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.

TickerPriceDrugIndicationStageLinkClinical Trial IDUpdated
ABIO
1.61GencaroChronic Heart FailurePhase 2b/3Phase 2b/3 to begin enrolment 1Q 201401/09/2014
ACAD
19.28PimavanserinAlzheimer'sPhase 2Phase 2 initiated November 201311/15/2013
ACAD
19.28PimavanserinParkinson’s disease psychosis (PDP)Phase 3NDA filing due late 2014NCT0117400402/28/2014
ACAD
19.28AGN201781Chronic painPhase 2Phase 2 completed. Futher development pending fundingNCT0053335104/24/2013
ACHN
2.79007 Trial of Sovaprevir and ACH-3102 and ribavirinmgnPhase 2Phase 2 rapid virologic response, or RVR, of Sovaprevir and ACH-3102 combo in HCV Hepatitis C patients released Sept 2013NCT0184956202/10/2013
ACHN
2.79ACH-3422 + ACH-3102 ± NS3/4A protease inhibitorHCV Hepatitis C Phase 2Phase 2 to be initiated by early 201501/14/2014
ACHN
2.79ACH-3422HCV Hepatitis CPhase 2Phase 2 to be initiated by end of 201401/14/2014
ACHN
2.79ACH-3102 in combination with ribavirinGenotype 1b, IL28B CC genotype, HCVPhase 2Phase 2 initiated Oct 2012. Interim SVR4 results following 12 weeks released Apr 201304/24/2013
ACHN
2.79ACH-3102 + sofosbuvirTreatment-naive HCV patientsPhase 2Phase 2 to be initiated 2Q 201403/09/2014
ACHN
SovaprevirHepatitis C viral infection (HCV)Placed on clinical hold Jul 2013.Expects opinion from FDA by end of 1H 201403/09/2014
ACHN
ACH-3102 in combination with ACH-2684 Genotype 1b HCVPhase 2Phase 2 to be initiated 2Q 201403/09/2014
ACOR
35.34AC105Acute treatment of spinal cord injuryPhase 2Phase 2 trial initiated Sept 2013NCT0175068409/01/2013
ACOR
35.34DalfampridinePost stroke deficitsPhase 2b/3Phase3 trial to be initiated 2014NCT0160582501/14/2014
ACOR
35.34Diazepam Nasal SprayEpilepsyNDAFiled Nov 2013NCT0141707811/28/2013
ACRX
10.23ARX-02Cancer breakthrough painPhase 2Further development halted until funding securedNCT0083304004/19/2012
ACRX
10.23ARX-03Mild sedation and pain reliefPhase 2Further development halted until funding securedNCT0089469904/19/2012
ACRX
10.23ZalvisoPost-operative pain following open abdominal surgery and hip or knee replacement surgeryPDUFAPDUFA Jul 27 2014NCT0166076312/17/2013
ACRX
10.23ARX-04Moderate-to-severe acute painPhase 3Phase 3 to be initiated 2H 2014. Data due 2H 2015NCT0171034503/04/2014
ACST
1.04CaPreHypertriglyceridemiaPharmacokinetic (PK)PK trial to be initiated 2Q 2014. Data due 3Q 201401/31/2014
ACST
1.04CaPre (TRIFECTA trial)HypertriglyceridemiaPhase 2Phase 2 trial to be completed 1H 201401/31/2014
ACUR
1.28OXECTAPain reliefApprovedApproved Jun 17, 201106/20/2011
ACUR
1.28Study AP-ADF-301 (Study 301)Abuse LiabilityPhase 2Disappointing data released Aug 201308/28/2013
ADHD
14.63MDX (Metadoxine Extended Release (MG01CI))Adult ADHDPhase 3Phase 3 initiated March 2014. To be completed end of 201403/19/2014
ADMP
5.19Epinephrine PFSAnaphylaxisNDA505(b)(2) submission planned possibly during 1Q 201402/04/2014
ADMP
5.19APC-1000Asthma/COPDPhase 3Phase 3 planned02/04/2014
ADMP
5.19APC-3000Allergic RhinitisPhase 3Phase 3 planned02/04/2014
ADMA
8.00RI-002Primary Immune Deficiency DiseasesPhase 3Phase 3 prelim data due 4Q 201412/15/2013
AEGR
43.52LomitapideHomozygous familial hypercholesterolemia (HoFH)ApprovedApproved Dec 24 2012NCT0073023612/25/2012
AERI
14.91RhopressaGlaucomaPhase 3Phase 3 to be initiated summer of 2014. Data due mid-201503/19/2014
AERI
14.91RoclatanGlaucomaPhase 2bPhase 2b initiated Jan 2014. Data due early 3Q 201403/19/2014
AEZS
PerifosineCancer - ColorectalPhase 3Primary endpoint not metNCT0109701804/03/2012
AEZS
1.12AEZS-108Cancer - Refractory triple-negative breast cancerPhase 2First patient enrolled Feb 2013NCT0169828102/24/2013
AEZS
1.12PerifosineCancer - MyelomaPhase 3 Failed - Mar 2013NCT0100224803/13/2013
AEZS
1.12AEZS-130Adult Growth Deficiency PDUFAPDUFA Nov 5 2014NCT0044874701/07/2014
AEZS
1.12AEZS-108Cancer - OvarianPhase 2CompleteNCT0056925704/24/2013
AEZS
1.12AEZS-108Cancer - BladderPhase 2Expects to continue Phase 2 in 2013NCT0123451909/01/2013
AEZS
1.12AEZS-108Cancer - Endometrial Phase 3Phase 3 trial initiated Jul 2013 under SPANCT0176715508/01/2013
AEZS
1.12AEZS-130Cancer cachexiaPhase 2Phase 2 first patient recruited Aug 2012. OngoingNCT0161499004/24/2013
AEZS
AEZS-108Metastatic Hormone-Resistant Prostate CancerPhase 2OngoingNCT0124062909/01/2013
AFFY
0.64PeginesatideAnemia in chronic renal failure (CRF)ApprovedPDUFA Mar 27 2012 - APPROVED but withdrawnNCT0059758403/28/2012
AGEN
2.41G-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 NCT0090506010/26/2013
AGEN
2.41G-200Cancer - Glioblastoma (GBM) 2nd linePhase 2Enrolling 1H 2013NCT0181481309/01/2013
AGEN
2.41HerpVGenital herpesPhase 2Phase 2 enrolment completed Feb 2013NCT0168759504/24/2013
ALIM
6.30IluvienDiabetic macular edemaPDUFACRL Nov 2011. Second CRL Oct 17 2013. New PDUFA Sept 26 2014NCT0034496804/16/2014
ALIOF
97.21Macitentan (Opsumit)Pulmonary arterial hypertensionApprovedApproved Oct 18 2013NCT0066017910/22/2013
ALIOF
97.21CadazolidClostridium difficile associated diarrhea (CDAD)Phase 3Phase 3 planned03/10/2013
ALIOF
97.21PonesimodModerate to severe chronic plaque psoriasis.Phase 3Phase 3 plannedNCT0120809003/10/2013
ALIOF
PonesimodRelapsing-remitting Multiple SclerosisNCT0109332604/30/2013
ALIOF
Selexipag - GRIPHONPulmonary arterial hypertension (PAH)Phase 3 Phase 3 final data due mid 201408/12/2013
ALKS
45.03ALKS 33 Binge eating disorderPhase 2Data released Jul 2011, endpoint not met. Likely to discontinueNCT0109843507/08/2011
ALKS
45.03BYDUREONDiabetes - Type 2ApprovedApproved Jan 201205/19/2012
ALKS
45.03ALKS 37Opioid-induced constipationPhase 2bPhase 2b fail. Will not proceed to Phase 3NCT0138279705/31/2012
ALKS
45.03ALKS 5461Major depressive disorder Phase 2Phase 2 data released Apr 2013. Phase 3 planned for 1Q 2014NCT0150020001/09/2014
ALKS
45.03ALKS 9070 aripiprazole lauroxilSchizophreniaPhase 3Phase 3 trial initiated Dec 2011,enrolment completed Oct 2014, data due 1H 2014NCT0146903901/09/2014
ALKS
45.03Paliperidone Palmitate 3 Month and 1 Month FormulationsSchizophreniaPhase 3Phase 3 initiated Jun 2012. Expect to be completed 2H 2014NCT0151542304/24/2013
ALKS
Paliperidone Palmitate 3 Month FormulationSchizophreniaPhase 3Phase 3 initiated Jun 2012. Expect to be completed 2H 2014NCT0152951504/24/2013
ALKS
45.03ALKS 3831SchizophreniaPhase 2Phase 2 initiated Jul 2013. Data due 1H 201512/14/2013
ALNY
54.61ALN-RSV01RSV (respiratory syncytial virus) infected adult lung transplant patientsPhase 2bData released May 2012. Missed primary endpoint.NCT0106593505/31/2012
ALNY
54.61ALN-TTR02 - patisiranFamilial Amyloidotic Polyneuropathy (FAP) in Patients with ATTRPhase 2 - open labelPhase 2 enrolment completed Sept 2013. Initial data due 2014NCT0161796701/12/2014
ALNY
54.61ALN-TTR02 - patisiran APOLLOFamilial Amyloidotic Polyneuropathy (FAP) in Patients with ATTRPhase 3Phase 3 trial initiated Nov 2013, continues to enrol patients as of Jan 201401/12/2014
ALNY
54.61ALN-TTRscTTR-mediated amyloidosis (ATTR)Phase 2Phase 2 data due late 2014. Phase 3 to be initiated late 201401/12/2014
ALXA
4.10Staccato loxapine (ADASUVE)SchizophreniaApprovedApproved Dec 21 2012NCT0062858912/23/2012
ALXA
4.10AZ-002Acute repetitive seizuresPhase 2Phase 2 to be initiated 1Q 201411/07/2013
AMAG
17.75FerahemeIron 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 2014NCT0111413901/23/2014
AMBI
6.41QuizartinibCancer - relapsed/refractory acute myeloid leukemiaPhase 3Phase 3 initiated Apr 2014. Interim data 2H 2015. Topline data 1Q 2016NCT0156566803/23/2014
AMBI
6.41AC410InflammationPhase 1Phase 1 enrolment complete05/31/2013
AMPE
5.52OptinaDiabetic Macula EdemaPhase 2bPhase 2b trial completed enrolment Feb 2014. BLA filing end of 2014NCT0182167702/19/2014
AMPE
5.52ZertanePremature ejaculationPhase 3Pivotal trial pending. Will spin off Zertane into a standalone company called Vyrix Pharmaceuticals, Inc12/15/2013
AMPE
5.52AmpionOsteoarthritis of the KneePhase 3Phase 3 data released Aug 2013. Final pivotal trial to be initiated Jan 2014. Possible BLA filing 3Q 2014NCT0183933112/08/2013
AMRN
1.60Vascepa Elevated triglyceride levelsApprovedApproved Jul 26 2012NCT0104768307/27/2012
AMRN
1.60Vascepa High Triglycerides With Mixed DyslipidemiaPDUFAFDA rejected appeal reinstate re-instate the ANCHOR SPA agreement. Intend to appeal. PDUFA delayed until following the appealNCT0104750101/22/2014
ANAC
15.37GSK ‘052Complicated urinary tract infections (cUTI)Phase 2bPhase 2b enrolment halted Feb 2012 due to 'microbiological finding' in cUTI patients. Discontinued Oct 201210/21/2012
ANAC
15.37GSK ‘052Complicated intra-abdominal infections (cIAI) Phase 2bPhase 2b enrolment halted Feb 2012 due to 'microbiological finding' in cUTI patients. Discontinued Oct 201210/21/2012
ANAC
15.37TavaboroleOnychomycosisPDUFAPDUFA July 29 2014NCT0130211910/02/2013
ANAC
15.37AN2728Mild-to-moderate atopic dermatitisPhase 3Phase 3 initiated March 2014NCT0160234104/01/2014
ANAC
15.37AN2728Mild-to-moderate plaque-type psoriasisPhase 2bPromising Prelim Phase 2b data released Jun 2011. Phase 3 planning on holdNCT0130005204/25/2013
ANIK
39.33MonoviscOsteoarthritisApprovedApproved Feb 2014NCT0065343202/16/2014
ANIK
CingalOsteoarthritisPhase 3Phase 3 initiated 2Q 201308/01/2013
ANTH
2.88Varespladib - Vista 16Acute Coronary Syndromes (ACS)Phase 3Failed Phase 3 efficacy trialsNCT0113024603/11/2012
ANTH
2.88BlisibimodLupusPhase 3Missed primary endpoints in Phase 2b trial Jun 2012. Phase 3 trial initiated Mar 2013. Interim data mid 2014NCT0139574510/30/2013
ANTH
2.88BlisibimodIgA nephropathyPhase2Phase 2 initiated Jun 201306/25/2013
APPY
2.31Appy1Acute appendicitis Phase 3Data released Mar 13 2014. 510k filed March 2014NCT0165217004/01/2014
APRI
2.39PrevOncoCancer - HCC - liver cancerPhase 2Phase 3 and SPA in discussions with the FDA04/06/2012
APRI
2.39FemproxFemale sexual arousal disorderPhase 3Planning clinical development04/25/2013
APRI
2.39MycoVaOnychomycosisPhase 3Additional trials required in US for approval04/25/2013
APRI
2.39VitarosErectile DysfunctionApproved in Canada. Partner "Warner Chilcott continues to pursue the approval of the drug"NCT0177632004/25/2013
ARIA
7.09RidaforolimusCancer - SarcomaCRLCRL Jun 6 2012. New trials requiredNCT0053823906/06/2012
ARIA
7.09Oral 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
7.09AP26113 - ALTA (ALK in Lung Cancer Trial of AP26113)Cancer - locally advanced or metastatic non-small cell lung cancer (NSCLC)Pivotal Phase 2Initiated 1Q 2014. Full patient enrollment 3Q 2015, final data analysis will be performed when patients have completed six months of AP26113 treatment. First data due at a medical meeting in 2015.NCT0144946103/25/2014
ARIA
7.09Oral ponatinib - IclusigNewly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)Phase 3Discontinued Oct 2013NCT0165080510/20/2013
ARIA
Ponatinib Second Line Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to ImatinibPhase 2Enrolment paused Oct 2013 due to safety issuesNCT0174683610/11/2013
ARIA
Oral ponatinib - IclusigAdvanced Squamous Cell Lung Cancers With FGFR Kinase AlterationsPhase 2/3Enrolment paused Oct 2013 due to safety issuesNCT0176174710/11/2013
ARIA
Ponatinib Front-line Treatment of Adult Affected of Philadelphia+/BCR-ABL+ Acute Lymphoblastic Leukemia (ALL)Phase 2Enrolment paused Oct 2013 due to safety issuesNCT0164110710/11/2013
ARIA
Hyper-CVAD and PonatinibPh-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL)Phase 2Enrolment paused Oct 2013 due to safety issuesNCT0142498210/11/2013
ARIA
Ponatinib Advanced NSCLC w/ RET TranslocationsPhase 2Enrolment paused Oct 2013 due to safety issuesNCT0181373410/11/2013
ARIA
PonatinibFront-line Treatment of Adult Affected of Philadelphia+/BCR-ABL+ Acute Lymphoblastic Leukemia (ALL) Phase 2Enrolment paused Oct 2013 due to safety issuesNCT0164110710/11/2013
ARIA
PonatinibAdvanced Medullary Thyroid CancerPhase 2Enrolment paused Oct 2013 due to safety issuesNCT0183864210/11/2013
ARIA
PonatinibGastrointestinal stromal tumors (GIST)Phase 2Enrolment paused Oct 2013 due to safety issues. Hope to resume 2Q 2014NCT0187466502/26/2014
ARNA
6.30LorcaserinObesityApprovedApproved Jun 27 2012NCT0060390206/28/2012
ARNA
APD811Pulmonary Arterial HypertensionPhase 2Phase 2 to be initiated 1H 201401/14/2014
ARNA
Lorcaserin Smoking cessationPhase 2Phase 2 initiated March 201403/28/2014
ARQL
1.71Tivantinib (ARQ 197)Cancer - GastricPhase 2WithdrawnNCT0107029004/06/2012
ARQL
1.71Tivantinib (ARQ 197)Previously Treated Subjects With Non-Squamous, Non-Small-Cell Lung Cancer With Wild-type Epidermal Growth Factor ReceptorPhase 3Phase 3 ATTENTION trial initiated Aug 2011. Patient enrolment halted Aug 2012. Failed to meet endpoint Jan 2014NCT0137737601/17/2014
ARQL
1.71Tivantinib (ARQ 197)Cancer - NSCLCPhase 3Discontinued Oct 2012NCT0124419110/21/2012
ARQL
1.71Tivantinib (ARQ 197) + irinotecan and cetuximab Cancer - colorectalPhase 2Phase 2 failed Jan 2013NCT0107504801/12/2013
ARQL
1.71Tivantinib (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 2014NCT0175576701/17/2014
ARQL
1.71Tivantinib (ARQ 197)Cancer - Previously Treated KRAS Mutation Positive Subjects With Locally Advanced or Metastatic Non-Small Cell Lung CancerPhase 2Phase 2 initiated Jul 2012. Data due 2013NCT0139575804/25/2013
ARQL
Pazopanib, an Oral VEGFR Inhibitor, and ARQ 197 (Tivantinib)Cancer - Advanced Solid TumorsPhase 1/2NCT0146892205/01/2013
ARQL
Tivantinib (ARQ 197)Metastatic Triple-Negative Breast CancerPhase 2NCT0154299605/01/2013
ARQL
Tivantinib (ARQ 197)Cancer - Refractory Multiple MyelomaPhase 2NCT0144791405/01/2013
ARQL
Tivantinib (ARQ 197)Metastatic Triple-negative Breast CancerPhase 2NCT0157552205/01/2013
ARQL
Tivantinib (ARQ 197)Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate CancerPhase 2NCT0151941405/01/2013
ARQL
ARQ 197 Plus ErlotinibMetastatic EGFR Mutation-positive Non-small-cell Lung CancerPhase 2NCT0158073505/01/2013
ARQL
Cetuximab With Tivantinib Head and Neck Cancer That Is Recurrent, Metastatic, or Cannot Be Removed By SurgeryPhase 2NCT0169695505/01/2013
ARRY
3.84Selumetinib with NexavarCancer - recurrent low-grade serous ovarianPhase 2Data presented Apr 2012NCT0055107004/05/2012
ARRY
Selumetinib (AZD6244) in Combination With DocetaxelCancer - NSCLC second line non small lung cancerPhase 3Phase 3 initiated Oct 2013NCT0175028110/23/2013
ARRY
3.84Selumetinib (AZD6244) + plus dacarbazine Cancer - metastatic uveal melanoma Phase 3Phase 3 estimated primary completion date for the trial is mid-2015NCT0093622102/05/2014
ARRY
3.84Selumetinib (AZD6244) combined with radioactive iodineCancer - differentiated thyroid cancer Phase 3Pivotal trial initiated August 201311/02/2013
ARRY
3.84ARRY 797Osteoarthritis of the KneePhase 2Seeking partner for further developmentNCT0136601402/05/2013
ARRY
3.84ARRY 797LMNA-Related DCMPhase 2Phase 2 preliminary results from this study due by the end of 2014.02/05/2014
ARRY
3.84Binimetinib (MEK162)Cancer - NRAS melanomaPhase 3Phase 3 initiated Jul 2013. NDA filing expected 2015NCT0176316402/05/2014
ARRY
MEK162 (ARRY-162) - MILORecurrent low-grade serous ovarian cancer (LGSOC)Phase 3Phase 3 initiated July 2013NCT0184987407/03/2013
ARRY
MEK162 (ARRY-162) - COLUMBUSCancer - BRAF mutant melanomaPhase 3Phase 3 initiated 2H 2013NCT0132008511/02/2013
ARRY
3.84ARRY 614MDSPhase 1Phase 3 decision to be made late 2013NCT0149649504/25/2013
