jan 2014. Initial phase to be completed late 201404/11/2014
RNN
0.77ZoraxelErectile DysfunctionPhase 2aPhase 2a complete. Phase 2b development requires partner04/27/2013
RNN
0.77ArchexinCancer - pancreaticPhase 2aPhase 2 completed 201204/27/2013
RPRX
9.75Androxal Secondary hypogonadismNDAAnnounced Feb 2, 2015 that they have filed their NDA 02/03/2015
RPRX
9.75ProellexUterine fibroids (vaginal treatment)Phase 2bPhase 2b initiated Dec 201401/01/2015
RPRX
9.75ProellexUterine fibroids (oral treatment)Phase 2bPhase 2b initiated Dec 201401/01/2015
RPRX
9.75ProellexEndometriosisPhase 2Phase 2 to resume while on partial clinical hold. Low dose only. Enrollment due to be completed 2Q 2013. Complete 4Q 201304/27/2013
RPTP
10.75RP 103Non-alcoholic fatty liver disease (NAFLD) in childrenPhase 2bPhase 2b initiated Jun 2012. Enrolment target hit Jan 2014. Data due 2H 201502/28/2015
RPTP
10.75RP 103Mitochondrial disorders including Leigh syndromePhase 2Phase 2 data due 201502/28/2015
RPTP
10.75RP 103Huntington's DiseasePhase 2Topline Phase 2/3 data released Feb 2014 02/21/2014
RPTP
10.75PROCYSBICystinosisApprovedApproved08/09/2013
RPTP
10.75ConviviaALDH2Phase 2aPhase 2 completed, seeking partner04/27/2013
RTGN
4.01RUT58-60Prevention of infection post abdominal surgeryPhase 1/2Phase 1/2 to be completed 1Q 201508/16/2014
RTRX
14.06Sparsentan (DUET) Focal segmental glomerulosclerosis (FSGS)Phase 2/3Enrolment due to be completed late 2014 or early 201505/17/2014
RTRX
14.06RE-034 Infantile Spasms and Membranous NephropathyPhase 3Phase 3 to be initiated 3Q 201405/17/2014
RVNC
16.50RT002Moderate to severe glabellar (frown) linesPhase 2Phase 2 initiated January 2015. Data due late 201503/04/2015
RVNC
16.50RT001 Lateral canthal lines (crow’s feet lines)Phase 3Phase 3 planned for early 201511/13/2014
RVX
16.92RVX-208 Pre-diabetes mellitus Phase 2Phase 2 initiated Oct 2012, data released mid 201408/10/2014
RXDX
7.97RXDX-101Cancer - solid tumorsPhase 1/2Phase 1/2 trial initiated July 201407/22/2014
RXII
1.20(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
1.20 (RXI-109-1401)Recurrence of keloids after keloid revision surgeryPhase 2Phase 2 initiated April 201405/01/2014
RXII
1.20RXI-109-1402Suppressing recurrence of hypertrophic scars after bilateral scar revision surgery in the breast areaPhase 2Phase 2 initiated July 201404/25/2014
SAGE
44.39SAGE-547Postpartum DepressionPhase 2aPhase 2a data due mid 201502/28/2015
SAGE
44.39SAGE-547SRSEPhase 1/2Phase 1/2 updated data released Jan 2015. 12 of 17 evaluable patients met efficacy endpoint. Pivotal trial to be initiated by mid-201502/28/2015
SAGE
44.39SAGE-547Essential tremorPhase 2Phase 2 data due mid 201502/28/2015
SCMP
15.19Rescula (unoprostone isopropyl) Retinitis pigmentosaPhase 3Phase 3 interim data due 1Q 201511/23/2014
SCMP
15.19CobiprostoneOral MucositisPhase 1b/2aPhase 1b/2a initiated 4Q 201302/27/2014
SCMP
15.19SPI-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
15.19LubiprostonePediatric functional constipationPhase 3Phase 3 initiated Dec 2013, with data due early 201612/18/2013
SCMP
15.19Amitiza/ LubiprostoneChronic idiopathic constipationApprovedApproved 200604/27/2013
SCMP
15.19Cobiprostone Non-erosive reflux disease (NERD)Phase 2Phase 2 dosing commenced February 201503/05/2015
SCYX
