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
1.43GencaroChronic Heart FailurePhase 2b/3Phase 2b/3 to begin enrolment 1Q 201401/09/2014
ACAD
23.81PimavanserinAlzheimer'sPhase 2Phase 2 initiated November 201311/15/2013
ACAD
23.81AGN201781Chronic painPhase 2Phase 2 completed. Futher development pending fundingNCT0053335104/24/2013
ACAD
PimavanserinParkinson’s disease psychosis (PDP)Phase 3NDA filing due late 2014NCT0117400408/06/2014
ACHN
007 Trial of Sovaprevir and ACH-3102 and ribavirinPhase 2Phase 2 rapid virologic response, or RVR, of Sovaprevir and ACH-3102 combo in HCV Hepatitis C patients released Sept 2013NCT0184956202/10/2013
ACHN
11.75ACH-3102 + sofosbuvirTreatment-naive HCV patientsPhase 2Phase 2 initiated April 2014. 12 week data released August 201408/16/2014
ACHN
ACH-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
SovaprevirHepatitis C viral infection (HCV)Phase 2Placed on clinical hold Jul 2013.Clinical hold lifted June 201406/11/2014
ACHN
ACH-3102 in combination with ACH-3422HCV Hepatitis C Phase 2Phase 2 to be initiated 4Q 201408/09/2014
ACOR
32.73AC105Acute treatment of spinal cord injuryPhase 2Phase 2 trial initiated Sept 2013NCT0175068409/01/2013
ACOR
32.73DalfampridinePost stroke deficitsPhase 2b/3Phase 3 trial to be initiated 2H 2014NCT0160582507/10/2014
ACOR
32.73Diazepam Nasal SprayEpilepsyCRLCRL issued May 2014NCT0141707805/04/2014
ACRX
6.99ARX-02Cancer breakthrough painPhase 2Further development halted until funding securedNCT0083304004/19/2012
ACRX
6.99ARX-03Mild sedation and pain reliefPhase 2Further development halted until funding securedNCT0089469904/19/2012
ACRX
6.99ZalvisoPost-operative pain following open abdominal surgery and hip or knee replacement surgeryCRLCRL Jul 26 2014NCT0166076307/27/2014
ACRX
6.99ARX-04Moderate-to-severe acute painPhase 3Phase 3 to be initiated 2H 2014.NCT0171034508/17/2014
ACST
0.94CaPreHypertriglyceridemiaPharmacokinetic (PK)PK trial to be initiated 2Q 2014. Data due 3Q 201401/31/2014
ACST
0.94CaPre (TRIFECTA trial)HypertriglyceridemiaPhase 2Phase 2 trial of CaPre (TRIFECTA trial) for Hypertriglyceridemia to be completed 1H 2014, with data due at a future date (as per company PR)01/31/2014
ACUR
0.92OXECTAPain reliefApprovedApproved Jun 17, 201106/20/2011
ACUR
0.92Study AP-ADF-301 (Study 301)Abuse LiabilityPhase 2Disappointing data released Aug 201308/28/2013
ADHD
20.61MDX (Metadoxine Extended Release (MG01CI))Adult ADHDPhase 3Phase 3 initiated March 2014. Topline data due 3Q 201407/15/2014
ADHD
20.61MDX (Metadoxine Extended Release (MG01CI))Fragile X SyndromePhase 2bPhase 2b data due 4Q 201408/20/2014
ADHD
MDX (Metadoxine Extended Release (MG01CI))Pediatric ADHDPhase 2bPhase 2b data due by end of 201408/14/2014
ADMA
9.35RI-002Primary Immune Deficiency DiseasesPhase 3Phase 3 prelim data due 4Q 201408/12/2014
ADMP
3.88Epinephrine PFSAnaphylaxisPDUFAPDUFA estimate on or around May 29 2015. No official date given08/03/2014
ADMP
APC-1000Asthma/COPDPhase 3Phase 3 planned02/04/2014
ADMP
3.88APC-3000Allergic RhinitisPhase 3Phase 3 planned02/04/2014
ADMS
18.20Memantine HCl extended release (ER) and donepezil HCl Moderate to severe dementia of the Alzheimer's type.NDANDA filed by partner FRX March 4 201404/25/2014
ADMS
18.20ADS-5102Levodopa-Induced DyskinesiaPhase 3Phase 3 initiated June 2014. Enrolment to be completed in 201508/09/2014
ADMS
Amantadine Traumatic Brain InjuryPhase 2/3 Phase 2/3 planned for 201404/25/2014
ADMS
18.20AmantadineUnknownPhase 2/3Phase 2/3 planned for 201504/25/2014
AEGR
30.97LomitapideHomozygous familial hypercholesterolemia (HoFH)ApprovedApproved Dec 24 2012NCT0073023612/25/2012
AERI
17.49RhopressaGlaucomaPhase 3Phase 3 initiated July 2014. Data due mid-201508/10/2014
AEZS
1.31AEZS-108Cancer - Refractory triple-negative breast cancerPhase 2First patient enrolled Feb 2013NCT0169828102/24/2013
AEZS
1.31PerifosineCancer - MyelomaPhase 3 Failed - Mar 2013NCT0100224803/13/2013
AEZS
AEZS-130Adult Growth Deficiency PDUFAPDUFA Nov 5 2014NCT0044874701/07/2014
AEZS
1.31AEZS-108Cancer - OvarianPhase 2CompleteNCT0056925704/24/2013
AEZS
1.31AEZS-130Cancer cachexiaPhase 2Phase 2 first patient recruited Aug 2012. OngoingNCT0161499004/24/2013
AEZS
PerifosineCancer - ColorectalPhase 3Primary endpoint not metNCT0109701804/03/2012
AEZS
AEZS-108Cancer - BladderPhase 2Expects to continue Phase 2 in 2013NCT0123451909/01/2013
AEZS
AEZS-108Cancer - Endometrial Phase 3Phase 3 trial initiated Jul 2013 under SPA, Interim analysis due 1H 2015NCT0176715505/11/2014
AEZS
AEZS-108Metastatic Hormone-Resistant Prostate CancerPhase 2OngoingNCT0124062909/01/2013
AFFY
0.28PeginesatideAnemia in chronic renal failure (CRF)ApprovedPDUFA Mar 27 2012 - APPROVED but withdrawnNCT0059758403/28/2012
AGRX
7.47TwirlaContraceptive patch Phase 3Phase 3 data due 1Q 2016. CRL issued 201308/16/2014
AGEN
3.16G-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
3.16G-200Cancer - Glioblastoma (GBM) 2nd linePhase 2Enrolling 1H 2013NCT0181481309/01/2013
AGEN
3.16HerpVGenital herpesPhase 2Phase 2 enrolment completed Feb 2013NCT0168759504/24/2013
AKBA
23.31AKB-6548Anemia associated with chronic kidney disease (CKD)Phase 2bPhase 2b data due 4Q 201408/12/2014
ALDR
16.99ALD403 MigrainePhase 2b Phase 2b to be initiated 2H 201408/17/2014
ALDR
16.99Clazakizumab Rheumatoid arthritis (RA)Phase 2bPhase 2b to be completed 1H 201508/17/2014
ALDR
16.99Clazakizumab Psoriatic arthritis (PsA)Phase 2Phase 2 data due by end of 201408/17/2014
ALDX
3.65NS2 Sjögren-Larsson Syndrome (SLS)Phase 3Phase 3 planned for 2014. Data due 2H 201508/17/2014
ALDX
NS2Acute anterior uveitisPhase 2Phase 2 planned for 2014. Data due 2H 201508/17/2014
ALIM
5.65IluvienDiabetic macular edemaPDUFACRL Nov 2011. Second CRL Oct 17 2013. New PDUFA Sept 26 2014NCT0034496804/16/2014
ALIOF
123.63Macitentan (Opsumit)Pulmonary arterial hypertensionApprovedApproved Oct 18 2013NCT0066017910/22/2013
ALIOF
CadazolidClostridium difficile associated diarrhea (CDAD)Phase 3Phase 3 planned03/10/2013
ALIOF
123.63PonesimodModerate 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 released June 201406/28/2014
ALKS
45.07ALKS 33 Binge eating disorderPhase 2Data released Jul 2011, endpoint not met. Likely to discontinueNCT0109843507/08/2011
ALKS
45.07BYDUREONDiabetes - Type 2ApprovedApproved Jan 201205/19/2012
ALKS
45.07ALKS 37Opioid-induced constipationPhase 2bPhase 2b fail. Will not proceed to Phase 3NCT0138279705/31/2012
ALKS
45.07ALKS 9070 aripiprazole lauroxilSchizophreniaNDANDA filed August 2014NCT0146903908/26/2014
ALKS
45.07palmitate 3-month formulationSchizophreniaPhase 3NDA filing of three-month formulation of INVEGA SUSTENNA for the treatment of Schizophrenia due by end of 2014NCT0151542308/16/2014
ALKS
45.07ALKS 3831SchizophreniaPhase 2Phase 2 initiated Jul 2013. Enrolment to be completed 201408/17/2014
ALKS
45.07ALKS 3831SchizophreniaPhase 2Second Phase 2 trial initiated June 2014. Data due mid 201706/03/2014
ALKS
ALKS 5461Major depressive disorder Phase 2Phase 3 (two trials) initiated Jun 2014. Data due 2016. Third Phase 3 trial initiated mid 2014.NCT0150020008/03/2014
ALKS
Paliperidone Palmitate 3 Month FormulationSchizophreniaPhase 3Phase 3 initiated Jun 2012. Expect to be completed 2H 2014NCT0152951504/24/2013
ALNY
69.52ALN-RSV01RSV (respiratory syncytial virus) infected adult lung transplant patientsPhase 2bData released May 2012. Missed primary endpoint.NCT0106593505/31/2012
ALNY
69.52ALN-TTR02 - patisiranFamilial Amyloidotic Polyneuropathy (FAP) in Patients with ATTRPhase 2 - open labelPhase 2 enrolment completed Sept 2013. Initial data due October 10 2014NCT0161796708/09/2014
ALNY
69.52ALN-TTR02 - patisiran APOLLOFamilial Amyloidotic Polyneuropathy (FAP) in Patients with ATTRPhase 3Phase 3 trial initiated Nov 2013, continues to enrol patients as of Aug 201408/09/2014
ALNY
ALN-TTRscTTR-mediated amyloidosis (ATTR)Phase 2Phase 2 data due late 2014. Phase 3 to be initiated late 201408/09/2014
ALXA
3.51Staccato loxapine (ADASUVE)SchizophreniaApprovedApproved Dec 21 2012NCT0062858912/23/2012
ALXA
3.51AZ-002Acute repetitive seizuresPhase 2Phase 2 to be initiated 2H 201408/03/2014
ALXN
172.27Asfotase alfaHypophosphatasia (HPP)BLARolling BLA filing ongoing07/27/2014
AMAG
22.00FerahemeIron 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
6.98QuizartinibCancer - relapsed/refractory acute myeloid leukemiaPhase 3Phase 3 initiated Apr 2014. Interim data 2H 2015. Topline data 1Q 2016NCT0156566803/23/2014
AMBI
6.98AC410InflammationPhase 1Phase 1 enrolment complete05/31/2013
AMPE
4.87OptinaDiabetic Macula EdemaPhase 2bPhase 2b trial completed enrolment Feb 2014.Data due 4Q 2014NCT0182167706/26/2014
AMPE
4.87ZertanePremature ejaculationPhase 3Pivotal trial pending. Will spin off Zertane into a standalone company called Vyrix Pharmaceuticals, Inc12/15/2013
AMPE
4.87AmpionOsteoarthritis of the KneePhase 3Phase 3 data released Aug 2013. Final pivotal trial ongoing. Possible BLA filing 1Q 2015NCT0183933108/07/2014
AMRN
1.90Vascepa Elevated triglyceride levelsApprovedApproved Jul 26 2012NCT0104768307/27/2012
AMRN
1.90Vascepa REDUCE-IT outcomes trial High Triglycerides With Mixed DyslipidemiaREDUCE-IT outcomes trialREDUCE-IT outcomes trial to be completed in 2017NCT0104750105/11/2014
ANAC
22.52GSK ‘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
22.52GSK ‘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
22.52TavaboroleOnychomycosisApprovedApproved July 8 2014NCT0130211907/09/2014
ANAC
22.52AN2728Mild-to-moderate atopic dermatitisPhase 3Phase 3 data due 2H 2015NCT0160234108/09/2014
ANAC
22.52AN2728Mild-to-moderate plaque-type psoriasisPhase 2bPromising Prelim Phase 2b data released Jun 2011. Phase 3 planning on holdNCT0130005204/25/2013
ANIK
41.78MonoviscOsteoarthritisApprovedApproved Feb 2014NCT0065343202/16/2014
ANIK
CingalOsteoarthritisPhase 3Phase 3 initiated 2Q 201308/01/2013
ANTH
2.59Varespladib - Vista 16Acute Coronary Syndromes (ACS)Phase 3Failed Phase 3 efficacy trialsNCT0113024603/11/2012
ANTH
2.59BlisibimodLupusPhase 3Missed primary endpoints in Phase 2b trial Jun 2012. Phase 3 trial initiated Mar 2013. Interim analysis completed July 2014NCT0139574508/03/2014
ANTH
2.59BlisibimodIgA nephropathyPhase 2Phase 2 initiated Jun 201306/25/2013
ANTH
Sollpura (liprotamase)Exocrine Pancreatic InsufficiencyPhase 3Phase 3 due to be initiated mid 201507/15/2014
APPY
1.63Appy1Acute appendicitis Phase 3Data released Mar 13 2014. 510k filed March 2014. Supplemental filling due 4Q 2014NCT0165217008/12/2014
APRI
1.95PrevOncoCancer - HCC - liver cancerPhase 2Phase 3 and SPA in discussions with the FDA04/06/2012
APRI
1.95FemproxFemale sexual arousal disorderPhase 3Planning clinical development04/25/2013
APRI
1.95VitarosErectile DysfunctionApproved in Canada. Partner "Warner Chilcott continues to pursue the approval of the drug"NCT0177632004/25/2013
APRI
MycoVaOnychomycosisPhase 3Additional trials required in US for approval04/25/2013
APRI
RayVa Secondary Raynaud's PhenomenonPhase 2aPhase 2a to be initiated 2H 201405/24/2014
AQXP
6.34AQX-1125 LEADERSHIPBladder pain syndrome/interstitial cystitis (BPS/IC). Phase 2Phase 2 data due 1H 201508/12/2014
AQXP
6.34AQX-1125 FLAGSHIPChronic obstructive pulmonary disease (COPD)Phase 2Phase 2 data due 1H 201508/12/2014
ARDX
13.44TenapanorHyperphosphatemia in end stage renal disease (ESRD) patients on hemodialysisPhase 2bPhase 2b data due 1H 201508/10/2014
ARDX
13.44TenapanorLate-stage chronic kidney disease (CKD) Phase 2aPhase 2a data due 2H 201508/10/2014
ARDX
13.44TenapanorConstipation-predominant irritable bowel syndrome (IBS-C) Phase 2bPhase 2b data due 4Q 201408/10/2014
ARGS
8.75AGS-003 ADAPT Trial Phase 3AGS-003 Phase 3 ADAPT Trial on Track to Complete Enrollment 1Q 201508/14/2014
ARGS
8.75AGS-004 HIVPhase 2bPhase 2b data expected around 3Q 201408/14/2014
ARGS
8.75AGS-003 Early stage RCC, non-clear cell mRCC, and other solid tumorsPhase 2Phase 2 trials planned for 201408/14/2014
ARIA
6.50RidaforolimusCancer - SarcomaCRLCRL Jun 6 2012. New trials requiredNCT0053823906/06/2012
ARIA
6.50AP26113 - 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
6.50Oral ponatinib - IclusigNewly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)Phase 3Discontinued Oct 2013NCT0165080510/20/2013
ARIA
Oral 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
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. Initial data released at ASCO 2014. Trial resumed 2Q 2014NCT0187466506/02/2014
ARNA
4.25LorcaserinObesityApprovedApproved 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 2014. Data due around the end of 2014.08/03/2014
ARQL
1.29Tivantinib (ARQ 197)Cancer - GastricPhase 2WithdrawnNCT0107029004/06/2012
ARQL
1.29Tivantinib (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
1.29Tivantinib (ARQ 197)Cancer - NSCLCPhase 3Discontinued Oct 2012NCT0124419110/21/2012
ARQL
1.29Tivantinib (ARQ 197) + irinotecan and cetuximab Cancer - colorectalPhase 2Phase 2 failed Jan 2013NCT0107504801/12/2013
ARQL
1.29Tivantinib (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
1.29Tivantinib (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
4.01Selumetinib with NexavarCancer - recurrent low-grade serous ovarianPhase 2Data presented Apr 2012NCT0055107004/05/2012
ARRY
4.01Selumetinib (AZD6244) + plus dacarbazine SUMITCancer - metastatic uveal melanoma Phase 3Phase 3 estimated primary completion date for the trial is mid-2015NCT0093622102/05/2014
ARRY
4.01Selumetinib (AZD6244) combined with radioactive iodine - ASTRACancer - differentiated thyroid cancer Phase 3Pivotal trial initiated August 2013. The estimated primary completion date for the ASTRA study is June 201608/17/2014
ARRY
Selumetinib (AZD6244) in Combination With DocetaxelCancer - NSCLC second line non small lung cancerPhase 3Phase 3 initiated Oct 2013. The estimated primary completion date for the SELECT-1 study is July 2016NCT0175028108/17/2014
ARRY
MEK162 (ARRY-162) - MILORecurrent low-grade serous ovarian cancer (LGSOC)Phase 3Phase 3 initiated July 2013NCT0184987407/03/2013
ARRY
4.01ARRY 797Osteoarthritis of the KneePhase 2Seeking partner for further developmentNCT0136601402/05/2013
ARRY
4.01ARRY 797LMNA-Related DCMPhase 2Phase 2 preliminary results from this study due by the end of 2014.08/16/2014
ARRY
4.01Binimetinib (MEK162)Cancer - NRAS melanomaPhase 3Phase 3 initiated Jul 2013. NDA filing expected 2015NCT0176316402/05/2014
ARRY
4.01ARRY 614MDSPhase 1Phase 3 decision to be made late 2013NCT0149649504/25/2013
ARRY
4.01DanoprevirHCV Hepatitis C Phase 2Phase 3 decision to be made 201304/25/2013
ARRY
4.01AMG 151 (ARRY-403) Glucokinase activatorType 2 diabetesPhase 2AMG returned rights to ARRYNCT0146443708/07/2013
ARRY
4.01ARRY 502Asthma Phase 2aPhase 2 topline data released July 23 2013. Endpoint met. Full data released Mar 2014NCT0156169003/04/2014
ARRY
4.01ARRY 543/ ASLAN001 Cancer - HER2/EGFR inhibitor for gastric cancerPhase 2OngoingNCT0161452204/25/2013
ARRY
MEK162 (ARRY-162) - COLUMBUSCancer - BRAF mutant melanomaPhase 3Phase 3 initiated 2H 2013NCT0132008511/02/2013
ARRY
ARRY-520 (Filanesib)Cancer - Refractory Multiple Myeloma MMPhase 2Phase 3 to be initiated 2H 201408/16/2014
ARRY
ARRY 380Cancer - metastatic breast cancerPhase 3Phase 3 planned with ONCY08/07/2013
ARWR
15.19ARC-520Chronic HBVPhase 2Phase 2a data due 3Q 201408/03/2014
ASMB
7.39VEN 309 (iferanserin)Symptomatic hemorrhoidsPhase 3First of two Phase 3 trials initiated Aug 2011. Did not meet endpoint08/12/2012
