Clinical Database

Over 500 indications in Phase 2,3 or NDA development. Updated daily, includes PRs and live share price.

TickerPriceDrugIndicationStageLinkUpdated
ABIO
0.43GencaroChronic Heart FailurePhase 3Initiate Phase 3 pending funding. Able to initiate 6mths following funding12/16/2011
ACAD
1.42PimavanserinAlzheimer'sPhase 2Progress halted10/28/2010
ACAD
1.42PimavanserinSchizophreniaPhase 3Progress halted10/28/2010
ACAD
1.42AGN-XX/YYChronic painPhase 2Ongoing08/20/2011
ACAD
1.42PimavanserinParkinson's DiseasePhase 3Aim to complete 2H 201205/09/2012
ACHN
6.50ACH-1625HCV Hepatitis C Phase 2Phase 2 data released April 201204/24/2012
ACHN
6.50ElvucitabineHIVPhase 2Seeking partner to advance07/31/2010
ACHN
6.50ACH-2928HCV Hepatitis C Phase 1bPhase 1b data released Dec 201112/06/2011
ACRX
3.60ARX-01 Post-operative pain following open abdominal surgeryPhase 3Phase 3 initiated March 2012. Topline data are due 2H 2012. Second Phase 3 initiated April 2012. Data also due 2H 2012. Third Phase 3 trial to be initiated later in 2012 with data due late 2012/early201305/09/2012
ACRX
3.60ARX-02Cancer breakthrough painPhase 2Further development halted until funding secured04/19/2012
ACRX
3.60ARX-03Mild sedation and pain reliefPhase 2Further development halted until funding secured04/19/2012
ACUR
2.64OXECTAPain reliefApprovedApproved Jun 17, 201106/20/2011
ACUR
2.64AcuroxPain reliefCRLNegative committee vote07/31/2010
AEGR
14.14LomitapideHomozygous familial hypercholesterolemia (HoFH)Phase 3PDUFA on or about Jan 5 201205/01/2012
AEGR
14.14LomitapideFfamilial chylomicronemiaPhase 3Initiate Phase 3 2H 201103/16/2011
AEZS
0.46AEZS-130Adult Growth Deficiency Phase 3SPA granted, meet with FDA followed by NDA filing sometime 201203/28/2012
AEZS
0.46AEZS-130Cancer cachexiaPhase 2Phase 2 initiated Mar 201203/09/2012
AEZS
0.46PerifosineCancer - ColorectalPhase 3Primary endpoint not met04/03/2012
AEZS
0.46AEZS-108Cancer - BladderPhase 1/2Initiated12/14/2010
AEZS
0.46AEZS-108Cancer - Endometrial Phase 2Intend to initiate Phase 3 trial in 201203/28/2012
AEZS
0.46PerifosineCancer - MyelomaPhase 3 Stated that it intends to continue development. License rights returned from KERX05/08/2012
AEZS
0.46PerifosineCancer - Kidney Phase 2Data presented Sept 200907/31/2010
AEZS
0.46AEZS-108Cancer - OvarianPhase 2Final data late 201007/31/2010
AFFY
13.06PeginesatideAnemia in chronic renal failure (CRF)ApprovedPDUFA Mar 27 2012 - APPROVED03/28/2012
AFFY
13.06PeginesatideHemodialysisPhase 2Completed12/22/2010
AGEN
5.45G-200Cancer - Glioma 2nd linePhase 2Data May 20 2010, ongoing additional06/10/2011
AGEN
5.45G-100Cancer - Glioma first linePhase 2Enrolling08/27/2011
AIS
2.90AnturolOveractive bladderApprovedApproved Dec 8 201112/08/2011
AIS
2.90LibigelFemale sexual dysfunctionPhase 3Submit NDA by late 201208/13/2010
AIS
2.90VIBEXRheumatoid arthritis (RA)Aim to file NDA early 201305/09/2012
ALIM
2.40IluvienDiabetic macular edemaCRLCRL Nov 2011, two new trials required. Plans to meet with FDA during 2Q 201204/02/2012
ALKS
16.42BYDUREONDiabetes - Type 2PDUFACRL issued Oct 19, 2010, new PDUFA Jan 28 201108/20/2011
ALKS
16.42VIVITROLOpioid dependenceApprovedPDUFA Oct 12 '10, Advisory Panel vote 12-1 in favour09/17/2010
ALKS
16.42ALKS 33Cocaine addictionPhase 1/2Initiate Ph2a Sept 201108/27/2011
ALKS
16.42ALKS 37Opioid-induced constipationPhase 2bPhase 2b initiated, data due mid 201212/16/2011
ALKS
16.42ALKS 33 Binge eating disorderPhase 2Data released July 2011, endpoint not met. Likely to discontinue07/08/2011
ALKS
16.42ALKS 5461Major depressive disorder Phase 2Initiated January 2012,data mid 201301/04/2012
ALKS
16.42ALKS 9070 SchizophreniaPhase 3Phase 3 trial initiated Dec 2011, data due 1H 201312/19/2011
ALNY
9.91ALN-RSV01RSV (respiratory syncytial virus) infected adult lung transplant patientsPhase 2bEnrolment complete, data due mid 201205/04/2012
ALNY
9.91ALN-TTR02Transthyretin-mediated amyloidosis (ATTR)Phase 2Initiate Phase 2 2H 201205/04/2012
ALNY
9.91ALN-PCSSevere hypercholesterolemiaPhase 1Prelim data released Jan 2012. Further data scheduled for 1H 201202/10/2012
ALTH
1.79FOLOTYNCancer - Peripheral T-cell LymphomaAcclerated approvalReceived SPA Mar 2011, initiated Ph3 Aug 201108/19/2011
ALTH
1.79FOLOTYNCancer - NSCLCPhase 2bNot pursuing Ph3 development01/11/2011
ALTH
1.79FOLOTYNCancer - NHL 2nd line Phase 1/2aData expected 1H 201212/16/2011
ALTH
1.79FOLOTYNCancer - Lymphoma 2nd linePhase 2Ongoing08/27/2011
ALTH
1.79FOLOTYNCancer - bladderPhase 2Data expected sometime 201212/14/2011
ALTH
1.79FOLOTYNCancer - BreastPhase 2Data expected sometime 201212/14/2011
ALXA
0.38Staccato loxapine SchizophreniaCRLCRL ISSUED MAY 3 201205/04/2012
ALXA
0.38Staccato loxapineMigrainePhase 2bDevelopment under review07/27/2010
ALXA
0.38Staccato prochlorperazine MigrainePhase 2bDevelopment under review07/27/2010
ALXA
0.38AZ 007InsomniaPhase 1Working on technical product development of AZ-007. Had initially hoped to initiate Ph 2 in 201105/21/2011
AMLN
26.80BYDUREONDiabetes - Type 2PDUFACRL issued Oct 19, 2010, new PDUFA Jan 28 201108/20/2011