9.75SCY-078Candida infectionsPhase 2Phase 2 to be initiated by the end of 201411/15/2014
SGEN
35.80ADCETRIS - AETHERACancer - post-transplant Hodgkin lymphoma (HL) patientssBLAAnnounced Feb 18, 2015 that a sBLA submission has been filed02/21/2015
SGEN
35.80ADCETRIS + Rituxan and standard chemotherapy (R-CHOP) Diffuse large B-cell lymphoma Phase 2Phase 2 initiated August 201308/16/2013
SGEN
35.80ADCETRISCancer - CD30-positive Nonlymphomatous MalignanciesPhase 2Enrolling05/25/2013
SGEN
35.80ADCETRIS in combination with bendamustineCancer - second-line HLPhase 1/2Phase 1/2 initiated Jun 201305/08/2013
SGEN
35.80ADCETRISCancer - CD30-positive non-Hodgkin lymphomaPhase 2Initiated Aug 2011. Interim data released at ASH 201204/27/2013
SGEN
35.80SGN-75Cancer - advanced metastatic renal cell carcinoma (RCC)Phase 1bPhase 1b initiated Aug 2012. Ongoing04/27/2013
SGMO
17.97SB-BCLmR-HSPCbeta-thalassemiaPhase 1/2Phase 1/2 to be initiated in 201502/12/2015
SGMO
17.97SB-728-1401HIV/AIDSPhase 2Phase 2 data due by the end of 201501/13/2015
SGMO
17.97CERE-110 Alzheimer's DiseasePhase 2Phase 2 data due 201511/24/2014
SGMO
17.97SB-728-902HIV/AIDSPhase 2Data presented Dec 201312/07/2013
SGMO
17.97SB-728-1101HIV/AIDSPhase 2Data presented Dec 201312/07/2013
SGYP
3.14PlecanatideChronic 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 201501/31/2015
SGYP
3.14PlecanatideConstipation-predominant irritable bowel syndrome (IBS-C).Phase 2bFirst Phase 3 trial initiated mid-Dec 2014. Second Phase 3 trial to be initiated 1H 201512/19/2014
SGYP
3.14SP-333Opioid-induced constipation (OIC)Phase 2Phase 2 initiated Oct 2013. Enrollment completed July 2014. Data released Nov 201411/22/2014
SLXP
157.43RELISTOR (methylnaltrexone bromide) - subcutaneous useOpioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain.ApprovedApproved September 29 201410/01/2014
SLXP
157.43Budesonide foamModerate ulcerative proctitis or proctosigmoiditis ApprovedTentative approval granted September 15 2014 pending patent issues09/16/2014
SLXP
157.43XIFAXANIrritable bowel syndrome with diarrhea (IBS-D)NDAFiled response to CRL Aug 29 201409/03/2014
SLXP
157.43RUCONESTHereditary angioedema (HAE)ApprovedApproved July 16, 201407/17/2014
SLXP
157.43EIR rifaximin Crohn’s diseasePhase 3Phase 3 due to be initiated 2H 201305/11/2013
SNSS
2.31VoreloxinCancer - Acute myeloid leukemia AMLPhase 3Endpoint not met Oct 201410/11/2014
SNSS
2.31Vosaroxin 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
2.31VoreloxinAdult patients with previously treated intermediate-2 or high-risk myelodysplastic syndrome (MDS)Phase 1/2Phase 1/2 initiated Oct 201310/29/2013
SNSS
2.31VoreloxinCancer - 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
2.59STA-9090 Ganetespib - GALAXY-2Cancer - NSCLCPhase 3Phase 3 trial initiated Apr 2013 with first analysis due 2H 2015, second analysis due 1H 201602/06/2015
SNTA
2.59Ganetespib - I-SPY 2 TRIAL Cancer - breastPhase 2Phase 2 initiated Oct 201410/30/2014
SNTA
2.59Ganetespib AML-18 trialCancer - AMLPhase 2/3Expect to initiated in 2H 201408/10/2014
SNTA
2.59Ganetespib AML-19 trialCancer - AMLPhase 2/3Phase 3 to be initiated 2H 201408/10/2014
SNTA
2.59Ganetespib AML-LI trialCancer - AMLPhase 2/3Phase 3 part of trial initiated mid-201407/22/2014
SNTA
2.59Ganetespib ENCHANT trialCancer - HER2+ and triple-negative breast cancerPhase 2Update provided March 201403/23/2014