ARRY
3.84DanoprevirHCV Hepatitis C Phase 2Phase 3 decision to be made 201304/25/2013
ARRY
3.84AMG 151 (ARRY-403) Glucokinase activatorType 2 diabetesPhase 2AMG returned rights to ARRYNCT0146443708/07/2013
ARRY
3.84ARRY 502Asthma Phase 2aPhase 2 topline data released July 23 2013. Endpoint met. Full data released Mar 2014NCT0156169003/04/2014
ARRY
3.84ARRY 543/ ASLAN001 Cancer - HER2/EGFR inhibitor for gastric cancerPhase 2OngoingNCT0161452204/25/2013
ARRY
3.84ARRY-520 (Filanesib)Cancer - Refractory Multiple Myeloma MMPhase 2Phase 3 to be initiated mid-201402/05/2014
ARRY
ARRY 380Cancer - metastatic breast cancerPhase 3Phase 3 planned with ONCY08/07/2013
ASTM
3.63ixmyelocel-TCritical limb ischemia DiscontinuedEnrolment discontinuedNCT0148389803/28/2013
ASTM
3.63ixmyelocel-TStem cells - Dilated Cardiomyopathy Phase 2bCommenced enrolment Phase 2b Apr 2013. Enrolment due to be completed 1Q 2014. Topline data due 2Q 2015NCT0167098112/14/2013
ATHX
2.63MultistemUlcerative colitisPhase 2Phase 2 initial data due early May 2014NCT0124091503/15/2014
ATHX
2.63MultistemIschemic strokePhase 2Initiated 3Q 2011. Ongoing. Initial data due late 2014NCT0143648703/15/2014
ATHX
2.63MultistemGvHDPhase 2/3Phase 2 planned for 2014NCT0067785903/15/2014
ATHX
2.63MultistemAcute myocardial infarctionPhase 1Phase 2 to be initiated 2014NCT0067722211/15/2013
ATRS
3.04AnturolOveractive bladderApprovedApproved Dec 8 201112/08/2011
ATRS
3.04OTREXUPRheumatoid arthritis (RA)ApprovedApproved Oct 14 2013NCT0173794410/16/2013
ATRS
3.04VIBEX QuickShotTestosterone deficiencyPhase 2Phase 2 pharmacokinetic study data released Feb 201402/21/2014
AUXL
26.46XIAFLEXEdematous fibrosclerotic panniculopathy (“cellulite”)Phase 1bPhase 2a trial commenced Oct 2013. Topline data due 1Q 2015NCT0151890710/24/2013
AUXL
26.46XIAFLEXPeyronie’sApprovedApproved Dec 6 2013NCT0122159712/08/2013
AUXL
26.46XIAFLEXAdhesive Capsulitis (“Frozen Shoulder syndrome”)Phase 2aPhase 2b dosing commenced Dec 2013NCT0148396312/14/2013
AUXL
26.46XIAFLEXDupuytren's ContracturePDUFAPDUFA Date Scheduled for October 20, 201402/25/2014
AUXL
26.46AvanafilErectile dysfunctionApprovedApproved Apr 27 2012. PDUFA for sNDA 20 Sept 201401/22/2014
AVEO
1.39FiclatuzumabCancer - Non-small cell lung cancer (NSCLC)Phase 2Phase 2 prelim data - not statistical significance shown05/04/2012
AVEO
1.39TivozanibCancer - colorectalPhase 2Phase 2 data due 2014 but unlikely to meet endpointNCT0147859412/14/2013
AVEO
1.39Tivozanib BATON-BC Cancer - metastatic triple negative breast cancer Phase 2Discontinued due to insufficient enrolmentNCT0174536701/31/2014
AVEO
1.39TivozanibCancer - advanced renal cell carcinomaCRLNegative 1-13 vote at Adcom meeting May 2 2013.Early CRL Jun 10 2013NCT0103078306/11/2013
AVNR
3.42NUEDEXTAPseudobulbar affectApprovedApproved Oct 30 2010NCT0057344307/26/2011
AVNR
3.42NUEDEXTA AVP-923Central neuropathic pain in patients with multiple sclerosisPhase 2Phase 2 failed to meet endpointNCT0132423212/11/2013
AVNR
3.42NUEDEXTA AVP-923Agitation in patients with Alzheimer's disease (AD)Phase 2Initiated Phase 2 Sep 2012. OngoingNCT0158444004/25/2013
AVNR
3.42NUEDEXTA AVP-923Diabetic peripheral neuropathic painPhase 3Phase 3 additional trial required04/25/2013
AVNR
3.42NUEDEXTA AVP-923Levodopa induced dyskinesia (LID) in patients with Parkinson's disease (PD).Phase 2Phase 2 enrolment commenced Oct 201310/23/2013
AVNR
3.42AVP-825Acute migrainePDUFAPDUFA November 26 201403/27/2014
BCRX
8.34Peramivir - Study 303INFLUENZA ACUTE Phase 3PDUFA Dec 23 2014NCT0095799612/21/2013
BCRX
8.34UlodesineGoutPhase 2bPhase 3 initiation pending partnershipNCT0126526409/02/2013
BCRX
8.34UlodesineModerate renal impairmentPhase 2Phase 3 initiation pending partnershipNCT0140787409/02/2013
BCRX
BCX4161 Hereditary angioedemaPhase 2Phase 2 initiated Nov 2013 11/09/2013
BDSI
7.40BEMA BuprenorphinePain - acute and chronic Phase 3Initiated Dec 2010, data mid-late Sep 2011 - FAILEDNCT0125645010/04/2011
BDSI
7.40BEMA BuprenorphineModerate to severe chronic pain in opioid naive subjectsPhase 3Phase 3 data released Jan 2014NCT0167516701/24/2014
BDSI
7.40BEMA BuprenorphineOpioid experienced patient groupPhase 3Phase 3 data due mid 201403/16/2014
BDSI
7.40BEMA Buprenorphine/Naloxone (BNX) - BUNAVAILOpioid dependenceNDANDA filed Aug 1 2013. Estimated PDUFA June 7 2014NCT0166611911/14/2013
BDSI
7.40Clonidine gelPainful diabetic neuropathy (PDN) Phase 3Phase 3 trial due to be initiated 1Q 2014. Interim data due end of 201404/04/2014
BDSI
BEMA Buprenorphine (BUNAVAIL) - EN3409 (308 trial)Opioid-Naive Subjects With Chronic Low Back PainPhase 3Phase 3 trials expected to be completed late 2013/early 2014NCT0163394405/02/2013
BIND
9.56 BIND-014 Cancer - Prostate CancerPhase 2Phase 2 initiated Aug 2013. Aim to complete in 2014NCT0181274603/26/2014
BIND
9.56 BIND-014 Cancer - Non-small cell lung cancer (NSCLC)Phase 2Phase 2 initiated Aug 2013. Aim to complete in 2014NCT0179247903/26/2014
BIOD
2.40Liquid glucagon glucagon rescue device Severe hypoglycemiaPivotal trial initiation 2H 2014. NDA filing possible 201512/19/2013
BIOD
2.40BIOD-123Diabetes - Type 1Phase 2Phase 2 data released Sept 2013NCT0168662009/09/2013
BLRX
2.03BL-1020SchizophreniaPhase 2/ 3Discontinues trial following poor interim analysisNCT0136334903/21/2013
BLRX
2.03BL-8040Cancer - Acute myeloid leukemia (AML) Phase 2aPhase 2a enrolment began Jun 2013. Partial data released Dec 2013. Full data end of 2014 or early 2015NCT0183839503/18/2014
BLRX
2.03BL-7040 Inflammatory Bowel DiseasePhase 2aPhase 2a data released Apr 2013NCT0150636204/19/2013
BLRX
2.03BL-8020- Ribavirin Monotherapy Followed by Combined Treatment With Ribavirin and HydroxychloroquineHepatitis CPhase 1/2Phase 1/2 trial initiated Apr 2013. Partial data expected end of 2013. Final data due 1H 2014NCT0183384505/08/2013
BLRX
2.03BL-8040Chronic Myeloid Leukemia Phase 1/2Phase 1/2 initiated Apr 201404/11/2014
BLRX
2.03 BL-7010Celiac diseasePhase 1/2Phase 1/2 safety trial to be initiated late 2013. Data mid-2014. Efficacy trial to be initiated 2H 201403/11/2014
BLRX
2.03BL-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
19.53Lenti-DChildhood cerebral adrenoleukodystrophy (CCALD)Phase 2/3Phase 2/3 trial initiated October 2013. Enrolment due to be completed 201503/06/2014
BLUE
19.53HGB-205Beta-Thalassemia and Sickle Cell AnemiaPhase 1/2First patient transplanted Dec 201312/03/2013
BMRN
PEG-PALPhenylketonuria (PKU) Phase 3Phase 3 data due 4Q 2014NCT0181972702/28/2014
BMRN
61.37BMN-701Pompe DiseasePhase 2/3Phase 2/3 Switch Study Expected to Begin 1Q 201402/28/2014
BMRN
61.37BMN-673Cancer -gBRCA breast cancer Phase 3Phase 3 initiated Oct 2013: Enrollment completion due 2H 201502/28/2014
BMRN
61.37BMN-111AchondroplasiaPhase 1/2Phase 2 initiated Jan 2014: Data on first three cohorts in Phase 1/2 with BMN 111 for the treatment of achondroplasia due 2Q 201502/28/2014
BMRN
61.37BMN 190Batten DiseasePhase 1/2Phase 1/2 initiated Sep 2013. Data due 2H 201502/28/2014
BMRN
61.37Vimizim (GALNS)(MPS IVA) Morquio A SyndromeApprovedApproved Feb 14 2014NCT0127506602/16/2014
BOTA
5.16Laninamivir Octanoate - IGLOO Adults with symptomatic influenza A or B infectionPhase 2Phase 2 initiated Jun 2013. Data due mid 2014NCT0179388312/08/2013
CBRX
6.59PROCHIEVE (progesterone gel)Reduction of risk of preterm birthCRLCRL Feb 26 2012NCT0061555002/28/2012
CBST
63.93Bevenopran (CB-5945) ASCENTChronic opioid-induced constipation (OIC).Phase 3Three Phase 3 efficacy trials initiated Jul 2013NCT01696643 07/21/2013
CBST
63.93Ceftolozane/ tazobactam CXA-201Complicated Intraabdominal InfectionsPhase 3Phase 3 data released Dec 2013, with an NDA filing due 1H 2014NCT0144567812/17/2013
CBST
63.93Ceftolozane/ tazobactam CXA-201Ventilator-associated bacterial pneumonia (VABP) for ceftolozane/tazobactamPhase 3Phase 3 trial to be initiated around mid-year 2013.01/25/2013
CBST
63.93Surotomycin (CB-315)C. difficile-associated diarrhea (CDAD).Phase 3Phase 3 initiated Jul 2012. NDA filing 2015NCT0159750501/25/2013
CBST
63.93Tedizolid phosphateAcute bacterial skin and skin structure infections (ABSSSI)PDUFAPDUFA June 20 2014 under priority review. Advisory Committee Meeting March 31 201402/12/2014
CCXI
5.30CCX140Type 2 Diabetes and AlbuminuriaPhase 2Phase 2 completedNCT0144025707/28/2012
CCXI
5.30CCX354 (GSK2941266) -(CARAT-1)Rheumatoid arthritis.Phase 2CompletedNCT0102772807/28/2012
CCXI
5.30CCX140Diabetic nephropathy Phase 2Phase 2 data released Sept 2013. Final data due 4Q 2014NCT0144714703/15/2014
CCXI
5.30Vercirnon CCX282 - (SHIELD-1)Crohn's diseasePhase 3Failed to meet endpoint Aug 2013NCT0127766608/25/2013
CCXI
5.30CCX168Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. Phase 2Data released December 2013NCT0136338812/04/2013
CCXI
CCX354 (GSK2941266) - (CARAT-2)Rheumatoid arthritis.Phase 2CompletedNCT0124291705/03/2013
CCXI
Vercirnon CCX282 - (SHIELD-2)Crohn's diseasePhase 3Initiated in Nov 2011.NCT0146447605/03/2013
CCXI
Vercirnon CCX282 - (SHIELD-3) Open labelCrohn's diseasePhase 3Initiated in Nov 2011.NCT0131899305/03/2013
CCXI
Vercirnon CCX282 - (SHIELD-4)Crohn's diseasePhase 3Initiated in Nov 2011.NCT0153641805/03/2013
CEMP
9.23CEM-101 (solithromycin )Uncomplicated urogenital gonococcal infectionsPhase 2Phase 2 Top-line results released Oct 2012. As of early 2013 the company was discussing funding opportunities with NIAID to pursue Phase 3 trialNCT0159144704/25/2013
CEMP
9.23Taksta CEM-102ABSSSIPhase 2Phase 2 completed. Intend NOT to pursue future developmentNCT0094814204/25/2013
CEMP
9.23CEM-101 (solithromycin )CAPBPhase 3Data due 1Q 2015NCT0175633902/28/2014
CEMP
9.23Taksta CEM-102Prosthetic joint infection (PJI) Phase 2Plans to meet FDA in 1H 2014 to discuss Phase 3 trial NCT0175692402/28/2014
CERS
4.44INTERCEPT PlateletsPMASecond and third modules for PMA scheduled for submission at the end of December 2013 and March 2014, respectively10/30/2013
CERS
4.44INTERCEPT B123PlasmaPMALast plasma module for PMA filed Dec 2013. FDA decision possible 201412/05/2013
CERS
4.44INTERCEPT Acute and Chronic AnemiaPhase 3Phase 3 Eruopean trials initiated 201306/12/2013
CHTP
4.76DroxidopaADHDPhase 2Topline data released Jul 2011NCT0098381407/26/2011
CHTP
4.76DroxidopaFibromyalgia Phase 2Phase 2 topline data released Dec 2011NCT0132337412/22/2011
CHTP
4.76CH-4051Rheumatoid arthritisPhase 2Data released May 2012. Missed primary endpoint. Discontinues further developmentNCT0111614105/31/2012
CHTP
4.76NORTHERA Neurogenic Orthostatic HypotensionApprovedApproved Tuesday, February 18, 2014.NCT0117624002/19/2014
CLDX
14.69CDX-1307Cancer - bladderPhase 2DiscontinuedNCT0109449608/13/2011
CLDX
14.69CDX-110 rindopepimut - ACT IVCancer- glioblastoma multiforme (GBM) front linePhase 3Initiated Phase 3 Dec 2011. Aim to complete enrolment by mid 2014NCT0148047903/04/2014
CLDX
14.69CDX-011 EMERGECancer - Metastatic breastPhase 2bPrelim data released May 23 2012. Updated data released Dec 2012. Phase 3 trial initiated Dec 2013NCT0115675303/04/2014
CLDX
14.69CDX-110 (rindopepimut) in combination with Avastin - ReACTCancer- glioblastoma multiforme (GBM) refractoryPhase 2Phase 2 data due by end of 2014NCT0149832803/04/2014
CLDX
14.69CDX-1135 Dense deposit disease (DDD)Phase 2Discontinued03/04/2014
CLDX
14.69Glembatumumab vedotinCancer - melanomaPhase 2Phase 2 planning03/04/2014
CLSN
3.13ThermoDoxCancer - colorectal liver metastases (CRLM)Phase 2Initiated Phase 2 Feb 2012NCT0146459302/14/2012
CLSN
3.13ThermoDoxCancer - Hepatocellular carcinoma - liver cancerPhase 3Failed to meet primary endpoint. New Phase 3 to be initiated 1H 2014NCT0061798102/25/2014
CLSN
3.13ThermoDoxRecurrent Chest Wall Breast Cancer (RCWBC)Phase 2Phase 2 interim data released Feb 201402/28/2014
CLVS
56.22CO-101 LEAPCancer - pancreaticPhase 3Failed trialNCT0112478611/14/2012
CLVS
56.22Rucaparib ARIEL3 Cancer - ovarian second linePivotalPivotal trial initiated late 2013NCT0148271502/28/2014
CLVS
56.22Rucaparib ARIEL2Cancer - ovarian second linePhase 2Phase 2 dosing initiated Oct 201310/31/2013
CLVS
56.22CO-1686Cancer - 2nd line T790M+ NSCLC Phase 2OngoingNCT0152692802/28/2014
CLVS
56.22CO-1686Cancer - 1st line EGFR NSCLCPhase 1/2Initiate Phase 2 trial in 1st line EGFR NSCLC patients in early 201411/02/2013
CMRX
19.24SUPPRESS trial of CMX001 Cytomegalovirus (CMV) infection following an allogeneic hematopoietic stem cell transplant (HSCT)Phase 3Phase 3 dosing commenced Sept 2013. Data mid-2015NCT0176917003/09/2014
CMRX
19.24CMX001AdV diseasePhase 2Phase 2 top line data released Aug 2013NCT0124134408/15/2013
CNAT
6.19Emricasan Acute-on-Chronic Liver Failure (ACLF) Phase 2bPhase 2b initiated Sept 2013. Pharmacokinetic data and the directional movement of biomarkers and functional parameters are due 2H 201403/28/2014
CNAT
6.19EmricasanChronic Liver Failure (CLF)Phase 2Phase 2b to be initiated 2H 201403/28/2014
CNAT
6.19EmricasanSevere alcoholic hepatitisPhase 2Phase 2 initiated Sept 201309/22/2013
CNAT
6.19EmricasanLiver fibrosis post-orthotopic liver transplant due to Hepatitis C virus infection (HCV-POLT)Phase 2bPhase 2b to be initiated 2H 201403/28/2014
CNAT
6.19EmricasanNon-alcoholic steatohepatitis (NASH)Phase 2Phase 2 trial initiated Mar 201403/04/2014
CNDO
1.84TSO - (CNDO-201) (TRUST-I)Crohn’s diseasePhase 2Phase 2 endpoint not met Oct 2013NCT0157647110/15/2013
CNDO
TSO - (CNDO-201) (TRUST-2)Crohn’s diseasePhase 2Phase 2 discontinued Nov 2013 due to lack of efficacyNCT0127957711/09/2013
CNDO
1.84CNDO-109 Cancer - acute myeloid leukemia (AML)Phase 1/2Phase 1/2 initiated Nov 2012NCT0152055803/29/2013
CNDO
1.84TSO - (CNDO-201)Ulcerative colitisPhase 2Phase 2 initiated Sep 201309/15/2013
CORT
3.62Corlux - KorlymCushing's SyndromeApprovedApproved Feb 17 201207/20/2012
CORT
3.62Corlux - Korlym Psychotic depressionPhase 3Enrolled more patients during 3Q 2011. Interim analysis 2Q 2014NCT0063749401/31/2014
CPIX
4.52AcetadoteAcute liver failureApprovedApproved Jan 13, 201101/14/2011
CPIX
4.52AcetadoteNon-Acetaminophen Induced Acute Liver FailureCRLCRL received Dec 2010. 11/05/2011
CPIX
4.52Hepatoren HRSPhase 2Ongoing04/25/2013
CPRX
2.03VigabatrinAddiction to cocainePhase 2bPhase 2b fail.11/10/2012
CPRX
2.03Firdapse Lambert-Easton Myasthenic Syndrome (LEMS)Phase 3Phase 3 data due 3Q 2014. NDA mid 2015NCT0137792204/02/2014
CRIS
2.30GDC-0449 vismodegib (everolimus)Cancer - Advanced Basal Cell CarcinomaApprovedApproved Jan 31 201201/30/2012
CRIS
2.30Debio 0932Cancer - NSCLC without known EGFR mutationsPhase 1/2Ongoing. Phase 2 portion to initiated 2H 201401/14/2014
CRIS
2.30GDC-0449 vismodegib (Erivedge)Cancer - Operable Nodular BCCPhase 2Phase 2 data of Erivedge for Operable Nodular BCC released at the American Association of Dermatology’s Annual Meeting Mar 21-25 2014NCT01201915
CRIS
2.30CUDC-907Cancer - Phase 1Phase 2 to be initiated late 2014NCT0174298801/14/2014
CRIS
2.30CUDC-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
2.30Erivedge (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
CRTX
0.00CRTX 080HyponatremiaCRLCRL Oct 29 2012.11/03/2012
CSII
26.17Orbital atherectomy systemCalcified coronary arteriesPMAPMA approved Oct 22 201310/23/2013
CTIC
2.99OpaxioCancer - OvarianPhase 3Enrolment completed Jan 2014NCT0010874501/29/2014
CTIC
2.99Pacritinib -PERSIST-1MyelofibrosisPhase 3Topline data due 2H 2014. A second planned Phase 3 trial is on track to initiate in early 2014NCT0177318701/15/2014