AMLN
26.80Pramlintide / metreleptinObesityPhase 2Discontinued08/07/2011
AMLN
26.80MetreleptinLipodystrophyBLARolling BLA commenced Dec 20, 2010. Final submission filed Apr 3, 2012. Requested priority review04/04/2012
AMRN
10.07AMR101 Elevated triglyceride levelsPDUFAPDUFA July 26 201211/26/2011
AMRN
10.07AMR101Patients on statin therapy with high triglyceridesCardiovascular outcomesInitiation of REDUCE-IT cardiovascular outcomes trial by end of 201211/30/2011
ANAC
5.31GSK ‘052Complicated urinary tract infections (cUTI)Phase 2bPhase 2b enrolment halted Feb 2012 due to 'microbiological finding' in cUTI patients02/07/2012
ANAC
5.31AN2728Mild-to-moderate atopic dermatitisPhase 2aVarious Phase 2 trials to be initiated in 2012. Phase 3 to be initiated mid 201305/11/2012
ANAC
5.31AN2728Mild-to-moderate plaque-type psoriasisPhase 2bPromising Prelim Phase 2b data released Dec 2011. Phase 3 planning on hold03/14/2012
ANAC
5.31TavaboroleOnychomycosisPhase 3Top-line data from the second Phase 3 trial due 1Q 2013. NDA due 1H 210305/11/2012
ANAC
5.31TavaboroleOnychomycosisPhase 3Top-line data from the first Phase 3 trial is expected Jan 2013. NDA filing due 1H 201305/11/2012
ANAC
5.31GSK ‘052Complicated intra-abdominal infections (cIAI) Phase 2bPhase 2b enrolment halted Feb 2012 due to 'microbiological finding' in cUTI patients02/07/2012
ANIK
13.50MonoviscOsteoarthritisPMAWaiting for FDA Advisory Panel08/13/2011
ANTH
1.95A-623 BlisibimodLupusPhase 2b Topline data due 2Q 201205/04/2012
ANTH
1.95A-001Acute chest syndromePhase 2Complete08/20/2011
ANTH
1.95Varespladib - Vista 16Acute Coronary Syndromes (ACS)Phase 3Failed Phase 3 efficacy trials03/11/2012
ANX
0.54ANX-514 (docetaxel)Cancer - chemo alternative to TaxotereFDA rejects, new trial required with possible resubmission in 201410/26/2011
ANX
0.54ANX-188Sickle cell diseasePhase 3Plans Phase 3 by end of 201205/08/2012
ANX
0.54ExelbineCancer - NSCLCCRLCRL Aug 2011, bioequivalence study required10/04/2011
APPY
0.56AppyScoreAppendicitis - Blood test510k clinical trialData July - FAIL07/31/2010
APPY
0.56AppyScoreAcute appendicitis Phase 3Initiate Pivotal trial mid 201202/02/2012
APRI
2.47VitarosErectile DysfunctionApproved in Canada06/27/2010
APRI
2.47MycoVaOnychomycosisPhase 3Preparing for pre-NDA meeting to request regulatory guidance in EU and US04/06/2012
APRI
2.47FemproxFemale sexual arousal disorderPhase 3Preparing second Phase 304/06/2012
APRI
2.47PrevOncoCancer - HCC - liver cancerPhase 2Phase 3 and SPA in discussions with the FDA04/06/2012
ARIA
15.98Oral ponatinibCancer - chronic myeloid leukemia, acute lymphoblastic leukemiaPhase 3NDA filing 3Q 201205/10/2012
ARIA
15.98Oral ponatinibCancer - newly diagnosed chronic myeloid leukemia, acute lymphoblastic leukemiaPhase 3Phase 3 to be initiated 3Q 201205/10/2012
ARIA
15.98RidaforolimusCancer - SarcomaPDUFANDA accepted Oct 5 2011, MAA filed July 2011. PDUFA June 5 2012. Advisory Committee March 20 2012 voted against approval 13-103/21/2012
ARIA
15.98RidaforolimusCancer - Endometrial Phase 2Interim data released Oct '1010/25/2010
ARIA
15.98RidaforolimusCancer - Breast,Endometrial, Prostate,LungPhase 2Ongoing07/31/2010
ARIA
15.98AP26113Cancer - ALK-positive and EGFR-positive lung cancerPhase 1/2Phase 1 initiated Sept 2011, Phase 2 to be initiated mid 201205/10/2012
ARNA
5.52LorcaserinObesityCRL/new PDUFAPDUFA June 27 2012, Advisory Committee Mtg May 10 2012 18-4-1 in favour05/11/2012
ARQL
5.78Tivantinib (ARQ 197)Cancer - NSCLCPhase 3Phase 3 MARQUEE trial initiated Jan 2011 - SPA approved, complete patient enrollment in 2012 with interim data also due later in 201203/02/2012
ARQL
5.78Tivantinib (ARQ 197)Cancer - NSCLC Phase 3Phase 3 ATTENTION trial initiated August 201104/06/2012
ARQL
5.78Tivantinib (ARQ 197)Cancer - NSCLC patients with a mutated form of the KRAS genePhase 2Phase 2 initiated July 201204/06/2012
ARQL
5.78Tivantinib (ARQ 197)Cancer - GastricPhase 2Initiated July 2010, data to be released later in 201204/06/2012
ARQL
5.78Tivantinib (ARQ 197)Cancer - hepatocellular carcinoma (HCC)Phase 2Phase 2 met endpoint Jan 2012. Full data later in 2012 01/17/2012
ARQL
5.78Tivantinib (ARQ 197) + irinotecan and cetuximab Cancer - colorectalPhase 2Aim to complete enrolment 201203/02/2012
ARRY
3.58MEK162 (ARRY-162)Cancer - MEK inhibitor for cancerPhase 2Various Phase 1 and 2 trials ongoing05/01/2012
ARRY
3.58MEK162 (ARRY-162)Cancer - MEK inhibitor for melanomaPhase 2Phase 2 data due by early 201305/01/2012
ARRY
3.58Selumetinib (AZD6244) + plus dacarbazineCancer - MelanomaPhase 2Phase 2 topline data due 201205/01/2012
ARRY
3.58Selumetinib (AZD6244) plus docetaxelCancer - NSCLC second line non small lung cancerPhase 2Phase 2 data released Sept 2011. Primary endpoint (OS) not met. Secondary endpoints met (PFS ORR). Further data due 2Q 201205/01/2012
ARRY
3.58Selumetinib compared with TemodarCancer - metastatic melanoma of the eyePhase 2Ongoing08/20/2011
ARRY
3.58Selumetinib with CamptosaCancer - 2nd line colorectal cancerPhase 2Ongoing08/20/2011
ARRY
3.58Selumetinib with NexavarCancer - Advanced hepatocellular carcinomaPhase 2Ongoing08/20/2011