SNTA
2.59Ganetespib CHIARA trial Cancer - ALK+ NSCLC patientsPhase 205/01/2013
SNTA
2.59ElesclomolCancer - ovarianPhase 2Ongoing04/27/2013
SNTA
2.59STA-9090 GanetespibCancer - rectalPhase 2Phase 2 ongoing04/27/2013
SNTA
2.59STA-9090 GanetespibCancer - hepaticPhase 1/2Ongoing04/27/2013
SNY
48.31PraluentHypercholesterolemiaPDUFAPDUFA priority review date July 24 201501/26/2015
SPHS
0.77PRX302Benign 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
6.24Captisol-enabled, propylene glycol-free (PG-free) melphalanConditioning treatment prior to autologous stem cell transplant for patients with multiple myelomaNDA filingAnnounced Dec 26, 2014 that a NDA fiing has been submitted12/27/2014
SPPI
6.24SPI-2012 (also referred to as "LAPS-GCSF")Chemotherapy-Induced NeutropeniaPhase 2Phase 3 to be initiated in 201509/10/2014
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
SPPI
6.24ApaziquoneCancer - BladderPhase 3Failed to meet primary endpoint in Phase 3 trial - Apr 2012. NDA possible 201405/10/2013
SPPI
6.24BelinostatCancer - Carcinoma of Unknown Primary (CUP)Phase 2Primary endpoint of PFS was not met although there was a highly significant increase in the response rate 04/27/2013
SPPI
6.24SPI-1620Cancer - recurrent or progressive carcinomaPhase 2Phase 2 to be initiated 2H 201304/27/2013
SRNE
13.39CynviloqCancerBioequivalence trialTop-line pharmacokinetic results from TRIBECA (TRIal establishing bioequivalence BE between Cynviloq and Albumin-bound paclitaxel) due in March 201501/14/2015
SRPT
14.11EteplirsenDuchenne muscular dystrophyNDANDA to be filed mid 201502/28/2015
SSH
5.26C-Pulse Heart Assist System - COUNTER HFModerate to severe heart failurePivotal Expects to complete enrolment 1H 201604/27/2014
SSH
5.26C-Pulse Heart Assist System - OPTIONS HF study Moderate to severe heart failureData due mid 201504/27/2014
STEM
1.28HuCNS-SC cellsAge-Related Macular DegenerationPhase 1/2Phase I/II dosing initiated Jun 2012. First patient enrolled Oct 2012. Enrolment completed June 2014. Phase 2 to be initiated late 2014 or early 201511/23/2014
STEM
1.28HuCNS-SC cellsSpinal cord injury Phase 1/2Interim data released May and Sept 2012. 2nd cohort dosing initiated Sept 2012.12mth data released Feb 2013. Enrolment completed April 2014. Additional Interim data due May 2014. Final data due mid 2015. Phase 2 trial initiated Oct 201410/11/2014
STEM
1.28HuCNS-SC cellsPelizaeus-Merzbacher disease (PMD)Phase 1/2Phase 1 completed04/27/2013
STML
15.78SL-701Cancer - blastic plasmacytoid dendritic cell neoplasm (BPDCN)Phase 2b pivotalPhase 2b planned04/27/2013
STML
15.78SL-701Cancer- adult relapsed or refractory acute myeloid leukemia (AML) Phase 2bPhase 2b planned04/27/2013
STML
15.78SL-701Cancer - malignant gliomaPhase 2bPhase 2b planned04/27/2013
STML
15.78SL-701Cancer - second line glioblastoma (GBM)Phase 2bPhase 2b planned04/27/2013
SUPN
9.82SPN-812ADHDPhase 2bPhase 2b due to commence 2H 201511/12/2014
SUPN
9.82SPN-810Impulsive Aggression in ADHDPhase 2bPhase 3 due to commence 2H 201511/12/2014
SUPN
9.82Trokendi XR SPN-538EpilepsyApprovedApproved Aug 19 201308/22/2013
SYN
2.31 SYN-004C. difficile InfectionPhase 2Phase 2 to be initiated 1Q 201501/01/2015
SYN
2.31SYN-004Constipation-Predominant Irritable Bowel Syndrome (C-IBS)Phase 2Phase 2 to commence 1H 2015. 11/15/2014