CTIC
2.99BrostallicinCancer - breastPhase 2Interim data released Dec 2012. Final data released ASCO 2013NCT0109145406/03/2013
CTIC
2.99OpaxioCancer - glioblastoma multiformePhase 2OngoingNCT0140206312/07/2013
CTIC
2.99OpaxioCancer - head and neck cancerPhase 1/2OngoingNCT0066021812/07/2013
CTIC
2.99PixantroneCancer - Relapsed/refractory diffuse large B-cell lymphoma ("DLBCL")PivotalInitiated Mar 2011. OngoingNCT0132154104/25/2013
CTIC
2.99PixantroneCancer - 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 trialNCT0132154104/25/2013
CTIC
2.99TosedostatCancer - relapsed or refractory MDSPhase 2Partial clinical hold removed Jan 2014. Original hold was placed in mid 2013NCT0163660901/06/2014
CTIC
2.99TosedostatCancer - newly diagnosed AML/MDSPhase 2Placed on partial clinical hold due to death of patientNCT0156705901/06/2014
CTIC
2.99PacritinibMyelofibrosisPhase 3Second Phase 3 trial (PERSIST-2) is planned to initiate in 4Q 2013. 10/08/2013
CUR
3.78 NSI-566Amyotrophic lateral sclerosis (Lou Gehrig's)Phase 2Phase 2 trial initiated Sep 2013. Expect all patients to be treated by 2Q 2014NCT0134845110/11/2013
CUR
3.78NSI-189DepressionPhase 1bPhase 1b data currently being compiled as of Nov 2013NCT0152064911/28/2013
CUR
3.78NSI-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
1.28MultiklineCancer - Head and NeckPhase 3Initiated Dec 2010, enrolling. 117 patients enrolled as of Apr 2013. 146 patients as of Feb 2014. Full enrolment due to be completed by end of 2015NCT0126584902/28/2014
CYCC
3.17SeliciclibCancer - NSCLCPhase 2bRetrospective analysis were insufficient to allow meaningful correlation. TerminatedNCT0037207301/11/2012
CYCC
3.17Sapacitabine (SEAMLESS)Cancer - Acute myeloid leukemiaPhase 3Phase 3 enrolment 50% complete as of end of 2013. Hopes to complete enrolment in 2014, with topline data due in 2015NCT0130379603/26/2014
CYCC
3.17SapacitabineCancer - NSCLCPhase 2OngoingNCT0088596304/26/2013
CYCC
3.17SapacitabineCancer - Myelodysplastic syndromesPhase 2Updated data released Dec 2013NCT0059018712/10/2013
CYTK
9.07tirasemtiv (formerly CK-2017357)Peripheral artery diseasePhase 2aData Ph2a released Jun 2011NCT0113101306/03/2011
CYTK
9.07tirasemtiv (formerly CK-2017357)Myasthenia gravis Phase 2aData released Nov 2012NCT0126828002/06/2013
CYTK
9.07Oral formulations of omecamtiv mecarbil COSMIC-HFHeart failure and left ventricular systolic dysfunction.Phase 2Phase 2 enrolment commenced Feb 2013NCT0178651202/13/2013
CYTK
9.07Omecamtiv mecarbil ATOMIC-AHFAcute heart failurePhase 2bData released Sept 3 at EUROPEAN SOCIETY OF CARDIOLOGY CONGRESS missed primary endpointNCT0130001309/03/2013
CYTK
9.07tirasemtiv (formerly CK-2017357) BENEFIT-ALSAmyotrophic Lateral SclerosisPhase 2bData due at the American Academy of Neurology Annual Meeting in Philadelphia from April 26 to May 3 2014.NCT0170914902/07/2014
CYTR
3.00INNO-206 aldoxorubicinCancer - relapsed glioblastomaPhase 2Phase 2 initiated Nov 2013. Prelim data due 2H 201403/06/2014
CYTR
3.00INNO-206 aldoxorubicinCancer - AIDS-related Kaposi’s sarcomaPhase 2Phase 2 initiated Jan 201401/24/2014
CYTR
3.00TamibaroteneCancer - non-small-cell lung cancer (NSCLC)Phase 2bTerminated May 2013NCT0133715405/09/2013
CYTR
3.00INNO-206 aldoxorubicin with doxorubicinCancer - soft tissue sarcomas refractoryPhase 3Phase 3 initiated March 2014 under SPA, expect to complete trial enrollment in 201503/25/2014
CYTR
3.00INNO-206 aldoxorubicinCancer - soft tissue sarcomas first linePhase 2bPositive PFS data released December 11 2013NCT0151418812/12/2013
CYTR
3.00BafetinibCancer - B-Cell Chronic Lymphocytic Leukemia (B-CLL)Phase 2Phase 2 proof of concept completed. Seeking partner for further development09/08/2013
CYTR
3.00BafetinibCancer - B-cell chronic lymphocytic leukemia (B-CLL)Phase 2Phase 2 proof of concept completed. Seeking partner for further development09/08/2013
CYTR
3.00INNO-206 aldoxorubicinCancer Phase 2Phase 2 clinical trial with INNO-206 for pancreatic cancer initiated Apr 2012. No objective responses to dateNCT0158039704/26/2013
CYTR
3.00TamibaroteneCancer - Acute promyelocytic leukemia Phase 2Phase 2 SPA obtained but not currently open04/26/2013
DARA
2.48KRN5500Pain - Neuropathic Phase 2Seeking partner for development09/08/2013
DCTH
3.86CHEMOSAT systemCancer - unresectable metastatic ocular melanoma in the liverCRLCRL Sept 13 201309/15/2013
DCTH
3.86Melphalan Hepatic Delivery System (Melphalan HDS)Hepatocellular carcinoma (HCC)Phase 2Phase 3 to be initiated by 1Q 201411/07/2013
DEPO
12.83DM-1796Postherpetic neuralgia - shinglesApprovedApproved Jan 28 201101/30/2011
DEPO
12.83DM-1992Parkinson's diseasePhase 2Phase 2 data released Nov 2012. Considering partnership opportunites to advance product.NCT0151541011/08/2012
DEPO
12.83SEFELSAHot flashesCRLCRL May 31 201306/01/2013
DNDN
2.69PROVENGECancer - castrate-resistant (hormone-refractory) prostate cancerApprovedApproved 201004/18/2012
DNDN
2.69DN24-02Cancer - high risk HER2+ urothelial carcinoma following surgical resectionPhase 2Phase 2 initiated Jun 2011. OngoingNCT0135322209/08/2013
DNDN
2.69PROVENGE Clinical Trial P10-2Sequencing of PROVENGE and androgen deprivation therapy (“ADT”)Phase 2 Initiated Phase 2 Aug 2011. Enrolment completeNCT0143139104/26/2013
DNDN
2.69PROVENGE Clinical Trial P11-3.PROVENGE with concurrent versus sequential administration of abiraterone acetate plus prednisone in men with metastatic castrate-resistant prostate cancer. Phase 2 ongoingPhase 2 initiated Dec 2011. Enrolment completeNCT0148786304/26/2013
DRRX
1.29EladurChronic back painPhase 2bData released Apr 2011. FAIL04/12/2011
DRRX
1.29PosidurPost-operative pain relief CRLCRL Feb 12 201402/13/2014
DRRX
1.29RemoxyChronic painCRLCRL Jun 23, 2011. Resubmission no earlier than mid-201502/28/2014
DRTX
12.78DalbavancinAcute bacterial skin and skin structure infections (ABSSSI)PDUFAPDUFA May 26 2014 under priority review. Advisory Committee Meeting March 31 2014 positive 12-0 voteNCT0143133904/01/2014
DSCI
9.66DSC127 Diabetic foot ulcersPhase 3Phase 3 data due early 2016NCT0183034803/16/2014
DSCO
1.96Surfaxin Respiratory Distress Syndrome - SevereApprovedApproved Mar 6 201203/07/2012
DSCO
1.96AerosurfRespiratory Distress Syndrome - ModeratePhase 2aPhase 2a data due 3Q 201403/15/2014
DSCO
1.96Surfaxin LS - lyophilized dosage form of SURFAXINNeonatal RDSPhase 2 Talks with FDA regarding further development 04/26/2013
DVAX
1.50AZD1419AsthmaPhase 1Phase 1 planned04/26/2013
DVAX
1.50HEPLISAVHepatitis BCRLCRL 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 4Q 2015.04/16/2014
DYAX
6.80EcallantideACE Inhibitor-Induced AngioedemaPhase 2Discontinued due to lack of efficacy - Jun 201206/15/2012
DYAX
6.80Ramucirumab (IMC-1121B): - RainbowGastric CancerPhase 3Phase 3 enrolment completed Sept 2012NCT0117066305/04/2013
DYAX
Necitumumab - SQUIRECancer - NSCLCPhase 3OngoingNCT0098105805/04/2013
DYAX
Trebananib (AMG 386)OvarianPhase 3OngoingNCT0120474905/04/2013
EBS
25.10BioThrax Anthrax - pre-exposure prophylaxis indicationApprovedApproved May 17 201203/29/2013
EBS
TRU-016 in combination with bendamustine Study 16201Cancer - Refractory Chronic Lymphocytic Leukemia (CLL)Phase 2Phase 2 data due 2H 2013NCT0118868103/29/2013
EBS
25.10BioThrax Anthrax - Post-exposure prophylaxisPhase 2NCT01151189
EBS
25.10NuThrax - AV7909Anthrax Phase 2NCT01770743
EBS
25.10MVA85A Preventing tuberculosis (TB) in infantsPhase 2bPhase 2b complete03/29/2013
ECYT
18.65vintafolideCancer - folate receptor-positive triple negative breast cancerPhase 2Initiate Phase 2 2Q 201402/25/2014
ECYT
18.65vintafolideCancer - ovarianPhase 3Completion of enrollment of 250 folate receptor-positive (100%) patients in the Phase 3 PROCEED trial and decision on the potential expansion of enrollment in 2Q 2014NCT0117065002/25/2014
ECYT
18.65Vintafolide (TARGET)Cancer - NSCLCPhase 2bPhase 2b topline data released March 2014. Endpoint met.NCT0157765403/23/2014
EDAP
3.01 Ablatherm-HIFU (High Intensity Focused Ultrasound) Cancer - Low risk, localized prostate cancerPMAPMA submitted Feb 201302/02/2013
ENDP
57.70ODM-201 (ARAFOR)Castrate resistant prostate cancerPhase 2OngoingNCT0131764103/31/2013
ENDP
57.70 EN3342SchizophreniaPhase 1/2OngoingNCT0177443503/31/2013
ENDP
57.70AVEED (testosterone undecanoate) intramuscular injectionMen diagnosed with hypogonadismApprovedApproved March 6 201409/06/2013
ENDP
57.70BEMA Buprenorphine (BUNAVAIL) - EN3409 (308 trial)Opioid-Naive Subjects With Chronic Low Back PainPhase 3Phase 3 released Jan 2014. Endpoint metNCT0163394401/24/2014
ENDP
57.70BEMA Buprenorphine (BUNAVAIL) - EN3409 (307 trial)Opioid-Experienced Subjects With Chronic Lower Back PainPhase 3Phase 3 database to be unlocked mid 2014, with data due shortly afterNCT0167516701/24/2014
ENMD
1.92ENMD-2076Cancer - triple-negative breast cancerPhase 2Phase 2 initiated Jul 2012NCT0163924808/16/2012
ENMD
1.92ENMD-2076 Cancer - Advanced/Metastatic Soft Tissue SarcomaPhase 2Phase 2 initiated Jan 2013NCT0171974401/24/2013
ENMD
1.92ENMD-2076Cancer - OvarianPhase 2Ongoing. Enrolment closedNCT0110467503/22/2013
ENMD
1.92ENMD-2076Cancer - Ovarian Clear Cell CarcinomasPhase 2Phase 2 initiated Oct 201311/02/2013
ENMD
1.92MKC-1Cancer - NSCLCPhase 2Need funding to continue04/26/2013
ENMD
1.92MKC-1Cancer - PancreaticPhase 2Need funding to continue04/26/2013
ENTA
33.13ABT-450HCV - genotype 1Phase 3Ongoing. NDA filing due early 2Q 2014NCT0170475502/02/2014
ENTA
33.13Co-Pilot -ABT-450/r plus ABT-333 plus weight-based ribavirinHCV genotype 1, non-cirrhotic patientsPhase 2Ongoing03/22/2013
ENTA
33.13Navigator - ABT-450/r with Abbott’s NS5A inhibitor ABT-267 with and without ribavirinHCV Phase 2OngoingNCT0145853503/22/2013
ENTA
33.13Aviator - ABT-450/r in various combinationsHCV genotype 1 non-cirrhotic patientsPhase 2bPhase 2b data released Apr 2013NCT0146482704/24/2013
ENZY
19.36VayarolHypertriglyceridemiaPhase 2Phase 3 planned12/15/2013
EPZM
19.98EPZ-5676Mixed lineage leukemia, or MLL-rPhase 1Phase 1 initiated Sep 2012NCT0168415005/31/2013
EPZM
EPZ-6438Non-Hodgkin lymphoma - EZH2 point mutationPhase 1/2Initiated Phase 1/2 Jun 201306/14/2013
ESPR
ETC-1002-007HypercholesterolemiaPhase 2aTop-line data released Sept 03 201309/04/2013
ESPR
13.82ETC-1002-008HypercholesterolemiaPhase 2bPhase 2b initiation Oct 2013. Data due 4Q 201403/06/2014
ESPR
13.82ETC-1002-009HypercholesterolemiaPhase 2b Data due 4Q 201403/06/2014
ETRM
1.63VBLOCObesityPMAPMA filed June 2013 despite not meeting endpoints. Adcom meeting June 17 201403/11/2014
EVOK
6.66EVK-001Recurrent diabetic gastroparesis in women with diabetes mellitusPhase 3Phase 3 initiation due 1H 2014. Data due mid 201503/26/2014
EXAS
12.44CologuardCancer - Colorectal DNA testPivotalData of DeeP-C clinical trial for Cologuard released Apr 2013. PMA filed in full Jun 7 2013. Postive Adcom vote 10-0 Mar 27 201403/28/2014
EXEL
3.32XL184 cabozantinibCancer - OvarianPhase 206/06/2011
EXEL
3.32XL184 cabozantinibCancer - NSCLCPhase 2Phase 2 initiated Jul 2012NCT0163950807/27/2012
EXEL
3.32Cabozantinib Plus AbirateroneChemotherapy-Naïve Patients with Metastatic Castration-Resistant Prostate CancerPhase 2Phase 2 initiated Dec 201312/03/2013
EXEL
3.32XL184 cabozantinibCancer - Castration-Resistant Prostate CancerPhase 3Initiated COMET-1 Phase 3 Dec 2011, not under SPA. Data due 2014NCT0160522703/26/2014
EXEL
3.32XL184 cabozantinibCancer - Castration-Resistant Prostate CancerPhase 3Data Phase 3 1H 2014 - COMET-2 trial not under SPANCT0152244308/05/2012
EXEL
3.32XL184 cabozantinibCancer - Medullary thyroid ApprovedApproved Nov 29 201211/30/2012
EXEL
3.32VemurafenibCancer - malignant melanomaPhase 3Phase 3 initiated Jan 2013. Data due 2014NCT0168951910/31/2013
EXEL
3.32XL184 cabozantinibCancer - metastatic renal cell cancer (RCC)Phase 3Phase 3 initiated May 201305/31/2013
EXEL
3.32XL184 cabozantinibCancer - advanced hepatocellular cancer (HCC)Phase 3Phase 3 initiated Sept 201309/11/2013
FATE
7.25ProHema Adult hematologic malignanciesPhase 2Phase 2 data due mid-2015. Interim data due 2H 201403/19/2014
FATE
7.25ProHemaLysosomal Storage DisordersPhase 2Phase 2 to be initiated 2H 201403/19/2014
FLML
10.60IFN-Alpha-2b XHepatitis C HCVPhase 2Ongoing04/07/2012
FLML
10.60Bloxiverz (neostigmine methylsulfate)Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgeryPDUFAApproved Jun 306/05/2013
FLML
??????PDUFAPDUFA April 28 201409/12/2013
FOLD
1.82Migalastat co-administered with enzyme replacement therapy (ERT) 013Fabry Disease Phase 218-month clinical data from Study 012 due 2H14 NCT0119687101/19/2014
FOLD
1.82AT2220/ERT enzyme replacement therapy (010)Pompe DiseasePhase 2NCT01380743
FOLD
1.82migalastat HCl monotherapy (011)Fabry DiseasePhase 3 6 month data released Dec 2012 did not show statistical significance. 12/24 month data due 2Q 2014NCT0092530112/07/2013
FOLD
1.82Migalastat HCl monotherapy (012)Fabry DiseasePhase 3Initiated Phase 3 Study 012 Fabry disease Sept 2011. Target enrolment reached as of Oct 2012. Data due 2H 2014.NCT0121865912/07/2013
FPRX
14.64FP-1039FGFR1Phase 1bPhase 1b initiated July 2013. Prelim data due 2H 201409/22/2013
FURX
77.12PPD-10558DyslipidemiaPhase 2Data released Dec 2011. Missed endpoint. Cease further development12/09/2011
FURX
77.12JNJ-Q2Community acquired bacterial pneumonia (CABP)Phase 2Enrolment terminated 201103/08/2012
FURX
77.12AlogliptinDiabetes - Type 2ApprovedCRL. NDA resubmitted Jul 27 2012. Approved Jan 25 201301/26/2013
FURX
77.12JNJ-Q2Acute bacterial skin and skin structure infections (ABSSSI)Phase 2Seeking partner for further development09/09/2013
FURX
77.12MuDelta - eluxadolineIrritable bowel syndromePhase 3Data released Feb 2014. Enpoints met. NDA filing due 2Q 2014NCT0155374702/05/2014
GALE
1.86GALE-401Essential Thrombocythemia (ET)Phase 2Phase 2 to be initiated mid 201401/14/2014
GALE
1.86NeuVax (E75) - PRESENTCancer - low-to-intermediate HER2+ breast cancerPhase 3Initiated Phase 3 Jan 2012 under SPANCT0147924401/20/2012
GALE
1.86NeuVax in combination with HerceptinBreast cancerPhase 2bPhase 2b ongoingNCT0157003603/13/2013
GALE
1.86Folate Binding Protein (FBP) vaccineEndometrial and ovarian cancerPhase 2Phase 2 initiated Jan 2014. Enrolment due to completed by the end of 2014.03/18/2014
GERN
1.97GRNOPC1Acute spinal cord injuryPhase 1Discontinued11/15/2011
GERN
1.97ImetelstatCancer - BreastPhase 2Discontinued due to poor PFS data09/11/2012
GERN
1.97ImetelstatCancer - NSCLCPhase 2Not pursuing future development09/11/2012
GERN
1.97GRN1005Cancer - Brain Metastases - breast cancerPhase 2Discontinued12/04/2012
GERN
1.97GRN1005Cancer - Brain Metastases - NSCLCPhase 2Discontinued12/04/2012
GERN
1.97ImetelstatCancer - MyelomaPhase 2Placed on clinical hold Mar 201403/15/2014
GERN
1.97ImetelstatCancer - essential thrombocythemiaPhase 2Placed on clinical hold Mar 201403/15/2014
GERN
1.97ImetelstatMyelofibrosisPhase 2Phase 2 initiation likely to be delayed due to clinical hold03/15/2014
GEVA
79.38Sebelipase alfa (SBC-102)Late onset lysosomal acid lipase deficiency (LAL Deficiency)Phase 3Phase 3 initiated Jan 2013. Data due 3Q 2014NCT0175718403/04/2014
GNVC
2.50TnferadeCancer - PancreaticPhase 3Failed04/26/2013
GTXI
1.36Toremifene 80mgCancer - ProstateCRLDevelopment terminated following CRL03/02/2011
GTXI