ASMB
7.39VEN 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
ASMB
7.39VEN 308 (phenylephrin)Ileal pouch anal anastomosis, or IPAAPhase 2bPhase 2b initiation dependent on funding04/27/2013
ASPX
21.63SD-809Huntington's disease (HD)Phase 3Phase 3 topline data due 4Q 201408/19/2014
ASPX
21.63SD-809Tardive Dyskinesia (TD)Phase 2/3Phase 2b topline data due mid 201508/09/2014
ASTM
3.89ixmyelocel-TCritical limb ischemia DiscontinuedEnrolment discontinuedNCT0148389803/28/2013
ASTM
3.89ixmyelocel-TStem cells - Dilated Cardiomyopathy Phase 2bCommenced enrolment Phase 2b Apr 2013. Enrolment due to be completed 2014. Topline data due 2015NCT0167098108/17/2014
ATHX
1.41MultistemUlcerative colitisPhase 2Phase 2 initial data early May 2014 - failed to show benefitNCT0124091504/29/2014
ATHX
1.41MultistemIschemic strokePhase 2Initiated 3Q 2011. Ongoing. Initial data due 1H 2015NCT0143648708/12/2014
ATHX
1.41MultistemAcute myocardial infarctionPhase 1Phase 2 to be initiated 2014NCT0067722205/17/2014
ATHX
MultistemGvHDPhase 2/3Phase 2 planned for 2014NCT0067785905/17/2014
ATRS
2.12AnturolOveractive bladderApprovedApproved Dec 8 201112/08/2011
ATRS
2.12OTREXUPRheumatoid arthritis (RA)ApprovedApproved Oct 14 2013NCT0173794410/16/2013
ATRS
2.12VIBEX QuickShotTestosterone deficiencyPhase 3Phase 3 initiated July 201407/23/2014
AUXL
18.63XIAFLEXEdematous fibrosclerotic panniculopathy (“cellulite”)Phase 2aPhase 2b to commence 2Q 2015NCT0151890708/22/2014
AUXL
18.63XIAFLEXPeyronie’sApprovedApproved Dec 6 2013NCT0122159712/08/2013
AUXL
18.63XIAFLEXDupuytren's ContracturePDUFAPDUFA Date Scheduled for October 20, 201402/25/2014
AUXL
18.63AvanafilErectile dysfunctionApprovedApproved Apr 27 2012. PDUFA for sNDA 20 Sept 201401/22/2014
AUXL
XIAFLEXAdhesive Capsulitis (“Frozen Shoulder syndrome”)Phase 2bPhase 2b data due 1Q 2015NCT0148396308/10/2014
AVEO
1.37FiclatuzumabCancer - Non-small cell lung cancer (NSCLC)Phase 2Phase 2 prelim data - not statistical significance shown05/04/2012
AVEO
1.37TivozanibCancer - colorectalPhase 2Phase 2 discontinuedNCT0147859408/13/2014
AVEO
1.37Tivozanib BATON-BC Cancer - metastatic triple negative breast cancer Phase 2Discontinued due to insufficient enrolmentNCT0174536701/31/2014
AVEO
1.37TivozanibCancer - advanced renal cell carcinomaCRLNegative 1-13 vote at Adcom meeting May 2 2013.Early CRL Jun 10 2013NCT0103078306/11/2013
AVNR
6.10NUEDEXTAPseudobulbar affectApprovedApproved Oct 30 2010NCT0057344307/26/2011
AVNR
6.10NUEDEXTA AVP-923Central neuropathic pain in patients with multiple sclerosisPhase 2Phase 2 failed to meet endpointNCT0132423212/11/2013
AVNR
6.10NUEDEXTA AVP-923Agitation in patients with Alzheimer's disease (AD)Phase 2Phase 2 data due late September/early October 2014NCT0158444008/06/2014
AVNR
6.10NUEDEXTA AVP-923Levodopa induced dyskinesia (LID) in patients with Parkinson's disease (PD).Phase 2Phase 2 enrolment commenced Oct 201310/23/2013
AVNR
AVP-786Major Depressive DisorderPhase 2c08/27/2014
AVNR
6.10AVP-825Acute migrainePDUFAPDUFA November 26 201403/27/2014
AVNR
NUEDEXTA AVP-923Diabetic peripheral neuropathic painPhase 3Phase 3 additional trial required04/25/2013
BCRX
13.70Peramivir - Study 303INFLUENZA ACUTE Phase 3PDUFA Dec 23 2014NCT0095799612/21/2013
BCRX
13.70UlodesineGoutPhase 2bPhase 3 initiation pending partnershipNCT0126526409/02/2013
BCRX
13.70UlodesineModerate renal impairmentPhase 2Phase 3 initiation pending partnershipNCT0140787409/02/2013
BCRX
13.70BCX4161 Hereditary angioedemaPhase 2Phase 2 data released May 201405/28/2014
BDSI
14.66BEMA BuprenorphinePain - acute and chronic Phase 3Initiated Dec 2010, data mid-late Sep 2011 - FAILEDNCT0125645010/04/2011
BDSI
14.66BEMA BuprenorphineModerate to severe chronic pain in opioid naive subjectsPhase 3Phase 3 data released Jan 2014NCT0167516701/24/2014
BDSI
14.66Clonidine gelPainful diabetic neuropathy (PDN) Phase 3Phase 3 topline data due 1Q 201508/09/2014
BDSI
BEMA BuprenorphineOpioid experienced patient groupNDANDA to be filed late 2014 or early 201508/09/2014
BDSI
BEMA Buprenorphine/Naloxone (BNX) - BUNAVAILOpioid dependenceApprovedApproved June 7 2014NCT0166611906/08/2014
BIND
10.28 BIND-014 Cancer - Prostate CancerPhase 2Topline data due 4Q 2014NCT0181274608/09/2014
BIND
10.28 BIND-014 Cancer - Non-small cell lung cancer (NSCLC)Phase 2Topline data due 4Q 2014NCT0179247908/09/2014
BIOD
1.92Liquid glucagon glucagon rescue device Severe hypoglycemiaPivotal trial initiation 2H 2014. NDA filing possible 201512/19/2013
BIOD
1.92BIOD-123Diabetes - Type 1Phase 2Phase 2 data released Sept 2013NCT0168662009/09/2013
BLRX
1.65BL-1020SchizophreniaPhase 2/ 3Discontinues trial following poor interim analysisNCT0136334903/21/2013
BLRX
1.65BL-8040Cancer - Acute myeloid leukemia (AML) Phase 2aPhase 2a enrolment began Jun 2013. Partial data released Dec 2013. Full data early 2015NCT0183839508/10/2014
BLRX
1.65BL-7040 Inflammatory Bowel DiseasePhase 2aPhase 2a data released Apr 2013NCT0150636204/19/2013
BLRX
1.65BL-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
1.65BL-8040Chronic Myeloid Leukemia Phase 1/2Phase 1/2 to be initiated late 201408/10/2014
BLRX
1.65 BL-7010Celiac diseasePhase 1/2Phase 1/2 safety trial to be initiated late 2013. Efficacy trial to be initiated early 2015.08/10/2014
BLRX
1.65BL-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
36.97Lenti-DChildhood cerebral adrenoleukodystrophy (CCALD)Phase 2/3Phase 2/3 trial initiated October 2013. Enrolment due to be completed 201503/06/2014
BLUE
36.97HGB-205Beta-Thalassemia and Sickle Cell AnemiaPhase 1/2First patient transplanted Dec 201312/03/2013
BMRN
71.55BMN-701Pompe DiseasePhase 2/3Phase 2/3 enrolment due to be completed 1H 201508/03/2014
BMRN
71.55BMN-673Cancer -gBRCA breast cancer Phase 3Phase 3 initiated Oct 2013: Enrollment completion due 2H 201508/03/2014
BMRN
71.55BMN-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 201508/03/2014
BMRN
71.55BMN 190Batten DiseasePhase 1/2Phase 1/2 initiated Sep 2013. Data due 2H 201508/03/2014
BMRN
71.55Vimizim (GALNS)(MPS IVA) Morquio A SyndromeApprovedApproved Feb 14 2014NCT0127506602/16/2014
BMRN
PEG-PALPhenylketonuria (PKU) Phase 3Phase 3 data due 4Q 2015NCT0181972708/03/2014
BOTA
2.42Laninamivir Octanoate - IGLOO Adults with symptomatic influenza A or B infectionPhase 2Phase 2 initiated Jun 2013. Topline data did not meet the primary endpoint - July 2014NCT0179388308/03/2014
CARA
10.25IV CR845Acute painPhase 3Phase 3 planned for 201405/14/2014
CARA
CR845 Uremic PruritusPhase 2Phase 2 topline data due 1H 201508/10/2014
CBRX
6.01PROCHIEVE (progesterone gel)Reduction of risk of preterm birthCRLCRL Feb 26 2012NCT0061555002/28/2012
CBST
68.53Bevenopran (CB-5945) ASCENTChronic opioid-induced constipation (OIC).Phase 3Three Phase 3 efficacy trials initiated Jul 2013NCT01696643 07/21/2013
CBST
68.53Ceftolozane/ tazobactam CXA-201Complicated Urinary Tract Infections (cUTI) and Complicated Intra-Abdominal Infections (cIAI)Phase 3PDUFA Dec 21 2014- priority reviewNCT0144567806/22/2014
CBST
68.53Surotomycin (CB-315)C. difficile-associated diarrhea (CDAD).Phase 3Phase 3 initiated Jul 2012. NDA filing 2015NCT0159750501/25/2013
CBST
68.53Tedizolid phosphateAcute bacterial skin and skin structure infections (ABSSSI)ApprovedApproved June 20 201406/22/2014
CBST
Ceftolozane/ tazobactam CXA-201Ventilator-associated bacterial pneumonia (VABP) for ceftolozane/tazobactamPhase 3Phase 3 trial to be initiated around mid-year 2013.01/25/2013
CCXI
5.10CCX140Type 2 Diabetes and AlbuminuriaPhase 2Phase 2 completedNCT0144025707/28/2012
CCXI
5.10CCX354 (GSK2941266) -(CARAT-1)Rheumatoid arthritis.Phase 2CompletedNCT0102772807/28/2012
CCXI
5.10CCX140Diabetic nephropathy Phase 2Phase 2 data released Sept 2013. Final data due 4Q 2014NCT0144714708/09/2014
CCXI
5.10CCX168Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. Phase 2Data released December 2013NCT0136338812/04/2013
CCXI
Vercirnon CCX282 - (SHIELD-1)Crohn's diseasePhase 3Failed to meet endpoint Aug 2013NCT0127766608/25/2013
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
10.10CEM-101 (solithromycin )Uncomplicated urogenital gonococcal infectionsPhase 3Phase 3 initiated August 201408/16/2014
CEMP
10.10CEM-101 (solithromycin )CAPBPhase 3Data due 1Q 201508/03/2014
CEMP
10.10Taksta CEM-102Prosthetic joint infection (PJI) Phase 2Plans to meet FDA in 2H 2014 to discuss Phase 3 trial 08/03/2014
CERS
3.78INTERCEPT PlateletsPMAFDA decision possible 1H 201508/03/2014
CERS
3.78INTERCEPT B123PlasmaPMAFDA decision possible 1H 201508/03/2014
CERS
3.78INTERCEPT Acute and Chronic AnemiaPhase 3Phase 3 Eruopean trials initiated 201306/12/2013
CERU
4.07CRLX101 in Combination with Chemotherapy and Radiation Rectal CancerPhase 1b/2Data due 1Q 201508/16/2014
CERU
4.07CRLX101, in combination with AvastinCancer - relapsed ovarianPhase 2Data due 1Q 201508/16/2014
CERU
4.07CRLX101, in combination with AvastinCancer - Relapsed Renal Cell CarcinomaPhase 2Data due 4Q 201508/16/2014
CERU
4.07CRLX301Cancer - solid tumoursPhase 2Phase 2 to be initiated by end of 201404/25/2014
CERU
4.07CRLX101 and XelodaNeoadjuvant Rectal CancerPhase 1b/2Ongoing04/25/2014
CLDN
11.44MYDICAR - CUPID 2 TrialIschemic or dilated cardiomyopathyPhase 2bPhase 2b data due April 201507/08/2014
CLDN
MYDICAREnd-stage renal disease (ESRD)Phase 2aInitial Phase 2a data due 201508/10/2014
CLDX
16.42CDX-1307Cancer - bladderPhase 2DiscontinuedNCT0109449608/13/2011
CLDX
16.42CDX-110 rindopepimut - ACT IVCancer- glioblastoma multiforme (GBM) front linePhase 3Initiated Phase 3 Dec 2011. Aim to complete screening by September 2014NCT0148047908/10/2014
CLDX
16.42CDX-011 EMERGECancer - Metastatic breastPhase 2bPrelim data released May 23 2012. Updated data released Dec 2012. Phase 3 trial initiated Dec 2013NCT0115675303/04/2014
CLDX
16.42CDX-1135 Dense deposit disease (DDD)Phase 2Discontinued03/04/2014
CLDX
16.42Glembatumumab vedotinCancer - melanomaPhase 2Phase 2 to be initiated late 201408/10/2014
CLDX
CDX-110 (rindopepimut) in combination with Avastin - ReACTCancer- glioblastoma multiforme (GBM) refractoryPhase 2Phase 2 data due by end of 2014NCT0149832808/10/2014
CLSN
3.17ThermoDoxCancer - colorectal liver metastases (CRLM)Phase 2Initiated Phase 2 Feb 2012NCT0146459302/14/2012
CLSN
3.17ThermoDoxCancer - Hepatocellular carcinoma - liver cancerPhase 3Failed to meet primary endpoint. New Phase 3 to be initiated 2Q 2014NCT0061798105/12/2014
CLSN
3.17ThermoDoxRecurrent Chest Wall Breast Cancer (RCWBC)Phase 2Phase 2 interim data released Feb and July 201407/27/2014
CLVS
49.89CO-101 LEAPCancer - pancreaticPhase 3Failed trialNCT0112478611/14/2012
CLVS
49.89Rucaparib ARIEL3 Cancer - ovarian second linePivotalPivotal trial initiated late 2013NCT0148271502/28/2014
CLVS
49.89Rucaparib ARIEL2Cancer - ovarian second linePhase 2Phase 2 dosing initiated Oct 2013. Enrolment due to be completed early 201508/09/2014
CLVS
49.89Rucaparib RUCAPANCCancer - pancreaticPhase 2Phase 2 initiated June 201406/17/2014
CLVS
49.89CO-1686Cancer - 2nd line T790M+ NSCLC Phase 2NDA filing due mid 2015NCT0152692808/09/2014
CLVS
CO-1686Cancer - 1st line EGFR NSCLCPhase 1/2Initiate Phase 2 trial in 1st line EGFR NSCLC patients in early 201411/02/2013
CMRX
25.75SUPPRESS trial of CMX001 Cytomegalovirus (CMV) infection following an allogeneic hematopoietic stem cell transplant (HSCT)Phase 3Phase 3 dosing commenced Sept 2013. Data 2H 2015NCT0176917008/10/2014
CMRX
25.75CMX001AdV diseasePhase 2Phase 2 top line data released Aug 2013NCT0124134408/15/2013
CNAT
6.46Emricasan 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 201408/14/2014
CNAT
6.46EmricasanChronic Liver Failure (CLF)Phase 2Phase 2b to be initiated 2H 201408/14/2014
CNAT
EmricasanSevere alcoholic hepatitisPhase 2Phase 2 initiated Sept 201309/22/2013
CNAT
6.46EmricasanNon-alcoholic steatohepatitis (NASH)Phase 2Phase 2 trial initiated Mar 2014. Topline data due 1Q 201508/14/2014
CNAT
EmricasanLiver fibrosis post-orthotopic liver transplant due to Hepatitis C virus infection (HCV-POLT)Phase 2bPhase 2b initiated May 2014. Initial open-label biomarker data expected 1H 2015.08/14/2014
CNCE
CTP-499 Diabetic Kidney DiseasePhase 2Phase 3 planned. Intend to apply for SPA later in 2014 for Phase 3 trial07/09/2014
CNCE
AVP-786 Neurologic and Psychiatric DisordersPhase 2Phase 2 initiated August 201408/27/2014
CNDO
2.13TSO - (CNDO-201) (TRUST-I)Crohn’s diseasePhase 2Phase 2 endpoint not met Oct 2013NCT0157647110/15/2013
CNDO
2.13CNDO-109 Cancer - acute myeloid leukemia (AML)Phase 1/2Phase 1/2 initiated Nov 2012NCT0152055803/29/2013
CNDO
2.13TSO - (CNDO-201)Ulcerative colitisPhase 2Phase 2 initiated Sep 201309/15/2013
CNDO
TSO - (CNDO-201) (TRUST-2)Crohn’s diseasePhase 2Phase 2 discontinued Nov 2013 due to lack of efficacyNCT0127957711/09/2013
CORI
6.26AG200-15ContraceptivePhase 3Additional Phase 3 planned following rejection of NDA04/25/2014
CORI
6.26MicroCor hPTH(1-34) OsteoporosisPhase 2Phase 2 planned for 201405/17/2014
CORI
6.26Corplex Tamsulosin Benign prostatic hyperplasiaPhase 2Phase 2 planned 1H 201504/25/2014
CORT
2.80Corlux - KorlymCushing's SyndromeApprovedApproved Feb 17 201207/20/2012
CORT
2.80Corlux - Korlym Psychotic depressionPhase 3Trial stopped early - FAILNCT0063749405/11/2014
CPIX
5.16AcetadoteAcute liver failureApprovedApproved Jan 13, 201101/14/2011
CPIX
5.16AcetadoteNon-Acetaminophen Induced Acute Liver FailureCRLCRL received Dec 2010. 11/05/2011
CPIX
5.16Hepatoren HRSPhase 2Ongoing04/25/2013
CPRX
3.00VigabatrinAddiction to cocainePhase 2bPhase 2b fail.11/10/2012
CPRX
3.00Firdapse Lambert-Easton Myasthenic Syndrome (LEMS)Phase 3Phase 3 data due 3Q 2014. NDA early 2015NCT0137792208/12/2014
CRIS
1.59GDC-0449 vismodegib (everolimus)Cancer - Advanced Basal Cell CarcinomaApprovedApproved Jan 31 201201/30/2012
CRIS
1.59Debio 0932Cancer - NSCLC without known EGFR mutationsPhase 1/2Ongoing. Phase 2 portion to initiated 2H 201401/14/2014
CRIS
1.59CUDC-907Cancer - Phase 1Phase 2 to be initiated late 2014NCT0174298801/14/2014
CRIS
1.59CUDC-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
1.59Erivedge (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
CRIS
GDC-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
CRME
7.19Vernakalant IV Atrial fibrillationPhase 3Phase 3 placed on clinical hold Oct 2010 due to patient death07/07/2014
CSII
30.08Orbital atherectomy systemCalcified coronary arteriesPMAPMA approved Oct 22 201310/23/2013
CTIC
2.55OpaxioCancer - OvarianPhase 3Enrolment completed Jan 2014NCT0010874501/29/2014
CTIC
2.55Pacritinib -PERSIST-1MyelofibrosisPhase 3Topline data due early 2015, with NDA filing late 2015. A second planned Phase 3 trial was initiated in March 2014NCT0177318708/10/2014
CTIC
2.55BrostallicinCancer - breastPhase 2Interim data released Dec 2012. Final data released ASCO 2013NCT0109145406/03/2013
CTIC
2.55OpaxioCancer - glioblastoma multiformePhase 2OngoingNCT0140206312/07/2013
CTIC
2.55OpaxioCancer - head and neck cancerPhase 1/2OngoingNCT0066021812/07/2013
CTIC
2.55PixantroneCancer - Relapsed/refractory diffuse large B-cell lymphoma ("DLBCL")PivotalInitiated Mar 2011. OngoingNCT0132154104/25/2013
CTIC
2.55PixantroneCancer - 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
2.55TosedostatCancer - relapsed or refractory MDSPhase 2Partial clinical hold removed Jan 2014. Original hold was placed in mid 2013NCT0163660901/06/2014
CTIC