ARRY
3.58Selumetinib with NexavarCancer - recurrent low-grade serous ovarianPhase 2Data presented Apr 201204/05/2012
ARRY
3.58ARRY-520 plus dexamethasoneCancer - Refractory Multiple Myeloma MMPhase 2Further Phase 2 data due by early 201305/01/2012
ARRY
3.58ARRY 520 and VelcadeCancer - relapsed and refractory MMPhase 1bPhase 1b currently enrolling. Data expected by early 201305/01/2012
ARRY
3.58AMG 151 (ARRY-403) Glucokinase activatorType 2 diabetesPhase 2aOngoing05/01/2012
ARRY
3.58ARRY 502Asthma Phase 2aPhase 2 topline data due 1Q 2013. Will seek partner for further development05/01/2012
ARRY
3.58ARRY 543Cancer - HER2 / EGFR inhibitor for cancerPhase 2Ongoing11/01/2011
ARRY
3.58ARRY 797Pain reliefPhase 2Topline Data due summer 201205/01/2012
ASTM
2.01ixmyelocel-TCritical limb ischemia Phase 2bEnrolment began May 2012. Phase 3 under SPA Feb 2012. Completion due 201505/10/2012
ASTM
2.01ixmyelocel-TStem cells - Dilated Cardiomyopathy Phase 2Initiate Phase 2b 1H 201211/08/2011
ASTX
1.59DacogenAcute myeloid leukemia (AML). CRLCRL issued Mar 6 201203/07/2012
ASTX
1.59AT13387Cancer -Phase 2Initiate proof of concept trials 2H 201205/01/2012
ASTX
1.59SGI-110Cancer - MDS/AMLPhase 2Phase 2 data readout due late 201211/01/2011
ASTX
1.59AmuvatinibCancer - Small cell lung cancerPhase 2Data due by early 201305/01/2012
ASTX
1.59AT7519Phase 2Data due by early 201305/01/2012
ATHX
1.36MultistemAcute Myocardial Infarction - Heart attacksPhase 2Planning08/20/2011
ATHX
1.36MultistemUlcerative colitisPhase 2Phase 2 topline data due early 201305/15/2012
ATHX
1.36MultistemIschemic strokePhase 2Initiated 3Q 2011. Ongoing05/15/2012
AVEO
11.28FiclatuzumabCancer - Non-small cell lung cancer (NSCLC)Phase 2Phase 2 prelim data - not statistical significance shown05/04/2012
AVEO
11.28TivozanibCancer - colorectalPhase 2Initiated Phase 2 Dec 201112/22/2011
AVEO
11.28TivozanibCancer - advanced renal cell carcinomaPhase 3Phase 3 Topline data due released Jan 2012. Full data at ASCO 2012. MAA and NDA due to be filed 3Q 201205/17/2012
AVII
0.61AVII658 eteplirsenDuchenne muscular dystrophyPhase 2bPhase 2b data April 2012. Endpoint met but no improvement in walking04/26/2012
AVNR
2.71NUEDEXTAPseudobulbar affectApprovedApproved Oct 30 2010, possibly file MAA under accelerated review by the end of 201107/26/2011
AVNR
2.71NUEDEXTADiabetic peripheral neuropathic painPhase 3Phase 3 additional trial required07/31/2010
AVNR
2.71AVP-923Central neuropathic pain in patients with multiple sclerosisPhase 2Phase 2 initiated Nov 201111/05/2011
BCRX
3.30BCX4208GoutPhase 2bPhase 3 initiation pending partnership confirmation due by end of 201205/08/2012
BCRX
3.30BCX4208Moderate renal impairmentPhase 2Complete enrolment during 3Q 201205/08/2012
BCRX
3.30ForodesineCancer - Chronic lymphocytic leukemiaPhase 2Data Dec '1012/03/2010
BCRX
3.30ForodesineCancer - Chronic lymphocytic leukemiaPhase 2Data Sep '1009/15/2010
BCRX
3.30Peramivir - Study 303INFLUENZA ACUTE Phase 3Planned interim analysis of Phase 3 due following end of Southern Hemisphere flu season05/08/2012
BCRX
3.30Peramivir - Study 301INFLUENZA ACUTEPhase 3Data released Jan 201001/13/2011
BDSI
4.01BEMA BuprenorphinePain - acute and chronic Phase 3Initiated Dec 2010, data mid-late Sep 2011 - FAILED10/04/2011
BDSI
4.01BEMA Buprenorphine/Naloxone (BNX) Opioid dependencePivotalPivotal pharmacokinetic study due 3Q 2012 with NDA filing 1H 2013.05/12/2012
BDSI
4.01BEMA BuprenorphineChronic painPhase 3Plans to initiate Phase 3 trials during 3Q 201205/12/2012
BIOD
0.65VIAjectDiabetesCRLCRL Nov 1 201011/01/2010
BIOD
0.65BIOD-123Diabetes - Type 1Phase 1Intend to initiate Phase 2 trial 3Q 201204/17/2012
BIOD
0.65Liquid glucagonSevere hypoglycemiaNDA filing possible 4Q 2013 / 1Q 201405/11/2012
BNVI
0.03MenerbaHot flashesPhase 3Initiated first of two Phase 3 trials Oct 2011, data due 2Q 201310/28/2011
BNVI
0.03BezielleCancer - BreastPhase 1Complete07/31/2010
BPAX
0.34GVAXCancer vaccine - prostatePhase 2Clinical hold lifted by FDA, Phase 2 planning06/06/2011
BPAX
0.34GM-CSFCancer - Pancreatic cancer vaccinePhase 2Data released Mar 201103/03/2011
BPAX
0.34LibiGelFemale sexual dysfunctionPhase 3Failed Phase 3 efficacy trials12/14/2011
BPAX
0.34GVAXCancer vaccine - Acute myelogenous leukemiaPhase 2 Completed07/31/2010
BPAX
0.34Bio-T-GelMale hypogonadismPDUFAApproved 2/14/12 02/16/2012
CADX
2.90OFIRMEVPain and feverApprovedApproved Nov 4 '1011/04/2010
CBRX
0.61PROCHIEVE (progesterone gel)Reduction of risk of preterm birthCRLCRL Feb 26 201202/28/2012
CERS
3.38INTERCEPT PlateletsPhase 3 Phase 3 clinical trial completed; seeking FDA concurrence on an additional Phase 3 clinical trial - needs funding04/06/2012
CERS
3.38INTERCEPT B123PlasmaPhase 3Phase 3 clinical trials completed; seeking clarity on clinical pathway with the FDA04/06/2012
CHTP
1.99NORTHERA Neurogenic Orthostatic HypotensionCRLCRL Mar 28 2012 - FDA Requests Additional Clinical Efficacy Data. Meeting with FDA scheduled for May 2012. Minutes and CC due around the end of May05/02/2012
CHTP