1.36GTx-758 CapesarisCancer - ProstatePhase 2Placed on clinical hold. Hold lifted May 2012. Phase 2 trial continued on LOWER doses. Ongoing. Prelim data released Jan 2014NCT0161512001/30/2014
GTXI
1.36Ostarine (Enobosarm (GTx-024)) - POWER 1Cancer - muscle wasting in patients with non-small cell lung cancerPhase 3Failed to meet endpoints. NCT0135548408/22/2013
GTXI
1.36Ostarine (Enobosarm (GTx-024)) - POWER 2Cancer - muscle wasting in patients with non-small cell lung cancerPhase 3Failed to meet endpoints.NCT0135549708/22/2013
GTXI
Ostarine (Enobosarm (GTx-024))ER Positive Metastatic Breast CancerPhase 2Phase 2 initiated Apr 2013. Enrolling. Data due 2Q 2014NCT0161675811/14/2013
GWPH
44.64SativexCancer painPhase 3Phase 3 Initial topline Phase 3 data expected towards the end of 2014NCT0136160703/18/2014
GWPH
SativexMultiple Sclerosis (MS) spasticityPhase 3Phase 3 to be initiated 2H 201403/18/2014
GWPH
44.64GWP42004Type 2 diabetesPhase 2bEstimated completion date 2H 201503/18/2014
GWPH
44.64GWP42003SchizophreniaPhase 2Estimated completion date 2H 201503/18/2014
GWPH
44.64GWP42003Ulcerative colitis.Phase 2aPhase 2 data due mid 2014NCT0156231403/18/2014
GWPH
GWP42002:GWP42003Recurrent Glioblastoma Multiforme (GBM)Phase 1b/2aSafety cohort data expected in 201402/06/2014
HALO
7.55HyQCRLCRL issued Aug 1 201208/05/2012
HALO
7.55Subcutaneous Delivery of Cinryze with rHuPH20Hereditary angioedemaPhase 2bPhase 2 discontinued Aug 2013NCT0175615708/04/2013
HALO
7.55PEGPH20 Cancer - pancreaticPhase 2Placed on clinical hold Apr 2014NCT0183948704/10/2014
HALO
7.55PEGPH20 in combination with modified FOLFIRINOX chemotherapy (mFOLFIRINOX)Cancer - pancreaticPhase 1/2Phase 1/2 initiated Oct 2013NCT0195913901/14/2014
HALO
7.55HTI-501CelluoitePhase 2Phase 2 data due released Jul 2013. Topline data released 1Q 201403/26/2014
HEB
0.33Ampligen CFSCRLCRL Feb 4 2012. Resubmission. More trials required. Intends to appeal02/05/2013
HTBX
5.27HS-110Cancer - NSCLC non-small cell lung cancer Phase 2Phase 2 trial to be initiated 3Q 201404/02/2014
HTBX
5.27HS-410Cancer - bladder cancerPhase 2Phase 1/2 initiated Jan 2014. Dosing commenced March 201403/04/2014
HPTX
24.97RavictiUrea cycle disorders.ApprovedApproved Feb 1 201302/02/2013
HPTX
24.97RavictiHepatic encephalopathyPhase 2Phase 3 to be initiated 2H 2014 or early 201502/26/2014
HRTX
11.23APF530 - SustolPrevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)CRLCRL Mar 28 2013. Refile mid 201404/01/2014
HZNP
13.18LODOTRA (RAYOS)Rheumetoid ArthritisApprovedApproved 7/26/201207/27/2012
ICPT
237.51Obeticholic acid (OCA)Adult nonalcoholic steatohepatitis (NASH) patients. Phase 2Phase 2 Japan trial initiated Jan 2013. Complete 1H 201603/19/2013
ICPT
237.51Obeticholic acid (OCA)Adult nonalcoholic steatohepatitis (NASH) patients. Phase 2FLINT trial stopped early due to strong efficacy Jan 2014. Final results expected July 2014. Phase 3 to be initiated 1H 2015NCT0126549803/16/2014
ICPT
237.51Obeticholic acid (OCA)Primary biliary cirrhosis (PBC) - POISEPhase 3Phase 3 data met endpoint March 2014. NDA to be filed by end of 2014NCT0147352404/16/2014
ICPT
237.51Obeticholic acid (OCA)Portal hypertensionPhase 2Phase 2b to be initiated 2H 201401/10/2014
ICPT
237.51Obeticholic acid (OCA) - OBADIAH1Primary bile acid diarrhea (PBAD)Phase 2Phase 2b to be initiated 2H 2014NCT0158502501/10/2014
IDIX
5.50IDX320Hepatitis C HCVPhase 1/2Discontinues development due to SAE02/10/2011
IDIX
5.50IDX899HIVPhase 2bDiscontinued 201104/07/2012
IDIX
5.50IDX184Hepatitis C HCVPhase 2bDiscontinued to clinical hold02/05/2013
IDIX
5.50IDX719 and simeprevir (TMC435) - HELIX-1 TrialHepatitis C HCVPhase 2Phase 2 initiated May 2013. SVR4 data for patients in Part A of the study released Jan 2014NCT0185260401/14/2014
IDIX
5.50IDX719 and simeprevir (TMC435) - HELIX-2 TrialHepatitis C HCVPhase 2Phase 2 data due 2H 201402/28/2014
IDRA
2.94IMO-2125Treatment-Naïve HCVPhase 2Discontinued 201104/07/2012
IDRA
2.94IMO-2055Cancer - Squamous Cell, Head and NeckPhase 2Phase 2 data released May 2012. Failed to meet endpoints05/04/2012
IDRA
2.94IMO-8400PsoriasisPhase 2Phase 2 initiated Jun 2013. Data due 1Q 201412/08/2013
IDRA
2.94IMO-8400LupusPhase 2Phase 2 to be initiated 2H 2013 assuming funding sourced04/26/2013
IDRA
2.94IMO-8400Waldenström’s MacroglobulinemiaPhase 1/2Phase 1/2 enrolment initiated Dec 201312/05/2013
IMGN
14.21SAR3419Cancer - NHL Non-Hodgkin lymphomaPhase 2bCompletedNCT0079673110/20/2011
IMGN
SAR3419Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients (STARLYTE)Phase 2OngoingNCT0147288702/02/2014
IMGN
SAR3419Acute Lymphoblastic Leukemia (MYRALL)Phase 2OngoingNCT0144017902/02/2014
IMGN
14.21Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) - KadcylaCancer - 2nd-line HER2+ MBCApprovedApproved Feb 22 201302/24/2013
IMGN
14.21IMGN901 lorvotuzumab mertansine - NORTH trialCancer - small-cell lung cancer SCLCDiscontinuedPhase 2 discontinued due to high infection rate Nov 2013NCT0123767811/06/2013
IMGN
14.21Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) - Kadcyla - MARIANNE trialCancer - 1st-line HER2+ Metastatic Breast Cancer Phase 3Phase 3 data due late 2014NCT0112018402/02/2014
IMGN
14.21Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) - Kadcyla GATSBY trialCancer - metastatic HER2+ gastric cancer Phase 3NDA filing due 2015. Data due early 2015NCT0170255802/02/2014
IMMU
3.99Epratuzumab/ RituximabCancer - non-Hodgkin's lymphoma / Follicular LymphomaPhase 2Initial data released Dec 6 2010NCT0055350112/07/2010
IMMU
3.99Clivatuzumab tetraxetanCancer - PancreaticPhase 3Phase 3 initiated Jan 2014NCT0151056101/10/2014
IMMU
3.99Epratuzumab (EMBODY 1)LupusPhase 3Data due 1Q 2015NCT0126236512/14/2013
IMMU
3.99Epratuzumab (EMBODY 2)LupusPhase 3Data due 1Q 2015NCT0126179312/14/2013
IMMU
3.99EpratuzumabCancer - ALLPhase 2Phase 2 initial data presented at ASH 201204/26/2013
IMMU
3.99Epratuzumab in combination with chemotherapy in pediatric patients Cancer - ALLPhase 3Phase 3 planned04/26/2013
IMMU
3.99VeltuzumabCancer - immune thrombocytopenic purpura - ITPPhase 2Updated Phase 1/2 data presented at ASH Dec 201312/10/2013
IMMU
3.99Veltuzumab intravenousCancer - NHL Non-Hodgkin lymphomaPhase 2Phase 3 planned, need funding09/10/2013
IMMU
labetuzumab-SN-38 (IMMU-130) Cancer - colorectal cancerPhase 1/2Phase 1/2 enrolling12/14/2013
IMMU
hRS7-SN-38 (IMMU-132) Solid cancersPhase 2Ongoing12/14/2013
IMMY
6.99Impracor Topical NSAIDPain - anti-inflammatory creamPhase 3Phase 3 initiation delayed08/14/2013
IMUC
1.16ICT-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 early 2015NCT0128055203/15/2014
IMUC
1.16ICT-140Recurrent ovarian cancerPhase 2aPhase 2 planned for 3Q 201403/15/2014
INCY
43.98INCB39110Chronic plaque psoriasisPhase 2Phase 2 data released Oct 201310/06/2013
INCY
43.98INCB7839Cancer - breastPhase 2Discontinued 4Q 201110/28/2011
INCY
43.98INCB18424 ruxolitinibMyelofibrosisApprovedApproved Nov 201111/20/2011
INCY
INCB039110MyelofibrosisPhase 2Phase 2 interim data released Dec 2013NCT0163337212/10/2013
INCY
43.98INCB24360 in combination with ipilimumabCancer - MelanomaPhase 1/2OngoingNCT0160488902/13/2014
INCY
43.98LY3009104 BaricitinibRheumatoid arthritisPhase 3Phase 2b data released Nov 2012. Phase 3 planned for 2H 2012. Patient screening began Oct 2012. Ongoing as of Feb 201402/13/2014
INCY
LY3009104 BaricitinibDiabetic nephropathyPhase 2Phase 2 initiated Aug 2012. Data due 2015NCT0168340902/13/2014
INCY
43.98LY3009104 BaricitinibPsoriasisPhase 2bPhase 2b data due 2014NCT0149063202/13/2014
INCY
43.98INC280 (formerly INCB28060)Advanced hepatocellular carcinomaPhase 2Phase 2 initiated Apr 2013NCT0173782704/30/2013
INCY
43.98INCB18424 ruxolitinibCancer- Children with hematologic malignancies and solid tumorsPhase 1/2OngoingNCT0116416305/03/2013
INCY
43.98Jakafi (ruxolitinib) (RESPONSE)Polycythemia VeraPhase 3Phase 3 data released Mar 2014. sNDA due 2014NCT0124394403/07/2014
INCY
43.98Jakafi (ruxolitinib) (RELIEF)Disease-related symptoms in patients with Polycythemia VeraPhase 3Phase 3 data due mid-201402/13/2014
INCY
INCB18424 ruxolitinibPSTAT3+ Breast CancerPhase 2Initiated Phase 2 2Q 2012. OngoingNCT0156287305/03/2013
INCY
INCB18424 ruxolitinibEstrogen Receptor Positive Breast CancerPhase 2Initiated Phase 2 2Q 2012. OngoingNCT0159421605/03/2013
INCY
INCB18424 ruxolitinib Cancer - PancreaticPhase 3Phase 3 to be initiated 1H 201402/13/2014
INCY
INCB24360Cancer - OvarianPhase 2OngoingNCT0168525502/13/2014
INFI
IPI-926 SaridegibCancer - ChondrosarcomaPhase 2Development stopped due to poor interim data - Jun 201206/19/2012
INFI
10.60IPI-926 SaridegibMyelofibrosis Phase 2Development stopped due to poor interim data - Jun 201206/19/2012
INFI
10.60IPI-145 ASPIRARheumatoid arthritisPhase 2Phase 2 data due 2014NCT0185170702/26/2014
INFI
10.60IPI-145AsthmaPhase 2aPhase 2 data due 2014NCT0165375602/26/2014
INFI
10.60IPI-145Indolent non-Hodgkin lymphomaPhase 2Ongoing02/26/2014
INFI
10.60IPI-145Cancer -CLLPhase 3Ongoing02/26/2014
INFI
10.60Retaspimycin Hydrochloride with docetaxelCancer - NSCLCPhase 2Failed to meet endpoint Sept 2013NCT0136240009/27/2013
INFI
10.60Retaspimycin Hydrochloride with everolimusCancer - NSCLCPhase 2Phase 2 enrolment completed. Does not plan to further developmentNCT0142794609/27/2013
INO
2.67DNA vaccineLeukemia Phase 2Interim Phase 2 data released Dec 2012NCT0133406012/12/2012
INO
2.67(INO-8000)Hepatitis C Phase 2Phase 2 to be initiated later in 201301/10/2013
INO
2.67VGX-3100Cervical dysplasiaPhase 2Data due mid 2014NCT0130452403/18/2014
INO
2.67DNA vaccineHepatitis C Phase 2Interim Phase 2 data released Apr 2013 - did not show a statistically significant difference - FAIL04/03/2013
INSM
12.53IPLEXMMD - Myotonic muscular dystrophy Phase 2Announced early 2012 - no longer priority04/07/2012
INSM
12.53ARIKACE (CLEAR-108)cystic fibrosisPhase 3 Phase 3 Euro data released 1 July 2013. Met endpoint but slighly inferior data to competitionNCT01315691 (US trial - not Euro)07/02/2013
INSM
12.53ARIKACE (TARGET-NTM)Non-tuberculous Mycobacterial Lung DiseasePhase 2Clinical hold lifted Jan 2012. Topline data released March 26 2014. Missed primary endpoint. Met key secondary endpointNCT0131523603/27/2014
INSV
0.18BromSite (ISV-303) Pain after cataract surgeryPhase 3Phase 3 data released Dec 2013. NDA filing due 2H 2014NCT0180854703/28/2014
IPXL
24.31IPX056Multiple Sclerosis Phase 3Second Phase 3 trial on hold12/21/2011
IPXL
24.31IPX066Parkinson's NDACRL Jan 21 2013. NDA resubmitted April 11 201404/16/2014
IPXL
24.31 IPX159Restless LegsPhase 2bFailed to meet endpoints. Discontinues development02/27/2013
IRWD
10.61Linaclotideirritable bowel syndrome with constipation (IBS‐C).ApprovedApproved Aug 30 201208/31/2012
IRWD
10.61IW-9179Functional dyspepsiaPhase 2aOngoingNCT0171241210/21/2012
IRWD
10.61 IW-3718 Gastroesophageal reflux disease (GERD) Phase 2aPhase 2a initiated March 2014. Data due 1H 201503/19/2014
ISIS
34.57Mipomersen (KYNAMRO)Homozygous familial hypercholesterolemia (HoFH)ApprovedApproved Jan 29 201301/30/2013
ISIS
34.57ISIS-TTRRxFamilial amyloid polyneuropathyPhase 2/3Phase 2/3 trial initiated early 201202/20/2013
ISIS
34.57ISIS-SMNRxChildren with spinal muscular atrophy (SMA)Phase 2Phase 2 topline data released Feb 2014. Phase 3 to be initiated by the end of 2014NCT0183965602/22/2014
ISIS
34.57ISIS-APOCIIIRxType 2 diabetes and high triglyceride levelsPhase 2Data released Jun 2013NCT0164730806/24/2013
ISIS
34.57ISIS-APOCIIIRxHigh triglyceridesPhase 2Phase 2 data released July 22 2013. Phase 3 to be initiated 2014NCT0152942404/01/2014
ISIS
34.57ISIS-CRPRx (ASET)Atrial fibrillationPhase 2Initiated Feb 2013. Data due 1H 2014NCT0171085208/06/2013
ISIS
34.57ISIS-CRPRxRheumatoid arthritisPhase 2Discontinued following disappointing Phase 2 data Aug 2013NCT0141410108/08/2013
ISIS
34.57ISIS-EIF4ERx Combination With CarboplatinCancer - NSCLCPhase 2NCT0123403804/27/2013
ISIS
34.57ISIS-EIF4ERxCancer - ProstatePhase 2NCT0123402504/27/2013
ISIS
34.57ISIS-FXIRxClotting disorders in patients undergoing knee replacement surgeryPhase 2NCT0171336104/27/2013
ISIS
34.57ISIS-GCCRRx Type 2 diabetes who are also on metforminPhase 204/27/2013
ISIS
34.57ISIS-GCGRRx Type 2 diabetes who despite taking metformin have uncontrolled glucose levelPhase 204/27/2013
ISIS
34.57ISIS-PTP1BRxType 2 diabetesPhase 204/27/2013
ISIS
34.57TG-1101Cancer - hepatocellular carcinoma (HCC)Phase 1/2Phase 2 initiated May 2013NCT0183960405/07/2013
ISIS
34.57LY2181308Cancer - Acute myeloid leukemia AMLPhase 2Discontinued 201204/27/2013
ISIS
34.57OGX-427 Cancer - metastatic CRPCPhase 2NCT0112047004/27/2013
ISIS
34.57OGX-427 in combination with ZytigaCancer - metastatic CRPCPhase 2Initiated Phase 2 late Dec 2012NCT0168143304/27/2013
ISIS
34.57iCo-007Diabetic macular edemaPhase 2NCT0156514804/27/2013
ISIS
34.57OGX-427 in combination with gemcitabine and cisplatin Borealis-1Cancer - bladderPhase 2Phase 2 data due 2H 2014NCT0178054509/12/2013
ISIS
OGX-427 Borealis-2Cancer - Relapsed or Refractory Metastatic Bladder CancerPhase 2Phase 2 initiated Apr 2013NCT0178054505/01/2013
ITMN
28.31Pirfenidone - ASCENDIdiopathic pulmonary fibrosisPhase 3Phase 3 data met endpointsNCT0136620902/26/2014
KBIO
2.36KB001-ACystic fibrosis (CF) patients with chronic Pseudomonas aeruginosa (Pa) lung colonizationPhase 2Phase 2 data due 4Q 2014NCT0169534303/15/2014
KBIO
2.36Pa ventilator associated pneumonia (VAP)Phase 2bPhase 2b trial to be initiated 2Q 201503/15/2014
KBIO
2.36KB003Severe asthma patients inadequately controlled by corticosteroidsPhase 2Phase 2 data released Jan 2014. Failed to reach endpointNCT0160327701/30/2014
KBIO
2.36KB004MDS and AMLPhase 2Phase 2 initiated Feb 2014. Top-line Data due 2Q 201503/15/2014
KERX
13.92PerifosineCancer - ColorectalPhase 3Primary endpoint not met Apr 201204/03/2012
KERX
13.92PerifosineCancer - MyelomaPhase 3 Returned license to AEZS. AEZS plans to continue development. Failed05/08/2012
KERX
13.92ZerenexHyperphosphatemiaPDUFAPDUFA Jun 7 201410/22/2013
KERX
13.92ZerenexNon-Dialysis Dependent Chronic Kidney DiseasePhase 2Phase 2 initiated Nov 2012, study completion expected in 3Q 2013NCT0173639708/01/2013
KMDA
14.32Inhaled formulation of AATAATDPhase 2Phase 2 planned in US in 201308/04/2013
KMDA
14.32Inhaled formulation of AATAATD - Alpha-1 Antitrypsin deficiencyPhase 2/3EU Phase 2/3 data due early 201410/30/2013
KMDA
14.32GlassiaPediatric patients newly diagnosed with type 1 diabetesPhase 2/3Phase 2/3 initiated Mar 201403/06/2014
KMDA
14.32KamRABProphylaxis of rabies diseasePhase 2/3Phase 2/3 initiated by partner Kedrion 2Q 201305/31/2013
KPTI
32.40SelinexorCancerPhase 1Phase 2/3 to be initiated 1H 201412/15/2013
KPTI
32.40SelinexorCancer - solid tumor malignanciesPhase 1Phase 2 to be initiated early 201412/15/2013
KYTH
36.28ATX-101 Reduction of Localized Subcutaneous Fat in the Submental AreaPhase 3Phase 3 data released Sep 2013. Endpoints met. NDA filing due 2Q 2014NCT0154203403/18/2014
LGND
62.90 Kyprolis (Carfilzomib)Cancer - multiple myelomaApprovedApproved Jul 2012. Partnered with ONXX07/21/2012
LGND
62.90Promacta/RevoladeThrombocytopenia (low blood platelet counts) in patients with chronic hepatitis CApprovedsNDA approved Nov 19 201211/20/2012
LGND
62.90Captisol-Enabled MelphalanCancer - multiple myelomaPivotalPhase 2 data released Nov 2011, initiated pivotal trial Dec 2012. Enrolment completed Oct 2013. NDA planned mid 2014NCT0166063312/08/2013