2.55TosedostatCancer - newly diagnosed AML/MDSPhase 2Placed on partial clinical hold due to death of patientNCT0156705901/06/2014
CTIC
2.55PacritinibMyelofibrosisPhase 3Second Phase 3 trial (PERSIST-2) is planned to initiate in 4Q 2013. 10/08/2013
CUR
3.63 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
3.63NSI-189DepressionPhase 2Phase 2 to be initiated 1Q 2015NCT0152064908/09/2014
CUR
3.63NSI-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
1.08MultiklineCancer - 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 2015NCT0126584908/03/2014
CYCC
3.48SeliciclibCancer - NSCLCPhase 2bRetrospective analysis were insufficient to allow meaningful correlation. TerminatedNCT0037207301/11/2012
CYCC
3.48Sapacitabine (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 2H 2015NCT0130379608/16/2014
CYCC
3.48SapacitabineCancer - NSCLCPhase 2OngoingNCT0088596304/26/2013
CYCC
3.48SapacitabineCancer - Myelodysplastic syndromesPhase 2Updated data released Dec 2013NCT0059018712/10/2013
CYTK
4.38tirasemtiv (formerly CK-2017357)Peripheral artery diseasePhase 2aData Ph2a released Jun 2011NCT0113101306/03/2011
CYTK
4.38tirasemtiv (formerly CK-2017357)Myasthenia gravis Phase 2aData released Nov 2012NCT0126828002/06/2013
CYTK
4.38Oral formulations of omecamtiv mecarbil COSMIC-HFHeart failure and left ventricular systolic dysfunction.Phase 2Phase 2 enrolment commenced Feb 2013NCT0178651202/13/2013
CYTK
4.38Omecamtiv mecarbil ATOMIC-AHFAcute heart failurePhase 2bData released Sept 3 at EUROPEAN SOCIETY OF CARDIOLOGY CONGRESS missed primary endpointNCT0130001309/03/2013
CYTK
4.38tirasemtiv (formerly CK-2017357) BENEFIT-ALSAmyotrophic Lateral SclerosisPhase 2bFailed to meet endpoint April 2014NCT0170914904/27/2014
CYTR
3.29INNO-206 aldoxorubicinCancer - relapsed glioblastomaPhase 2Phase 2 initiated Nov 2013. Prelim data due 2H 201408/10/2014
CYTR
3.29INNO-206 aldoxorubicinCancer - AIDS-related Kaposi’s sarcomaPhase 2Phase 2 initiated Jan 2014. Prelim data due 2Q 201508/10/2014
CYTR
3.29TamibaroteneCancer - non-small-cell lung cancer (NSCLC)Phase 2bTerminated May 2013NCT0133715405/09/2013
CYTR
3.29INNO-206 aldoxorubicin with doxorubicinCancer - soft tissue sarcomas refractoryPhase 3Phase 3 initiated March 2014 under SPA, expect to complete trial enrollment in 2H 201508/10/2014
CYTR
3.29INNO-206 aldoxorubicinCancer - soft tissue sarcomas first linePhase 2bPositive PFS data released December 11 2013. OS data due 2H 2014NCT0151418808/10/2014
CYTR
INNO-206 aldoxorubicinCancer - NSCLCPhase 2bPhase 2b to be initiated 2H 201408/10/2014
CYTR
3.29BafetinibCancer - B-Cell Chronic Lymphocytic Leukemia (B-CLL)Phase 2Phase 2 proof of concept completed. Seeking partner for further development09/08/2013
CYTR
3.29BafetinibCancer - B-cell chronic lymphocytic leukemia (B-CLL)Phase 2Phase 2 proof of concept completed. Seeking partner for further development09/08/2013
CYTR
3.29INNO-206 aldoxorubicinCancer Phase 2Phase 2 clinical trial with INNO-206 for pancreatic cancer initiated Apr 2012. No objective responses to dateNCT0158039704/26/2013
CYTR
3.29TamibaroteneCancer - Acute promyelocytic leukemia Phase 2Phase 2 SPA obtained but not currently open04/26/2013
DARA
1.25KRN5500Pain - Neuropathic Phase 2Seeking partner for development09/08/2013
DCTH
2.33CHEMOSAT systemCancer - unresectable metastatic ocular melanoma in the liverCRLCRL Sept 13 201309/15/2013
DCTH
2.33Melphalan Hepatic Delivery System (Melphalan HDS)Hepatocellular carcinoma (HCC)Phase 2Phase 2 data due 1H 201508/09/2014
DEPO
15.10DM-1796Postherpetic neuralgia - shinglesApprovedApproved Jan 28 201101/30/2011
DEPO
15.10DM-1992Parkinson's diseasePhase 2Phase 2 data released Nov 2012. Considering partnership opportunites to advance product.NCT0151541011/08/2012
DEPO
15.10SEFELSAHot flashesCRLCRL May 31 201306/01/2013
DNDN
1.40PROVENGECancer - castrate-resistant (hormone-refractory) prostate cancerApprovedApproved 201004/18/2012
DNDN
1.40DN24-02Cancer - high risk HER2+ urothelial carcinoma following surgical resectionPhase 2Phase 2 initiated Jun 2011. OngoingNCT0135322209/08/2013
DNDN
1.40PROVENGE Clinical Trial P10-2Sequencing of PROVENGE and androgen deprivation therapy (“ADT”)Phase 2 Initiated Phase 2 Aug 2011. Enrolment completeNCT0143139104/26/2013
DNDN
1.40PROVENGE 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
DPRX
9.50LocilexMild infections of diabetic foot ulcersPhase 3Second Phase 3 under SPA initiated July 2014. Data due 1Q 2015. NDA filing due 2H 201508/16/2014
DRRX
1.58EladurChronic back painPhase 2bData released Apr 2011. FAIL04/12/2011
DRRX
1.58PosidurPost-operative pain relief CRLCRL Feb 12 201402/13/2014
DRRX
1.58RemoxyChronic painCRLCRL Jun 23, 2011. Resubmission no earlier than mid-201502/28/2014
DRRX
ORADUR-HydromorphoneORADUR-HydromorphonePhase 3Phase 3 to be initiated 201508/09/2014
DRRX
ReldayPhase 3Phase 3 to be initiated by ZGNX in 4Q 201408/09/2014
DRTX
16.77DalbavancinAcute bacterial skin and skin structure infections (ABSSSI)ApprovedApproved May 23 2014NCT0143133905/24/2014
DSCI
8.59DSC127 Diabetic foot ulcersPhase 3Phase 3 data due early 2016NCT0183034808/09/2014
DSCO
1.79Surfaxin Respiratory Distress Syndrome - SevereApprovedApproved Mar 6 201203/07/2012
DSCO
1.79AerosurfRespiratory Distress Syndrome - ModeratePhase 2aPhase 2a data due 4Q 201408/09/2014
DSCO
1.79Surfaxin LS - lyophilized dosage form of SURFAXINNeonatal RDSPhase 2 Talks with FDA regarding further development 04/26/2013
DVAX
1.45HEPLISAVHepatitis 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 2015.08/09/2014
DYAX
10.13EcallantideACE Inhibitor-Induced AngioedemaPhase 2Discontinued due to lack of efficacy - Jun 201206/15/2012
DYAX
10.13CYRAMZA (ramucirumab)Gastric CancerApprovedApproved April 2014NCT0117066308/03/2014
DYAX
CYRAMZA (ramucirumab)Colorectal cancerPhase 3Phase 3 data due by end of 201408/03/2014
DYAX
CYRAMZA (ramucirumab)Non-small cell lung cancer (NSCLC)BLAFiling due by end of 201408/03/2014
DYAX
Necitumumab - SQUIRECancer - NSCLCBLABLA filing due by end of 2014NCT0098105808/03/2014
DYAX
Trebananib (AMG 386)OvarianPhase 3Met endpointNCT0120474908/03/2014
EBS
24.82BioThrax Anthrax - pre-exposure prophylaxis indicationApprovedApproved May 17 201203/29/2013
EBS
24.82BioThrax Anthrax - Post-exposure prophylaxisPhase 2NCT01151189
EBS
24.82NuThrax - AV7909Anthrax Phase 2NCT01770743
EBS
24.82MVA85A Preventing tuberculosis (TB) in infantsPhase 2bPhase 2b complete03/29/2013
EBS
TRU-016 in combination with bendamustine Study 16201Cancer - Refractory Chronic Lymphocytic Leukemia (CLL)Phase 2Phase 2 data due 2H 2013NCT0118868103/29/2013
EBS
Anthrax Immune Globulin Intravenous (Human) [AIGIV] AnthraxBLABLA filed early August 201408/10/2014
ECYT
6.88vintafolideCancer - folate receptor-positive triple negative breast cancerPhase 2Initiate Phase 2 2Q 201402/25/2014
ECYT
6.88vintafolideCancer - ovarianPhase 3Trial stopped due to poor efficacyNCT0117065005/04/2014
ECYT
6.88Vintafolide (TARGET)Cancer - NSCLCPhase 2bPhase 2b topline data released March 2014. Endpoint met.NCT0157765403/23/2014
EDAP
1.68 Ablatherm-HIFU (High Intensity Focused Ultrasound) Cancer - Low risk, localized prostate cancerPMAPMA submitted Feb 2013. Adcom negative vote July 30 201408/03/2014
EGLT
9.42Egalet-001Abuse-Deterrent MorphineBioequivalence StudiesBioequivalence Studies initiated Mar 2014. NDA planned for 4Q 201408/16/2014
EGLT
9.42Egalet-002Moderate to severe chronic painPhase 3Phase 3 trial planned for 1Q 201508/14/2014
EGRX
12.63RyanodexMalignant hyperthermiaApprovedApproved July 22, 2014 under priority review07/24/2014
EGRX
12.63EP-3101 (bendamustine RTD) Chronic lymphocytic leukemia; Indolent non-Hodgkin's lymphomaApproved (tentative)Tentative approval July 2 2014. Teva has also received orphan drug and related pediatric exclusivity expiring in September 2015 and May 2016 for the CLL and NHL indications, respectively. 07/03/2014
EGRX
RTU bivalirudin liquidNDA filingNDA filing due 1H 201508/12/2014
ENDP
65.23ODM-201 (ARAFOR)Castrate resistant prostate cancerPhase 2OngoingNCT0131764103/31/2013
ENDP
65.23 EN3342SchizophreniaPhase 1/2OngoingNCT0177443503/31/2013
ENDP
65.23AVEED (testosterone undecanoate) intramuscular injectionMen diagnosed with hypogonadismApprovedApproved March 6 201409/06/2013
ENDP
65.23BEMA BuprenorphineOpioid experienced patient groupPhase 3Phase 3 data released July 2014. Pre-NDA meeting July 2014NCT0167516707/08/2014
ENDP
BEMA Buprenorphine (BUNAVAIL) - EN3409 (308 trial)Opioid-Naive Subjects With Chronic Low Back PainPhase 3Phase 3 released Jan 2014. Endpoint metNCT0163394401/24/2014
CASI
1.75ENMD-2076Cancer - triple-negative breast cancerPhase 2Phase 2 initiated Jul 2012NCT0163924808/16/2012
CASI
1.75ENMD-2076 Cancer - Advanced/Metastatic Soft Tissue SarcomaPhase 2Phase 2 initiated Jan 2013NCT0171974401/24/2013
CASI
1.75ENMD-2076Cancer - OvarianPhase 2Ongoing. Enrolment closedNCT0110467503/22/2013
CASI
1.75MKC-1Cancer - NSCLCPhase 2Need funding to continue04/26/2013
CASI
1.75MKC-1Cancer - PancreaticPhase 2Need funding to continue04/26/2013
CASI
ENMD-2076Cancer - Ovarian Clear Cell CarcinomasPhase 2Phase 2 initiated Oct 201311/02/2013
ENTA
42.58ABT-450HCV - genotype 1PDUFAPDUFA under priority review approx December 21 2014NCT0170475506/14/2014
ENTA
42.58Co-Pilot -ABT-450/r plus ABT-333 plus weight-based ribavirinHCV genotype 1, non-cirrhotic patientsPhase 2Ongoing03/22/2013
ENTA
42.58Navigator - ABT-450/r with Abbott’s NS5A inhibitor ABT-267 with and without ribavirinHCV Phase 2OngoingNCT0145853503/22/2013
ENTA
42.58Aviator - ABT-450/r in various combinationsHCV genotype 1 non-cirrhotic patientsPhase 2bPhase 2b data released Apr 2013NCT0146482704/24/2013
ENZY
8.98VayarolHypertriglyceridemiaPhase 2Phase 3 planned12/15/2013
EPZM
36.67EPZ-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
15.69ETC-1002-008HypercholesterolemiaPhase 2bPhase 2b initiation Oct 2013. Data due early October 201408/16/2014
ESPR
15.69ETC-1002-009HypercholesterolemiaPhase 2b Data due 1Q 201508/16/2014
ESPR
ETC-1002-007HypercholesterolemiaPhase 2aTop-line data released Sept 03 201309/04/2013
ESPR
ETC-1002-014Hypercholesterolemia and hypertensionPhase 2Phase 2 data due 2Q 201508/16/2014
ETRM
1.34VBLOCObesityPMAPMA filed June 2013 despite not meeting endpoints. Adcom meeting June 17 2014. Mixed vote: 8 to 1 for SAFETY, 4 to 5 against EFFICACY, 6 to 2 "in favor," with 1 abstention on whether the relative benefits outweighed the relative risk. Approval decision due 2014 06/18/2014
EVOK
6.85EVK-001Recurrent diabetic gastroparesis in women with diabetes mellitusPhase 3Phase 3 initiated April 2014. Data due mid 201508/14/2014
EXAS
21.43CologuardCancer - Colorectal DNA testApprovedApproved August 201408/16/2014
EXEL
4.15XL184 cabozantinibCancer - OvarianPhase 206/06/2011
EXEL
4.15XL184 cabozantinibCancer - NSCLCPhase 2Phase 2 initiated Jul 2012NCT0163950807/27/2012
EXEL
4.15Cabozantinib Plus AbirateroneChemotherapy-Naïve Patients with Metastatic Castration-Resistant Prostate CancerPhase 2Phase 2 initiated Dec 201312/03/2013
EXEL
4.15XL184 cabozantinibCancer - Castration-Resistant Prostate CancerPhase 3Data Phase 3 2H 2014 - COMET-2 trial not under SPANCT0152244307/15/2014
EXEL
4.15XL184 cabozantinibCancer - Medullary thyroid ApprovedApproved Nov 29 201211/30/2012
EXEL
XL184 cabozantinibCancer - progressive, metastatic medullary thyroid Phase 3Phase 3 data due 201408/16/2014
EXEL
4.15VemurafenibCancer - malignant melanomaPhase 3Phase 3 initiated Jan 2013. Endpoint metNCT0168951908/16/2014
EXEL
4.15XL184 cabozantinibCancer - metastatic renal cell cancer (RCC)Phase 3Phase 3 initiated May 2013. Enrollement due to be completed 2014. Data due 201508/16/2014
EXEL
XL184 cabozantinibCancer - Castration-Resistant Prostate CancerPhase 3Initiated COMET-1 Phase 3 Dec 2011, not under SPA. Data due 2014NCT0160522708/16/2014
EXEL
XL184 cabozantinibCancer - advanced hepatocellular cancer (HCC)Phase 3Phase 3 initiated Sept 201309/11/2013
FATE
5.22ProHema Adult hematologic malignanciesPhase 2Phase 2 data due mid-2015. Interim data due 2H 201408/16/2014
FATE
5.22ProHemaLysosomal Storage DisordersPhase 2Phase 2 to be initiated 2H 201403/19/2014
FLML
14.72IFN-Alpha-2b XHepatitis C HCVPhase 2Ongoing04/07/2012
FLML
14.72Bloxiverz (neostigmine methylsulfate)Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgeryApprovedApproved Jun 306/05/2013
FLML
VAZCULEP (phenylephrine hydrochloride)Clinically important hypotension resulting primarily from vasodilation in the setting of anesthesiaApprovedApproved June 30 201407/01/2014
FLXN
13.12FX006Osteoarthritis of the knee Phase 2bPhase 2b initiated April 2014. Data due 1H 201508/09/2014
FLXN
13.12FX007Phase 2Phase 2 trial to be initiated 201404/24/2014
FOLD
6.20AT2220/ERT enzyme replacement therapy (010)Pompe DiseasePhase 2NCT01380743
FOLD
6.20Migalastat HCl monotherapy (012)Fabry DiseasePhase 3Phase 3 data released August 2014. Endpoints metNCT0121865908/21/2014
FOLD
migalastat HCl monotherapy (011)Fabry DiseasePhase 3 6 month data released Dec 2012 did not show statistical significance. 12/24 month data released April 2014NCT0092530105/01/2014
FPRX
12.20FP-1039FGFR1Phase 1bPhase 1b initiated July 2013. Prelim data due by end of 201408/16/2014
GALE
2.34GALE-401Essential Thrombocythemia (ET)Phase 2Phase 2 to be initiated 2H 201408/12/2014
GALE
2.34NeuVax (E75) - PRESENTCancer - low-to-intermediate HER2+ breast cancerPhase 3Initiated Phase 3 Jan 2012 under SPA. Enrolment due to be completed 2014NCT0147924408/12/2014
GALE
2.34NeuVaxCancer - HER2 3+ Breast CancerPhase 2Phase 2 to be initiated 2H 201404/29/2014
GALE
2.34NeuVax in combination with HerceptinBreast cancerPhase 2bPhase 2b ongoingNCT0157003605/11/2014
GALE
2.34GALE 301 -Folate Binding Protein (FBP) vaccineEndometrial and ovarian cancerPhase 2Phase 2 initiated Jan 2014. Enrolment completed June 2014. Data due mid 201503/18/2014
GBIM
9.47GS-4774Chronic hepatitis B infectionPhase 2Phase 2 initiated by GILD Sept 201307/09/2014
GBIM
9.47GI-6207Medullary thyroid cancerPhase 2Phase 2 ongoing07/09/2014
GBIM
9.47GI-4000Cancer - Non-small cell lung cancerPhase 2Phase 2b planned07/09/2014
GBIM
9.47GI-4000Cancer - colorectal cancer Phase 2Phase 2a ongoing07/09/2014
GERN
2.36GRNOPC1Acute spinal cord injuryPhase 1Discontinued11/15/2011
GERN
2.36ImetelstatCancer - BreastPhase 2Discontinued due to poor PFS data09/11/2012
GERN
2.36ImetelstatCancer - NSCLCPhase 2Not pursuing future development09/11/2012
GERN
2.36ImetelstatCancer - MyelomaPhase 2Placed on clinical hold Mar 201403/15/2014
GERN
2.36ImetelstatCancer - essential thrombocythemiaPhase 2Placed on clinical hold Mar 201403/15/2014
GERN
2.36ImetelstatMyelofibrosisPhase 2Phase 2 clinical hold lifted Jun 201406/12/2014
GEVA
76.97Sebelipase alfa (SBC-102)Late onset lysosomal acid lipase deficiency (LAL Deficiency)Phase 3Phase 3 initiated Jan 2013. Data released June 2014. BLA filing due 1Q 2015NCT0175718408/03/2014
GLMD
6.80AramcholNon-Alcoholic Steatohepatitis (NASH)Phase 2bInitiate Phase 2b 2H 2014. Interim analysis due 3Q 2015. Data due 4Q 201607/27/2014
GLMD
6.80AramcholCholesterol GallstonesPhase 2aInitiation and data of Phase 2a trial due 2H 201404/25/2014
GLYC
7.88GMI-1070 (rivipansel)Vaso-occlusive crisis of sickle cell diseasePhase 3Phase 3 planned for 2H 201408/10/2014
GNCA
13.14GEN-003Herpes simplex virus type 2 (HSV-2) Phase 1/2Phase 2 trial initiated July 2014. Interim data due mid 201508/10/2014
GNCA