1.99DroxidopaChronic Fatigue SyndromePhase 2Initiated Aug 2010, ongoing07/28/2011
CHTP
1.99CH-4051Rheumatoid arthritisPhase 2Interim Data released Nov 2011, full data 2Q 201211/05/2011
CHTP
1.99DroxidopaFibromyalgia Phase 2Phase 2 topline data released Dec 201112/22/2011
CHTP
1.99DroxidopaADHDPhase 2Prelim data released July 201107/26/2011
CLDX
4.11CDX-110 rindopepimutCancer- glioblastoma multiforme (GBM) front linePhase 3Initiated Phase 3 Dec 201112/02/2011
CLDX
4.11CDX-110 (rindopepimut) in combination with AvastinCancer- glioblastoma multiforme (GBM) refractoryPhase 2Initiated Phase 2 Jan 201201/04/2012
CLDX
4.11CDX-011Cancer - Metastatic breastPhase 2bAccrual completed Dec 2011, data to be released May 23 201205/02/2012
CLDX
4.11CDX-1135 Dense deposit disease (DDDPhase 2Plans to initiate Phase 2 2H 201205/04/2012
CLDX
4.11CDX-1307Cancer - bladderPhase 2Discontinued08/13/2011
CLDX
4.11CDX-1401Cancer - VariousPhase 1/2Phase 1 portion of trial - data due 2H 201203/11/2012
CLSN
1.76ThermoDoxCancer - Hepatocellular carcinoma - liver cancerPhase 3DMSB recommends continue through to final PFS analysis due end of 201204/24/2012
CLSN
1.76ThermoDoxCancer - Recurrent Chest Wall BreastPhase 1/2 PiovtalDSMB recommends advancement to Phase 2 trials06/08/2011
CLSN
1.76ThermoDoxCancer - colorectal liver metastases (CRLM)Phase 2Initiated Phase 2 Feb 201202/14/2012
CLVS
18.49CO-101Cancer - pancreaticPhase 3Topline Phase 3 data due 4Q 201205/09/2012
CLVS
18.49CO-1686Cancer - NSCLCPhase 1/2Initiated Phase 1/2 trial 1Q 201205/09/2012
CORT
3.88Corlux - KorlymCushing's SyndromePDUFAPDUFA date Feb 17 201206/30/2011
CORT
3.88Corlux - KorlymPsychotic depressionPhase 3Enrolled more patients during 3Q 201111/07/2011
CPIX
6.59AcetadoteAcute liver failureApprovedApproved Jan 13, 201101/14/2011
CPIX
6.59AcetadoteNon-Acetaminophen Induced Acute Liver FailureCRLCRL received Dec 2010. Meeting held with FDA. Evaluating future11/05/2011
CPIX
6.59HepatorenHRSPhase 2Ongoing03/08/2012
CPRX
0.80VigabatrinAddiction to cocainePhase 2bInitiated Nov 18 2010, Data - early 1Q 201304/03/2012
CRIS
4.47GDC-0449 vismodegibCancer - Advanced Basal Cell CarcinomaApprovedApproved Jan 31 201201/30/2012
CRIS
4.47GDC-0449 vismodegibGorlin syndromePhase 2Interim data presented Apr 201104/04/2011
CRIS
4.47GDC-0449 vismodegibCancer - Operable Nodular BCCPhase 2Ongoing11/01/2011
CRIS
4.47Debio 0932Cancer - lungPhase 1/2Initiate Phase 1/2 trial 2Q 201205/09/2012
CRTX
5.27CRTX 080HyponatremiaNDAPDUFA date Oct 29 201203/14/2012
CTIC
0.86PixantroneCancer - Non-Hodgkin lymphomaPDUFANDA withdrawn Jan 2012. Plans to resubmit 201201/30/2012
CTIC
0.86PixantroneCancer - Non-Hodgkin lymphomaEMACHMP conditional recommendation given Feb 17 2012. TBC by EMA 02/17/2012
CTIC
0.86PixantroneCancer - Relapsed/refractory diffuse large B-cell lymphoma ("DLBCL")PivotalInitiated March 201107/29/2011
CTIC
0.86PixantroneCancer - breastPhase 2Data due 201203/11/2012
CTIC
0.86OpaxioCancer - OvarianPhase 3Interim Data due 201303/11/2012
CTIC
0.86OpaxioCancer - EsophagealPhase 2Assessing the viability of Phase 307/29/2011
CTIC
0.86OpaxioCancer - astrocytomas and glioblastomasPhase 2Interim data presented at ASCO 2011, addittional trial initiated Aug 201108/19/2011
CTIC
0.86TosedostatCancer - relapsed or refractory MDSPhase 2Initiate Phase 3 2H 201203/11/2012
CUR
0.91Cellular TherapyAmyotrophic lateral sclerosis (Lou Gehrig's)Phase 1Aim to complete 2012, and file for Phase 2 with FDA during 201204/01/2012
CUR
0.91NSI-189DepressionPhase 1Initiate Phase 1b late 201110/28/2011
CVM
0.39MultiklineCancer - Head and NeckPhase 3Initiated Dec 201012/23/2010
CXM
0.23ExcellagenWound careApproved510(k) approved Oct 10 201110/11/2011
CXM
0.23GenerxCoronary artery disease Phase 3Initiated Phase 3 Russian trial Mar 201203/21/2012
CXM
0.23ExcellarateDiabetic foot ulcersPhase 2b
CYCC
0.43SeliciclibCancer - NSCLCPhase 2bRetrospective analysis were insufficient to allow meaningful correlation.01/11/2012
CYCC
0.43SapacitabineCancer - Myelodysplastic syndromesPhase 2Updateddata due 201204/01/2012
CYCC
0.43SapacitabineCancer - Acute myeloid leukemiaPhase 3Under SPA. - changed to 2-arm trial from original 3-arm11/15/2011
CYCC
0.43SapacitabineCancer - NSCLCPhase 2Enrolment ongoing, updated data due 201204/01/2012
CYCC
0.43SeliciclibCancer - NasopharyngealPhase 2Ongoing07/31/2010
CYTK
0.90CK-2017357Amyotrophic Lateral SclerosisPhase 2aFirst cohort (Part A) data released Nov 201112/02/2011
CYTK
0.90CK-2017357Amyotrophic Lateral SclerosisPhase 2aPhase 2 multiple-dose trial in patients with ALS who are also receiving riluzole (CY 4024). Data from Part B to be available in 1H 201203/14/2012
CYTK
0.90CK-2017357Amyotrophic Lateral SclerosisPhase 2aPhase II dose-titration trial in patients with ALS (CY 4025). Data available in 1H 201203/14/2012
CYTK
0.90CK-2017357Peripheral artery diseasePhase 2aData Ph2a released Jun 201106/03/2011
CYTK
0.90Omecamtiv mecarbilAcute heart failurePhase 2bDecision regarding progression to the second cohort of the ATOMIC-AHF trial in 2Q 2012 following a review of data from the first cohort04/27/2012