SYN
2.31Trimesta ( oral estriol)Relapsing-remitting MS in womenPhase 2Phase 2 data released Apr 201405/01/2014
SYN
2.31FlupirtineFibromyalgiaPhase 2Pending. Partner Meda has received the go-ahead from the FDA to conduct a Phase 2 proof of concept trial04/27/2013
TBPH
20.86TelavancinStaphylococcus aureus bacteremiaPhase 3Phase 3 first patient enrolled late February 201502/26/2015
TCON
16.81TRC105 Renal Cell CarcinomaPhase 2Phase 2 initiated Dec 2014. Phase 2 data due early to mid 201602/01/2015
TCON
16.81TRC105Soft tissue sarcomasPhase 1b/2Phase 1b data due mid 2015. Phase 2 data due late 201502/01/2015
TCON
16.81TRC105Hepatocellular 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
16.81TRC105GlioblastomaPhase 2Phase 2 data due early to mid 201602/01/2015
TCON
16.81TRC105Breast 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
4.54TH-302Cancer - multiple myeloma Phase 1/2Initiated dosing in final part of trial July 2014. Initial data presented at ASH 201412/07/2014
THLD
4.54EvofosfamideCancer - glioblastoma (GBM)Phase 1/2Phase 1/2 interim data released Nov 201411/19/2014
THLD
4.54Evofosfamide MAESTROCancer - PancreaticPhase 3Number of protocol-specified events may be reached 2H 2015, with data available shortly after03/04/2015
THLD
4.54EvofosfamideCancer - soft tissue sarcoma (406 trial)Phase 3Number of protocol-specified events may be reached 2H 2015, with data available shortly after03/04/2015
THLD
4.54EvofosfamideCancer - second line NSCLCPhase 2Phase 2 initiated July 201407/02/2014
THLD
4.54TH-4000Cancer - EGFR-positive, T790M-negative non-small cell lung cancerPhase 2Phase 2 to be initiated 1H 201503/04/2015
THRX
19.97BREO ELLIPTAAsthmaPDUFAsNDA PDUFA April 30 2014. Advisory Committee Meeting March 19, 201502/07/2015
THRX
19.97TD-9855FibromyalgiaPhase 2Phase 2 data released April 201405/01/2014
THRX
19.97TD-4208Chronic obstructive pulmonary disease (COPDPhase 2bPhase 2b data released Sept 2013. Dose ranging Phase 2b trial initiated April 2014 04/11/2014
THRX
19.97Velusetragdiabetic or idiopathic gastroparesisPhase 2Phase 2 data due 1H 201402/07/2014
THRX
19.97TD-9855Attention deficit/hyperactivity disorder (ADHD)Phase 2Phase 2 endpoint not met Nov 201301/17/2014
THRX
19.97UMEC/VI (62.5/25mcg and 125/25mcg doses) ANORO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)ApprovedApproved Dec 18 201312/19/2013
THRX
19.97VIBATIV (telavancin hydrochloride) for injectionHospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)ApprovedApproved Jun 21 201306/24/2013
THRX
19.97BREO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)ApprovedApproved May 10 201305/11/2013
THRX
19.97TD−1211Opioid-induced constipation (OIC)Phase 2bPhase 2b data released Jul 2012. Evaluating Phase 3 strategy due to FDA requirements for this class of drug04/27/2013
TKAI
15.01GaleteroneCancer - castration-resistant prostate cancer (CRPC)Phase 2Phase 3 to be initiated 1H 201511/11/2014
TKMR
19.57TKM-PLK1Gastrointestinal Neuroendocrine Tumors (GI-NET) Phase 1/2Final data due mid-201501/01/2015
TKMR
19.57TKM-Ebola Ebola Phase 1/2Placed on partial clinical hold but available under expanded use program09/23/2014
TKMR
19.57ALN-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
19.57TKM-PLK1Adrenocortical Carcinoma (ACC)Phase 1/2Enrolling as of June 2014. Interim data due 2H 201407/22/2014