13.14GEN-004Phase 2Phase 2 to be initiated 3Q 201406/24/2014
GNVC
2.11TnferadeCancer - PancreaticPhase 3Failed04/26/2013
GTXI
0.97Toremifene 80mgCancer - ProstateCRLDevelopment terminated following CRL03/02/2011
GTXI
0.97GTx-758 CapesarisCancer - ProstatePhase 2Placed on clinical hold. Hold lifted May 2012. Phase 2 trial continued on LOWER doses. Ongoing. Prelim data released Jan 2014. Data due 1Q 2015NCT0161512008/07/2014
GTXI
0.97Ostarine (Enobosarm (GTx-024)) - POWER 1Cancer - muscle wasting in patients with non-small cell lung cancerPhase 3Failed to meet endpoints. NCT0135548408/22/2013
GTXI
0.97Ostarine (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. Prelim Data due late 2Q 2014 at ASCONCT0161675805/12/2014
GWPH
95.30SativexCancer painPhase 3Phase 3 Initial topline Phase 3 data expected towards the end of 2014NCT0136160708/10/2014
GWPH
95.30GWP42004Type 2 diabetesPhase 2bEstimated completion date 2H 201508/10/2014
GWPH
95.30GWP42003SchizophreniaPhase 2Estimated completion date 2H 201508/10/2014
GWPH
95.30GWP42003Ulcerative colitis.Phase 2aEstimated completion date 2H 2014NCT0156231408/10/2014
GWPH
SativexMultiple Sclerosis (MS) spasticityPhase 3Phase 3 to be initiated 2H 201403/18/2014
GWPH
GWP42002:GWP42003Recurrent Glioblastoma Multiforme (GBM)Phase 1b/2aSafety cohort data expected in 201408/10/2014
GWPH
EpidiolexDravet SyndromePhase 2/3Phase 2/3 trial to be initiated 2H 201408/10/2014
GWPH
EpidiolexLennox-Gastaut syndrome (LGS)Phase 3Phase 3 to be initiated early 201508/10/2014
HALO
9.89HYQVIASubcutaneous treatment for patients with primary immunodeficiency (PI)PDUFA HALO noted in a PR Dec 2 2013 that they had refiled their BLA and expected a 6 month review for HYQVIA for Subcutaneous treatment for patients with primary immunodeficiency (PI). On May 21 they noted in a release that the PDUFA date was extended by a further 3 months (3+6 = 9 month review in total). BioPharmCatalyst previously used this timeframe of 9 months from December 2, 2013 for an ESTIMATED PDUFA date occuring by September 2, 2014. However, this date has been removed from the calendar as per a request from HALO Investor Relations who would like to inform that no official specific PDUFA date has been issued by the company execept that it will occur during "late 3Q 2014"08/03/2014
HALO
9.89Subcutaneous Delivery of Cinryze with rHuPH20Hereditary angioedemaPhase 2bPhase 2 discontinued Aug 2013NCT0175615708/22/2014
HALO
9.89PEGPH20 Cancer - pancreaticPhase 2Clinical hold lifted June 2014.Patient enrolment recommenced July 2014.NCT0183948707/23/2014
HALO
9.89PEGPH20 in combination with modified FOLFIRINOX chemotherapy (mFOLFIRINOX)Cancer - pancreaticPhase 1/2Phase 1/2 initiated Oct 2013NCT0195913901/14/2014
HALO
9.89HTI-501CelluoitePhase 2Phase 2 data due released Jul 2013. Topline data released 1Q 201403/26/2014
HEB
0.28Ampligen CFSCRLCRL Feb 4 2012. Resubmission. More trials required. Intends to appeal02/05/2013
HPTX
26.00RavictiUrea cycle disorders.ApprovedApproved Feb 1 201302/02/2013
HPTX
26.00RavictiHepatic encephalopathyPhase 2Phase 3 to be initiated 2H 2014 or early 201502/26/2014
HPTX
26.00 DiaPep277Type 1 diabetesPhase 3Phase 3 data due 1Q 201506/13/2014
HRTX
9.79APF530 - SustolPrevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)CRLCRL Mar 28 2013. Refile 4Q 201408/05/2014
HTBX
6.29HS-110Cancer - NSCLC non-small cell lung cancer Phase 2Phase 2 trial to be initiated 3Q 201408/16/2014
HTBX
6.29HS-410Cancer - bladder cancerPhase 2Phase 1/2 initiated Jan 2014. Enrolment of Phase 1 portion expected to be completed 3Q 2014. Phase 2 portion to commence 4Q 2014. Data due 3Q 201608/16/2014
HZNP
9.78LODOTRA (RAYOS)Rheumetoid ArthritisApprovedApproved 7/26/201207/27/2012
ICPT
299.90Obeticholic acid (OCA)Adult nonalcoholic steatohepatitis (NASH) patients. Phase 2Phase 2 Japan trial initiated Jan 2013. Complete 1H 201603/19/2013
ICPT
299.90Obeticholic acid (OCA)Adult nonalcoholic steatohepatitis (NASH) patients. Phase 2FLINT trial stopped early due to strong efficacy Jan 2014. Phase 3 to be initiated 1H 2015NCT0126549808/13/2014
ICPT
299.90Obeticholic acid (OCA)Primary biliary cirrhosis (PBC) - POISEPhase 3Phase 3 data met endpoint March 2014. NDA to be filed 1H 2015NCT0147352408/13/2014
ICPT
299.90Obeticholic acid (OCA)Portal hypertensionPhase 2Phase 2b to be initiated 2H 201401/10/2014
ICPT
299.90Obeticholic acid (OCA) - OBADIAH1Primary bile acid diarrhea (PBAD)Phase 2Phase 2b to be initiated 2H 2014NCT0158502501/10/2014
ICPT
299.90Obeticholic acid (OCA)Primary Sclerosing Cholangitis (PSC)Phase 2Phase 2 to be initiated by end of 201408/13/2014
IDRA
2.90IMO-2125Treatment-Naïve HCVPhase 2Discontinued 201104/07/2012
IDRA
2.90IMO-2055Cancer - Squamous Cell, Head and NeckPhase 2Phase 2 data released May 2012. Failed to meet endpoints05/04/2012
IDRA
2.90IMO-8400PsoriasisPhase 2Phase 2 initiated Jun 2013. Data released Mar 201404/25/2014
IDRA
2.90IMO-8400Waldenström’s MacroglobulinemiaPhase 1/2Phase 1/2 enrolment initiated Dec 201312/05/2013
IDRA
2.90 IM0-8400 DLBCL who harbor the MYD88 L265P mutationPhase 1/2Phase 1/2 to be initiated 2H 201405/17/2014
IMGN
12.18SAR3419Cancer - NHL Non-Hodgkin lymphomaPhase 2bCompletedNCT0079673110/20/2011
IMGN
12.18Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) - KadcylaCancer - 2nd-line HER2+ MBCApprovedApproved Feb 22 201302/24/2013
IMGN
12.18IMGN901 lorvotuzumab mertansine - NORTH trialCancer - small-cell lung cancer SCLCDiscontinuedPhase 2 discontinued due to high infection rate Nov 2013NCT0123767811/06/2013
IMGN
12.18Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) - Kadcyla GATSBY trialCancer - metastatic HER2+ gastric cancer Phase 3NDA filing due 2015. Data due early 2015NCT0170255808/03/2014
IMGN
12.18Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) - Kadcyla KRISTINE trialCancer - neo-adjuvant settingPhase 3Phase 3 enrolling08/03/2014
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
Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) - Kadcyla - MARIANNE trialCancer - 1st-line HER2+ Metastatic Breast Cancer Phase 3Phase 3 data due 2H 2014NCT0112018408/03/2014
IMMU
3.34Epratuzumab/ RituximabCancer - non-Hodgkin's lymphoma / Follicular LymphomaPhase 2Initial data released Dec 6 2010NCT0055350112/07/2010
IMMU
3.34Clivatuzumab tetraxetanCancer - PancreaticPhase 3Phase 3 initiated Jan 2014NCT0151056101/10/2014
IMMU
3.34Epratuzumab (EMBODY 2)LupusPhase 3Data due 1H 2015NCT0126179308/26/2014
IMMU
3.34EpratuzumabCancer - ALLPhase 2Phase 2 initial data presented at ASH 201204/26/2013
IMMU
3.34Epratuzumab in combination with chemotherapy in pediatric patients Cancer - ALLPhase 3Phase 3 planned04/26/2013
IMMU
3.34VeltuzumabCancer - immune thrombocytopenic purpura - ITPPhase 2Updated Phase 1/2 data presented at ASH Dec 201312/10/2013
IMMU
3.34Veltuzumab intravenousCancer - NHL Non-Hodgkin lymphomaPhase 2Phase 3 planned, need funding09/10/2013
IMMU
Epratuzumab (EMBODY 1)LupusPhase 3Data due 1Q 2015NCT0126236512/14/2013
IMMU
labetuzumab-SN-38 (IMMU-130) Cancer - colorectal cancerPhase 1/2Phase 1/2 enrolling12/14/2013
IMMU
hRS7-SN-38 (IMMU-132) Cancer - pancreaticPhase 1/2Data released May 201405/24/2014
IMMY
8.01Impracor Topical NSAIDPain - anti-inflammatory creamPhase 3Phase 3 initiation delayed08/14/2013
IMUC
0.91ICT-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
0.91ICT-140Recurrent ovarian cancerPhase 2aPhase 2 planned for 3Q 201403/15/2014
INCY
55.18INCB39110Non-small cell lung cancerPhase 2Phase 2 underway - July 201408/03/2014
INCY
55.18INCB7839Cancer - breastPhase 2Discontinued 4Q 201110/28/2011
INCY
55.18INCB18424 ruxolitinibMyelofibrosisApprovedApproved Nov 201111/20/2011
INCY
55.18INCB24360 in combination with ipilimumabCancer - MelanomaPhase 1/2Prelim data released at ASCo 2014NCT0160488906/03/2014
INCY
55.18LY3009104 BaricitinibRheumatoid arthritisPhase 3Data from first Phase 3 trials due late 201408/03/2014
INCY
55.18LY3009104 BaricitinibPsoriasisPhase 2bPhase 2b data due 2014NCT0149063202/13/2014
INCY
55.18INC280 (formerly INCB28060)Advanced hepatocellular carcinomaPhase 2Phase 2 initiated Apr 2013NCT0173782704/30/2013
INCY
55.18INCB18424 ruxolitinibCancer- Children with hematologic malignancies and solid tumorsPhase 1/2OngoingNCT0116416305/03/2013
INCY
55.18Jakafi (ruxolitinib) (RESPONSE)Polycythemia VeraPDUFAPDUFA December 5 2014NCT0124394408/06/2014
INCY
55.18Jakafi (ruxolitinib) (RELIEF)Disease-related symptoms in patients with Polycythemia VeraPhase 3Endpoint not met, mid-201407/24/2014
INCY
LY3009104 BaricitinibDiabetic nephropathyPhase 2Phase 2 initiated Aug 2012. Data due 2015NCT0168340902/13/2014
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
11.58IPI-926 SaridegibMyelofibrosis Phase 2Development stopped due to poor interim data - Jun 201206/19/2012
INFI
11.58IPI-145 ASPIRARheumatoid arthritisPhase 2Phase 2 data due 2H 2014NCT0185170708/09/2014
INFI
11.58IPI-145AsthmaPhase 2aPhase 2 data due 2H 2014NCT0165375608/09/2014
INFI
11.58IPI-145Indolent non-Hodgkin lymphomaPhase 2Ongoing02/26/2014
INFI
IPI-926 SaridegibCancer - ChondrosarcomaPhase 2Development stopped due to poor interim data - Jun 201206/19/2012
INFI
IPI-145Cancer -relapsed follicular lymphoma (FL).Phase 3Phase 3 to be initiated by end of 201408/09/2014
INFI
Retaspimycin Hydrochloride with docetaxelCancer - NSCLCPhase 2Failed to meet endpoint Sept 2013NCT0136240009/27/2013
INFI
Retaspimycin Hydrochloride with everolimusCancer - NSCLCPhase 2Phase 2 enrolment completed. Does not plan to further developmentNCT0142794609/27/2013
INO
10.32DNA vaccineLeukemia Phase 2Interim Phase 2 data released Dec 2012NCT0133406012/12/2012
INO
10.32(INO-8000)Hepatitis C Phase 2Phase 2 to be initiated later in 201301/10/2013
INO
10.32VGX-3100Cervical dysplasiaPhase 2Phase 3 to be initiated early 2016NCT0130452408/12/2014
INO
10.32DNA vaccineHepatitis C Phase 2Interim Phase 2 data released Apr 2013 - did not show a statistically significant difference - FAIL04/03/2013
INSM
14.04IPLEXMMD - Myotonic muscular dystrophy Phase 2Announced early 2012 - no longer priority04/07/2012
INSM
14.04ARIKAYCEcystic 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
14.04ARIKAYCENon-tuberculous Mycobacterial Lung DiseasePhase 3Clinical hold lifted Jan 2012. Topline data released March 26 2014. Missed primary endpoint. Met key secondary endpoint. Two Phase 3 trials to be initiated, data due 1H 2016 and in 2017.NCT0131523608/05/2014
INSV
0.30BromSite (ISV-303) Pain after cataract surgeryPhase 3Phase 3 data released Dec 2013. NDA filing due 1Q 2015NCT0180854708/14/2014
INSY
35.55Dronabinol Oral SolutionAnorexiaNDANDA filed August 12 201408/14/2014
IPXL
24.91IPX056Multiple Sclerosis Phase 3Second Phase 3 trial on hold12/21/2011
IPXL
24.91IPX066Parkinson's NDACRL Jan 21 2013. NDA resubmitted April 11 201404/16/2014
IPXL
IPX159Restless LegsPhase 2bFailed to meet endpoints. Discontinues development02/27/2013
IRWD
12.95Linaclotideirritable bowel syndrome with constipation (IBS‐C).ApprovedApproved Aug 30 201208/31/2012
IRWD
LinaclotideOpioid-induced constipation (OIC)Phase 2Phase 2 due to be initiated 3Q 2014. Data due 2H 2015.08/05/2014
IRWD
12.95IW-9179Functional dyspepsiaPhase 2aEnded trial prior to completing enrolment due to various issuesNCT0171241205/01/2014
IRWD
12.95IW-9179GastroparesisPhase 2aPhase 2a initiated March 2014. Data due 1H 201505/01/2014
IRWD
12.95 IW-3718 Gastroesophageal reflux disease (GERD) Phase 2aPhase 2a initiated March 2014. Data due 1H 201508/05/2014
ISIS
40.01Mipomersen (KYNAMRO)Homozygous familial hypercholesterolemia (HoFH)ApprovedApproved Jan 29 201301/30/2013
ISIS
40.01ISIS-TTRRxFamilial amyloid polyneuropathyPhase 2/3Phase 2/3 trial initiated early 201202/20/2013
ISIS
40.01ISIS-SMNRxChildren with spinal muscular atrophy (SMA)Phase 3Phase 3 initiated July 2014. Additional Phase 3 study to be initiated later in 2014NCT0183965608/05/2014
ISIS
40.01ISIS-APOCIIIRxHigh triglyceridesPhase 2Phase 2 data released July 22 2013. Phase 3 to be initiated 2014NCT0152942408/05/2014
ISIS
40.01ISIS-APO(a)RxHigh lipoprotein(a), or Lp(a)Phase 2Phase 2 initiated July 201407/18/2014
ISIS
40.01ISIS-CRPRx (ASET)Atrial fibrillationPhase 2Initiated Feb 2013. Data released 2014NCT0171085208/17/2014
ISIS
40.01ISIS-CRPRxRheumatoid arthritisPhase 2Discontinued following disappointing Phase 2 data Aug 2013NCT0141410108/08/2013
ISIS
40.01ISIS-EIF4ERx Combination With CarboplatinCancer - NSCLCPhase 2NCT0123403804/27/2013
ISIS
40.01TG-1101Cancer - hepatocellular carcinoma (HCC)Phase 1/2Phase 2 initiated May 2013NCT0183960405/07/2013
ISIS
40.01LY2181308Cancer - Acute myeloid leukemia AMLPhase 2Discontinued 201204/27/2013
ISIS
40.01OGX-427 Cancer - metastatic CRPCPhase 2NCT0112047004/27/2013
ISIS
40.01OGX-427 in combination with ZytigaCancer - metastatic CRPCPhase 2Initiated Phase 2 late Dec 2012NCT0168143304/27/2013
ISIS
40.01iCo-007Diabetic macular edemaPhase 2NCT0156514804/27/2013
ISIS
40.01OGX-427 in combination with gemcitabine and cisplatin Borealis-1Cancer - bladderPhase 2Phase 2 data due 2H 2014NCT0178054509/12/2013
ISIS
ISIS-EIF4ERxCancer - ProstatePhase 2NCT0123402504/27/2013
ISIS
ISIS-FXIRxClotting disorders in patients undergoing knee replacement surgeryPhase 2Phase 2 data released May 2014NCT0171336105/24/2014
ISIS
ISIS-GCCRRx Type 2 diabetesPhase 2Phase 2 data due 201408/05/2014
ISIS
ISIS-PTP1BRxType 2 diabetesPhase 2Phase 2 data due 201408/05/2014
ISIS
OGX-427 Borealis-2Cancer - Relapsed or Refractory Metastatic Bladder CancerPhase 2Phase 2 initiated Apr 2013NCT0178054505/01/2013
ITMN
72.98Pirfenidone - ASCENDIdiopathic pulmonary fibrosisPDUFAPDUFA November 23 2014NCT0136620907/04/2014
KBIO
1.47KB001-ACystic fibrosis (CF) patients with chronic Pseudomonas aeruginosa (Pa) lung colonizationPhase 2Phase 2 data due early 1Q 2015NCT0169534308/03/2014
KBIO
1.47Pa ventilator associated pneumonia (VAP)Phase 2bPhase 2b trial to be initiated mid 201505/11/2014
KBIO
1.47KB003Severe asthma patients inadequately controlled by corticosteroidsPhase 2Phase 2 data released Jan 2014. Failed to reach endpointNCT0160327701/30/2014
KBIO
1.47KB004MDS and AMLPhase 2Phase 2 initiated Feb 2014. Top-line Data due 2Q or 3Q 201504/27/2014
KERX
17.89PerifosineCancer - ColorectalPhase 3Primary endpoint not met Apr 201204/03/2012
KERX
17.89PerifosineCancer - MyelomaPhase 3 Returned license to AEZS. AEZS plans to continue development. Failed05/08/2012
KERX
17.89ZerenexHyperphosphatemiaPDUFAPDUFA extended to Sept 7 201405/24/2014
KERX
17.89ZerenexIron deficiency anemia in non-dialysis dependent CKD patientsPhase 3Phase 3 to be initiated 3Q 2014NCT0173639705/11/2014
KITE
26.25KTE-C19Relapsed/refractory diffuse large B cell lymphoma, or DLBCLPhase 1/2Phase 1/2 planned for 201507/09/2014
KMDA
6.64Inhaled formulation of AATAATDPhase 2Phase 2 planned in US in 201308/04/2013
KMDA
6.64Inhaled formulation of AATAATD - Alpha-1 Antitrypsin deficiencyPhase 2/3Top-line data from the pivotal Phase 2/3 clinical trial did not meet primary endpoint - May 201405/17/2014
KMDA
6.64GlassiaPediatric patients newly diagnosed with type 1 diabetesPhase 2/3Phase 2/3 initiated Mar 201403/06/2014
KMDA
6.64KamRABProphylaxis of rabies diseasePhase 2/3Phase 2/3 initiated by partner Kedrion 2Q 201305/31/2013
KPTI
38.81SelinexorCancer - glioblastoma following treatment with radiation and temozolomide.Phase 2Phase 2 initiated April 201405/01/2014
KPTI