CYTK
0.90CK-2017357Myasthenia gravis Phase 2aData due 2H 201204/27/2012
CYTR
2.96TambaroteneCancer - non-small-cell lung cancer (NSCLC)Phase 2bData due 2H 201204/20/2011
CYTR
2.96BafetinibCancer - B-Cell Chronic Lymphocytic Leukemia (B-CLL)Phase 2Phase 2 proof of concept completed. Seeking partner for further development04/06/2012
CYTR
2.96INNO-206Cancer Phase 2Phase 2 clinical trial with INNO-206 for pancreatic cancer initiated Apr 201204/27/2012
CYTR
2.96INNO-206Cancer - SarcomasPhase 2bInitiated Phase 2b in Dec 201112/22/2011
CYTR
2.96TambaroteneCancer - Acute promyelocytic leukemia Phase 2 Ongoing04/06/2012
CYTR
2.96BafetinibCancer - B-cell chronic lymphocytic leukemia (B-CLL)Phase 2Phase 2 proof of concept completed. Seeking partner for further development04/06/2012
DARA
0.85KRN5500Pain - Neuropathic Phase 2Phase 2b start 2H 201108/19/2011
DCTH
1.99CHEMOSAT systemCancer - melanomaRTFNDA filed Dec 22 2010, refused to file, new NDA filing due August 201205/09/2012
DCTH
1.99CHEMOSAT systemCancer - liverPhase 2Data released Aug 201108/27/2011
DEPO
5.12SeradaHot flashesPhase 3 Data released Oct 2011, missed one primary endpoint. Intends to file NDA 2H 201205/09/2012
DEPO
5.12DM-1796Postherpetic neuralgia - shinglesApprovedApproved Jan 28 201101/30/2011
DEPO
5.12DM-1992Parkinson's diseasePhase 2Phase 2 initiated Nov 201101/26/2012
DNDN
7.27PROVENGECancer - castrate-resistant (hormone-refractory) prostate cancerApprovedApproved 201004/18/2012
DNDN
7.27PROVENGE Clinical Trial P10-2Sequencing of PROVENGE and androgen deprivation therapy (“ADT”)Phase 2 ongoingInitiated Phase 2 Aug 201104/18/2012
DNDN
7.27PROVENGE 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 201104/18/2012
DNDN
7.27DN24-02Cancer - high risk HER2+ urothelial carcinoma following surgical resectionPhase 2Phase 2 initiated June 201104/18/2012
DRRX
0.76EladurChronic back painPhase 2bData released April 2011. FAIL04/12/2011
DRRX
0.76RemoxyChronic painCRLCRL Jun 23, 2011. Will conduct two bioavailability studies in 2Q 2012 and then meet with the FDA during 3Q 201205/04/2012
DRXX
0.76PosidurPost operative pain Phase 3Failed to meet endpoints Jan 2012 in Phase 3 trial. Intends to meet with FDA during summer 2012 with possible late 2012 NDA filing05/04/2012
DSCO
2.38Surfaxin Respiratory Distress Syndrome - SevereApprovedApproved Mar 6 201203/07/2012
DSCO
2.38Surfaxin LSNeonatal RDSPhase 2 Talks with FDA regarding further development 04/06/2012
DSCO
2.38AerosurgRespiratory Distress Syndrome - ModeratePhase 2aCompleted Phase 2. Plan to meet 2H 2011 with FDA regarding further development08/19/2011
DSCO
2.38Aerosolized KL4 SufactantPatients requiring ventilatory supportPhase 2aPlans to seek market authorization for the initial AFECTAIR product in the U.S. in the fourth quarter of 2011, and in the EU in the first half of 2012.08/19/2011
DVAX
3.59HEPLISAVHepatitis BNDAFiled BLA Apr 26 2012 in healthy adults. sNDA for patients with chronic kidney disease will be filed if the initial BLA is approved04/27/2012
DYAX
1.61EcallantideACE Inhibitor-Induced AngioedemaPhase 2Initiated Aug 2011, data expected 2H 201202/23/2012
ECYT
6.35EC145Cancer - ovarianPhase 3Phase 3 PFS data due 1H 201404/07/2012
ECYT
6.35EC145Cancer - NSCLCPhase 2Intends to initiate Phase 2 2Q 2012. Final PFS data is expected to be available by early 201404/07/2012
ENMD
1.94ENMD-2076Cancer - OvarianPhase 2Phase 2 final data released Oct 201110/05/2011
ENMD
1.94MKC-1Cancer - NSCLCPhase 2Need funding to continue
ENMD
1.94MKC-1Cancer - BreastPhase 2Need funding to continue
ENMD
1.94MKC-1Cancer - PancreaticPhase 2Need funding to continue
ENZN
6.02PEG-SN38Cancer - breastPhase 2Enrolment completed 3Q 201110/29/2011
ENZN
6.02PEG-SN38Cancer - ColorectalPhase 2Discontinued May 201108/29/2011
EPCT
0.19CrolibulinCancer - Anaplastic thyroid cancer (ATC)Phase 2Initiate Phase 2 1H 201203/01/2012
EPCT
0.19CepleneCancer - Acute myeloid leukemia AMLPhase 3FDA fails to file NDA 2010, New Ph3 trial req'd under SPA. But no intention to proceed with Phase 3 trial due to cost04/07/2012
EPCT
0.19NP-1 AmiKetPain - DPN, PHN, CPNPhase 3Phase 3 pending04/07/2012
EXAS
9.88CologuardCancer - Colorectal DNA testPivotalExpects to complete its ongoing DeeP-C clinical trial for Cologuard during 2012 as well as making its FDA submission in 201202/24/2012
EXEL
4.61XL184 cabozantinibCancer - OvarianPhase 2Interim data released ASCO 201106/06/2011
EXEL
4.61XL184 cabozantinibCancer - Castration-Resistant Prostate CancerPhase 3Initiated Phase 3 Dec 2011, not under SPA02/09/2012
EXEL
4.61XL184 cabozantinibCancer - Castration-Resistant Prostate CancerPhase 3Initiate Phase 3 2Q 2012 - COMET-1 trial not under SPA05/04/2012
EXEL
4.61XL184 cabozantinibCancer - Medullary thyroid NDARolling NDA filing to be completed 1H 201202/10/2012
EXEL
4.61XL184 cabozantinibCancer - glioblastomaPhase 2Ongoing08/13/2011
EXEL
4.61XL184 cabozantinibCancer - NSCLCPhase 1/2Ongoing08/13/2011
EXEL
4.61XL184 cabozantinibCancer - Breast cancerPhase 2Phase 2 initiated Nov 201111/21/2011
EXEL