LGND
62.90Bazedoxifene/Conjugated Estrogens (BZA/CE), formerly known as APRELAMenopausal symptomsApprovedApproved Oct 3 201310/06/2013
LGND
62.90Merck Captisol ProgramUndisclosedPhase 3Expect Merck to potentially file a 505(b)(2) in 201304/27/2013
LGND
62.90Captisol-enabled Clopidogrel - MDCO-157Phase 3Phase 3 planned by MDCO04/27/2013
LGND
62.90DinaciclibRefractory chronic lymphocytic leukemia (CLL)Phase 2b/3Phase 2b/3 trial initiated Oct 2012NCT0158022804/27/2013
LGND
62.90MEDI-528Asthma Phase 2Ongoing04/27/2013
LGND
62.90PromactaOncology-related thrombocytopenia in patients with solid tumors, Myelodysplastic Syndrome (MDS), or Secondary Acute Myeloid Leukemia (AML) after MDSPhase 2Ongoing04/27/2013
LGND
62.90PromactaAplastic AnemiasNDAsNDA filed Feb 28 2014NCT0170316903/03/2014
LGND
62.90MK-8931Mild-to-moderate Alzheimer's diseasePhase 2/3Phase 2/3 initiated by Merck in Dec 2012NCT0173934804/27/2013
LGND
62.90Captisol-enabled Carbamazepine-IVAcute seizure disorderPhase 3Phase 3 ongoing04/27/2013
LGND
62.90Captisol-enabled DelafloxacinAcute bacterial skin and skin structure infections (ABSSSI)Phase 3Phase 3 initiated by Rib-X Pharmaceuticals May 201305/15/2013
LGND
62.90LGD-4033Muscle wasting associated with cancer (cachexia), acute rehabilitation (e.g. hip fracture), and acute illness.Phase 2Phase 2 pending04/27/2013
LJPC
9.14GCS-100Chronic kidney diseasePhase 2Phase 2 data due March 201402/22/2014
LMNX
17.28MK-8931Alzheimer’s DiseasePhase 2/3Phase 1/2 ongoing by MRKNCT0173934803/31/2013
LPTN
4.57iSONEPWet-AMDPhase 2Phase 2 initiated Sep 2012. Expects to complete dosing 1H 2014. Data due 3Q 2014NCT0141415310/09/2013
LPTN
4.57ASONEPRenal cell carcinoma (RCC)Phase 2aPhase 2a initiated dosing May 23 2013NCT0176203305/24/2013
LXRX
1.55LX1032 Telotristat etiprateCarcinoid SyndromePhase 3Phase 3 initiated Sep 2012. OngoingNCT0167791005/11/2013
LXRX
1.55LX1032 Telotristat etiprateUlcerative colitisPhase 2OngoingNCT0145605205/11/2013
LXRX
1.55LX2931RA + autoimmune diseasesPhase 2Phase 2 Data did not achieve statistical significance 201004/27/2013
LXRX
1.55LX4211DiabetesPhase 2bPhase 2b data released Jun 2012. Phase 3 planned05/11/2013
LXRX
1.55LX4211Patients with type 2 diabetes and moderate to severe renal impairmentPhase 2Phase 2 data released Sept 2013. Met endpoint02/10/2013
MACK
4.50MM-111Cancer - gastricPhase 2Phase 2 initiated July 2013NCT0177485107/22/2013
MACK
4.50MM-121Cancer - ovarianPhase 2Missed endpoint Oct 2013NCT0144770611/02/2013
MACK
4.50MM-121Cancer - NSCLCPhase 2Endpoint not met Nov 2013NCT0099412311/09/2013
MACK
4.50MM-121 Cancer -hormone receptor positive breast cancerPhase 2Data released Nov 2013NCT0115104611/27/2013
MACK
4.50MM-121 Cancer - triple negative breast cancer cohort in the neoadjuvant settingPhase 2Phase 2 data due 2Q 201402/28/2014
MACK
4.50MM-398 NAPOLI-1Cancer - second line pancreaticPhase 3Phase 3 data due 2Q 2014NCT0149450602/28/2014
MACK
4.50MM-398Cancer - ColorectalPhase 2Ongoing04/27/2013
MDCO
24.90MDCO-2010Reduction of blood loss during surgeryPhase 2bPhase 2b discontinued due to safety10/21/2012
MDCO
24.90CangrelorReduction of thrombotic cardiovascular events including stent thrombosis (events related to blood clots in a stent, a device inserted to keep the artery open) in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI).PDUFAPDUFA April 30 2014. Adcom meeting Feb 12 2014 recommended against approval02/13/2014
MDCO
24.90OritavancinABSSSIPDUFAPDUFA August 6 2014 under priority reviewNCT0125273202/20/2014
MDCO
24.90FibrocapsHemostasisPDUFAPDUFA January 31, 2015.04/04/2014
MDCO
24.90Angiomax (bivalirudin) Peripheral endovascular intervention (PEI)Phase 3Phase 3 enrolment commenced Oct 201310/11/2013
MDCO
24.90IONSYSAcute postoperative painsNDAsNDA to be filed 1H 201403/18/2014
MDGN
6.45INFRADUREHepatitis C HCVPhase 1/2Two Phase I/II trials in Israel commenced enrolment Jan 201301/31/2013
MDGN
6.45Erythropoietin ("EPO") therapy delivered via EPODURE BiopumpAnemiaPhase 2Phase 2 US trial to be initiated 2H 2013NCT0155551504/26/2013
MDVN
58.84DimebonAlzheimer's diseasePhase 3Phase 3 fail. Development discontinued.01/17/2012
MDVN
58.84DimebonHuntington diseasePhase 3Topline HORIZON trial data released Apr 11 2011. FAILED. Discontinued06/28/2012
MDVN
58.84Enzalutamide Androgen receptor positive, triple-negative breast cancerPhase 2Phase 2 initiated June 201309/15/2013
MDVN
58.84EnzalutamideAdvanced Breast Cancer That Is Estrogen or Progesterone Receptor Positive and HER2 NormalPhase 2Phase 2 initiated Dec 201312/08/2013
MDVN
58.84MDV3100Cancer - prostate 2nd lineApprovedApproved Aug 31 201209/02/2012
MDVN
58.84MDV3100 enzalutamide PREVAILCancer - advanced prostate cancer who have not previously been treated with chemotherapyPhase 3Endpoints met October 2013. Final results released Jan 2014NCT0121299101/29/2014
MDVN
58.84MDV3100 cf Bicalutamide STRIVE trialCancer - prostate enrolling both metastatic and non-metastatic patientsPhase 2Initiated Aug 2012NCT0166492304/27/2013
MDVN
58.84MDV3100 cf Bicalutamide TERRAIN trial Cancer - prostate enrolling only metastaticPhase 2Initiated Mar 2011, enrolling NCT0128891104/27/2013
MDVN
58.84 Enzalutamide PROSPERNon-Metastatic Castration-Resistant Prostate CancerPhase 3Phase 3 initiated Nov 201312/08/2013
MEIP
8.65Pracinostat in combination with VidazaElderly patients with newly diagnosed acute myeloid leukemia (AML)Phase 2Preliminary data from this open-label trial is anticipated by December 2014.01/15/2014
MEIP
8.65Pracinostat and Vidaza or DacogenRefractory Myelodysplastic SyndromePhase 2Preliminary data from this open-label trial is anticipated by December 2014.01/15/2014
MEIP
8.65Pracinostat in combination with Vidaza First line intermediate-2 or high-risk Myelodysplastic SyndromePhase 2Enrolment due to be completed by June 2014, with topline data expected by December 201401/15/2014
MELA
0.52MelafindCancer - melanoma detectionApprovedApproved Nov 201111/05/2011
MGNX
20.21Margetuximab (MGAH22)Cancer - Advanced gastroesophageal Phase 3Phase 3 to commence 2H 201403/23/2014
MGNX
20.21Margetuximab (MGAH22)Cancer - metastatic breast cancerPhase 2aEnrolling. Data due 201411/14/2013
MGNX
20.21MGA271CancerPhase 2Phase 2 to be initiated by early 201510/23/2013
MNKD
6.39AFREZZA Type 1/2 diabetesPDUFACRL received Jan 19, 2011. New PDUFA date extended to July 15 2014. Adcom April 1 2014 voted in favour of approval (13-1 and 14-0)NCT01445951 (171 trial)04/08/2014
MNOV
1.86MN-166Methamphetamine dependencePhase 2Funded by NIDA09/15/2013
MNOV
1.86MN-221Acute Asthma and COPDPhase 2Prelim data released May 2012. Failed to reach meet endpoint. Further development dependent on partnership and meeting with FDA in Oct 201309/15/2013
MNOV
1.86MN-166Progressive multiple sclerosis (progressive MS).Phase 2bPh2b initiated Jul 2013. Data due 201607/21/2013
MNOV
1.86MN-166Chronic medication overuse headache (MOH) painPhase 2Phase 2 to be completed mid 201304/27/2013
MNOV
1.86MN-166Opioid AbusersPhase 2aPhase 2a initiated Nov 2012. To be completed mid-2014 and followed by a Phase 2 trial in opioid dependence04/27/2013
MNOV
1.86MN-001NASH (nonalcoholic steatohepatitis)Phase 2Phase 2 planned01/15/2014
MNTA
11.56Generic CopaxoneMultiple sclerosisaNDAFiled 2007. FDA still reviewing05/01/2013
MNTA
11.56M402Cancer - advanced metastatic pancreatic cancerPhase 1/2Initiated Phase 1/2 proof of concept trial Jul 2012. Data from Part A of trial due 1H 2014NCT0162124302/11/2014
MSTX
0.55ExelbineCancer - NSCLCCRLCRL Aug 2011. Discontinued10/04/2011
MSTX
0.55ANX-188Sickle cell diseasePhase 3Phase 3 initiated Jan 2013. Expect to complete enrolment by end of 2015NCT0173781401/09/2014
MSTX
0.55ANX-188Complications of arterial disease, initially as an adjunct to thrombolytics in acute limb ischemia (ALI)Phase 2Initiated Phase 2 March 2014.03/27/2014
MSTX
0.55ANX-514 (docetaxel)Cancer - chemo alternative to TaxotereDiscontinued 201204/27/2013
NAVB
1.66LymphoseekHead and Neck CancerPDUFAPDUFA Jun 16 2014NCT0091132602/20/2014
NAVB
1.66LymphoseekLymphatic-tissue tracing agentApprovedApproved Mar 13 201303/14/2013
NAVB
1.66NAV4694Cerebral Beta-Amyloid When Compared With Postmortem HistopathologyPhase 3Phase 3 enrloment commenced Jun 2013NCT0188682003/28/2013
NAVB
1.66NAV4694Predicting 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. NCT0181221302/07/2014
NAVB
1.66NAV5001 Imaging Agent for Parkinson’s DiseasePhase 3Phase 3 initiated Dec 201312/08/2013
NBIX
13.84Urocortin 2Cardiovascular diseasesPhase 2Phase 2 data released May 2012. Partner required for further development05/18/2012
NBIX
13.84Elagolix Uterine FibroidsPhase 2bPhase 2b initiated Mar 2013. Ongoing as of Feb 2014NCT0181753002/07/2014
NBIX
13.84Elagolix - Violet Petal StudyEndometriosisPhase 3Initiated Phase 3 Jun 2012.Data due Mar 2014. NDA filing expected 2016. NCT0162052803/28/2013
NBIX
ElagolixEndometriosisPhase 3Second Phase 3 trial initiated Aug 2013. Topline data due 3Q 2014. Due to be completed 2015. NDA filing 201608/31/2013
NBIX
13.84 VMAT2 NBI-98854 - Kinect Tardive dyskinesiaPhase 2Failed to meet primary endpoint in Phase 2b trial - Sept 2013.NCT0168803709/10/2013
NBIX
13.84VMAT2 NBI-98854 - Kinect 2Tardive dyskinesiaPhase 2Second Phase 2b trial met endpoint Jan 2014. Phase 3 to be initiated 2H 2014NCT0173312102/07/2014
NBS
6.66AMR-001Left ventricular dysfunction following acute ST segment elevation myocardial infarction (STEMI)Phase 2Phase 2 initial data due 3Q 201401/07/2014
NBY
1.00Auriclosene (NVC-422)Urine infectionPhase 2Phase 2 Topline Data released 3QNCT0124312508/06/2013
NBY
1.00Auriclosene (NVC-422)Viral conjunctivitisPhase 2Initiated Phase 2b May 2012. Data due mid 2014NCT0153233603/09/2014
NBY
1.00Auriclosene (NVC-422)Impetigo skin infection studyPhase 2bFailed to meet endpoint Nov 2013. Plans to reinitiate trial in 2014NCT0167003212/20/2013
NKTR
11.05Etirinotecan pegol NKTR-102 (BEACON)Cancer - Metastatic Breast CancerPhase 3Phase 3 initiated Dec 2011. Enrolment completed July 2013. Interim analysis completed Jan 2014. Topline data due early 2015NCT0149210102/27/2014
NKTR
11.05Etirinotecan pegol NKTR-102Cancer - NSCLCPhase 2Phase 2 initiated Feb 2013NCT0177310902/06/2013
NKTR
11.05Etirinotecan pegol NKTR-102Cancer - relapsed or refractory Small-Cell Lung Cancer (SCLC)Phase 2Phase 2 initiated Oct 201310/25/2013
NKTR
11.05NaloxegolOpioid-induced constipation (OIC)PDUFAPDUFA Sept16 2014. Anesthetic and Analgesic Drug Products Advisory Committee meeting June 11-12, 2014. 03/18/2014
NKTR
11.05Inhaled Amikacin Solution (BAY41-6551T)Gram-Negative Pneumonia (INHALE 1)Phase 3Phase 3 data due 2015NCT0179999312/08/2013
NKTR
11.05Etirinotecan pegol NKTR-102Cancer - ovarianPhase 2Completed Dec 2012. Considering future development09/18/2013
NKTR
11.05Etirinotecan pegol NKTR-102Cancer - colorectalPhase 2EnrolingNCT0085637504/27/2013
NKTR
11.05NKTR-181Chronic painPhase 2Missed endpoint Sept 2013 but Phase 3 planned for mid-2014NCT0161983911/09/2013
NKTR
11.05 BAX 855 PEGylated Factor VIII therapyPhase 3Baxter initiated Phase 3 Feb 2013. Data and BLA filing due late 2014NCT0173647511/14/2013
NKTR
11.05Cipro 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.NCT0176484104/27/2013
NKTR
11.05FovistaWet-AMDPhase 3Phase 3 initial topline data due 201601/23/2014
NKTR
11.05REGULATE-PCI - REG1percutaneous coronary intervention (PCI)Phase 3First of three Phase 3 interim analyses due 2Q 2014. Second analysis due end of 3Q 2014. Partnered with RGDO02/02/2014
NLNK
21.09Indoximod in combination with docetaxelCancer - breastPhase 2Phase 2 initiated Apr 2013. Ongoing as of March 2014NCT0179205003/12/2014
NLNK
21.09HyperAcute LungCancer - NSCLCPhase 2b/3Initiated Phase 2b/3 Oct 2012, ongoing as of March 2014NCT0177457803/12/2014
NLNK
21.09HyperAcute Melanoma - dorgenmeltucel-LCancer - melanomaPhase 1b/2Planning03/12/2014
NLNK
21.09HyperAcute Pancreas - IMPRESSSurgically resected pancreatic cancerPhase 3Enrloment completed Sept 2013. First of two interim analyses completed March 2014. Trial to continue as planned.NCT0107298103/09/2014
NLNK
Sipuleucel-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 2014NCT0156092303/12/2014
NPSP
24.85GATTEXShort Bowel Syndrome ApprovedApproved Dec 21 201212/23/2012
NPSP
24.85GATTEXShort Bowel Syndrome - seeking additions to labelPDUFAPDUFA Jun 28 201411/14/2013
NPSP
24.85NatparaHypoparathyroidismPDUFAPDUFA Oct 24 201401/08/2014
NPSP
NPSP795 Autosomal dominant hypocalcemia or ADHPhase 2Aim to be initiated Phase 2 mid 201408/09/2013
NSPR
2.36MGuardSTEMI - ST segment elevation myocardial infarctionInvestigational Device Exemption (IDE) support trialMaster 12-month data due 4Q 201308/18/2013
NSPR
2.36MGuardSTEMI - 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
4.05RSV vaccineRespiratory Syncytial Virus (RSV)Phase 2Initiated Phase 2 trials Sept 2012. Topline data released Apr 201304/03/2013
NVAX
4.05RSV vaccineRespiratory Syncytial Virus (RSV) in women of childbearing age.Phase 2Phase 2 dosing initiated Oct 201310/08/2013
NVAX
4.05Seasonal Influenza VaccineSeasonal FluPhase 2Further Phase 2 trials planned09/18/2013
NVGN
3.95Intravenous ME-143Cancer - triple-negative breast cancerPhase 2Phase 2 enrolling04/27/2013
NWBO
5.70DCVaxCancer - Glioblastoma multiforme (GBM) brain cancerPhase 3First trigger for interim analysis hit. Feedback due from DMC in late January/early February. Topline data due 1H 2015 as per Jan 2014 conferenceNCT0004596801/30/2014
NWBO
5.70DCVaxCancer - inoperable solid tumor cancersPhase 1/2Ongoing01/28/2014
NYMX
5.26NX-1207Cancer - low grade localized prostatePhase 2Phase 2 recruitment ccompleted Jan 13 2014. Enrolment to be completed shortly. Initial data due 6-8 weeks following completion of enrolment (estimate early 2Q 2014)NCT0162051501/29/2014
NYMX
5.26NX-1207 (NX02-0018)BPH Phase 3Phase 3 data due 2Q 2014NCT0094549001/29/2014
OCRX
8.83OCR-002 (IV)Hepatic encephalopathyPhase 2bPhase 2b planned to start by end of 201311/07/2013
OCRX
8.83OCR-002 (oral)Hepatic encephalopathyPhase 2bPhase 2b planned to start 201411/07/2013
OGXI
10.25OGX-427 with PrednisoneCancer - chemotherapy-naive patients with metastatic CRPCPhase 2Phase 2 ongoingNCT0112047011/09/2013
OGXI
10.25OGX-427 in combination with Zytiga - Pacific TrialCancer - castrate-resistant prostatePhase 2Initiated Phase 2 late Dec 2012NCT0168143312/20/2012
OGXI
10.25OGX-427 Borealis-2Cancer - advanced or metastatic bladder cancerPhase 2Phase 2 initiated Apr 2013NCT0178054505/01/2013
OGXI
10.25OGX-427 in combination with gemcitabine and cisplatin Borealis-1Cancer - bladderPhase 2Phase 2 data due 2H 2014NCT0178054503/12/2014
OGXI
10.25Custirsen, in combination with first-line docetaxel chemotherapy SYNERGYCancer - castrate-resistant prostatePhase 3Completed enrolment Nov 2012. Data due mid-2014NCT0118818703/12/2014
OGXI
10.25Custirsen in combination with Jevtana (cabazitaxel)-AFFINITYCancer - castrate-resistant prostate second-linePhase 3Initiated 2nd Phase 3 trial Aug 2012. Enrolment due to be completed by the end of 2014NCT0157865503/12/2014
OGXI
10.25Custirsen ENSPIRITCancer - NSCLCPhase 3Phase 3 initiated Oct 2012. EnrollingNCT0163073303/12/2014
OGXI
OGX-427 in Combination with ABRAXANE plus Gemcitabine - Rainier TrialMetastatic Pancreatic CancerPhase 2Phase 2 initiated Aug 2013NCT0184481708/28/2013