38.81SelinexorCancer - Advanced Gynecologic Malignancies (SIGN Study)Phase 2Phase 2 initiated April 2014NCT0202598504/25/2014
KPTI
38.81SelinexorCancer - hormone-refractory prostate cancer (HRPC)Phase 2Phase 2 initiated June 201406/10/2014
KPTI
38.81SelinexorCancer - Relapsed/Refractory Acute Myeloid Leukemia (AML)Phase 2Phase 2 initiated June 25 201406/25/2014
KPTI
SelinexorCancer - DLBCL Phase 2bPhase 2b to be initiated 4Q 201408/10/2014
KYTH
36.96ATX-101 Reduction of Localized Subcutaneous Fat in the Submental AreaPDUFAPDUFA May 13 2015NCT0154203407/13/2014
LGND
51.85 Kyprolis (Carfilzomib)Cancer - multiple myelomaApprovedApproved Jul 2012. Partnered with ONXX07/21/2012
LGND
51.85Promacta/RevoladeThrombocytopenia (low blood platelet counts) in patients with chronic hepatitis CApprovedsNDA approved Nov 19 201211/20/2012
LGND
51.85Captisol-Enabled MelphalanCancer - multiple myelomaPivotalPhase 3 enrolment completed Oct 2013. Phase 3 data released April 2014. NDA filing due 3Q 2014NCT0166063304/24/2014
LGND
51.85Bazedoxifene/Conjugated Estrogens (BZA/CE), formerly known as APRELAMenopausal symptomsApprovedApproved Oct 3 201310/06/2013
LGND
51.85Merck Captisol ProgramUndisclosedPhase 3Expect Merck to potentially file a 505(b)(2) in 201304/27/2013
LGND
51.85Captisol-enabled Clopidogrel - MDCO-157Phase 3Phase 3 planned by MDCO04/27/2013
LGND
51.85DinaciclibRefractory chronic lymphocytic leukemia (CLL)Phase 2b/3Phase 2b/3 trial initiated Oct 2012NCT0158022804/27/2013
LGND
51.85MEDI-528Asthma Phase 2Ongoing04/27/2013
LGND
51.85PromactaOncology-related thrombocytopenia in patients with solid tumors, Myelodysplastic Syndrome (MDS), or Secondary Acute Myeloid Leukemia (AML) after MDSPhase 2Ongoing04/27/2013
LGND
51.85PromactaAplastic AnemiasNDAsNDA filed Feb 28 2014NCT0170316903/03/2014
LGND
51.85MK-8931Mild-to-moderate Alzheimer's diseasePhase 2/3Phase 2/3 initiated by Merck in Dec 2012NCT0173934804/27/2013
LGND
51.85Captisol-enabled Carbamazepine-IVAcute seizure disorderPhase 3Phase 3 ongoing04/27/2013
LGND
51.85Captisol-enabled DelafloxacinAcute bacterial skin and skin structure infections (ABSSSI)Phase 3Phase 3 initiated by Rib-X Pharmaceuticals May 201305/15/2013
LGND
51.85LGD-4033Muscle wasting associated with cancer (cachexia), acute rehabilitation (e.g. hip fracture), and acute illness.Phase 2Phase 2 pending04/27/2013
LJPC
10.52GCS-100Chronic kidney diseasePhase 2Phase 2 data due March 201402/22/2014
LMNX
19.12MK-8931Alzheimer’s DiseasePhase 2/3Phase 1/2 ongoing by MRKNCT0173934803/31/2013
LPCN
8.23LPCN 1021Men with low testosterone (Low T)Phase 3Phase 3 data due 3Q 2014. NDA filing due 2H 201508/26/2014
LPCN
LPCN 1111Oral testosterone productPhase 2aPhase 2a topline data due 2H 201408/26/2014
LPTN
3.40iSONEPWet-AMDPhase 2Phase 2 initiated Sep 2012. Expects to complete dosing 1H 2014. Data due 3Q 2014NCT0141415310/09/2013
LPTN
3.40ASONEPRenal cell carcinoma (RCC)Phase 2aPhase 2a initiated dosing May 23 2013. Interim data reported July 2014NCT0176203307/27/2014
LXRX
1.53LX1032 Telotristat etiprateCarcinoid SyndromePhase 3Phase 3 initiated Sep 2012. Enrolment due to be completed by end of 2014NCT0167791005/12/2014
LXRX
1.53LX1032 Telotristat etiprateUlcerative colitisPhase 2OngoingNCT0145605205/11/2013
LXRX
1.53LX2931RA + autoimmune diseasesPhase 2Phase 2 Data did not achieve statistical significance 201004/27/2013
LXRX
1.53LX4211DiabetesPhase 2bPhase 2b data released Jun 2012. Phase 3 planned05/11/2013
LXRX
1.53LX4211Patients with type 2 diabetes and moderate to severe renal impairmentPhase 2Phase 2 data released Sept 2013. Met endpoint02/10/2013
MACK
6.74MM-111Cancer - gastric, esophageal and gastroesophageal cancers Phase 2Phase 2 initiated July 2013. Data due 2015NCT0177485108/14/2014
MACK
6.74MM-121Cancer - ovarianPhase 2Missed endpoint Oct 2013NCT0144770611/02/2013
MACK
6.74MM-121Cancer - NSCLCPhase 2Endpoint not met Nov 2013NCT0099412311/09/2013
MACK
6.74MM-121 Cancer -hormone receptor positive breast cancerPhase 2Data released Nov 2013NCT0115104611/27/2013
MACK
6.74MM-121 Cancer - triple negative breast cancer cohort in the neoadjuvant settingPhase 2Phase 2 data released June 201406/22/2014
MACK
6.74MM-398 NAPOLI-1Cancer - second line pancreaticPhase 3NDA filng due 2014NCT0149450608/14/2014
MACK
6.74MM-398Cancer - ColorectalPhase 2Ongoing04/27/2013
MACK
6.74MM-141CancerPhase 2Phase 2 to be initiated 201508/14/2014
MACK
6.74MM-151CancerPhase 2Phase 2 to be initiated 201405/04/2014
MACK
6.74MM-302 HERMIONECancer - HER2-positive locally advanced or metastatic breast cancerPhase 2Phase 2 initiated August 201408/14/2014
MDCO
26.09MDCO-2010Reduction of blood loss during surgeryPhase 2bPhase 2b discontinued due to safety10/21/2012
MDCO
26.09CangrelorReduction 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).CRLAdcom meeting Feb 12 2014 recommended against approval. CRL April 30 201405/01/2014
MDCO
26.09OritavancinABSSSIPDUFAApproved August 6 2014 under priority reviewNCT0125273208/10/2014
MDCO
26.09FibrocapsHemostasisPDUFAPDUFA January 31, 2015.04/04/2014
MDCO
26.09Angiomax (bivalirudin) Peripheral endovascular intervention (PEI)Phase 3Phase 3 enrolment commenced Oct 201310/11/2013
MDCO
26.09IONSYSAcute postoperative painsNDAsNDA to be filed 1H 201403/18/2014
MDGN
6.25INFRADUREHepatitis C HCVPhase 1/2Two Phase I/II trials in Israel commenced enrolment Jan 201301/31/2013
MDGN
6.25Erythropoietin ("EPO") therapy delivered via EPODURE BiopumpAnemiaPhase 2Phase 1/2 trial commenced enrolment Jun 2014NCT0155551506/06/2014
MDVN
88.62DimebonAlzheimer's diseasePhase 3Phase 3 fail. Development discontinued.01/17/2012
MDVN
88.62DimebonHuntington diseasePhase 3Topline HORIZON trial data released Apr 11 2011. FAILED. Discontinued06/28/2012
MDVN
88.62Enzalutamide Androgen receptor positive, triple-negative breast cancerPhase 2Phase 2 initiated June 2013. Enrolment continues as of May 201405/11/2014
MDVN
88.62EnzalutamideAdvanced Breast Cancer That Is Estrogen or Progesterone Receptor Positive and HER2 NormalPhase 2Phase 2 initiated Dec 2013. Enrolment continues as of May 201405/11/2014
MDVN
88.62XTANDICancer - prostate 2nd lineApprovedApproved Aug 31 201209/02/2012
MDVN
88.62XTANDICancer - mCRPC who have not received chemotherapyPDUFAPDUFA Sept 18 201405/11/2014
MDVN
88.62MDV3100 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
88.62MDV3100 cf Bicalutamide STRIVE trialCancer - prostate enrolling both metastatic and non-metastatic patientsPhase 2Completed enrolment March 2014NCT0166492305/11/2014
MDVN
88.62MDV3100 cf Bicalutamide TERRAIN trial Cancer - prostate enrolling only metastaticPhase 2Completed enrolment July 2013NCT0128891105/11/2014
MDVN
88.62 Enzalutamide PROSPERNon-Metastatic Castration-Resistant Prostate CancerPhase 3Phase 3 initiated Nov 2013. Enrolment ongoing as of May 201405/11/2014
MDWD
7.64NexoBridSevere burnsPhase 3Phase 3 planned 1H 201404/25/2014
MDWD
7.64EscharEx Chronic and other hard-to-heal woundsPhase 2Phase 2 data due 2H 2015 (Israel)05/24/2014
MEIP
7.24Pracinostat in combination with VidazaElderly patients with newly diagnosed acute myeloid leukemia (AML)Phase 2Preliminary data from this open-label trial is anticipated by December 2014.08/17/2014
MEIP
7.24Pracinostat and Vidaza or DacogenRefractory Myelodysplastic SyndromePhase 2Preliminary data from this open-label trial is anticipated by December 2014.08/17/2014
MEIP
7.24Pracinostat 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 1Q 201508/17/2014
MELA
2.25MelafindCancer - melanoma detectionApprovedApproved Nov 201111/05/2011
MGNX
22.34Margetuximab (MGAH22)Cancer - Advanced gastroesophageal Phase 3Phase 3 to commence 2H 201405/11/2014
MGNX
22.34Margetuximab (MGAH22)Cancer - metastatic breast cancerPhase 2aEnrolling. 08/17/2014
MGNX
22.34MGA271CancerPhase 2Phase 2 to be initiated by early 201510/23/2013
MNKD
7.34AFREZZA Type 1/2 diabetesApprovedApproved June 27 2014NCT01445951 (171 trial)06/28/2014
MNOV
2.25MN-166Opioid dependence Phase 2Phase 2 interim data released August 201408/19/2014
MNOV
2.25MN-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
2.25MN-166Progressive multiple sclerosis (progressive MS).Phase 2bPh2b initiated Jul 2013. Data due 201607/21/2013
MNOV
2.25MN-166Chronic medication overuse headache (MOH) painPhase 2Phase 2 to be completed mid 201304/27/2013
MNOV
2.25MN-001NASH (nonalcoholic steatohepatitis)Phase 2Phase 2 planned01/15/2014
MNTA
11.97Generic CopaxoneMultiple sclerosisaNDAFiled 2007. FDA still reviewing05/01/2013
MNTA
11.97M402Cancer - advanced metastatic pancreatic cancerPhase 1/2Initiated Phase 1/2 proof of concept trial Jul 2012. Data from Part A of trial due 2H 2014NCT0162124308/03/2014
MSTX
0.61ExelbineCancer - NSCLCCRLCRL Aug 2011. Discontinued10/04/2011
MSTX
0.61ANX-188Sickle cell diseasePhase 3Phase 3 initiated Jan 2013. Expect to complete enrolment 4Q 2015NCT0173781408/13/2014
MSTX
0.61ANX-188Complications of arterial disease, initially as an adjunct to thrombolytics in acute limb ischemia (ALI)Phase 2Initiated Phase 2 March 2014. Expect to complete enrolment 4Q 201508/13/2014
MSTX
0.61ANX-514 (docetaxel)Cancer - chemo alternative to TaxotereDiscontinued 201204/27/2013
MSTX
AIR001 Pulmonary Hypertension Phase 2Phase 2 prelim data due 3Q 201408/13/2014
MSTX
MST-188 Heart Failure Phase 2Phase 2 to be initiated 2H 2014. Interim data due 2H 201508/13/2014
NAVB
1.28LymphoseekHead and Neck CancerApprovedApproved Jun 13 2014NCT0091132606/14/2014
NAVB
1.28LymphoseekLymphatic-tissue tracing agentApprovedApproved Mar 13 201303/14/2013
NAVB
1.28NAV4694Cerebral Beta-Amyloid When Compared With Postmortem HistopathologyPhase 3Phase 3 enrloment commenced Jun 2013NCT0188682003/28/2013
NAVB
1.28NAV4694Predicting 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
1.28NAV5001 Imaging Agent for Parkinson’s DiseasePhase 3Phase 3 initiated Dec 201312/08/2013
NBIX
16.19Urocortin 2Cardiovascular diseasesPhase 2Phase 2 data released May 2012. Partner required for further development05/18/2012
NBIX
16.19Elagolix Uterine FibroidsPhase 2bPhase 2b initiated Mar 2013. Ongoing as of Feb 2014NCT0181753002/07/2014
NBIX
16.19Elagolix EndometriosisPhase 3Initiated Phase 3 Jun 2012.Data due late 2014. NDA filing expected 2016. NCT0162052808/17/2014
NBIX
16.19VMAT2 NBI-98854 - Kinect 2Tardive dyskinesiaPhase 2Second Phase 2b trial met endpoint Jan 2014. Phase 3 to be initiated 2H 2014NCT0173312108/10/2014
NBIX
ElagolixEndometriosisPhase 3Second Phase 3 trial initiated Aug 2013. Topline data due 3Q 2014. Due to be completed 2015. NDA filing 201608/31/2013
NBS
5.82AMR-001Left ventricular dysfunction following acute ST segment elevation myocardial infarction (STEMI)Phase 2Phase 2 data due 2H 201404/27/2014
NBY
0.77Auriclosene (NVC-422)Urine infectionPhase 2Phase 2 Topline Data released 3QNCT0124312508/06/2013
NBY
0.77Auriclosene (NVC-422)Viral conjunctivitisPhase 2bData released August 2014. Endpoints not metNCT0153233608/21/2014
NBY
0.77Auriclosene (NVC-422)Impetigo skin infection studyPhase 2bFailed to meet endpoint Nov 2013. Plans to reinitiate trial in 2014NCT0167003212/20/2013
NERV
6.80MIN-101SchizophreniaPhase 2bPhase 2b trial to be initiated in Europe in 4Q 201407/09/2014
NKTR
14.41Etirinotecan 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 1Q 2015NCT0149210108/03/2014
NKTR
14.41Etirinotecan pegol NKTR-102Cancer - NSCLCPhase 2Phase 2 initiated Feb 2013NCT0177310902/06/2013
NKTR
14.41Etirinotecan pegol NKTR-102Cancer - relapsed or refractory Small-Cell Lung Cancer (SCLC)Phase 2Phase 2 initiated Oct 201310/25/2013
NKTR
14.41NaloxegolOpioid-induced constipation (OIC)PDUFAPDUFA Sept16 2014. Anesthetic and Analgesic Drug Products Advisory Committee meeting June 11-12, 2014. 08/10/2014
NKTR
14.41Inhaled Amikacin Solution (BAY41-6551T)Gram-Negative Pneumonia (INHALE 1)Phase 3Phase 3 data due 1H 2015NCT0179999304/27/2014
NKTR
14.41Etirinotecan pegol NKTR-102Cancer - ovarianPhase 2Completed Dec 2012. Considering future development09/18/2013
NKTR
14.41Etirinotecan pegol NKTR-102Cancer - colorectalPhase 2EnrolingNCT0085637504/27/2013
NKTR
14.41Etirinotecan pegol NKTR-102Cancer - gliomaPhase 2Phase 2 data released at ASCO 201406/02/2014
NKTR
14.41NKTR-181Chronic painPhase 2Missed endpoint Sept 2013 but Phase 3 planned for mid-2014NCT0161983911/09/2013
NKTR
14.41 BAX 855 Hemophilia ABLABLA filing due late 2014NCT0173647508/22/2014
NKTR
14.41Cipro 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
14.41FovistaWet-AMDPhase 3Phase 3 initial topline data due 201601/23/2014
NLNK
28.12Indoximod in combination with docetaxelCancer - breastPhase 2Phase 2 initiated Apr 2013. Ongoing as of March 2014NCT0179205003/12/2014
NLNK
28.12HyperAcute LungCancer - NSCLCPhase 2b/3Initiated Phase 2b/3 Oct 2012, ongoing as of March 2014NCT0177457803/12/2014
NLNK
28.12HyperAcute Melanoma - dorgenmeltucel-LCancer - melanomaPhase 1b/2Planning03/12/2014
NLNK
28.12HyperAcute Pancreas - IMPRESSSurgically resected pancreatic cancerPhase 3Enrloment completed Sept 2013. First of two interim analyses completed March 2014. Trial to continue as planned. Second analysis due late 2014NCT0107298105/11/2014
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
29.37GATTEXShort Bowel Syndrome ApprovedApproved Dec 21 201212/23/2012
NPSP
29.37GATTEXShort Bowel Syndrome - seeking additions to labelApprovedApproved June 201407/01/2014
NPSP
29.37NatparaHypoparathyroidismPDUFAPDUFA Oct 24 2014. Adcom meeting Sept 12 201406/11/2014
NPSP
NPSP795 Autosomal dominant hypocalcemia or ADHPhase 2Phase 2 initiated August 2014. Preliminary top-line data due late 2014 or early 201508/05/2014
NRX
4.02PyridorinDiabetic nephropathyPhase 3Phase 3 initiated June 2014. Enrolment due to be half complete by 1Q 201508/12/2014
NSPR
2.43MGuardSTEMI - ST segment elevation myocardial infarctionInvestigational Device Exemption (IDE) support trialMaster 12-month data due 4Q 201308/18/2013
NSPR
2.43MGuardSTEMI - 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
4.79RSV vaccineRespiratory Syncytial Virus (RSV)Phase 2Initiated Phase 2 trials Sept 2012. Topline data released Apr 201304/03/2013
NVAX
4.79RSV vaccineRespiratory Syncytial Virus (RSV) in women of childbearing age.Phase 2Phase 2 topline data released April 201404/29/2014
NVAX
4.79Seasonal Influenza VaccineSeasonal FluPhase 2Further Phase 2 trials planned09/18/2013
NVGN
3.27Intravenous ME-143Cancer - triple-negative breast cancerPhase 2Phase 2 enrolling04/27/2013
NWBO
5.95DCVaxCancer - Glioblastoma multiforme (GBM) brain cancerPhase 3First trigger for interim analysis hit. Topline data due 1H 2015 as per Jan 2014 conference. However, trial design was altered in Aug 2014. No timeline update in PRNCT0004596808/17/2014
NWBO
5.95DCVaxCancer - inoperable solid tumor cancersPhase 1/2Initial data released May 2014. Phase 2 portion planned07/17/2014
NYMX
5.06NX-1207Cancer - low grade localized prostatePhase 2Phase 2 data released April 2014NCT0162051505/01/2014
NYMX
5.06NX-1207 (NX02-0018)BPH Phase 3Phase 3 data due 2Q 2014NCT0094549001/29/2014
OCRX
5.77OCR-002 (IV)Hepatic encephalopathyPhase 2bPhase 2b enrolment to be completed mid-201508/12/2014
OCRX
5.77OCR-002 (oral)Hepatic encephalopathyPhase 2bPhase 2b planned to start 201411/07/2013
OGXI
3.38OGX-427 with PrednisoneCancer - chemotherapy-naive patients with metastatic CRPCPhase 2Phase 2 ongoingNCT0112047011/09/2013
OGXI
3.38OGX-427 in combination with Zytiga - Pacific TrialCancer - castrate-resistant prostatePhase 2Initiated Phase 2 late Dec 2012NCT0168143312/20/2012