4.61XL184 cabozantinibCancer - Breast cancer randomized discontinuation trial (RDT)Phase 2Prelim data released Dec 201112/07/2011
EXEL
4.61XL 281Development halted07/15/2011
FLML
4.63IFN-Alpha-2b XHepatitis C HCVPhase 2Ongoing04/07/2012
FOLD
4.67migalastat HCl monotherapyFabry DiseasePhase 3Completed enrolment Study 011 Dec '11. Data due 3Q 201205/12/2012
FOLD
4.67Migalastat HCl monotherapyFabry DiseasePhase 3Initiated Phase 3 Study 012 Fabry disease Sept 2011. Enrolment due to be completed by end of 2012.05/12/2012
FOLD
4.67Migalastat co-administered with enzyme replacement therapy (ERT)Fabry Disease Phase 2Interim Phase 2 Study 013 due 3Q12 with final results due at Fall 2012 scientific conference05/12/2012
FOLD
4.67AT2220/ERT enzyme replacement therapyPompe DiseasePhase 2Initiated Dec 2011, preliminary data from Phase 2 Study 010 due 2Q 201205/12/2012
FURX
15.76PPD-10558DyslipidemiaPhase 2Data released Dec 2011. Missed endpoint. Cease further development12/09/2011
FURX
15.76MuDeltaIrritable bowel syndromePhase 2Initiate Phase 3 3Q 201203/08/2012
FURX
15.76JNJ-Q2Acute bacterial skin and skin structure infections (ABSSSI)Phase 2Phase 3 planned pending funding04/07/2012
FURX
15.76JNJ-Q2Community acquired bacterial pneumonia (CABP)Phase 2Enrolment terminated 201103/08/2012
FURX
15.76AlogliptinDiabetes - Type 2CRLTakeda resubmitted NDA July 26 2011, PDUFA 4/25/2012, issued CRL04/26/2012
GALE
1.49NeuVax (E75)Cancer - low-to-intermediate HER2+ breast cancerPhase 3Initiated Phase 3 Jan 2012 under SPA01/20/2012
GENT
9.63DefibrotideVOD - treatmentNDANDA withdrawn 2011. Hopeful of submitting new NDA during 201203/28/2012
GENT
9.63DefibrotideVOD - preventionNDANDA withdrawn 2011. Hopeful of submitting new NDA during 201203/28/2012
GERN
1.37ImetelstatCancer - BreastPhase 2Topline data due by end of 4Q 201205/04/2012
GERN
1.37ImetelstatCancer - MyelomaPhase 2Topline data due by end of 4Q 201203/08/2012
GERN
1.37GRNOPC1Acute spinal cord injuryPhase 1Discontinued11/15/2011
GERN
1.37GRN1005Cancer - Brain Metastases - breast cancerPhase 2Topline data due by end of 2Q 201303/08/2012
GERN
1.37GRN1005Cancer - Brain Metastases - NSCLCPhase 2Topline data due by end of 2Q 201303/08/2012
GERN
1.37ImetelstatCancer - NSCLCPhase 2Topline data due by end of 4Q 201205/04/2012
GERN
1.37ImetelstatCancer - essential thrombocythemiaPhase 2Topline data due by end of 4Q 201203/08/2012
GEVA
38.80SBC-102LAL DeficiencyPhase 1/2Interim data released Feb 201202/10/2012
GNVC
2.51VaccineFMD
GNVC
2.51VaccineMalaria
GTXI
2.97OstarineCancer - muscle wasting in patients with non-small cell lung cancerPhase 3Data 1Q 201302/22/2012
GTXI
2.97GTx-758 CapesarisCancer - ProstatePhase 2bPlaced on clinical hold. Hold lifted May 2012. Intends to initiate Phase 2 trial on lower dose 3Q 201205/09/2012
GTXI
2.97Toremifene 80mgCancer - ProstateCRLDevelopment terminated following CRL03/02/2011
HALO
7.90HTI-501CelluoitePhase 1/2Phase 2 part of trial pending03/13/2012
HALO
7.90HerceptinCancer - Breast - Herceptin SCMAALine Extension Application to the European Medicines Agency Mar 201204/07/2012
HALO
7.90Ultrafast InsulinDiabetesPhase 2Further data due 201204/07/2012
HALO
7.90HyQBLAInformed by FDA that more data is required04/17/2012
HALO
7.90PEGPH20Cancer - pancreaticPhase 2Phase 1/2 Initiated Oct 201110/05/2011
HALO
7.90SC CinryzeHereditary angioedema (HAE)Phase 2Prelim data released Dec 2011. Dose finding study to be initiated12/06/2011
HALO
7.90GAMMAGARD LIQUID - BaxterPrimary immunodeficiency disordersPhase 3Filed for regulatory approval 2Q 201104/07/2012
HALO
7.90Subcutaneous (SC) MabThera (rituximab) - by RocheNon-Hodgkin's lymphoma (NHL) - intravenous already approvedPhase 3Phase 3 ongoing. MAA submission due 201204/07/2012
HEB
0.25Ampligen - pigCFSCRLGranted extension to resubmit NDA Jan 201204/07/2012
HGSI
13.99BENLYSTAVasculitisPhase 3Initiate Phase 3 during 201201/13/2012
HGSI
13.99BENLYSTAActive lupus nephritisPhase 3Initiate Phase 3 during 201201/13/2012
HGSI
13.99Albiglutide Type 2 diabetesPhase 3Initial Phase 3 data due mid 201201/13/2012
HGSI
13.99Subcutaneous BENLYSTALupusPhase 3Initiated Phase 3 Dec 2012, data due 2H 201401/13/2012
HGSI
13.99DarapladibCardiovascular diseasePhase 3Enrolment completed October 201101/13/2012
HGSI
13.99Mapatumumab with sorafenibCancer - advanced hepatocellular Phase 2Complete Phase 2 enrolment during 201201/13/2012
HZNP
3.80LODOTRARheumetoid ArthritisPDUFAPDUFA 7/6/201211/30/2011
IDIX
8.08IDX899HIVPhase 2bDiscontinued 201104/07/2012
IDIX
8.08IDX184Hepatitis C HCVPhase 2bPhase 2b interim data released Jan 2012, further data available 2H 201204/21/2012
IDIX
8.08IDX320Hepatitis C HCVPhase 1/2Discontinues development due to SAE02/10/2011
IDRA
1.03IMO-2055Cancer - Squamous Cell, Head and NeckPhase 2Phase 2 data released May 2012. Failed to meet endpoints05/04/2012
IDRA
1.03IMO-3100PsoriasisPhase 2Phase 2 Initiated during April 2012, due to be completed 1H 201305/10/2012
IDRA
1.03IMO-2125Treatment-Naïve HCVPhase 2Discontinued 201104/07/2012
IMGN
13.51IMGN901 lorvotuzumab mertansineCancer - small-cell lung cancer SCLCPhase 2Initiate Phase 2 early 2Q 201204/07/2012