TKMR
19.57ALN-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
5.02BirinapantCancer - 3rd line ovarianPhase 1/2Phase 1/2 trial to be completed at lower doses - announced Dec 16 2014. Data due 201502/28/2015
TLOG
5.02BirinapantMyelodysplastic syndromes, or MDSPhase 2Phase 2 data due mid 201502/28/2015
TLOG
5.02BirinapantCancer - acute myelogenous leukemia or AMLPhase 1/2Data due 201502/28/2015
TLOG
5.02SHAPECancer - Cutaneous T-Cell LymphomaPhase 2Phase 2 trial initiated mid-Dec 2014. Data due 201512/19/2014
TNXP
6.40TNX-102 SL PTSD - for the treatment of post-traumatic stress disorderPhase 2Phase 2 trial initiated mid Jan 201501/16/2015
TNXP
6.40TNX-201Episodic tension-type headachePhase 2Phase 2 to be initiated 2Q 2015. Data due 4Q 2015.03/04/2015
TNXP
6.40TNX-102 SL Fibromyalgia Phase 2b/3Endpoint not met - Sept 2014. Phase 3 to be initiated 2Q 2015. Data due 2H 201603/04/2015
TRGT
2.65TC-6499 Diabetic GastroparesisPhase 1/2Phase 1/2 initiated 4Q 2013. Topline data due 1H 201511/06/2014
TRLPF
0.65CompleoTRTTestosterone deficiency in menApprovedApproved May 201405/29/2014
TRVN
5.49TRV130 Moderate to severe acute painPhase 2bPhase 2 initiated May 2014. Topline data released Nov 2014. Second trial initiated Jan 2015. Topline data due mid 201501/07/2015
TRVN
5.49TRV027 - BLAST-AHFAcute heart failurePhase 2bPhase 2b data due 4Q 201511/12/2014
TSRO
55.00Niraparib - BRAVOCancer - breastPhase 3Phase 3 initiated 1Q 2014.Ongoing02/21/2015
TSRO
55.00Niraparib - NOVA (Niraparib Ovarian) Cancer - ovarianPhase 3Phase 3 enrolment to be completed 1Q 2015. Data due 2015.02/21/2015
TSRO
55.00RolapitantPrevention of chemotherapy induced nausea and vomiting, or CINV in HEC patientsPDUFANDA filed early Sept 2014. Estimated PDUFA Sept 8 201501/26/2015
TSRO
55.00TSR-011Cancer - NSCLCPhase 1/2Phase 2 dosing to be finalised by end of 201307/26/2013
TTHI
6.77ELND005Bipolar I Disorder (BPD 1)Phase 2Phase 2 data released Nov 2014 - development terminated02/12/2015
TTHI
6.77TT401 (LY2944876)Type 2 diabetesPhase 2Phase 2 initiated May 2014. Data due 4Q 201502/12/2015
TTHI
6.77ELND005Alzheimer's DiseasePhase 2Reported March 2015 that Phase 2 enrolment has been completed with data due mid 201503/04/2015
TTHI
6.77ELND005-DS201Down syndromePhase 2Phase 2 initiated Sept 201309/05/2013
TTNP
0.65ProbuphineOpioid dependencePhase 3PDUFA date Apr 30 2013 under priority review. Adcom Mar 21 2013 resulted in favourable vote 10-4. New Phase 3 trial initiated July 2014, due to be completed mid 2015, NDA due late 2015.11/22/2014
TTPH
38.91Eravacycline (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 201512/18/2014
TTPH
38.91Eravacycline (TP-434)cUTI - complicated urinary tract infectionsPhase 3Top-line data due mid 201512/18/2014
UTHR
162.88Oral treprostinilPulmonary arterial hypertension (PAH)ApprovedApproved Dec 20 201312/21/2013
VBLT
3.80VB-201Ulcerative colitisPhase 2Phase 2 failed to meet endpoints - Feb 2015 data02/21/2015
VBLT
3.80VB-111Cancer - recurrent glioblastoma, or rGBMPhase 2Phase 2 failed to meet endpoints - Feb 2015 data02/21/2015
VBLT
3.80VB-201Psoriasis Phase 2Phase 2 topline data due 1Q 201512/16/2014
VCEL
3.66ixmyelocel-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
21.44Vaxfectin-formulated therapeutic vaccineHerpesPhase 1/2Data due mid 201502/28/2015