OGXI
3.38OGX-427 Borealis-2Cancer - advanced or metastatic bladder cancerPhase 2Phase 2 initiated Apr 2013NCT0178054505/01/2013
OGXI
3.38OGX-427 in combination with gemcitabine and cisplatin Borealis-1Cancer - bladderPhase 2Phase 2 data due 1Q 2015NCT0178054508/09/2014
OGXI
3.38Custirsen, in combination with first-line docetaxel chemotherapy SYNERGYCancer - castrate-resistant prostatePhase 3Trial failed to meet endpoint - Apr 2014NCT0118818704/29/2014
OGXI
3.38Custirsen in combination with Jevtana (cabazitaxel)-AFFINITYCancer - castrate-resistant prostate second-linePhase 3Initiated 2nd Phase 3 trial Aug 2012. Data due late 2015 or early 2016NCT0157865508/22/2014
OGXI
3.38Custirsen ENSPIRITCancer - NSCLCPhase 3Phase 3 initiated Oct 2012. First interim analysis released August 2014. Trial to continue as planned.NCT0163073308/22/2014
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 open label initiated July 201407/02/2014
OHRP
8.59Squalamine Eye DropsNeovascular (Wet) Age-related Macular Degeneration (AMD)Phase 2Phase 2 interim data released June 24 2014. Final data due 1Q 2015NCT0167896306/25/2014
OHRP
8.59OHR-005Diabetic macular edema (DME)Phase 2Phase 2 initiated May 201405/10/2014
OHRP
8.59OHR/AVR118Cancer cachexia.Phase 2Phase 2 data presented Dec 2013NCT0120633512/27/2013
OMER
14.09OMS103HPACL Phase 3Disappointing Data released Mar 201104/01/2011
OMER
14.09OMS103HPPostoperative joint function Phase 3Data released Dec 2012. Missed primary endpoint. 03/19/2013
OMER
14.09OmidriaCataract surgeryApprovedApproved June 2 201406/03/2014
OMER
14.09OMS201UrologyPhase 2Phase 2 planning. Company have no plans for 2013, but will resume when they have adequate resources 04/27/2013
OMER
14.09OMER824Huntington diseasePhase 2Phase 2 initiated Feb 2014. Interim data due end of 2014. Final data due 201508/16/2014
OMER
14.09OMER824SchizophreniaPhase 2Phase 2 initiated Sept 2013. Data released Jan 201401/30/2014
OMER
14.09OMS721 Thrombotic microangiopathies (TMAs)Phase 2Phase 2 preliminary data due end of 201408/16/2014
ONCY
1.37REOLYSIN with FOLFOX-6 plus bevacizumabCancer - advanced or metastatic colorectal cancerPhase 2Phase 2 plannedNCT0162254305/04/2012
ONCY
1.37REOLYSIN - intravenous with gemcitabineCancer - PancreaticPhase 2Enrolment completed Oct 2012NCT0099832210/25/2012
ONCY
1.37 REOLYSIN with paclitaxel & carboplatinCancer - Head and NeckPhase 2Data released Apr 2014. Phase 3 plannedNCT0116654204/10/2014
ONCY
1.37Intravenous REOLYSIN with paclitaxel & carboplatinCancer - squamous cell carcinoma of the lung (SCCLC)Phase 2Final data released Sept 2013NCT0099819209/10/2013
ONCY
1.37Intravenous Administration of REOLYSIN in combination with paclitaxel and carboplatinNon-small cell lung with K-RAS or EGFR-activated tumoursPhase 2OngoingNCT0086162704/27/2013
ONCY
1.37Intravenous REOLYSIN in combination with paclitaxel and carboplatinCancer - metastatic melanomaPhase 2Prelim data released May 2013NCT0098446405/23/2013
ONCY
1.37REOLYSIN in Combination with Paclitaxel and CarboplatinCancer - Metastatic Pancreatic CancerPhase 2Enrolment completed July 2014NCT0128005807/09/2014
ONCY
1.37REOLYSIN with paclitaxel Cancer - ovarian, fallopian tube or primary peritonealPhase 2OngoingNCT0119926304/27/2013
ONTX
5.42IV rigosertib plus gemcitabine Cancer - metastatic pancreatic cancerPhase 3Phase 3 failed following interim analysis December 2013 12/18/2013
ONTX
5.42IV rigosertibCancer - MDS high riskPhase 3Phase 3 failed to meet endpoints02/20/2014
ONTX
5.42Oral rigosertibCancer - MDS low riskPhase 3Phase 3 under possible SPA to be initiated 1H 201408/16/2014
ONTX
5.42RigosertibCancer - relapsed or metastatic head and neck cancersPhase 2Initiated mid-201309/22/2013
ONTY
2.37Tecemotide - START2Cancer - Stage III Non-Small Cell Lung CancerPhase 3Phase 3 initiated April 201404/08/2014
ONTY
Tecemotide - EMR 63325-009Cancer - Stage III Non-Small Cell Lung CancerPhase 1/2Failed to meet endpoint August 201408/19/2014
ONTY
2.37PX-866 in combination with vemurafinibCancer - advanced BRAF-mutant melanoma Phase 1/2Initiated Phase 1 portion of trial May 201206/01/2012
ONTY
2.37StimuvaxCancer - NSCLCPhase 3Phase 3 failed to meet endpoints12/20/2012
ONTY
2.37ONT-10CancerPhase 2Phase 2 planned of 201405/10/2013
ONTY
2.37PX-866Cancer - prostatePhase 2Initiated Phase 2 Sept 2011. Phase 2 data due at ASCO 2013NCT0133108305/18/2013
ONTY
2.37PX-866Cancer - glioblastomaPhase 2Phase 2 data due at ASCONCT0125986905/18/2013
ONTY
2.37PX-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
2.37PX-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
39.45FovistaWet-AMDPhase 3Phase 3 initial topline data due 201608/10/2014
OPHT
39.45ZimuraGeographic atrophyPhase 2/3Phase 2/3 trial to be initiated late 201405/17/2014
OPHT
39.45Fovista and ZimuraWet AMDPhase 2/3Phase 2 trial to be initiated 201505/17/2014
OPK
8.97CTAP101 Capsules - (Rayaldy)Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) and vitamin D insufficiencyNDANDA filng due 2014NCT0165100008/13/2014
OPK
8.97Fermagate Tabletshyperphosphatemia in CKD patients on chronic hemodialysisPhase 3Phase 3 data due 1H 201709/12/2013
OPK
8.97hGH-CTPAdults - growth hormone deficiencyPhase 3Initiated Phase 3 Jun 2013. Data due 2H 201509/12/2013
OPK
8.97hGH-CTPChildren - growth hormone deficiencyPhase 3CC to discuss Phase 2 data Jun 23 2014 - Phase 3 data due 1H 2018 (yet to be initiated)NCT0159250006/22/2014
OPK
8.97Factor VIIa-CTPHemophiliaPhase 2Intend to initiate Phase 2 in 201404/27/2013
OPK
8.97Neurokinin-1 (“NK-1”) - Rolapitant (partnered with TSRO)Prevention of chemotherapy induced nausea and vomiting, or CINV Phase 3Intends to file NDA by mid Sept 2014NCT0150022608/13/2014
OPXA
1.46Tovaxin (Tcelna)Secondary Progressive MS (SPMS)Phase 2bPhase 2b initiated Sept 2012. 100 patients enrolled as of Nov 2013. Top-line data 2H 2016NCT0168476108/16/2014
OPXA
1.46Tovaxin (Tcelna)Relapsing Remitting MS (RRMS)Phase 2bFurther development pending funding09/18/2013
OREX
5.89ContraveObesityPDUFACRL Feb 1, 2011. New PDUFA extended to September 11 2014NCT0160170406/12/2014
OREX
5.89EmpaticEpilepsyPhase 2bPhase 3 planned. Needs partner04/27/2013
OSIR
14.25ProchymalDiabetesPhase 2Failed trial Jan 201201/03/2012
OSIR
14.25ProchymalRefractory GvHDTerminatedTerminated Feb 201204/08/2012
OSIR
14.25ProchymalCrohn’s diseasePhase 3Enrollment re-started May '10.OngoingNCT0123396004/27/2013
OSIR
14.25ProchymalAcute 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
8.61OraQuickHIV testApprovedApproved Jul 3 201207/03/2012
OXGN
2.20ZYBRESTATCancer - NSCLCPhase 2Concluding development09/01/2011
OXGN
2.20ZYBRESTATCancer - ATC Phase 2/3Concluding development11/10/2012
OXGN
2.20ZYBRESTATCancer - OvarianPhase 2Met primary endpoint March 2014. Further data to be presented at the International Gynecologic Cancer Society meeting from November 8 2014NCT0130521308/10/2014
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
PBMD
1.08CAN-004Cancer - ovarianPhase 2Phase 2 commenced April 201404/29/2014
PBYI
269.82PB272Adjuvant treatment for HER2+ breast cancerPhase 3Phase 3 data released July 2014. NDA due 1H 201507/23/2014
PBYI
269.82PB272 HER2-positive breast cancer first linePhase 2Phase 2 due to be completed 2H 201408/12/2014
PBYI
269.82PB272 Neoadjuvant treatment for patients with HER2-positive breast cancer (NSABP FB-7)Phase 2Phase 2 data due 2H 2014NCT0104237908/12/2014
PBYI
269.82PB272Third line HER2+ MBC Phase 3Phase 3 initiated June 201307/01/2014
PBYI
269.82PB272 in combination with toriselFourth line HER2-positive metastatic breast cancerPhase 2Phase 2 additional data due 2H 2014. Phase 3 initiation due 2H 201408/12/2014
PBYI
269.82PB272 HER2+ MBC that has metastasized to the brainPhase 2Data due 2014 or early 2015NCT0149466208/12/2014
PBYI
269.82PB272 HER2 mutated non-small cell lung cancerPhase 2Phase 2 data due 2014NCT0182726708/12/2014
PBYI
269.82PB272HER2-negative breast cancer patients who have a HER2 mutationPhase 2Phase 2 interim data due 2014NCT0111182508/12/2014
PCRX
107.71EXPARELPostsurgical painApprovedFDA Approved Oct 201110/31/2011
PCRX
107.71EXPARELSingle-dose injection femoral nerve block for total knee arthroplasty surgeryPDUFAPDUFA March 5 2015.08/03/2014
PCYC
120.24IMBRUVICACancer - relapsed or refractory follicular lymphomaPhase 2Phase 2 ongoingNCT0177979105/02/2013
PCYC
120.24IMBRUVICACancer - relapsed/refractory multiple myeloma (MM)Phase 1/2bOngoingNCT0147858108/03/2014
PCYC
120.24IMBRUVICA Cancer - relapsed or refractory MCL mantle cell lymphomaApprovedApproved Nov 13 2013NCT0164602108/31/2013
PCYC
120.24IMBRUVICA Cancer - newly diagnosed CD20 positive non-Hodgkin's lymphomaPhase 1b/2Update at ASCO 2013NCT0156975005/02/2013
PCYC
120.24IMBRUVICA in combination with bendamustine and rituximab - SHINE (MCL3002)Cancer - newly diagnosed MCLPhase 3Janssen plans to enroll 520 patientsNCT0177684002/21/2014
PCYC
120.24IMBRUVICA RESONATE™-17Deletion 17pPhase 2Phase 2 data due 2014NCT0174469108/03/2014
PCYC
120.24IMBRUVICA RESONATECancer - Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL/SLL)ApprovedApproved July 29 2014NCT0157870708/03/2014
PCYC
120.24IMBRUVICA RESONATE -2Cancer - newly diagnosed elderly CLL/SLL patientsPhase 3Phase 3 data due 2H 201508/03/2014
PCYC
120.24IMBRUVICA Cancer - Chronic Lymphocytic Leukemia Who Have Received at Least One Prior TherapyApprovedApproved Feb 12 2014NCT0172248702/13/2014
PCYC
IMBRUVICA - SPARK (MCL2001)R/R MCL who progress after bortezomib therapyPhase 2Enrolment completedNCT0159994908/01/2013
PCYC
IMBRUVICA in combination with bendamustine and rituximab - HELIOS (CLL3001)Cancer - Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL/SLL)Phase 3Phase 3 data due 1H 2015NCT0161109008/03/2014
PCYC
IMBRUVICAR/R CLL/SLLPhase 3Phase 3 initiated 4Q 201302/21/2014
PCYC
IMBRUVICAMarginal Zone Lymphoma (MZL)Phase 2Phase 2 initiated 4Q 201308/03/2014
PCYC
IMBRUVICAWaldenström’s MacroglobulinemiaPhase 3Phase 3 initiated 2Q 201408/03/2014
PFE
29.21Palbociclib (PD-0332991) in combination with letrozoleER+, HER2- locally advanced or metastatic breast cancerPhase 3Received Breakthrough Therapy designation. Phase 3 enrollingNCT0174042704/27/2013
PFE
29.21LyricaPartial Onset SeizuresPhase 3Phase 3 endpoints met04/27/2013
PFE
29.21Pregabalin 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
5.44MIP-1404Cancer - prostate cancerPhase 2Phase 2 initiated Oct 2012NCT0166753610/21/2012
PGNX
5.44AzedraPheochromocytomasPhase 2bIntends to restart Phase 2b trialNCT0087461411/27/2013
PGNX
5.44PSMA 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
5.44Subcutaneous RELISTORchronic painPDUFAPDUFA September 29 201408/12/2014
PGNX
Oral RelistorChronic, Non-Cancer Pain Subjects with Opioid-Induced ConstipationPhase 3Phase 3 completed. Further progress on hold04/27/2013
PLX
2.45TaliglueraseGaucher diseaseApprovedApproved May 1 201205/02/2012
PLX
2.45PRX-102Fabry diseasePhase 1/2Phase1/2 initiated Dec 2012NCT0167889812/10/2012
PLX
2.45PRX-112Gaucher diseasePhase 2Phase 2 due to be completed 3Q 201406/19/2014
POZN
8.37PA32540 and PA8140Cardiovascular patients at risk for developing aspirin-associated gastric ulcersPDUFACRL Apr 25 2014. New PDUFA December 30 201407/17/2014
PPHM
1.66BavituximabHCVPhase 2Phase 2 prelim data released Dec 2012. Seeking partner to advance program03/11/2012
PPHM
1.66CotaraCancer - GlioblastomaPhase 2Phase 3 planning. Needs partner to advance12/10/2012
PPHM
1.66Bavituximab with gemcitabineCancer - pancreatic Phase 2Patient enrolment completed Jun 2012. Interim data released Feb 2013. Evaluating next stepsNCT0127279102/14/2013
PPHM
1.66BavituximabCancer - Refractory NSCLCPhase 3Interim data released Sept 2012 reported to be faulty. Phase 3 SUNRISE trial initiated Dec 2013NCT0199967312/31/2013
PPHM
1.66Bavituximab 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
1.66 Bavituximab + cabazitaxelCancer - castration-resistant prostate cancerPhase 1/2Discontinued Mar 201304/27/2013
PPHM
1.66BavituximabCancer - LiverPhase 2Phase 2 part of trial is enrollingNCT0126470504/27/2013
PRAN
2.06PBT-2Alzheimer'sPhase 2Phase 2 endpoint not met04/01/2014
PRAN
2.06PBT-2Huntington's DiseasePhase 2Data released Feb 2014NCT0159088802/19/2014
PRGO
148.12Betamethasone Valerate Foam 0.12%Generic equivalent of Luxiq FoamApprovedApproved Nov 201203/29/2013
PSDV
4.76Injectable sustained-release micro-insertPosterior uveitisPhase 3Pivotal trial initiated Jul 2013 (first of two Phase 3 trials)NCT0169418607/02/2013
PSDV
4.76IluvienDiabetic macular edemaPDUFACRL Nov 2011. Second CRL Oct 17 2013. New PDUFA Sept 26 201404/16/2014
PSTI
2.77PLX-PAD (stem cells)CLI - Critical limb ischemia Phase 1/2CompleteNCT0095121009/16/2011
PSTI
2.77PLX cellsBuerger's DiseasePhase 2Phase 2 planned in India08/17/2012
PSTI
2.77PLX-PAD Muscle injuryPhase 1/2Phase 1/2 data released Jan 21 2014NCT0152566701/22/2014
PSTI
2.77PLX-PAD (stem cells)Pulmonary Arterial Hypertension (PAH) Phase 1Phase 1 plannedNCT0179595004/27/2013
PSTI
2.77PLX-PAD (stem cells)Intermittent claudication, or ICPhase 2Phase 2 put on clinical hold Jun 2013. Lifted Sept 2013NCT0167999009/17/2013
PTCT
32.33Ataluren 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 2H 201508/09/2014
PTCT
Ataluren Nonsense mutation cystic fibrosisPhase 3Phase 3 initiated July 2014. Data due 2H 201608/09/2014
PTIE
4.31RemoxyChronic painCRLCRL Jun 23, 2011. Resubmission no earlier than mid-201510/23/2013
PTIE
ORADUR-HydromorphonePhase 3Phase 3 to be initiated 201508/09/2014
PTLA
27.07Betrixaban (The APEX Study)Venous thromboembolism (VTE) PreventionPhase 3Complete patient enrollment in APEX by the end of 2015.NCT0158321808/10/2014
PTLA
27.07Andexanet 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
27.07Andexanet alfaFactor Xa inhibitor reversal agentPhase 2Phase 3 initiated March 2014. Initial data due 4Q 2014. Full data due 1H 201508/10/2014
PTLA
27.07Cerdulatinib (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
0.88AZD2820ObesityPhase 1Phase 1 halted Jun 2012 due to adverse event. Development discontinued Sep 201209/08/2012
PTN
0.88Bremelanotidefemale sexual dysfunction (FSD)Phase 2bPhase 3 initiation 2H 201405/17/2014
PTN
PL-3994Acute exacerbations of asthmaPhase 2aCompleted04/28/2013
QCOR
0.00ActharAmyotrophic lateral sclerosis (ALS)Phase 2Phase 2 patients screening commenced July 2013. Enrolment completed as of July 201407/27/2014
QCOR
0.00ActharDiabetic NephropathyPhase 2Enrolment ongoing as of July 2014NCT0160123607/27/2014
QCOR
0.00ActharAcute Respiratory Distress Syndrome (ARDS)Phase 2Phase 2 site selection has been initiated as of July 201407/27/2014
QLTI
5.57punctal plug drug deliveryAllergic conjunctivitisPhase 2aData released Feb 2011, trial failed, study stopped02/09/2011
QLTI
5.57QLT091001Impaired Dark Adaptation (IDA)Phase 2aPhase 2a initiated Dec 201312/10/2013
QLTI
5.57punctal plug drug deliveryGlaucomaPhase 2Sold to Mati04/28/2013
QRXPY
0.14MOXDUOModerate to severe acute painPDUFACRL Aug 2013. New PDUFA May 25 2014. New CRL May 27 201405/28/2014
RARE
52.73rhGUS Mucopolysaccharidosis 7 (MPS 7) Phase 1/2Phase 1/2 initiated December 2013. Interim 12-week data are expected to be presented at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium on September 3, 201408/12/2014
RARE
52.73Triheptanoin Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD)Phase 2Phase 2 initiated February 2014. Data due 201508/12/2014
RARE