IMGN
13.51IMGN901 (lorvotuzumab mertansine)Cancer - Merkel cell carcinomaPivotal pendingInitiate pivotal trial there is a benefit in aggressively developing IMGN901 for MCC as well as for SCLC08/29/2011
IMGN
13.51Trastuzumab emtansine ( T-DM1, trastuzumab-DM1)Cancer - 1st-line HER2+ Metastatic Breast Cancer Phase 2Phase 2 complete, positive data, file NDA 201408/29/2011
IMGN
13.51Trastuzumab emtansine ( T-DM1, trastuzumab-DM1)Cancer - 3rd-line HER2+ MBCBLAPhase 3 initiated Sept 201110/28/2011
IMGN
13.51Trastuzumab emtansine ( T-DM1, trastuzumab-DM1)Cancer - 2nd-line HER2+ MBCPhase 3Phase 3 met PFS endpoint Mar 2012. NDA planned04/01/2012
IMGN
13.51SAR3419Cancer - NHL Non-Hodgkin lymphomaPhase 2Initiated Phase 2 Oct 201110/20/2011
IMMU
3.40EpratuzumabLupusPhase 3Data due 1H 201408/29/2011
IMMU
3.40Epratuzumab/ RituximabCancer - non-Hodgkin's lymphoma / Follicular LymphomaPhase 2Initial data Dec 6 201012/07/2010
IMMU
3.40VeltuzumabRheumatoid ArthritisPhase 2Ongoing04/07/2012
IMMU
3.40Clivatuzumab tetraxetanCancer - PancreaticPhase 3Phase 3 to commence once Phase 1b is completed05/12/2012
IMMU
3.40Veltuzumab intravenousCancer - NHL Non-Hodgkin lymphomaPhase 2Phase 3 planned, need funding04/07/2012
IMMU
3.40EpratuzumabCancer - ALLPhase 2Planning04/07/2012
IMMU
3.40VeltuzumabCancer - immune thrombocytopenic purpura - ITPPhase 2Updated Phase 2 data presented at ASH Dec 201112/12/2011
INCY
21.75INCB18424 ruxolitinibMyelofibrosisPDUFAApproved Nov 201111/20/2011
INCY
21.75LY3009104Rheumatoid arthritisPhase 2Phase 2b data due later in 201204/26/2012
INCY
21.75LY3009104PsoriasisPhase 2bPhase 2b data due 201304/26/2012
INCY
21.75INCB18424 ruxolitinibPolycythemia VeraPhase 3Phase 3 data due 2H 201304/26/2012
INCY
21.75INCB18424 ruxolitinibCancer - PancreaticPhase 2Initiated July 2011. Data due 2H 201304/26/2012
INCY
21.75INCB7839Cancer - breastPhase 2Discontinued 4Q 201110/28/2011
INCY
21.75INCB28060Cancer - Solid tumoursPhase 1/2Ongoing04/26/2012
INCY
21.75INCB24360Cancer - MelanomaPhase 2Initiated Phase 2 by early 2Q 201204/26/2012
INCY
21.75INCB24360Cancer - OvarianPhase 1/2Initiate Phase 2 late 201204/26/2012
INCY
21.75INCB18424Cancer- Children with solid tumors, leukemia, or myeloproliferative neoplasmsPhase 1/2Ongoing02/16/2012
INFI
12.45IPI-145InflammationPhase 1Initiate Phase 2 2H 201203/14/2012
INFI
12.45Retaspimycin Hydrochloride with docetaxelCancer - NSCLCPhase 2Aim to complete enrolment of Phase 2 2H 201203/14/2012
INFI
12.45Retaspimycin Hydrochloride with everolimusCancer - NSCLCPhase 1b/2Aim to report topline data of dose-escalation portion of the Phase 1b/2 trial 2H 201201/04/2012
INFI
12.45IPI-926 SaridegibCancer - PancreaticPhase 2Phase 2 topline data due 2H 201201/04/2012
INFI
12.45IPI-926 SaridegibCancer - ChondrosarcomaPhase 2Aim to complete enrolment of Phase 2 2H 201203/14/2012
INFI
12.45IPI-926 SaridegibMyelofibrosis Phase 2Phase 2 topline data due 2H 201203/14/2012
INFI
12.45Retaspimycin HydrochlorideCancer - Breast Phase 2Discontinued08/04/2010
INSM
2.87ARIKACEcystic fibrosisPhase 3 US Phase 3 on clinical hold lifted May 201205/08/2012
INSM
2.87ARIKACENontuberculous MycobacteriaPhase 2Clinical hold lifted Jan 2012. Phase 2 to be initiated mid 201203/14/2012
INSM
2.87IPLEXMMD - Myotonic muscular dystrophy Phase 2Announced early 2012 - no longer priority04/07/2012
IPXL
20.97IPX066Parkinson's PDUFAPDUFA date October 21 201202/24/2012
IPXL
20.97IPX159Restless LegsPhase 2bPhase 2b initiated Dec 2011. Data due mid 201312/21/2011
IPXL
20.97IPX056Multiple Sclerosis Phase 3Second Phase 3 trial on hold12/21/2011
IRWD
11.27Linaclotidechronic constipationPDUFAPDUFA date extended by 3 mths likely early Sept 2012 - 04/23/2012
IRWD
11.27Linaclotideirritable bowel syndrome with constipation (IBS‐C).PDUFAPDUFA date extended by 3 mths likely early Sept 2012 -04/23/2012
ISIS
8.95MipomersenHeterozygous FHPhase 3Filed MAA Jul 27 201107/28/2011
ISIS
8.95ISIS-CRPRxAtrial fibrillationPhase 2Plan to initiate 201204/07/2012
ISIS
8.95ISIS-CRPRxRheumatoid arthritisPhase 2Phase 2 ongoing04/07/2012
ISIS
8.95ISIS-CRPRxCancer - Multiple MyelomaPhase 2Phase 2 pending09/02/2011
ISIS
8.95ISIS113715DiabetesPhase 2Data reported08/09/2010
ISIS
8.95ISIS-EIF4ERxCancer - NSCLCPhase 2Initiated Jan 201101/04/2011
ISIS
8.95ISIS-EIF4ERxCancer - ProstatePhase 2Initiated Jan 201101/04/2011
ISIS
8.95ISIS-APOCIIIHigh triglyceridesPhase 2Initiated Phase 2 in May 201205/05/2012
ISIS
8.95ISIS-FXIClotting disordersPhase 2Intend to initiate Phase 2 in 201204/07/2012
ISIS
8.95OGX-011 Cancer - prostatePhase 3Initiated 2Q 201008/09/2010
ISIS
8.95OGX-011Cancer - NSCLCPhase 3Phase 3 pending04/07/2012
ISIS
8.95EXC 001Treatment following abdominal surgeryPhase 2Data reported 2Q 201008/09/2010
ISIS
8.95ACHN-490Phase 2Initiated 2Q 201008/09/2010
ISIS
8.95Mipomersen (KYNAMRO)Homozygous familial hypercholesterolemia (HoFH)NDANDA filed Mar 29,2012, MAA filed July 27 201104/01/2012
ISIS
8.95LY2181308Cancer - Acute myeloid leukemia AMLPhase 2Aim to complete during 201204/07/2012
ISTA