VICL
1.01ASP0113Hematopoietic cell transplantPhase 3Initiated Phase 3 Jun 2013. Enrollment due to be completed end of 201502/28/2015
VICL
1.01ASP0113solid organ transplant (SOT)Phase 2Initiated Phase 2 Dec 2013. Enrolment due to be completed mid 201502/28/2015
VNDA
10.62VLY-686 (tradipitant)Chronic pruritusPhase 2Phase 2 data released March 2015 FAIL - no statistical difference from placebo03/05/2015
VNDA
10.62TasimelteonInsomniaApprovedApproved Jan 31 2014. 02/02/2014
VRTX
126.75VX-661Cystic fibrosis with 1 or 2 copies of the F508del mutationPhase 2bPhase 2b data due towards the end of 1Q 2015 according to earnings conference call Jan 28 201501/29/2015
VRTX
126.75Lumacaftor 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 review01/26/2015
VRTX
126.75Vacaftor Children ages 2 to 5 with cystic fibrosis who have the G551D or one of the eight additional gating mutationsPDUFAPDUFA March 17 201501/26/2015
VRX
203.89EfinaconazoleOnychomycosisPDUFACRL May 28 201305/29/2013
VRX
203.89LuliconazoleTinea cruris, pedis and corporisPDUFAPDUFA date Dec 11 201304/27/2013
VSAR
21.44VRS-317Growth hormone deficiency, or GHD - pediatricPhase 3Phase 3 initiated early Jan 2015. interim 6 month height velocity analysis by mid-2016 and top line data on the 12 month height velocity primary endpoint is expected in early 2017.02/14/2015
VSAR
21.44VRS-317Growth hormone deficiency, or GHD - adultPhase 2/3Phase 2/3 to be initiated in 2H 2015.02/14/2015
VSTM
7.98VS-6063Mesothelioma prior to surgeryPhase 2Phase 2 data due 2Q 201501/09/2015
VSTM
7.98VS-6063KRAS-mutated NSCLCPhase 2Phase 2 data due 2H 201501/09/2015
VTAE
11.22VTP-34072Type 2 DiabetesPhase 2Phase 2 initiated July 2014. Data due 1H 201511/13/2014
VTL
23.31ELAD (VTI-208)Alcohol-induced liver decompensation, or AILDPhase 3Phase 3 initiated 2013. Prelim data due 2Q 201501/14/2015
VTL
23.31ELAD (VTI-210)Severe acute alcoholic hepatitisPhase 3Phase 3 data due 201601/14/2015
VTL
23.31ELAD (VTI-212)Fulminant hepatic failure, or FHF, or surgery-induced acute liver failure, or SILFPhase 2/3Phase data due 201601/14/2015
VVUS
2.92AvanafilErectile dysfunctionApprovedApproved Apr 27 2012. sNDA label change also approved 17 Sept 201409/18/2014
XENE
19.06TV-45070OsteoarthritisPhase 2bPhase 2b data due 3Q 201502/21/2015
XENE
19.06TV-45070Postherpetic neuralgiaPhase 2b Phase 2b to be initiated March 2015. Trial completion mid 201602/21/2015
XENE
19.06XEN801AcnePhase 1/2Phase 2 to be initiated 2H 2015 pending positive Phase 1 data02/01/2015
XENT
25.40Steroid 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
41.39SotaterceptMyelodysplastic syndromes (MDS)Phase 2Phase 3 to be initiated 201503/04/2015
XLRN
41.39Sotatercept b -thalassemiaPhase 2Phase 3 to be initiated 201503/04/2015
XLRN
41.39SotaterceptEnd stage renal disease (ESRD) Phase 2bPhase 2b to be initiated 201501/13/2015
XLRN
41.39DalanterceptRenal Cell CarcinomaPhase 2Phase 2 data due at ASCO 201503/04/2015
XLRN
41.39DalanterceptHead and neck cancerPhase 2Phase 2 interim data due at ASCO 201402/27/2014
XLRN
41.39DalanterceptLiver cancerPhase 2aPhase 2a to be initiated 1Q or 2Q 201402/27/2014
XLRN
41.39Sotatercept Multiple myelomaPhase 2Phase 2 ongoing09/22/2013
XLRN
41.39Sotatercept Diamond-Blackfan anemia Phase 2Phase 2 ongoing09/22/2013
XLRN