OGXI
OGX-427 and carboplatin and pemetrexed - SpruceTrialNon-squamous, non-small cell lung cancer (NSCLC)Phase 2Phase 2 enrolment commenced Jul 2013NCT0182911308/01/2013
OGXI
OGX-427 plus gemcitabine and carboplatin - Cedar TrialNon-squamous, non-small cell lung cancer (NSCLC)Phase 2Phase 2 planned for 201309/18/2013
OHRP
9.61Squalamine Eye DropsNeovascular (Wet) Age-related Macular Degeneration (AMD)Phase 2Phase 2 interim data due 2Q 2014NCT0167896312/14/2013
OHRP
9.61OHR/AVR118Cancer cachexia.Phase 2Phase 2 data presented Dec 2013NCT0120633512/27/2013
OMER
11.33OMS103HPACL Phase 3Disappointing Data released Mar 201104/01/2011
OMER
11.33OMS103HPPostoperative joint function Phase 3Data released Dec 2012. Missed primary endpoint. 03/19/2013
OMER
11.33OMS302Cataract surgeryPDUFA10/06/2013
OMER
11.33OMS201UrologyPhase 2Phase 2 planning. Company have no plans for 2013, but will resume when they have adequate resources 04/27/2013
OMER
11.33OMER824Huntington diseasePhase 2Phase 2 initiated Feb 2014. Interim data due end of 2014. Final data due 201502/20/2014
OMER
11.33OMER824SchizophreniaPhase 2Phase 2 initiated Sept 2013. Data released Jan 201401/30/2014
OMER
11.33OMS721 Thrombotic microangiopathies (TMAs)Phase 2Phase 2 to be initiated 2Q 201403/15/2014
OMTH
0.00EpanovaTriglyceride levels greater than or equal to 500 mg/dL, or severe hypertriglyceridemiaPhase 3Plan NDA filing mid 2013. To be bought out by AZN05/29/2013
ONCY
1.60REOLYSIN with FOLFOX-6 plus bevacizumabCancer - advanced or metastatic colorectal cancerPhase 2Phase 2 plannedNCT0162254305/04/2012
ONCY
1.60REOLYSIN - intravenous with gemcitabineCancer - PancreaticPhase 2Enrolment completed Oct 2012NCT0099832210/25/2012
ONCY
1.60 REOLYSIN with paclitaxel & carboplatinCancer - Head and NeckPhase 2Data released Apr 2014. Phase 3 plannedNCT0116654204/10/2014
ONCY
1.60Intravenous REOLYSIN with paclitaxel & carboplatinCancer - squamous cell carcinoma of the lung (SCCLC)Phase 2Final data released Sept 2013NCT0099819209/10/2013
ONCY
1.60Intravenous Administration of REOLYSIN in combination with paclitaxel and carboplatinNon-small cell lung with K-RAS or EGFR-activated tumoursPhase 2OngoingNCT0086162704/27/2013
ONCY
1.60Intravenous REOLYSIN in combination with paclitaxel and carboplatinCancer - metastatic melanomaPhase 2Prelim data released May 2013NCT0098446405/23/2013
ONCY
1.60REOLYSIN in Combination with Paclitaxel and CarboplatinCancer - Metastatic Pancreatic CancerPhase 2OngoingNCT0128005804/27/2013
ONCY
1.60REOLYSIN with paclitaxel Cancer - ovarian, fallopian tube or primary peritonealPhase 2OngoingNCT0119926304/27/2013
ONTX
5.67IV rigosertib plus gemcitabine Cancer - metastatic pancreatic cancerPhase 3Phase 3 failed following interim analysis December 2013 12/18/2013
ONTX
5.67IV rigosertibCancer - MDS high riskPhase 3Phase 3 failed to meet endpoints02/20/2014
ONTX
5.67Oral rigosertibCancer - MDS low riskPhase 3Phase 3 under possible SPA to be initiated 2H 201403/12/2014
ONTX
5.67RigosertibCancer - relapsed or metastatic head and neck cancersPhase 2Initiated mid-201309/22/2013
ONTY
2.44Tecemotide - START2Cancer - Stage III Non-Small Cell Lung CancerPhase 3Phase 3 initiated April 201404/08/2014
ONTY
2.44PX-866 in combination with vemurafinibCancer - advanced BRAF-mutant melanoma Phase 1/2Initiated Phase 1 portion of trial May 201206/01/2012
ONTY
2.44StimuvaxCancer - NSCLCPhase 3Phase 3 failed to meet endpoints12/20/2012
ONTY
2.44ONT-10CancerPhase 2Phase 2 planned of 201405/10/2013
ONTY
2.44PX-866Cancer - prostatePhase 2Initiated Phase 2 Sept 2011. Phase 2 data due at ASCO 2013NCT0133108305/18/2013
ONTY
2.44PX-866Cancer - glioblastomaPhase 2Phase 2 data due at ASCONCT0125986905/18/2013
ONTY
2.44PX-866 in combination with docetaxel (Taxotere)Cancer - NSCLC or locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN)Phase 2Phase 2 NSCLC data did not show PFS improvement. SCCHN data due late 2013NCT0120409905/10/2013
ONTY
2.44PX-866 + cetuximab (Erbitux)Cancer - SCCHN or colorectal cancerPhase 2Phase 2 SCCHN data due late 2013, colorectal arm did not meet endpoint May 2013NCT0125262806/01/2013
OPHT
31.83FovistaWet-AMDPhase 3Phase 3 initial topline data due 201612/15/2013
OPK
8.33CTAP101 Capsules - (Rayaldy)Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) and vitamin D insufficiencyPhase 3Phase 3 data due mid 2014. NCT0165100003/04/2014
OPK
8.33Fermagate Tabletshyperphosphatemia in CKD patients on chronic hemodialysisPhase 3Phase 3 data due 1H 201709/12/2013
OPK
8.33hGH-CTPAdults - growth hormone deficiencyPhase 3Initiated Phase 3 Jun 2013. Data due 2H 201509/12/2013
OPK
8.33hGH-CTPChildren - growth hormone deficiencyPhase 3Initiated Phase 2. Expected to end in 2013. Phase 3 data due 1H 2018 (yet to be initiated)NCT0159250009/12/2013
OPK
8.33Factor VIIa-CTPHemophiliaPhase 2Intend to initiate Phase 2 in 201404/27/2013
OPK
8.33Neurokinin-1 (“NK-1”) - Rolapitant (partnered with TSRO)Prevention of chemotherapy induced nausea and vomiting, or CINV Phase 3Primary endpoints met but failed to meet secondary endpoints. Intends to file NDA mid 2014NCT0150022612/24/2013
OPTR
0.00FidaxomicinCDI - diarrheaApprovedFDA Approved May 27 201105/27/2011
OPTR
0.00OPT-822/821Cancer - metastatic breast cancerPhase 2/3Phase 2/3 initiated Dec 2010. OngoingNCT0151630704/27/2013
OPXA
1.51Tovaxin (Tcelna)Secondary Progressive MS (SPMS)Phase 2bPhase 2b initiated Sept 2012. 100 patients enrolled as of Nov 2013. Top-line data mid 2016.NCT0168476112/14/2013
OPXA
1.51Tovaxin (Tcelna)Relapsing Remitting MS (RRMS)Phase 2bFurther development pending funding09/18/2013
OREX
5.38ContraveObesityPDUFACRL Feb 1, 2011. New PDUFA June 10 2014NCT0160170401/08/2014
OREX
5.38EmpaticEpilepsyPhase 2bPhase 3 planned. Needs partner04/27/2013
OSIR
12.80ProchymalDiabetesPhase 2Failed trial Jan 201201/03/2012
OSIR
12.80ProchymalRefractory GvHDTerminatedTerminated Feb 201204/08/2012
OSIR
12.80ProchymalCrohn’s diseasePhase 3Enrollment re-started May '10.OngoingNCT0123396004/27/2013
OSIR
12.80ProchymalAcute myocardial infarctionPhase 2Interim data released Jul 2012. Trial extended for further four yearsNCT0087790304/27/2013
OSIR
GrafixDiabetic Foot UlcersData released Aug 201308/14/2013
OSUR
6.67OraQuickHIV testApprovedApproved Jul 3 201207/03/2012
OXGN
2.98ZYBRESTATCancer - NSCLCPhase 2Concluding development09/01/2011
OXGN
2.98ZYBRESTATCancer - ATC Phase 2/3Concluding development11/10/2012
OXGN
2.98ZYBRESTATCancer - OvarianPhase 2Met primary endpoint March 2014NCT0130521303/12/2014
PATH
0.00Zecuity MigraineApprovedApproved Jan 17 2013. To be acquired by ENDP12/17/2013
PBMD
1.08CVacCancer - ovarianPhase 3Phase 3 initiated Jan 2012. Enrolment halted Sept 2013NCT0152114309/19/2013
PBMD
1.08CVacCancer - resectable pancreatic cancer, metastatic colorectal cancer, and triple-negative breast cancerPhase 2Phase 2 trials planned06/25/2013
PBMD
1.08CVac CAN-003Cancer - ovarianPhase 2Failed Phase 2 Sept 2013NCT0106850909/19/2013
PBYI
72.85PB272Adjuvant treatment for HER2 positive breast cancerPhase 3Phase 3 to data due 1H 201403/04/2014
PBYI
72.85PB272 in combination with temsirolimusFourth line HER2-positive metastatic breast cancerPhase 2Phase 2 additional data due 2H 2014. Phase 3 initiation due 2H 201403/04/2014
PBYI
72.85PB272 HER2-positive metastatic breast cancer that has metastasized to the brainPhase 2Data due 2014NCT0149466203/04/2014
PBYI
72.85PB272 HER2-positive breast cancer first linePhase 2Phase 2 data due 1H 201403/04/2014
PBYI
72.85PB272 Neoadjuvant treatment for patients with HER2-positive breast cancer (NSABP FB-7)Phase 2Phase 2 data due 2H 2014NCT0104237903/04/2014
PBYI
72.85PB272 HER2 mutated non-small cell lung cancerPhase 2Phase 2 data due 2014NCT0182726703/04/2014
PBYI
72.85PB272HER2-negative breast cancer patients who have a HER2 mutationPhase 2Phase 2 interim data due 2014NCT0111182503/04/2014
PCRX
67.72EXPARELPostsurgical painApprovedFDA Approved Oct 201110/31/2011
PCRX
67.72EXPARELSingle-dose injection femoral nerve block for total knee arthroplasty surgeryPhase 2/3Failed second Phase 3 trail Aug 2013 following successful first trial. sNDA filing due 2Q 2014.02/28/2014
PCYC
90.04PCI-27483Cancer - pancreaticPhase 2Phase 2 enrolment completed. Interim data due in 2013NCT0102000604/27/2013
PCYC
90.04IbrutinibCancer - relapsed or refractory follicular lymphomaPhase 2Phase 2 ongoingNCT0177979105/02/2013
PCYC
90.04IbrutinibCancer - relapsed/refractory multiple myeloma (MM)Phase 2Ongoing, expansion of cohorts 1 and 2 is not planned due to the fact that the protocol-defined response rate was not achieved.NCT0147858112/08/2013
PCYC
90.04Ibrutinib Cancer - relapsed or refractory MCL mantle cell lymphomaApprovedApproved Nov 13 2013NCT0164602108/31/2013
PCYC
90.04Ibrutinib Cancer - newly diagnosed CD20 positive non-Hodgkin's lymphomaPhase 1b/2Update at ASCO 2013NCT0156975005/02/2013
PCYC
Ibrutinib - SPARK (MCL2001)R/R MCL who progress after bortezomib therapyPhase 2Enrolment completedNCT0159994908/01/2013
PCYC
90.04Ibrutinib in combination with bendamustine and rituximab - SHINE (MCL3002)Cancer - newly diagnosed MCLPhase 3Janssen plans to enroll 520 patientsNCT0177684002/21/2014
PCYC
Ibrutinib in combination with bendamustine and rituximab - HELIOS (CLL3001)Cancer - Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL/SLL)Phase 3EnrollingNCT0161109002/21/2014
PCYC
Ibrutinib - CLL3002R/R CLL/SLLPhase 3Phase 3 initiated 4Q 201302/21/2014
PCYC
90.04Ibrutinib RESONATE™-17Deletion 17pPhase 2Topline data due 2H 2014NCT0174469102/21/2014
PCYC
90.04Ibrutinib RESONATECancer - Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL/SLL)Phase 3Phase 3 trial met endpoints. NDA filing due 1H 2014NCT0157870701/08/2014
PCYC
90.04Ibrutinib RESONATE -2Cancer - newly diagnosed elderly CLL/SLL patientsPhase 3Phase 3 data due 2H 201502/21/2014
PCYC
90.04Ibrutinib Cancer - Chronic Lymphocytic Leukemia Who Have Received at Least One Prior TherapyPDUFAApproved Feb 12 2014NCT0172248702/13/2014
PFE
30.09Palbociclib (PD-0332991) in combination with letrozoleER+, HER2- locally advanced or metastatic breast cancerPhase 3Received Breakthrough Therapy designation. Phase 3 enrollingNCT0174042704/27/2013
PFE
30.09LyricaPartial Onset SeizuresPhase 3Phase 3 endpoints met04/27/2013
PFE
30.09Bazedoxifene/Conjugated EstrogensSymptoms Associated With Menopause And Prevention Of OsteoporosisPDUFAPDUFA date is Oct 3, 201304/27/2013
PFE
30.09Pregabalin FibromyalgiaPhase 3Endpoint met04/27/2013
PFE
Ertugliflozin (PF-04971729)Type 2 DiabetesPhase 3Partnered with MRK. Phase 3 trials to commence later in 201304/30/2013
PFE
EliquisVTE (venous thromboembolic disorders)PDUFAPDUFA March 15 2014NCT0064320107/13/2013
PGNX
3.56MIP-1404Cancer - prostate cancerPhase 2Phase 2 initiated Oct 2012NCT0166753610/21/2012
PGNX
3.56AzedraPheochromocytomasPhase 2bIntends to restart Phase 2b trialNCT0087461411/27/2013
PGNX
3.56PSMA 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
Oral RelistorChronic, Non-Cancer Pain Subjects with Opioid-Induced ConstipationPhase 3Phase 3 completed. Further progress on hold04/27/2013
PGNX
3.56Subcutaneous RELISTORchronic painCRLCRL Jul 27 2012 - Adcom meeting set for March 10-11 2014 has been POSTPONED02/07/2014
PLDLF
0Impavido Leishmaniasis PDUFAPDUFA Dec 19 2013 priority review 06/30/2013
PLX
4.18TaliglueraseGaucher diseaseApprovedApproved May 1 201205/02/2012
PLX
4.18PRX-102Fabry diseasePhase 1/2Phase1/2 initiated Dec 2012NCT0167889812/10/2012
POZN
8.73PA32540 and PA8140Cardiovascular patients at risk for developing aspirin-associated gastric ulcersPDUFAPDUFA Apr 25 201412/24/2013
PPHM
1.69BavituximabHCVPhase 2Phase 2 prelim data released Dec 2012. Seeking partner to advance program03/11/2012
PPHM
1.69CotaraCancer - GlioblastomaPhase 2Phase 3 planning. Needs partner to advance12/10/2012
PPHM
1.69Bavituximab with gemcitabineCancer - pancreatic Phase 2Patient enrolment completed Jun 2012. Interim data released Feb 2013. Evaluating next stepsNCT0127279102/14/2013
PPHM
1.69BavituximabCancer - Refractory NSCLCPhase 3Interim data released Sept 2012 reported to be faulty. Phase 3 SUNRISE trial initiated Dec 2013NCT0199967312/31/2013
PPHM
1.69Bavituximab plus carboplatin and paclitaxelCancer - front-line NSCLCPhase 2PFS disappointing data released Mar 2013. OS data showed not statistical meaningful improvement. Will not pursue Phase 3NCT0116060106/28/2013
PPHM
1.69 Bavituximab + cabazitaxelCancer - castration-resistant prostate cancerPhase 1/2Discontinued Mar 201304/27/2013
PPHM
1.69BavituximabCancer - LiverPhase 2Phase 2 part of trial is enrollingNCT0126470504/27/2013
PRAN
1.74PBT-2Alzheimer'sPhase 2Phase 2 endpoint not met04/01/2014
PRAN
1.74PBT-2Huntington's DiseasePhase 2Data released Feb 2014NCT0159088802/19/2014
PRGO
143.32Betamethasone Valerate Foam 0.12%Generic equivalent of Luxiq FoamApprovedApproved Nov 201203/29/2013
PSDV
3.56Injectable sustained-release micro-insertPosterior uveitisPhase 3Pivotal trial initiated Jul 2013 (first of two Phase 3 trials)NCT0169418607/02/2013
PSDV
3.56IluvienDiabetic macular edemaPDUFACRL Nov 2011. Second CRL Oct 17 2013. New PDUFA Sept 26 201404/16/2014
PSTI
3.48PLX-PAD (stem cells)CLI - Critical limb ischemia Phase 1/2CompleteNCT0095121009/16/2011
PSTI
3.48PLX cellsBuerger's DiseasePhase 2Phase 2 planned in India08/17/2012
PSTI
3.48PLX-PAD Muscle injuryPhase 1/2Phase 1/2 data released Jan 21 2014NCT0152566701/22/2014
PSTI
3.48PLX-PAD (stem cells)Pulmonary Arterial Hypertension (PAH) Phase 1Phase 1 plannedNCT0179595004/27/2013
PSTI
3.48PLX-PAD (stem cells)Intermittent claudication, or ICPhase 2Phase 2 put on clinical hold Jun 2013. Lifted Sept 2013NCT0167999009/17/2013
PTCT
19.77Ataluren Duchenne muscular dystrophy caused by nonsense mutations (nmDMD)Phase 3Phase 3 confirmatory trial initiated April 2013.Enrolment due to be completed mid 2014. Top-line data due mid 201503/07/2014
PTCT
Ataluren Nonsense mutation cystic fibrosisPhase 3Phase 3 initiation due 201403/07/2014
PTIE
5.19RemoxyChronic painCRLCRL Jun 23, 2011. Resubmission no earlier than mid-201510/23/2013
PTLA
22.96Betrixaban (The APEX Study)Venous thromboembolism (VTE) PreventionPhase 3Complete patient enrollment in APEX by the end of 2015.NCT0158321802/28/2014
PTLA
22.96Andexanet alfa (PRT4445) and XARELTO (rivaroxaban) Reverse the Effects of Several Blood Thinner Drugs on Laboratory TestsPhase 2Phase 2 data released Oct 2013NCT0175843210/15/2013
PTLA
22.96Andexanet alfaFactor Xa inhibitor reversal agentPhase 2Phase 3 initiated March 2014. Data due 4Q 201403/20/2014
PTLA
22.96Cerdulatinib (PRT2070)Refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia.Phase 1/2 Report Phase 1 proof-of-activity data in mid-2014. Report Phase 2a proof-of-concept data in the second half of 2015, including data in hematologic cancer patients with genetically-defined tumors.02/28/2014
PTN
1.12AZD2820ObesityPhase 1Phase 1 halted Jun 2012 due to adverse event. Development discontinued Sep 201209/08/2012
PTN
1.12Bremelanotidefemale sexual dysfunction (FSD)Phase 2bPhase 3 initiation 1H 201412/19/2014
PTN
PL-3994Acute exacerbations of asthmaPhase 2aCompleted04/28/2013
QCOR
78.46ActharAmyotrophic lateral sclerosis (ALS)Phase 2Phase 2 patients screening commenced July 2013. Ongoing as of Feb 201302/26/2014
QCOR
78.46ActharDiabetic NephropathyPhase 2Enrolment ongoingNCT0160123602/26/2014