52.73TriheptanoinGlucose Transporter Type-1 Deficiency Syndrome (Glut1 DS)Phase 2Phase 2 initiated March 2014. Data due 201508/12/2014
RARE
52.73KRN23X-linked Hypophosphatemia (XLH)Phase 2Phase 2 initiated July 2014. Interim data due 2015.08/12/2014
RCPT
50.56RPC1063 -RADIANCERelapsing Multiple Sclerosis (RMS). Phase 2/3Phase 2 Top-line data released June 2014. Phase 3 is ongoing08/17/2014
RCPT
50.56RPC1063Ulcerative Colitis (UC) Phase 2Phase 2 top-line data expected in 4Q 2014NCT0164751608/17/2014
RCPT
RPC4046 Eosiniphilic EsophagitisPhase 2Phase 2 planned 2H 201408/17/2014
RGDO
1.17REGULATE-PCI - REG1percutaneous coronary intervention (PCI)Phase 3Trial halted due to safety concerns - Aug 201408/26/2014
RDUS
14.00Abaloparatide-SCOsteoporosisPhase 3Phase 3 top-line data due late December 201408/16/2014
RDUS
14.00Abaloparatide-TD (patch)OsteoporosisPhase 2Phase 2 complete07/09/2014
RDUS
14.00RAD1901 Vasomotor symptoms such as hot flashesPhase 2Phase 2 complete07/09/2014
RGEN
20.66RG2417BipolarPhase 2bData released Mar 2011. FAIL02/09/2011
RGEN
20.66RG1068 - SecreFloPancreatic imagingCRLCRL issued Jun 22 201206/22/2012
RIGL
2.72R333Discoid Lupus ErythematosusPhase 2Failed to reach endpoint Oct 2013. Development to discontinueNCT0159705009/06/2013
RIGL
2.72R343AsthmaPhase 2Failed Phase 2 Aug 2013NCT0159104408/28/2013
RIGL
2.72R348Chronic dry eye diseasePhase 2Phase 2 data released August 2014 failed to meet endpoints08/14/2014
RIGL
2.72R348Chronic 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
2.72Fostamatinib 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
2.72Fostamatinib OSKIRA-4Phase 2b monotherapy trialPhase 2Phase 2b trial completed Dec 2012. Met one endpoint, failed to meet the other12/14/2012
RIGL
2.72Fostamatinib Immune Thrombocytopenic Purpura (ITP)Phase 3Phase 3 initiated July 2014. Data due end of 201507/17/2014
RIGL
2.72FostamatinibIgA nephropathyPhase 2Phase 2 planned for spring of 201401/12/2014
RLYP
26.52PATIROMER (RLY5016)HyperkalemiaPhase 3Phase 3 data released Oct 2013. NDA to be filed early 4Q 201408/14/2014
RMTI
9.36Soluble Ferric PyrophosphateIron deficiencyPDUFAPDUFA January 24 2015NCT0132234706/10/2014
RNA
9.39DrisapersenDuchenne Muscular Dystrophy (DMD)Phase 3Phase 3 endpoint not met Sept 2013. NDA filing due by end of 2014NCT0125401908/16/2014
RNA
9.39PRO044Duchenne Muscular Dystrophy (DMD) patients with a mutation around location 44 in the DNA for the dystrophin proteinPlacebo trial to commence 2015NCT0103730908/16/2014
RNA
9.39 PRO053DMDPhase 1/2Phase 1/2 initiated Jun 2013. Data due 1H 201508/16/2014
RNN
0.70SerdaxinMajor Depressive DisorderPhase 2bFailed to display efficacy12/13/2011
RNN
0.70ArchexinCancer - pancreaticPhase 2aPhase 2 completed 201204/27/2013
RNN
0.70ZoraxelErectile DysfunctionPhase 2aPhase 2a complete. Phase 2b development requires partner04/27/2013
RNN
ArchexinCancer - metastatic renal cell carcinoma (RCC)Phase 2Phase 2 initiation Jan 2014. Initial phase to be completed late 201404/11/2014
RPRX
18.15ProellexEndometriosisPhase 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
18.15ProellexUterine fibroids (vaginal treatment)Phase 2bEnd of Phase 2 meeting late May 2013. Phase 2b to be initiated 201411/05/2013
RPRX
18.15ProellexUterine fibroids (oral treatment)Clinical holdFull clinical hold. Intends to submit request to lift hold. Likely in 201411/05/2013
RPRX
18.15Androxal Secondary hypogonadismPhase 3Phase 3 topline data due 4Q 2014. NDA filing late 2014. NCT0173959507/17/2014
RPTP
11.46DR CysteamineCystinosisApprovedPDUFA date Apr 30, 2013. 3 month delay08/09/2013
RPTP
11.46ConviviaALDH2Phase 2aPhase 2 completed, seeking partner04/27/2013
RPTP
11.46DR CysteamineHuntington's DiseasePhase 2Topline Phase 2/3 data released Feb 2014 02/21/2014
RPTP
11.46DR 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
11.46TezampanelThrombotic DisorderPhase 1Discontinued04/27/2013
RTGN
5.20RUT58-60Prevention of infection post abdominal surgeryPhase 1/2Phase 1/2 to be completed 1Q 201508/16/2014
RTRX
13.13Sparsentan (DUET) Focal segmental glomerulosclerosis (FSGS)Phase 2/3Enrolment due to be completed late 2014 or early 201505/17/2014
RTRX
13.13RE-034 Infantile Spasms and Membranous NephropathyPhase 3Phase 3 to be initiated 3Q 201405/17/2014
RVNC
23.45RT002 injectable botulinum toxin type A Moderate to severe glabellar (frown) linesPhase 1/2Phase 1/2 data released April 201408/14/2014
RVNC
23.45RT001 Lateral canthal lines (crow’s feet lines)Phase 3Phase 3 planned for 1H 2014. Data due 2H 201408/14/2014
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 released mid 2014NCT0172846708/10/2014
RVX
RVX-208 (ASSURE trial)Coronary placque removalPhase 2bFailed to meet endpoint Jun 2013. Futher data presented Jan 2014NCT0106782001/16/2014
RXDX
7.73RXDX-101Cancer - solid tumorsPhase 1/2Phase 1/2 trial initiated July 201407/22/2014
RXII
2.54RXI-109Anti-scarringPhase 2Phase 2 initiated November 2013. First data due by end of 2014. 08/17/2014
RXII
2.54RXI-109Recurrence of keloids after keloid revision surgeryPhase 2Phase 2 initiated April 201405/01/2014
RXII
2.54RXI-109Suppressing recurrence of hypertrophic scars after bilateral scar revision surgery in the breast areaPhase 2Phase 2 initiated July 201404/25/2014
SCLN
6.90SCV-07Hepatitis C HCVPhase 2b stoppedData released Dec 2010, discontinues development12/15/2010
SCLN
6.90SCV-07OM - oral mucositis DiscontinuedDiscontinued Mar 2012 03/03/2012
SCMP
6.95LubiprostonePediatric functional constipationPhase 3Phase 3 initiated Dec 2013, with data due early 201612/18/2013
SCMP
6.95Rescula (unoprostone isopropyl) Retinitis pigmentosaPhase 3Phase 3 interim data due early 1Q 201501/14/2014
SCMP
6.95CobiprostoneOral MucositisPhase 1b/2aPhase 1b/2a initiated 4Q 201302/27/2014
SCMP
6.95SPI-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
6.95Amitiza/ LubiprostoneOpioid-induced bowel dysfunctionApprovedApproved Apr 23 201304/24/2013
SCMP
6.95Amitiza/ LubiprostoneChronic idiopathic constipationApprovedApproved 200604/27/2013
SCMP
6.95Amitiza/ Lubiprostone (liquid form)Chronic idiopathic constipationPhase 3Phase 3 due to be completed 1H 201401/14/2014
SCYX
6.11SCY-078Candida infectionsPhase 2Phase 2 planned for 201407/09/2014
SGEN
44.09ADCETRISCancer - Anaplastic large cell lymphomaApprovedAPPROVED Aug 19 201108/20/2011
SGEN
44.09ADCETRISCancer - Relapsed & Refractory Hodgkin lymphomaApprovedAPPROVED Aug 19 201108/20/2011
SGEN
44.09ADCETRIS ALCANZACancer - cutaneous T-cell lymphomaPhase 3Initiated May 2012. EnrollingNCT0157849905/08/2012
SGEN
44.09ADCETRIS - AETHERACancer - post-transplant Hodgkin lymphoma (HL) patientsPhase 3Phase 3 data due by October 2014NCT0110050208/03/2014
SGEN
44.09ADCETRISCancer - for front-line treatment of elderly patients with HLPhase 2Initiated Phase 2 Oct 2012. Data due 2014NCT0171680608/03/2014
SGEN
44.09ADCETRIS ECHELON-1Cancer - front-line advanced stage Hodgkin lymphomaPhase 3Phase 3 initiated Nov 2012NCT0171249011/03/2012
SGEN
44.09ADCETRIS ECHELON-2Cancer - front-line mature T-cell lymphomas, including sALCLPhase 3Phase 3 initiated Jan 2013NCT0177715201/25/2013
SGEN
44.09ADCETRIS in combination with bendamustineCancer - second-line HLPhase 1/2Phase 1/2 initiated Jun 2013NCT0187405405/08/2013
SGEN
44.09ADCETRISCancer - CD30-positive non-Hodgkin lymphomaPhase 2Initiated Aug 2011. Interim data released at ASH 2012NCT0142166704/27/2013
SGEN
44.09ADCETRISCancer - CD30-positive Nonlymphomatous MalignanciesPhase 2EnrollingNCT0146153805/25/2013
SGEN
44.09SGN-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
14.80SB-509-901Diabetic NeuropathyPhase 2bData 4Q 2011 - FAILED10/04/2011
SGMO
14.80SB-728-902HIV/AIDSPhase 2Data presented Dec 2013NCT0104465412/07/2013
SGMO
14.80SB-728-1101HIV/AIDSPhase 2Data presented Dec 2013NCT0154315212/07/2013
SGMO
CERE-110 Alzheimer's DiseasePhase 2Phase 2 data due 201502/12/2014
SGYP
3.82SP-333Opioid-induced constipation (OIC)Phase 2Phase 2 initiated Oct 2013. Enrollment completed July 2014. Data due 4Q 201408/12/2014
SGYP
3.82PlecanatideConstipation-predominant irritable bowel syndrome (IBS-C).Phase 2bPhase 2b topline data released Apr 2014. Phase 3 to be initiated 4Q 2014NCT0172231807/09/2014
SGYP
3.82PlecanatideChronic idiopathic constipation (CIC)Phase 3Phase 3 initiated Nov 2013. Second trial initiated Apr 2014. Topline data from first trial due 2Q 201508/12/2014
SLXP
157.64RELISTOR (methylnaltrexone bromide) - subcutaneous useOpioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain.PDUFAPDUFA September 29 201408/12/2014
SLXP
157.64TARGET 3 - rifaximin 550 mg TIDIrritable bowel syndrome with diarrhea (IBS-D)Phase 3EnrollingNCT0154317805/11/2013
SLXP
157.64EIR rifaximin Crohn’s diseasePhase 3Phase 3 due to be initiated 2H 201305/11/2013
SLXP
157.64Budesonide foamModerate ulcerative proctitis or proctosigmoiditis PDUFAPDUFA September 15 2014NCT0134967301/31/2014
SLXP
157.64RUCONESTHereditary angioedema (HAE)ApprovedApproved July 16, 201407/17/2014
SNSS
7.49VoreloxinCancer - Acute myeloid leukemia AMLPhase 3Enrolment expanded following interim Sept 2012 analysis. Data due 3Q or 4Q 2014NCT0119180108/06/2014
SNSS
7.49VoreloxinCancer - 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
7.49VoreloxinAdult patients with previously treated intermediate-2 or high-risk myelodysplastic syndrome (MDS)Phase 1/2Phase 1/2 initiated Oct 201310/29/2013
SNSS
7.49Vosaroxin 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
4.09STA-9090 GanetespibCancer - gastrointestinal stromal tumorsPhase 2Data presented at ASCO 201109/17/2011
SNTA
4.09STA-9090 Ganetespib - GALAXY-2Cancer - NSCLCPhase 3Phase 3 trial initiated Apr 2013 with first analysis due 2H 2015, second analysis due 1H 2016NCT0179848508/10/2014
SNTA
4.09ElesclomolCancer - ovarianPhase 2OngoingNCT0088861504/27/2013
SNTA
4.09STA-9090 GanetespibCancer - rectalPhase 2Phase 2 ongoing04/27/2013
SNTA
4.09STA-9090 GanetespibCancer - hepaticPhase 1/2OngoingNCT0166593704/27/2013
SNTA
4.09Ganetespib CHIARA trial Cancer - ALK+ NSCLC patientsPhase 2NCT0156201505/01/2013
SNTA
4.09Ganetespib ENCHANT trialCancer - HER2+ and triple-negative breast cancerPhase 2Update provided March 2014NCT0167745503/23/2014
SNTA
4.09Ganetespib AML-18 trialCancer - AMLPhase 2/3Expect to initiated in 2H 201408/10/2014
SNTA
4.09Ganetespib AML-LI trialCancer - AMLPhase 2/3Phase 3 part of trial initiated mid-201407/22/2014
SNTA
4.09Ganetespib AML-19 trialCancer - AMLPhase 2/3Phase 3 to be initiated 2H 201408/10/2014
SOMX
3.00SilenorInsomniaApprovedTo be acquired by PTX12/14/2012
SPEX
1.50D-TagatoseDiabetesPhase 3Development stopped04/08/2012
SPHS
3.29PRX302Benign prostatic hyperplasia Phase 3PLUS-1 Phase 3 trial initiated October 2013. Enrolment to be completed 2H 201408/09/2014
SPPI
8.15FusilevCancer - ColorectalApprovedApproved Apr 29 201105/01/2011
SPPI
8.15FusilevCancer - Removal of BioscanApprovedApproved Nov 20, 201111/21/2011
SPPI
8.15LucanthonePrimary therapy for Glioblastoma Multiforme (GBM)Phase 2Phase 2 initiated Jul 201207/03/2012
SPPI
8.15OzarelixCancer - prostatePhase 2bPhase 2b initiated Aug 201208/16/2012
SPPI
8.15ZevalinDiffuse Large B-Cell Lymphoma (DLBCL)Phase 3Phase 3 initiated Sep 201205/13/2013
SPPI
8.15ApaziquoneCancer - BladderPhase 3Failed to meet primary endpoint in Phase 3 trial - Apr 2012. NDA possible 201405/10/2013
SPPI
8.15BelinostatCancer - Peripheral T-Cell LymphomaApprovedApproved July 3 201407/04/2014
SPPI
8.15SPI-2012 (also referred to as "LAPS-GCSF")Chemotherapy-Induced NeutropeniaPhase 2Phase 2 initiated Apr 2013. Expects to make a Phase 3 Go/No-Go decision in 201408/09/2014
SPPI
8.15BelinostatCancer - 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
8.15SPI-1620Cancer - recurrent or progressive carcinomaPhase 2Phase 2 to be initiated 2H 201304/27/2013
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 released April 2014. NDA filing due 3Q 2014NCT0166063304/24/2014
SQNM
3.87SensiGene T21 Laboratory Developed Test (LDT) - MaterniT21Prenatal test for Down SyndromeR&DLaunched Oct 201110/17/2011
SRPT
23.20EteplirsenDuchenne muscular dystrophyNDANDA to be filed by end of 2014NCT0154040908/09/2014
SSH
5.47C-Pulse Heart Assist System - COUNTER HFModerate to severe heart failurePivotal Expects to complete enrolment 1H 2016NCT0174059604/27/2014
SSH
5.47C-Pulse Heart Assist System - OPTIONS HF study Moderate to severe heart failureData due mid 201504/27/2014
STEM
1.59HuCNS-SC cellsNCLPhase 1Discontinued due to lack of patient enrolment04/09/2011
STEM
1.59HuCNS-SC cellsSpinal cord injury Phase 1/2Interim data released May and Sept 2012. 2nd cohort dosing initiated Sept 2012.12mth data released Feb 2013. Enrolment completed April 2014. Additional Interim data due May 2014. Final data due mid 2015NCT0132133308/14/2014
STEM
1.59HuCNS-SC cellsPelizaeus-Merzbacher disease (PMD)Phase 1/2Phase 1 completedNCT0100500404/27/2013
STEM
1.59HuCNS-SC cellsAge-Related Macular DegenerationPhase 1/2Phase I/II dosing initiated Jun 2012. First patient enrolled Oct 2012. Enrolment completed June 2014. Final data due mid 2015NCT0163252708/14/2014
STML
11.56SL-701Cancer - blastic plasmacytoid dendritic cell neoplasm (BPDCN)Phase 2b pivotalPhase 2b planned04/27/2013
STML
11.56SL-701Cancer- adult relapsed or refractory acute myeloid leukemia (AML) Phase 2bPhase 2b planned04/27/2013
STML
11.56SL-701Cancer - malignant gliomaPhase 2bPhase 2b planned04/27/2013
STML
11.56SL-701Cancer - second line glioblastoma (GBM)Phase 2bPhase 2b planned04/27/2013
SUPN
8.96SPN-812ADHDPhase 2bPhase 2b trial to commence 201508/12/2014
SUPN
8.96Oxtellar XR SPN-804Adjunctive therapy for epilepsyApprovedApproved Oct 22 201210/24/2012
SUPN
8.96Trokendi XR SPN-538EpilepsyApprovedApproved Aug 19 201308/22/2013
SUPN
8.96SPN-810Impulsive Aggression in ADHDPhase 2bPhase 3 due to commence 201508/12/2014
SYN
2.25Trimesta ( oral estriol)Relapsing-remitting MS in womenPhase 2Phase 2 data released Apr 2014NCT0045120405/01/2014
SYN
2.27AEN-100ALSPhase 2Discontinued 04/27/2013
SYN
2.27FlupirtineFibromyalgiaPhase 2Pending. Partner Meda has received the go-ahead from the FDA to conduct a Phase 2 proof of concept trial04/27/2013
SYN
SYN-004C. difficile (C. diff.) InfectionsPhase 2Phase 2 to commence 1H 201508/16/2014
SYN
SYN-010Constipation-Predominant Irritable Bowel Syndrome (C-IBS)Phase 2Phase 2 to commence 2H 2014. Data due mid 201508/16/2014
TELK
1.00TELINTRAMyelodysplastic SyndromePhase 2Phase 3 planned. 04/27/2013
TELK
1.00TELINTRASevere chronic neutropenia, or SCNPhase 2Plan to terminate this study once the last patients complete treatment 2Q 2013.NCT0090958404/27/2013
TGTX
8.43Ublituximab 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
8.43TG-1101 and IMBRUVICA Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL)Phase 2Phase 2 initiated Dec 2013
THLD
4.08TH-302 MAESTROCancer - PancreaticPhase 3Phase 3 SPA agreed upon with FDA. Initiated Jan 2013NCT0174697901/26/2013
THLD
4.08TH-302 Cancer - Advanced MelanomaPhase 2Phase 2 initiated Aug 2013.
THLD
4.08TH-302Cancer - soft tissue sarcoma (406 trial)Phase 3Initiated Ph3 Sept 2011, under SPA, interim data due September 2014. Topline data due 2H 2015NCT0144008808/17/2014
THLD
4.08TH-302Cancer - multiple myeloma Phase 1/2Initiated dosing in final part of trial July 2014NCT0152287207/10/2014
THLD
4.08TH-302Cancer - second line NSCLCPhase 2Phase 2 initiated July 201407/02/2014
THRX
23.22BREO ELLIPTAAsthmaNDANDA filed on or about June 30 201407/01/2014