41.39SotaterceptMyelofibrosisPhase 2Phase 2 ongoing09/22/2013
XNCR
16.00XmAb5871Moderate 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
16.00MOR208 (XmAb5574)B-cell acute lymphoblastic leukemia (B-ALL) Phase 2Phase 2 initiated 2Q 201304/23/2014
XNCR
16.00MOR208 (XmAb5574)Non-Hodgkin lymphoma (NHL)Phase 2Phase 2 initiated 2Q 201304/23/2014
XNPT
7.13XP23829Moderate-to-severe plaque psoriasisPhase 2Phase 2 topline data due 3Q 201502/21/2015
XNPT
7.13XP23829Relapsing forms of multiple sclerosis (MS)Phase 3 planned01/13/2015
XNPT
7.13XP21279Parkinson's DiseasePhase 2bData released Dec 2011, no statistical improvement over Sinemet. However Phase 3 planned dependent on funding04/27/2013
XOMA
3.67XOMA 052 Gevokizumab EYEGUARD-BBehcet's uveitisPhase 3Waiting on final exacerbations to occur. Data will be released 6 weeks following final exacerbation. No firm timeline has been given by the company.02/26/2015
XOMA
3.67XOMA 052 Gevokizumab EYEGUARD-ANon-Infectious Uveitis (Active)Phase 3Data due 201511/27/2014
XOMA
3.67XOMA 052 Gevokizumab EYEGUARD-C Non-Infectious Uveitis ( Controlled )Phase 3Data due 201511/27/2014
XOMA
3.67XOMA 052 gevokizumabPyoderma GangrenosumPhase 2Initiated Phase 3 trial November 201411/05/2014
XOMA
3.67XOMA 052 GevokizumabErosive osteoarthritis of the handPhase 2Phase 2 prelim data released Oct 2013. Not pursuing futre development03/06/2014
XOMA
3.67XOMA 052 gevokizumabType 1 DiabetesPhase 205/04/2013
XOMA
3.67XOMA 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
3.67XOMA 052 GevokizumabModerate to Severe Acne VulgarisPhase 2Initiated Phase 2 Dec 2011. Topline Data released Jan 2013. Phase 3 planned04/27/2013
XON
49.14Ad-IL-12CancerPhase 2Updated data released at AACR Tumor Immunology and Immunotherapy Meeting December 201412/05/2014
ZFGN
39.35BeloranibSevere obesity Phase 2bAnnounced Dec 15 that they have initiated their Phase 2b trial12/16/2014
ZFGN
39.35BeloranibHypothalamic injury-associated obesity (HIAO)Phase 2aPhase 2a to be completed 201511/12/2014
ZFGN
39.35BeloranibPrader-Willi Syndrome (PWS)Phase 3First of two Phase 3 trials to initiated Oct 2014. Initial data due 4Q 201510/11/2014
ZFGN
39.35BeloranibCraniopharyngioma-associated obesityPhase 2aPhase 2a initiated June 201407/09/2014
ZGNX
1.69 Abuse deterrent formulations of Zohydro ERModerate to severe painApprovedApproved January 30 201501/31/2015
ZGNX
1.69Zohydro ERModerate to severe painApprovedApproved Oct 25 201310/26/2013
ZIOP
13.86Ad-RTS-hIL-12 + veledimex Cancer - breastPhase 1b/2Phase 1b/2 trial to be initiated in 201502/28/2015
ZIOP
13.86IL-12Cancer - breastPhase 2Updated data released at AACR Tumor Immunology and Immunotherapy Meeting December 201405/12/2014
ZIOP
13.86IL-12Cancer - melanomaPhase 2Updated data released at AACR Tumor Immunology and Immunotherapy Meeting December 201405/12/2014
ZSAN
10.50Daily ZP-PTHOsteoporosisPhase 3Phase 3 planned02/01/2015
ZSAN
10.50ZP-TriptanMigrainePhase 2Phase 2 to be initiated 2H 201502/01/2015
ZSAN
10.50ZP-GlucagonSevere hypoglycemiaPhase 2Phase 2 to be initiated and completed 1Q 2015 in Australia02/01/2015
ZSPH
49.39ZS-9HyperkalemiaPhase 3Phase 3 endpoints met09/24/2014

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.

16 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.

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