QCOR
78.46ActharAcute Respiratory Distress Syndrome (ARDS)Phase 2Enrolment to commence soon10/23/2013
QLTI
5.81punctal plug drug deliveryAllergic conjunctivitisPhase 2aData released Feb 2011, trial failed, study stopped02/09/2011
QLTI
5.81QLT091001Impaired Dark Adaptation (IDA)Phase 2aPhase 2a initiated Dec 201312/10/2013
QLTI
5.81punctal plug drug deliveryGlaucomaPhase 2Sold to Mati04/28/2013
QRXPY
3.40MOXDUOModerate to severe acute painPDUFACRL Aug 2013. New PDUFA May 25 2014. Adcom April 22 201403/25/2014
RCPT
35.03RPC1063 -RADIANCERelapsing Multiple Sclerosis (RMS). Phase 2/3Phase 2 Top-line data anticipated in mid-2014. Phase 3 is ongoingNCT0162839303/06/2014
RCPT
35.03RPC1063Ulcerative Colitis (UC) Phase 2Phase 2 top-line data expected in mid-2014NCT0164751603/06/2014
RCPT
RPC4046 Eosiniphilic EsophagitisPhase 2Phase 2 planned03/06/2014
RGDO
6.39REGULATE-PCI - REG1percutaneous coronary intervention (PCI)Phase 3First of three Phase 3 interim analyses due 2Q 2014. Second analysis due end of 3Q 2014. Partnered with RGDO02/02/2014
RGEN
15.40RG2417BipolarPhase 2bData released Mar 2011. FAIL02/09/2011
RGEN
15.40RG1068 - SecreFloPancreatic imagingCRLCRL issued Jun 22 201206/22/2012
RIGL
3.20R333Discoid Lupus ErythematosusPhase 2Failed to reach endpoint Oct 2013. Development to discontinueNCT0159705009/06/2013
RIGL
3.20R343AsthmaPhase 2Failed Phase 2 Aug 2013NCT0159104408/28/2013
RIGL
3.20R348Chronic dry eye diseasePhase 2Phase 2 data due 2H 201401/12/2014
RIGL
3.20R348Chronic dry eye disease - as a result of patients with acute or chronic graft vs. host disease (GvHD)Phase 2Phase 2 initiation due 2Q 201401/12/2014
RIGL
3.20Fostamatinib OSKIRA-1, OSKIRA-2, and OSKIRA-3RA - rheumatoid arthritis Phase 3Phase 3 OSKIRA-1 met one of two endpoints. OSKIRA-2, and OSKIRA-3 disappointing data released Jun 2013. Reeived rights back from AZN following decision not to purse NDA filingNCT0119775506/05/2013
RIGL
3.20Fostamatinib OSKIRA-4Phase 2b monotherapy trialPhase 2Phase 2b trial completed Dec 2012. Met one endpoint, failed to meet the other12/14/2012
RIGL
3.20Fostamatinib Immune Thrombocytopenic Purpura (ITP)Phase 3Phase 3 planned 1H 201401/12/2014
RIGL
3.20FostamatinibIgA nephropathyPhase 2Phase 2 planned for spring of 201401/12/2014
RLYP
22.68PATIROMER (RLY5016)HyperkalemiaPhase 3Phase 3 data released Oct 2013. NDA to be filed 3Q 201401/14/2014
RMTI
10.71Soluble Ferric Pyrophosphate Iron deficiencyPhase 3Phase 3 endpoint met July 2013NCT0132020207/13/2013
RMTI
10.71Soluble Ferric PyrophosphateIron deficiencyPhase 3NDA filed on or about March 24 2014NCT0132234703/25/2014
RNA
4.68DrisapersenDuchenne Muscular Dystrophy (DMD)Phase 3Phase 3 endpoint not met Sept 2013NCT0125401909/21/2013
RNA
4.68PRO044Duchenne Muscular Dystrophy (DMD) patients with a mutation around location 44 in the DNA for the dystrophin proteinPhase 1/2Phase 1/2 to be completed 4Q 2013NCT0103730906/30/2013
RNA
4.68 PRO053DMDPhase 1/2Phase 1/2 initiated Jun 201309/18/2013
RNN
0.96SerdaxinMajor Depressive DisorderPhase 2bFailed to display efficacy12/13/2011
RNN
0.96ArchexinCancer - pancreaticPhase 2aPhase 2 completed 201204/27/2013
RNN
ArchexinCancer - metastatic renal cell carcinoma (RCC)Phase 2Phase 2 initiation Jan 2014. Initial phase to be completed late 201404/11/2014
RNN
0.96ZoraxelErectile DysfunctionPhase 2aPhase 2a complete. Phase 2b development requires partner04/27/2013
RPRX
15.70ProellexEndometriosisPhase 2Phase 2 to resume while on partial clinical hold. Low dose only. Enrollment due to be completed 2Q 2013. Complete 4Q 2013NCT0172845404/27/2013
RPRX
15.70ProellexUterine fibroids (vaginal treatment)Phase 2bEnd of Phase 2 meeting late May 2013. Phase 2b to be initiated 201411/05/2013
RPRX
15.70ProellexUterine fibroids (oral treatment)Clinical holdFull clinical hold. Intends to submit request to lift hold. Likely in 201411/05/2013
RPRX
15.70Androxal Secondary hypogonadismPhase 3Phase 3 topline data due October 2014. NDA filing late 2014. NCT0173959504/16/2014
RPTP
8.50DR CysteamineCystinosisApprovedPDUFA date Apr 30, 2013. 3 month delay08/09/2013
RPTP
8.50ConviviaALDH2Phase 2aPhase 2 completed, seeking partner04/27/2013
RPTP
8.50DR CysteamineHuntington's DiseasePhase 2Topline Phase 2/3 data released Feb 2014 02/21/2014
RPTP
8.50DR CysteamineNon-alcoholic fatty liver disease (NAFLD) in childrenPhase 2bPhase 2b initiated Jun 2012. Enrolment target hit Jan 2014. Data due 1H 2015NCT0152926803/15/2014
RPTP
8.50TezampanelThrombotic DisorderPhase 1Discontinued04/27/2013
RVX
RVX-208 (SUSTAIN trial)Coronary placque removalPhase 2bData released Aug 2012. Endpoints metNCT0142318808/29/2012
RVX
RVX-208 Pre-diabetes mellitus Phase 2Phase 2 initiated Oct 2012, data due mid 2014NCT0172846712/24/2013
RVX
RVX-208 (ASSURE trial)Coronary placque removalPhase 2bFailed to meet endpoint Jun 2013. Futher data presented Jan 2014NCT0106782001/16/2014
SCLN
4.47SCV-07Hepatitis C HCVPhase 2b stoppedData released Dec 2010, discontinues development12/15/2010
SCLN
4.47SCV-07OM - oral mucositis DiscontinuedDiscontinued Mar 2012 03/03/2012
SCMP
6.96LubiprostonePediatric functional constipationPhase 3Phase 3 initiated Dec 2013, with data due early 201612/18/2013
SCMP
6.96Rescula (unoprostone isopropyl) Retinitis pigmentosaPhase 3Phase 3 interim data due early 1Q 201501/14/2014
SCMP
6.96CobiprostoneOral MucositisPhase 1b/2aPhase 1b/2a initiated 4Q 201302/27/2014
SCMP
6.96SPI-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
6.96Amitiza/ LubiprostoneOpioid-induced bowel dysfunctionApprovedApproved Apr 23 201304/24/2013
SCMP
6.96Amitiza/ LubiprostoneChronic idiopathic constipationApprovedApproved 200604/27/2013
SCMP
6.96Amitiza/ Lubiprostone (liquid form)Chronic idiopathic constipationPhase 3Phase 3 due to be completed 1H 201401/14/2014
SGEN
38.57ADCETRISCancer - Anaplastic large cell lymphomaApprovedAPPROVED Aug 19 201108/20/2011
SGEN
38.57ADCETRISCancer - Relapsed & Refractory Hodgkin lymphomaApprovedAPPROVED Aug 19 201108/20/2011
SGEN
38.57ADCETRIS ALCANZACancer - cutaneous T-cell lymphomaPhase 3Initiated May 2012. EnrollingNCT0157849905/08/2012
SGEN
38.57ADCETRIS - AETHERACancer - post-transplant Hodgkin lymphoma (HL) patientsPhase 3Phase 3 data due 2H 2014NCT0110050202/12/2014
SGEN
38.57ADCETRISCancer - for front-line treatment of elderly patients with HLPhase 2Initiated Phase 2 Oct 2012NCT0171680610/21/2012
SGEN
38.57ADCETRIS ECHELON-1Cancer - front-line advanced stage Hodgkin lymphomaPhase 3Phase 3 initiated Nov 2012NCT0171249011/03/2012
SGEN
38.57ADCETRIS ECHELON-2Cancer - front-line mature T-cell lymphomas, including sALCLPhase 3Phase 3 initiated Jan 2013NCT0177715201/25/2013
SGEN
38.57ADCETRIS in combination with bendamustineCancer - second-line HLPhase 1/2Phase 1/2 initiated Jun 2013NCT0187405405/08/2013
SGEN
38.57ADCETRISCancer - CD30-positive non-Hodgkin lymphomaPhase 2Initiated Aug 2011. Interim data released at ASH 2012NCT0142166704/27/2013
SGEN
38.57ADCETRISCancer - CD30-positive Nonlymphomatous MalignanciesPhase 2EnrollingNCT0146153805/25/2013
SGEN
38.57SGN-75Cancer - advanced metastatic renal cell carcinoma (RCC)Phase 1bPhase 1b initiated Aug 2012. OngoingNCT0167739004/27/2013
SGEN
ADCETRIS + Rituxan and standard chemotherapy (R-CHOP) Diffuse large B-cell lymphoma Phase 2Phase 2 initiated August 201308/16/2013
SGMO
CERE-110 Alzheimer's DiseasePhase 2Phase 2 data due 201502/12/2014
SGMO
14.26SB-509-901Diabetic NeuropathyPhase 2bData 4Q 2011 - FAILED10/04/2011
SGMO
14.26SB-728-902HIV/AIDSPhase 2Data presented Dec 2013NCT0104465412/07/2013
SGMO
14.26SB-728-1101HIV/AIDSPhase 2Data presented Dec 2013NCT0154315212/07/2013
SPHS
3.20PRX302Benign prostatic hyperplasia Phase 3PLUS-1 Phase 3 trial initiated October 2013. Enrolment to be completed 2H 201403/15/2014
SGYP
4.40SP-333Opioid-induced constipation (OIC)Phase 2Phase 2 initiated Oct 201311/02/2013
SGYP
4.40PlecanatideConstipation-predominant irritable bowel syndrome (IBS-C).Phase 2bPhase 2b initiated Dec 2012, completed enrollment Dec 2013, topline data beginning of 2Q 2014.NCT0172231803/29/2014
SGYP
4.40PlecanatideChronic idiopathic constipation (CIC)Phase 3Phase 3 initiated Nov 201311/14/2013
SLXP
100.66RELISTOR (methylnaltrexone bromide) - subcutaneous useOpioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain.CRLCRL Jul 27 2012 - Adcom meeting set for March 10-11 2014 has been POSTPONED02/07/2014
SLXP
100.66TARGET 3 - rifaximin 550 mg TIDIrritable bowel syndrome with diarrhea (IBS-D)Phase 3EnrollingNCT0154317805/11/2013
SLXP
100.66EIR rifaximin Crohn’s diseasePhase 3Phase 3 due to be initiated 2H 201305/11/2013
SLXP
100.66Budesonide foamModerate ulcerative proctitis or proctosigmoiditis PDUFAPDUFA September 15 2014NCT0134967301/31/2014
SLXP
100.66RUCONESTHereditary angioedema (HAE)PDUFAPDUFA July 16, 201402/25/2014
SNSS
5.18VoreloxinCancer - Acute myeloid leukemia AMLPhase 3Enrolment expanded following interim Sept 2012 analysis. Data due 3Q 2014NCT0119180103/07/2014
SNSS
5.18VoreloxinCancer - 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
SNSS
5.18VoreloxinAdult patients with previously treated intermediate-2 or high-risk myelodysplastic syndrome (MDS)Phase 1/2Phase 1/2 initiated Oct 201310/29/2013
SNSS
5.18Vosaroxin 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
SNTA
4.04STA-9090 GanetespibCancer - gastrointestinal stromal tumorsPhase 2Data presented at ASCO 201109/17/2011
SNTA
4.04STA-9090 Ganetespib - GALAXY-2Cancer - NSCLCPhase 3Phase 3 trial initiated Apr 2013 with first analysis due 2H 2015, second analysis due 1H 2016NCT0179848503/12/2014
SNTA
4.04ElesclomolCancer - ovarianPhase 2OngoingNCT0088861504/27/2013
SNTA
4.04STA-9090 GanetespibCancer - rectalPhase 2Phase 2 ongoing04/27/2013
SNTA
4.04STA-9090 GanetespibCancer - hepaticPhase 1/2OngoingNCT0166593704/27/2013
SNTA
4.04Ganetespib CHIARA trial Cancer - ALK+ NSCLC patientsPhase 2NCT0156201505/01/2013
SNTA
4.04Ganetespib ENCHANT trialCancer - HER2+ and triple-negative breast cancerPhase 2Update provided March 2014NCT0167745503/23/2014
SNTA
4.04Ganetespib AML-18 trialCancer - AMLPhase 2/3Expect to initiated in 1H 201401/10/2014
SNTA
4.04Ganetespib AML-LI trialCancer - AMLPhase 2/3Interim analysis is expected to be conducted in mid 201403/12/2014
SNTA
4.04Ganetespib AML-19 trialCancer - AMLPhase 2/3Expect to initiated in 2H 201401/10/2014
SNTS
0.00Budesonide - USUlcerative colitis diseaseApprovedApproved Jan 14 2013. 01/15/2013
SNTS
0.00RUCONESTHereditary Angioedema (HAE) attacksPDUFAPDUFA Apr 16 201406/18/2013
SNTS
0.00RifamycinTravelers’ diarrheaPhase 3First Phase 3 trial data released Sept 2012. Second trial protocol has been ammended with 250 patients addedNCT0120892204/27/2013
SNTS
0.00SAN-300Rheumatoid arthritis (RA) Phase 2Phase 2a initiated Dec 201312/24/2013
SOMX
3.00SilenorInsomniaApprovedTo be acquired by PTX12/14/2012
SPEX
1.78D-TagatoseDiabetesPhase 3Development stopped04/08/2012
SPPI
6.88FusilevCancer - ColorectalApprovedApproved Apr 29 201105/01/2011
SPPI
6.88FusilevCancer - Removal of BioscanApprovedApproved Nov 20, 201111/21/2011
SPPI
6.88LucanthonePrimary therapy for Glioblastoma Multiforme (GBM)Phase 2Phase 2 initiated Jul 201207/03/2012
SPPI
6.88OzarelixCancer - prostatePhase 2bPhase 2b initiated Aug 201208/16/2012
SPPI
6.88ZevalinDiffuse Large B-Cell Lymphoma (DLBCL)Phase 3Phase 3 initiated Sep 201205/13/2013
SPPI
6.88ApaziquoneCancer - BladderPhase 3Failed to meet primary endpoint in Phase 3 trial - Apr 2012. NDA possible 201405/10/2013
SPPI
Captisol-enabled, propylene glycol-free (PG-free) melphalanConditioning treatment prior to autologous stem cell transplant for patients with multiple myelomaPhase 3Phase 3 enrolment completed Oct 2013. Phase 3 data due 2Q 2014. NDA filing due mid 2014NCT0166063311/14/2013
SPPI
6.88BelinostatCancer - Peripheral T-Cell LymphomaPDUFAPDUFA August 9 201402/07/2014
SPPI
6.88SPI-2012 (also referred to as "LAPS-GCSF")Chemotherapy-Induced NeutropeniaPhase 2Phase 2 initiated Apr 201304/10/2013
SPPI
6.88BelinostatCancer - 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
6.88SPI-1620Cancer - recurrent or progressive carcinomaPhase 2Phase 2 to be initiated 2H 201304/27/2013
SQNM
2.59SensiGene T21 Laboratory Developed Test (LDT) - MaterniT21Prenatal test for Down SyndromeR&DLaunched Oct 201110/17/2011
SRPT
24.23EteplirsenDuchenne muscular dystrophyPhase 2bPhase 3 to be initiated possibly 2Q 2014NCT0154040911/14/2013
SSH
5.70C-Pulse Heart Assist System - COUNTER HFModerate to severe heart failurePivotal Expects to be completed by mid 2016NCT0174059603/12/2014
SSH
5.70C-Pulse Heart Assist System - OPTIONS HF study Moderate to severe heart failureData due 2Q 201503/12/2014
STEM
1.23HuCNS-SC cellsNCLPhase 1Discontinued due to lack of patient enrolment04/09/2011
STEM
1.23HuCNS-SC cellsSpinal cord injury Phase 1/2Interim data released May and Sept 2012. 2nd cohort dosing initiated Sept 2012.12mth data released Feb 2013. Additional Interim data due mid 2014NCT0132133301/12/2014
STEM
1.23HuCNS-SC cellsPelizaeus-Merzbacher disease (PMD)Phase 1/2Phase 1 completedNCT0100500404/27/2013
STEM
1.23HuCNS-SC cellsAge-Related Macular DegenerationPhase 1/2Phase I/II dosing initiated Jun 2012. First patient enrolled Oct 2012. Expect enrolment to be completed mid 2014. Phase 2 efficacy trial to be initiated late 2014NCT0163252702/13/2014
STML
15.80SL-701Cancer - blastic plasmacytoid dendritic cell neoplasm (BPDCN)Phase 2b pivotalPhase 2b planned04/27/2013
STML
15.80SL-701Cancer- adult relapsed or refractory acute myeloid leukemia (AML) Phase 2bPhase 2b planned04/27/2013
STML
15.80SL-701Cancer - malignant gliomaPhase 2bPhase 2b planned04/27/2013
STML
15.80SL-701Cancer - second line glioblastoma (GBM)Phase 2bPhase 2b planned04/27/2013
SUPN
8.19SPN-812ADHDPhase 2aCompleted 1Q 2011. Hope to develop an extended release formulation that will be the subject of a future Phase 2b trial04/27/2012
SUPN
8.19Oxtellar XR SPN-804Adjunctive therapy for epilepsyApprovedApproved Oct 22 201210/24/2012
SUPN
8.19Trokendi XR SPN-538EpilepsyApprovedApproved Aug 19 201308/22/2013
SUPN
8.19SPN-810Impulsive Aggression in ADHDPhase 2bPhase 2b data released Nov 2012. Plans to discuss Phase 3 plans with FDA later in 201305/14/2013
SYN
2.25Trimesta ( oral estriol)Relapsing-remitting MS in womenPhase 2Data due at the American Academy of Neurology Annual Meeting in Philadelphia from April 29-31NCT0045120404/01/2014
SYN
2.49AEN-100ALSPhase 2Discontinued 04/27/2013
SYN
2.49FlupirtineFibromyalgiaPhase 2Pending. Partner Meda has received the go-ahead from the FDA to conduct a Phase 2 proof of concept trial04/27/2013
TELK
1.35TELINTRAMyelodysplastic SyndromePhase 2Phase 3 planned. Aim to complete design of Phase 3 trial by end of 1Q 201304/27/2013
TELK
1.35TELINTRASevere chronic neutropenia, or SCNPhase 2Plan to terminate this study once the last patients complete treatment 2Q 2013.NCT0090958404/27/2013
TGTX
5.13Ublituximab TG-1101-101Relapsed 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 2013NCT0164797106/05/2013
TGTX
5.13TG-1101 and Ibrutinib Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL)Phase 2Phase 2 initiated Dec 2013
THLD
4.02TH-302 MAESTROCancer - PancreaticPhase 3Phase 3 SPA agreed upon with FDA. Initiated Jan 2013NCT0174697901/26/2013
THLD
4.02TH-302 Cancer - Advanced MelanomaPhase 2Phase 2 initiated Aug 2013.