THRX
23.22TD-9855Attention deficit/hyperactivity disorder (ADHD)Phase 2Phase 2 endpoint not met Nov 201301/17/2014
THRX
23.22TD-9855FibromyalgiaPhase 2Phase 2 data released April 201405/01/2014
THRX
23.22TD-4208Chronic obstructive pulmonary disease (COPDPhase 2bPhase 2b data released Sept 2013. Dose ranging Phase 2b trial initiated April 2014 NCT0170440404/11/2014
THRX
23.22Velusetragdiabetic or idiopathic gastroparesisPhase 2Phase 2 data due 1H 2014NCT0171893802/07/2014
THRX
23.22UMEC/VI (62.5/25mcg and 125/25mcg doses) ANORO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)ApprovedApproved Dec 18 201312/19/2013
THRX
23.22BREO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)ApprovedApproved May 10 201305/11/2013
THRX
23.22TD−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
23.22VIBATIV (telavancin hydrochloride) for injectionHospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)ApprovedApproved Jun 21 201306/24/2013
TKMR
19.13TKM-PLK1Gastrointestinal Neuroendocrine Tumors (GI-NET) Phase 1/2Enrolling as of June 2014. Interim data due 2H 201407/22/2014
TKMR
19.13TKM-PLK1Adrenocortical Carcinoma (ACC)Phase 1/2Enrolling as of June 2014. Interim data due 2H 201407/22/2014
TKMR
19.13TKM-Ebola Ebola Phase 1/2Placed on partial clinical hold07/07/2014
TKMR
19.13ALN-TTR02 - patisiranFamilial Amyloidotic Polyneuropathy (FAP) in Patients with ATTRPhase 2 - open labelPhase 2 enrolment completed Sept 2013. Initial data due October 2014. Partnered with ALNY08/17/2014
TKMR
19.13ALN-TTR02 - patisiran APOLLOFamilial Amyloidotic Polyneuropathy (FAP) in Patients with ATTRPhase 3Phase 3 trial initiated Nov 2013, continues to enrol patients as of Jan 2014. Partnered with ALNY07/07/2014
TLOG
4.49BirinapantMyelodysplastic syndromes, or MDSPhase 2Phase 2 planned for 1H 201404/23/2014
TLOG
4.49BirinapantCancer - ovarianPhase 1/2Phase 1/2 initiated 4Q 201304/23/2014
TLOG
4.49BirinapantCancer - acute myelogenous leukemia or AMLPhase 1/2Ongoing04/23/2014
TLON
Marqibo2nd line adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL)ApprovedApproved Aug 9 201208/11/2012
TNXP
14.25TNX-102 SL Fibromyalgia Phase 2b/3Topline data due 4Q 201408/09/2014
TNXP
14.25TNX-102 SL PTSD - for the treatment of post-traumatic stress disorderPhase 2Intends to initiate Phase 2 trial in PTSD in 4Q 2014.08/09/2014
TNXP
14.25TNX-201Episodic tension-type headachePhase 2Phase 2 to be initiated 1Q 201508/09/2014
TRGT
2.78AZD1446Alzheimer’s diseasePhase 2Phase 2 planned02/22/2012
TRGT
2.78TC-5214Major depressive disorder (MDD)Phase 3Phase 3 (RENAISSANCE 2 and RENAISSANCE 3 missed primary endpoint02/22/2012
TRGT
2.78TC-5214Major depressive disorder (MDD)Phase 3 (RENAISSANCE 4 and RENAISSANCE 5) - failed to meet primary endpoint Mar 2012. Discontinue development03/21/2012
TRGT
2.78TC-5214Switch monotherapyPhase 2bDiscontinued Mar 201203/27/2012
TRGT
2.78TC-6987Type 2 DiabetesPhase 2Phase 2 topline data released Mar 2012. Failed trial. Will not further development03/28/2012
TRGT
2.78TC-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
2.78TC-5619Attention deficit/hyperactivity disorder (ADHD)Phase 2Phase 2 topline data released Sep 2012. Failed to meet endpoint09/18/2012
TRGT
2.78TC-5214Overactive bladderPhase 2bDiscontinued Aug 2014.08/03/2014
TRGT
2.78TC-5619SchizophreniaPhase 2bPhase 2b trial failed to meet primary endpoint December 2013NCT0148892912/17/2013
TRGT
2.78TC-1734 (AZD3480)Alzheimer’s diseasePhase 2bPhase 2b data released July 2014. Endpoint not metNCT0146608807/15/2014
TRGT
2.78TC-6499 Diabetic GastroparesisPhase 1/2Phase 1/2 initiated 4Q 201306/26/2014
TRLPF
0.42CompleoTRTTestosterone deficiency in menApprovedApproved May 201405/29/2014
TRVN
6.09TRV027 - BLAST-AHFAcute heart failurePhase 2bPhase 2b data due 4Q 201508/16/2014
TRVN
6.09TRV130 Moderate to severe acute painPhase 2Phase 2 initiated May 2014. Topline data due 1Q 201508/16/2014
TSPT
2.17IntermezzoInsomniaApprovedApproved Nov 201111/23/2011
TSPT
2.17Ondansetron TO-2061Obsessive Compulsive DisorderPhase 2Endpoint not met Dec 201212/23/2012
TSRO
31.26TSR-011Cancer - NSCLCPhase 1/2Phase 2 dosing to be finalised by end of 201307/26/2013
TSRO
31.26NiraparibCancer - breastPhase 3Phase 3 initiated 1Q 201405/01/2014
TSRO
31.26RolapitantPrevention of chemotherapy induced nausea and vomiting, or CINV in HEC patientsPhase 3Intends to file NDA by mid Sept 2014NCT0150021308/13/2014
TSRO
31.26Niraparib - NOVA (Niraparib Ovarian) Cancer - ovarianPhase 3Phase 3 initiated July 201307/24/2013
TTHI
7.27ELND005Bipolar I Disorder (BPD 1)Phase 2Partner Elan initiated Phase 2 trial Aug 2012NCT0167401008/31/2012
TTHI
7.27ELND005Alzheimer'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 initiated May 201405/17/2014
TTNP
0.66ProbuphineOpioid dependencePhase 3PDUFA date Apr 30 2013 under priority review. Adcom Mar 21 2013 resulted in favourable vote 10-4. New Phase 3 trial initiated July 2014, due to be completed mid 2015, NDA due late 2015.08/16/2014
TTPH
12.39Eravacycline (TP-434)cIAI (complicated intra-abdominal infections)Phase 3Phase 3 initiated Sept 2013. Data due early 1Q 201508/14/2014
TTPH
12.39Eravacycline (TP-434)cUTI - complicated urinary tract infectionsPhase 3Phase 3 to be initiated 4Q 2013. Data from the lead-in portion due in September 2014 and top-line data mid 201508/14/2014
UTHR
94.51Oral treprostinilPulmonary arterial hypertension (PAH)ApprovedApproved Dec 20 201312/21/2013
UTHR
94.51314dAdd-on therapy to TyvasoPhase 3Phase 3 planned04/01/2013
UTHR
94.51Ch14.18 AntibodyCancer - neuroblastomaPhase 3Phase 3 completed. Human pharmacokinetics study ongoing. BLA filing planned04/01/2013
VICL
1.27TemusiIschemia Phase 3Endpoint not met11/20/2010
VICL
1.27Allovectin-7Cancer - melanomaPhase 3Failed to meet endpoints Aug 2013NCT0039507008/13/2013
VICL
1.27ASP0113Hematopoietic cell transplantPhase 3Initiated Phase 3 Jun 2013. Still enrolling as of August 201408/03/2014
VICL
1.27ASP0113solid organ transplant (SOT)Phase 2Initiated Phase 2 Dec 2013. Still enrolling as of August 201408/03/2014
VICL
1.27CollategenePeripheral arterial diseasePhase 2SPA for Phase 3 obtained. Phase 3 planning02/07/2013
VICL
Vaxfectin®-formulated therapeutic vaccineHerpesPhase 1/2Initiated Phase 1/2 during Dec 201312/18/2013
VNDA
12.95Fanapt (Injectable) SchizophreniaApprovedApproved02/15/2012
VNDA
12.95TasimelteonDepressionPhase 2bFailed to meet primary endpoint02/01/2013
VNDA
12.95TasimelteonInsomniaApprovedApproved Jan 31 2014. NCT0116303202/02/2014
VRTX
93.64VX-661 and ivacaftorAdults with cystic fibrosis (CF) who have two copies (homozygous) of F508delPhase 2Phase 2 data released Apr 201304/21/2013
VRTX
93.64VX-787InfluenzaPhase 2Phase 2a data met endpoints Mar 201304/21/2013
VRTX
93.64INCIVEK (telaprevir)genotype 1 HCVApprovedApproved04/21/2013
VRTX
93.64KALYDECO (ivacaftor)Cystic fibrosis with G551D mutationApprovedApproved04/21/2013
VRTX
93.64VX-135 in combination with VX-222HCVPhase 2Phase 2 planning04/21/2013
VRTX
93.64VX-222 in combination with telaprevir and RBVHCVPhase 2OngoingNCT0151691804/21/2013
VRTX
93.64VX-509Rheumatoid ArthritisPhase 2Phase 2 data due 2H 2013NCT0159045907/31/2013
VRTX
93.64VX-135 in combination with RBVHCVPhase 2Placed on partial clinical holdNCT0172694607/26/2013
VRTX
93.64VX-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 GSK2336805HCVPhase 2Phase 2 to be initiated 1H 201304/21/2013
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
VX-135 in combination with TMC435 (simeprevir)HCVPhase 2Phase 2 to be initiated 2H 201305/01/2013
VRX
117.10EfinaconazoleOnychomycosisPDUFACRL May 28 201305/29/2013
VRX
117.10LuliconazoleTinea cruris, pedis and corporisPDUFAPDUFA date Dec 11 201304/27/2013
VSAR
21.87VRS-317Growth hormone deficiency, or GHDPhase 2aPhase 2a released June 23, 201406/24/2014
VTL
25.05ELAD (VTI-208)Alcohol-induced liver decompensation, or AILDPhase 3Phase 3 initiated 2013. Data due 1H 201507/10/2014
VTL
25.05ELAD (VTI-210)Severe acute alcoholic hepatitisPhase 3Phase 3 data due 201608/10/2014
VTL
25.05ELAD (VTI-212)Fulminant hepatic failure, or FHF, or surgery-induced acute liver failure, or SILFPhase 2/3Phase data due 2015 or 201607/10/2014
VVUS
4.28AvanafilErectile dysfunctionApprovedApproved Apr 27 2012. PDUFA for sNDA 20 Sept 201401/22/2014
VVUS
4.28QnexaObesityApprovedApproved Jul 18 201207/18/2012
XLRN
28.55Sotatercept Multiple myelomaPhase 2Phase 2 ongoing09/22/2013
XLRN
28.55Sotatercept Diamond-Blackfan anemia Phase 2Phase 2 ongoing09/22/2013
XLRN
28.55SotaterceptMyelofibrosisPhase 2Phase 2 ongoing09/22/2013
XLRN
28.55SotaterceptMyelodysplastic syndromes (MDS)Phase 2Phase 2 interim data due at American Society of Hematology (ASH) meeting from December 6-9, 201408/16/2014
XLRN
28.55Sotatercept b -thalassemiaPhase 2Phase 2 interim data due at American Society of Hematology (ASH) meeting from December 6-9, 201408/16/2014
XLRN
28.55SotaterceptEnd stage renal disease (ESRD) who are on hemodialysisPhase 2aPhase 2 interim data due at American Society of Hematology (ASH) meeting from December 6-9, 201408/16/2014
XLRN
28.55ACE-536Myelodysplastic syndromes (MDS)Phase 2Phase 2 interim data due at American Society of Nephrology (ASN) meeting in November meeting November 11-16 201408/16/2014
XLRN
28.55ACE-536 b -thalassemiaPhase 2Phase 2 interim data due at American Society of Hematology (ASH) meeting from December 6-9, 201408/16/2014
XLRN
28.55DalanterceptHead and neck cancerPhase 2Phase 2 interim data due at ASCO 201402/27/2014
XLRN
28.55DalanterceptLiver cancerPhase 2aPhase 2a to be initiated 1Q or 2Q 201402/27/2014
XLRN
28.55DalanterceptRenal Cell CarcinomaPhase 2Expects in late March or early April to begin part 2 of the RCC study02/27/2014
XNCR
10.40XmAb5871Moderate to severe rheumatoid arthritisPhase 2aPhase 2 data due 2H 201408/03/2014
XNCR
10.40MOR208 (XmAb5574)B-cell acute lymphoblastic leukemia (B-ALL) Phase 2Phase 2 initiated 2Q 201304/23/2014
XNCR
10.40MOR208 (XmAb5574)Non-Hodgkin lymphoma (NHL)Phase 2Phase 2 initiated 2Q 201304/23/2014
XNPT
5.30Arbaclofen placarbilGERDPhase 2bFAIL - endpoints not met Mar 201103/22/2011
XNPT
5.30HorizantRestless LegsApprovedFDA Approved Apr 6 201104/07/2011
XNPT
5.30HorizantPostherpetic NeuralgiaApprovedApproved Jun 6 201206/07/2012
XNPT
5.30Arbaclofen placarbilSpasticity in multiple sclerosis (MS)Phase 3Failed May 2013NCT0136048905/21/2013
XNPT
5.30XP21279Parkinson's DiseasePhase 2bData released Dec 2011, no statistical improvement over Sinemet. However Phase 3 planned dependent on fundingNCT0117131304/27/2013
XNPT
5.30XP23829Moderate-to-severe plaque psoriasisPhase 2Phase 2 initiated June 201406/24/2014
XNPT
5.30XP23829Relapsing forms of multiple sclerosis (MS)Phase 3 planned01/15/2014
XOMA
4.40XOMA 052 gevokizumabDiabetesPhase 2aPrelim data released Jan '10, full data released 2Q 2011. No difference between drug and placebo06/09/2011
XOMA
4.40XOMA 052 gevokizumabType 2 DiabetesPhase 2bData released Mar 22, 2011. Endpoint not met12/22/2011
XOMA
4.40Perindopril and Amlodipine (PATH)CardiovascularPhase 3Phase 3 trial met endpoint. NDA plannedNCT0155699711/21/2012
XOMA
4.40XOMA 052 GevokizumabErosive osteoarthritis of the handPhase 2Phase 2 prelim data released Oct 2013. Not pursuing futre developmentNCT0168339603/06/2014
XOMA
4.40XOMA 052 Gevokizumab EYEGUARD-ANon-Infectious Uveitis (Active)Phase 3Data from EYEGUARD-A possibly due 2014NCT0168434504/25/2014
XOMA
4.40XOMA 052 Gevokizumab EYEGUARD-BBehcet's uveitisPhase 3Endpoint from EYEGUARD-B originally expected to be hit June 2014. Company noted on June 30 that they are still waiting on a handful of exacerbations to occur. Data will be released 6 weeks following final event07/01/2014
XOMA
4.40XOMA 052 Gevokizumab EYEGUARD-C Non-Infectious Uveitis ( Controlled )Phase 3Phase 3 initiated Oct 2012. Data possibly due 2014NCT0174753804/25/2014
XOMA
4.40XOMA 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
4.40XOMA 052 gevokizumabType 1 DiabetesPhase 2NCT0178803305/04/2013
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
XOMA 052 GevokizumabModerate to Severe Acne VulgarisPhase 2Initiated Phase 2 Dec 2011. Topline Data released Jan 2013. Phase 3 plannedNCT0149887404/27/2013
XOMA
XOMA 052 gevokizumabPyoderma GangrenosumPhase 2Initiated Phase 2 pilot trial Jun 201306/14/2013
XON
20.66Ad-IL-12CancerPhase 2In partnership with ZIOP10/23/2013
ZGNX
1.34Zohydro ERModerate to severe painApprovedApproved Oct 25 201310/26/2013
ZGNX
1.34 Abuse deterrent formulations of Zohydro ERModerate to severe painsNDAsNDA filing due by October 201407/03/2014
ZIOP
3.28Palifosfamide MATISSE studyCancer - small cell lung SCLCPhase 3Initiated Phase 3 Jun 2012. Ongoing. Interim data due 2H 2014NCT0155571008/17/2014
ZIOP
3.28PalifosfamideCancer - recurrent metastatic germ cell (testicular and ovarian) tumorsPhase 2Phase 2 initiated Mar 2013NCT0180853403/07/2013
ZIOP
3.28IL-12Cancer - breastPhase 2Data due 4Q 2014NCT0170375408/17/2014
ZIOP
3.28PalifosfamideCancer - sarcoma DiscontinuedFailed to meet endpoint. DiscontinuedNCT0116879103/27/2013
ZIOP
3.28IL-12Cancer - melanomaPhase 2Data due 4Q 2014NCT0139770808/17/2014
ZSPH
41.51ZS-9HyperkalemiaPhase 3Phase 3 pre-specified subset analysis of data fwill be presented as an oral presentation at the European Society of Cardiology (ESC) Congress in Barcelona August 30 - 3, 2014.08/27/2014
ZFGN
19.61BeloranibPrader-Willi Syndrome (PWS)Phase 3First of two Phase 3 trials to be initiated 2H 201407/09/2014
ZFGN
19.61BeloranibCraniopharyngioma-associated obesityPhase 2aPhase 2a initiated June 201407/09/2014
ZFGN
19.61BeloranibSevere obesity Phase 2bPhase 2b to be initiated 2H 201407/09/2014

About the author

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

16 Responses to “Company Pipeline Database”

  1. Shamil says:

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

    • admin says:

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

  2. Shamil says:

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

    • admin says:

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

    • admin says:

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

  3. Mark says:

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

    • admin says:

      Hi Mark,

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

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

      Adam

  4. Ken says:

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

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

    Thanks, Ken

    • admin says:

      Hi Ken,

      Thanks for your feedback.

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

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

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

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

  5. Ken says:

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

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

    Now that things are working again on my end…

    Thank you for your remarkable website.

    -Ken

    • admin says:

      Thanks Ken,

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

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

      Thanks,

      Adam

  6. Anat says:

    Hi,

    Thanks for the great work!

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

  7. zeng says:

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

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