THLD
4.02TH-302Cancer - soft tissue sarcoma (406 trial)Phase 3Initiated Ph3 Sept 2011, under SPA, interim data due mid 2014. Topline data due 1H 2015NCT0144008812/31/2013
THLD
4.02TH-302Cancer - multiple myeloma (408 trial)Phase 1/2Expect to complete enrollment in dose finding part of trial, and report preliminary results later in 2013NCT0152287204/27/2013
THRX
27.13BREO ELLIPTAAsthmaPhase 3Phase 3 Data released Jan 2012. NDA filing pending following further discussions07/15/2012
THRX
27.13TD-9855Attention deficit/hyperactivity disorder (ADHD)Phase 2Phase 2 endpoint not met Nov 201301/17/2014
THRX
27.13TD-9855FibromyalgiaPhase 2Phase 2 data due 1H 201402/07/2014
THRX
27.13TD-4208Chronic obstructive pulmonary disease (COPDPhase 2bPhase 2b data released Sept 2013. Dose ranging Phase 2b trial initiated April 2014 NCT0170440404/11/2014
THRX
27.13Velusetragdiabetic or idiopathic gastroparesisPhase 2Phase 2 data due 1H 2014NCT0171893802/07/2014
THRX
27.13UMEC/VI (62.5/25mcg and 125/25mcg doses) ANORO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)ApprovedApproved Dec 18 201312/19/2013
THRX
27.13BREO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)ApprovedApproved May 10 201305/11/2013
THRX
27.13TD−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
THRX
27.13VIBATIV (telavancin hydrochloride) for injectionHospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)ApprovedApproved Jun 21 201306/24/2013
TLON
Marqibo2nd line adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL)ApprovedApproved Aug 9 201208/11/2012
TNXP
9.97TNX-102 SL Fibromyalgia Pivotal Ongoing01/24/2014
TNXP
9.97TNX-102 SL PTSD - for the treatment of post-traumatic stress disorderPhase 2Intends to initiate Phase 2 trial in PTSD in 2Q 2014.01/24/2014
TRGT
4.08AZD1446Alzheimer’s diseasePhase 2Phase 2 planned02/22/2012
TRGT
4.08TC-5214Major depressive disorder (MDD)Phase 3Phase 3 (RENAISSANCE 2 and RENAISSANCE 3 missed primary endpoint02/22/2012
TRGT
4.08TC-5214Major depressive disorder (MDD)Phase 3 (RENAISSANCE 4 and RENAISSANCE 5) - failed to meet primary endpoint Mar 2012. Discontinue development03/21/2012
TRGT
4.08TC-5214Switch monotherapyPhase 2bDiscontinued Mar 201203/27/2012
TRGT
4.08TC-6987Type 2 DiabetesPhase 2Phase 2 topline data released Mar 2012. Failed trial. Will not further development03/28/2012
TRGT
4.08TC-6987AsthmaPhase 2Phase 2 data released Mar 2012, originally met co-primary endpoints BUT revised data showed that it failed to meet one of the two endpoints04/11/2012
TRGT
4.08TC-5619Attention deficit/hyperactivity disorder (ADHD)Phase 2Phase 2 topline data released Sep 2012. Failed to meet endpoint09/18/2012
TRGT
4.08TC-5214overactive bladderPhase 2bEnrolment completed Feb 2014. Phase 2b topline data due by mid 201402/11/2014
TRGT
4.08TC-5619SchizophreniaPhase 2bPhase 2b trial failed to meet primary endpoint December 2013NCT0148892912/17/2013
TRGT
4.08TC-1734 (AZD3480)Alzheimer’s diseasePhase 2bPhase 2b data due mid-2014NCT0146608811/06/2013
TRLPF
0.63CompleoTRTTestosterone deficiency in menNDANDA filed Apr 30 201305/14/2013
TSPT
2.93IntermezzoInsomniaApprovedApproved Nov 201111/23/2011
TSPT
2.93Ondansetron TO-2061Obsessive Compulsive DisorderPhase 2Endpoint not met Dec 201212/23/2012
TSRO
25.56TSR-011Cancer - NSCLCPhase 1/2Phase 2 dosing to be finalised by end of 201307/26/2013
TSRO
25.56NiraparibCancer - breastPhase 3Phase 3 screening patients for enrollment. Hope to initiate 1Q 201402/20/2014
TSRO
25.56RolapitantPrevention of chemotherapy induced nausea and vomiting, or CINV in MEC patients Phase 3Phase 3 data from third study due 2Q 2014NCT0150022602/20/2014
TSRO
25.56RolapitantPrevention of chemotherapy induced nausea and vomiting, or CINV in HEC patientsPhase 3Primary endpoints met but failed to meet secondary endpoints. Intends to file NDA mid 2014NCT0150021302/20/2014
TSRO
25.56Niraparib - NOVA (Niraparib Ovarian) Cancer - ovarianPhase 3Phase 3 initiated July 201307/24/2013
TTHI
5.54ELND005Bipolar I Disorder (BPD 1)Phase 2Partner Elan initiated Phase 2 trial Aug 2012NCT0167401008/31/2012
TTHI
5.54ELND005Alzheimer'sPhase 2Phase 2 enrolment commenced Nov 2012NCT0173563011/28/2012
TTHI
ELND005-DS201Down syndromePhase 2Phase 2 initiated Sept 201309/05/2013
TTHI
TT-401Type 2 diabetesPhase 2Phase 2 planned04/30/2013
TTNP
0.62ProbuphineOpioid dependenceCRLPDUFA date Apr 30 2013 under priority review. Adcom Mar 21 2013 resulted in favourable vote 10-4. New trials required12/24/2013
TTPH
9.75Eravacycline (TP-434)cIAI (complicated intra-abdominal infections)Phase 3Phase 3 initiated Sept 2013. Data due 1Q 201503/07/2014
TTPH
9.75Eravacycline (TP-434)cUTI - complicated urinary tract infectionsPhase 3Phase 3 to be initiated 4Q 2013. Data from the lead-in portion due in mid-2014 and top-line data mid-201503/07/2014
UTHR
98.22Oral treprostinilPulmonary arterial hypertension (PAH)ApprovedApproved Dec 20 201312/21/2013
UTHR
98.22314dAdd-on therapy to TyvasoPhase 3Phase 3 planned04/01/2013
UTHR
98.22Ch14.18 AntibodyCancer - neuroblastomaPhase 3Phase 3 completed. Human pharmacokinetics study ongoing. BLA filing planned04/01/2013
VICL
1.23TemusiIschemia Phase 3Endpoint not met11/20/2010
VICL
1.23Allovectin-7Cancer - melanomaPhase 3Failed to meet endpoints Aug 2013NCT0039507008/13/2013
VICL
1.23ASP0113Hematopoietic cell transplantPhase 3Initiated Phase 3 Jun 201308/01/2013
VICL
1.23ASP0113solid organ transplant (SOT)Phase 2Initiated Phase 2 Dec 201312/11/2013
VICL
Vaxfectin®-formulated therapeutic vaccineHerpesPhase 1/2Initiated Phase 1/2 during Dec 201312/18/2013
VICL
1.23CollategenePeripheral arterial diseasePhase 2SPA for Phase 3 obtained. Phase 3 planning02/07/2013
VNDA
13.85Fanapt (Injectable) SchizophreniaApprovedApproved02/15/2012
VNDA
13.85TasimelteonDepressionPhase 2bFailed to meet primary endpoint02/01/2013
VNDA
13.85TasimelteonInsomniaApprovedApproved Jan 31 2014. NCT0116303202/02/2014
VPHM
0.00PlenadrenAdrenal insufficiency in adultsPhase 3Phase 3 initiation pending discussion with FDA regarding trial design03/06/2013
VPHM
0.00VP 20621C. difficile infection (CDI)Phase 2Phase 2 initiated May 2011. Data released Apr 2013NCT0125972604/24/2013
VPHM
0.00MaribavirCytomegalovirus CMVPhase 2Interim data released Jun 2013. Expects to complete enrollment into both studies in mid-201408/04/2013
VPHM
0.00Subcutaneous Delivery of Cinryze with rHuPH20Hereditary angioedemaPhase 2bPhase 2 discontinued Aug 2013NCT0175615708/04/2013
VRTX
64.39VX-661 and ivacaftorAdults with cystic fibrosis (CF) who have two copies (homozygous) of F508delPhase 2Phase 2 data released Apr 201304/21/2013
VRTX
64.39VX-787InfluenzaPhase 2Phase 2a data met endpoints Mar 201304/21/2013
VRTX
64.39INCIVEK (telaprevir)genotype 1 HCVApprovedApproved04/21/2013
VRTX
64.39KALYDECO (ivacaftor)Cystic fibrosis with G551D mutationApprovedApproved04/21/2013
VRTX
VX-135 in combination with GSK2336805HCVPhase 2Phase 2 to be initiated 1H 201304/21/2013
VRTX
64.39VX-135 in combination with VX-222HCVPhase 2Phase 2 planning04/21/2013
VRTX
64.39VX-222 in combination with telaprevir and RBVHCVPhase 2OngoingNCT0151691804/21/2013
VRTX
64.39VX-509Rheumatoid ArthritisPhase 2Phase 2 data due 2H 2013NCT0159045907/31/2013
VRTX
VX-661 in Combination with IvacaftorCF - F508del mutation. Phase 2Phase 2 data released Apr 201305/01/2013
VRTX
VX-809 in Combination with Ivacaftor (TRAFFIC)CF- F508delPhase 3Phase 3 initiated Feb 2013.Enrolment due to be completed 2H 2013. NDA filing 2014NCT0180792307/31/2013
VRTX
VX-809 in Combination with Ivacaftor - TRANSPORTCF- F508delPhase 3Phase 3 initiated Feb 2013.Enrolment due to be completed 2H 2013. NDA filing 2014NCT0180794907/31/2013
VRTX
64.39VX-135 in combination with RBVHCVPhase 2Placed on partial clinical holdNCT0172694607/26/2013
VRTX
64.39VX-135 and Bristol-Myers Squibb's NS5A replication complex inhibitor daclatasvirTreatment-naïve people infected with genotype 1, 2 or 3 HCV, including those with cirrhosisPhase 2Phase 2 data from NZ trial due early 2014NCT0184245107/26/2013
VRTX
VX-135 in combination with TMC435 (simeprevir)HCVPhase 2Phase 2 to be initiated 2H 201305/01/2013
VRX
121.45EfinaconazoleOnychomycosisPDUFACRL May 28 201305/29/2013
VRX
121.45LuliconazoleTinea cruris, pedis and corporisPDUFAPDUFA date Dec 11 201304/27/2013
VTUS
1.07VEN 309 (iferanserin)Symptomatic hemorrhoidsPhase 3First of two Phase 3 trials initiated Aug 2011. Did not meet endpoint08/12/2012
VTUS
1.07VEN 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, 2014NCT0169022104/10/2014
VTUS
1.07VEN 308 (phenylephrin)Ileal pouch anal anastomosis, or IPAAPhase 2bPhase 2b initiation dependent on funding04/27/2013
VVUS
5.25AvanafilErectile dysfunctionApprovedApproved Apr 27 2012. PDUFA for sNDA 20 Sept 201401/22/2014
VVUS
5.25QnexaObesityApprovedApproved Jul 18 201207/18/2012
WCRX
0.00MINASTRINContraceptiveApprovedApproved Apr 22 201304/27/2013
WCRX
0.00WC3043EDPhase 3NDA to be filed 201404/27/2013
WCRX
0.00WC3055BPHPhase 2Aim to commence Phase 2 2H 201304/27/2013
XLRN
37.80Sotatercept Multiple myelomaPhase 2Phase 2 ongoing09/22/2013
XLRN
37.80SotaterceptChronic kidney diseasePhase 2Phase 2 initiation due 4Q 2013 or 1Q 201411/07/2013
XLRN
37.80Sotatercept Diamond-Blackfan anemia Phase 2Phase 2 ongoing09/22/2013
XLRN
37.80SotaterceptMyelofibrosisPhase 2Phase 2 ongoing09/22/2013
XLRN
37.80SotaterceptMyelodysplastic syndromes (MDS)Phase 2Phase 2 dose escalation interim data due 2Q 201411/07/2013
XLRN
37.80Sotatercept b -thalassemiaPhase 2Phase 2 dose escalation interim data due 2Q 201411/07/2013
XLRN
37.80SotaterceptEnd stage renal disease (ESRD) who are on hemodialysisPhase 2aPhase 2 interim data due at the National Kidney Foundation Spring Clinical Meeting in Las Vegas, Nevada in April 22-26 201402/27/2014
XLRN
37.80ACE-536Myelodysplastic syndromes (MDS)Phase 2Phase 2 dose escalation interim data due 2Q 201411/07/2013
XLRN
37.80ACE-536 b -thalassemiaPhase 2Phase 2 dose escalation interim data due 2Q 201411/07/2013
XLRN
37.80DalanterceptHead and neck cancerPhase 2Phase 2 interim data due at ASCO 201402/27/2014
XLRN
37.80DalanterceptLiver cancerPhase 2aPhase 2a to be initiated 1Q or 2Q 201402/27/2014
XLRN
37.80DalanterceptRenal Cell CarcinomaPhase 2Expects in late March or early April to begin part 2 of the RCC study02/27/2014
XNPT
4.18Arbaclofen placarbilGERDPhase 2bFAIL - endpoints not met Mar 201103/22/2011
XNPT
4.18HorizantRestless LegsApprovedFDA Approved Apr 6 201104/07/2011
XNPT
4.18HorizantPostherpetic NeuralgiaApprovedApproved Jun 6 201206/07/2012
XNPT
4.18Arbaclofen placarbilSpasticity in multiple sclerosis (MS)Phase 3Failed May 2013NCT0136048905/21/2013
XNPT
4.18XP21279Parkinson's DiseasePhase 2bData released Dec 2011, no statistical improvement over Sinemet. However Phase 3 planned dependent on fundingNCT0117131304/27/2013
XNPT
4.18XP23829Moderate-to-severe plaque psoriasisPhase 2Phase 2 to be initiated mid 201401/15/2014
XNPT
4.18XP23829Relapsing forms of multiple sclerosis (MS)Phase 3 planned01/15/2014
XOMA
4.32XOMA 052 gevokizumabDiabetesPhase 2aPrelim data released Jan '10, full data released 2Q 2011. No difference between drug and placebo06/09/2011
XOMA
4.32XOMA 052 gevokizumabType 2 DiabetesPhase 2bData released Mar 22, 2011. Endpoint not met12/22/2011
XOMA
4.32Perindopril and Amlodipine (PATH)CardiovascularPhase 3Phase 3 trial met endpoint. NDA plannedNCT0155699711/21/2012
XOMA
XOMA 052 GevokizumabCardiovascular disease - Acute Coronary SyndromePhase 2Initiated proof of concept Nov 201211/30/2012
XOMA
XOMA 052 GevokizumabNon-infectious scleritisPhase 2Phase 2 data due 2014NCT0183513202/25/2014
XOMA
4.32XOMA 052 GevokizumabErosive osteoarthritis of the handPhase 2Phase 2 prelim data released Oct 2013. Not pursuing futre developmentNCT0168339603/06/2014
XOMA
XOMA 052 GevokizumabModerate to Severe Acne VulgarisPhase 2Initiated Phase 2 Dec 2011. Topline Data released Jan 2013. Phase 3 plannedNCT0149887404/27/2013
XOMA
4.32XOMA 052 Gevokizumab EYEGUARD-ANon-Infectious Uveitis (Active)Phase 3Data from EYEGUARD-A due 2014NCT0168434512/07/2013
XOMA
4.32XOMA 052 Gevokizumab EYEGUARD-BBehcet's uveitisPhase 3Data from EYEGUARD-B due 1H 201412/07/2013
XOMA
4.32XOMA 052 Gevokizumab EYEGUARD-C Non-Infectious Uveitis ( Controlled )Phase 3Phase 3 initiated Oct 2012. Data due 2014NCT0174753812/07/2013
XOMA
4.32XOMA 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
4.32XOMA 052 gevokizumabType 1 DiabetesPhase 2NCT0178803305/04/2013
XOMA
XOMA 052 gevokizumabPyoderma GangrenosumPhase 2Initiated Phase 2 pilot trial Jun 201306/14/2013
XON
19.62Ad-IL-12CancerPhase 2In partnership with ZIOP10/23/2013
ZGNX
2.82Zohydro ERModerate to severe painApprovedApproved Oct 25 201310/26/2013
ZIOP
3.38Palifosfamide MATISSE studyCancer - small cell lung SCLCPhase 3Initiated Phase 3 Jun 2012. Ongoing. Interim data due 2H 2014NCT0155571004/02/2014
ZIOP
3.38PalifosfamideCancer - recurrent metastatic germ cell (testicular and ovarian) tumorsPhase 2Phase 2 initiated Mar 2013NCT0180853403/07/2013
ZIOP
3.38IL-12Cancer - breastPhase 2Data due 2014NCT0170375401/16/2014
ZIOP
3.38PalifosfamideCancer - sarcoma DiscontinuedFailed to meet endpoint. DiscontinuedNCT0116879103/27/2013
ZIOP
3.38IL-12Cancer - melanomaPhase 2Data due 2014NCT0139770801/16/2014
ZLCS
1.35SynaviveRheumatoid arthritisPhase 2bDevelopment discontinued due to failed Phase 2b trial Sept 2012. Met primary but failed secondary endpoint09/11/2012
ZLCS
1.35Prednisporin (FOV1101)Allergic conjunctivitisPhase 2bSanofi to continue development through sub license agreement10/26/2012
ZLCS
1.35 Z160Lumbosacral Radiculopathy (Neuropathic pain)Phase 2aFailed to meet endpoint. DiscontinuedNCT0165584912/07/2013
ZLCS
1.35Z160Postherpetic neuralgiaPhase 2aFailed to meet endpoint. DiscontinuedNCT0175787312/07/2013
ZLCS
1.35Z944PainPhase 1bPhase 1b completed Oct 2013. Phase 2 planned11/02/2013

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.

14 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).

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