9.07To be bought out by Bausch + Lomb 2Q 201203/27/2012
ITMN
10.08PirfenidoneIdiopathic pulmonary fibrosisPhase 3Data due 1H 201404/27/2012
ITMN
10.08DanoprevirHepatitis C HCVPhase 2bSold to Roche Oct '1010/07/2010
JAZZ
42.43Sodium oxybateFibromyalgiaCRLCRL Oct 11 '1010/11/2010
JAZZ
42.43Ropinirole gelRestless LegsPhase 2Development stopped08/10/2010
JAZZ
42.43Intranasal clonazepamEpilepsyPhase 2Evaluating development09/02/2011
KERX
1.54ZerenexHyperphosphatemiaPhase 3Short term efficacy final data presented April 28, 2011. NDA filing mid 1H 201204/28/2011
KERX
1.54ZerenexHyperphosphatemiaPhase 3Long term efficacy trial - aim to complete 4Q 201203/01/2012
KERX
1.54PerifosineCancer - ColorectalPhase 3Primary endpoint not met Apr 201204/03/2012
KERX
1.54PerifosineCancer - MyelomaPhase 3 Returned license to AEZS. AEZS plans to continue development05/08/2012
LGND
11.71BazedoxifeneOsteoporosisNDA?????????08/06/2010
LGND
11.71AprelaMenopausal symptomsPhase 3NDA filing due soon as of May 2 201205/04/2012
LGND
11.71Promacta/RevoladeHepatitis C HCVPhase 3First of two Phase 3 trials yields positive data. Data to be presented at upcoming conference 4Q 2011. 2nd trial to be completed 3Q 2011. sNDA due to be filed 201204/07/2012
LGND
11.71Captisol-Enabled MelphalanCancer - multiple myelomaPhase 2Phase 2 data released Nov 2011, initiate pivotal trial 2012 with NDA filing in 201302/24/2012
LGND
11.71BMS-582949AtherosclerosisPhase 2Ongoing02/15/2011
LGND
11.71CC-930Idiopathic pulmonary fibrosisPhase 2Initiated Jan 201102/15/2011
LGND
11.71MEDI-528Asthma Phase 2Complete 3Q 201102/15/2011
LGND
11.71DinaciclibCancerPhase 3Phase 3 to be initiated by Merck05/04/2012
LGND
11.71CarfilzomibCancer - multiple myelomaPDUFA PDUFA July 27 2012. ODAC meeting Jun 20 2012 05/04/2012
LGND
11.71SCH 527123COPD and AsthmaPhase 2bComplete 3Q 201202/15/2011
LXRX
1.51LX2931RA + autoimmune diseasesPhase 2Additional Ph2 trial initiated 3Q 2011. Data due 2Q 201204/07/2012
LXRX
1.51LX1032Ulcerative colitisPhase 2Ongoing04/07/2012
LXRX
1.51LX1032Carcinoid SyndromePhase 2aData released Aug 201108/20/2011
LXRX
1.51LX4211DiabetesPhase 2bPhase 2b data due mid 201204/13/2012
MAPP
11.54LEVADEXMigraineCRLCRL Mar 26 2012, meeting with FDA scheduled 2Q 201205/05/2012
MAPP
11.54MAP0005Asthma & chronic obstructive pulmonary disease (COPD)Phase 2aData released 200812/21/2010
MDCO
20.88OritavancinABSSSIPhase 3Complete enrolment 2Q 2012. File NDA 1H 201303/01/2012
MDCO
20.88CangrelorAntiplatelet agentPhase 3Ongoing03/01/2012
MDCO
20.88MDCO-2010Reduction of blood loss during surgeryPhase 2bPlan to initiate Phase 2b trial 2Q 201203/01/2012
MDGN
5.78Erythropoietin ("EPO") therapy delivered via EPODURE BiopumpAnemia in dialysis patients with end-stage renal disease ("ESRD").Phase 2bPhase 2b IND filed Apr 2012 for US trial. Phase 2a Israel trial to be initiated 2Q 201205/15/2012
MDGN
5.78INFRADUREHepatitis C HCVPhase 2aTwo Phase I/II trials in Israel slated to commence in Q3 201205/15/2012
MDVN
83.15DimebonAlzheimer's diseasePhase 3Phase 3 fail. Development discontinued.01/17/2012
MDVN
83.15MDV3100Cancer - prostate 2nd linePhase 3NDA to be filed 2Q 2012 seeking priority review05/09/2012
MDVN
83.15MDV3100Cancer - First line Prostate CancerPhase 2 Initiated May 2011, enrolling04/07/2012
MDVN
83.15MDV3100 cf BicalutamideCancer - prostatePhase 2Initiated Mar 2011, enrolling04/07/2012
MDVN
83.15DimebonHuntington diseasePhase 3Topline HORIZON trial data released Apr 11 2011. FAILED. Ph3 CONCERT trial data due 1H 201205/08/2011
MELA
2.84MelafindCancer - melanoma detectionApprovedApproved Nov 201111/05/2011
MNKD
1.60MKC1106-MTCancer - advanced melanomaPhase 2Initiated Oct 201010/20/2010
MNKD
1.60AFREZZAInsulinCRLCRL received Jan 19, 2011. Data from two new trials due around end of 2012, NDA filing 1H 201303/16/2012
MNOV
3.07MN-166Multiple sclerosisPhase 2Pending additional Ph2b, need partner08/19/2011
MNOV
3.07MN-166Chronic painPhase 2bFunding required08/19/2011
MNOV
3.07MN-221Acute Asthma and COPDPhase 2Prelim data due 2Q 201205/11/2012
MNTA
13.83Generic CopaxoneMultiple sclerosisaNDAFiled 2007. 30mth period where TEVA has protection from generics ends Jan 11 201112/12/2010
MNTA
13.83Generic LovenoxDeep vein thrombosisApprovedApproved July 201008/01/2010
MNTA
13.83M-118Acute coronary syndromesPhase 2Need partner to further
MNTA
13.83M402Cancer - advanced metastatic pancreatic cancerPhase 1/2Patient screening underway for Phase 1/2 proof of concept trial05/04/2012
MYRX
2.57AzixaCancer - Glioblastoma - 1st linePhase 2bSuspended future development of Azixa due to unlikely success09/09/2011
MYRX
2.57AzixaCancer - Glioblastoma - 2nd/3rd linePhase 2aSuspended future development of Azixa due to unlikely success09/09/2011
MYRX
2.57AzixaCancer - Relapsed Glioblastoma MultiformePhase 2Suspended future development of Azixa due to unlikely success09/09/2011
MYRX
2.57AzixaCancer - MelanomaPhase 2aSuspended future development of Azixa due to unlikely success09/09/2011
NABI
1.60NicVAXNicotine AddictionPhase 3 FAILED second Phase 3 trial11/07/2011
NABI
1.60NicVAXNicotine AddictionPhase 3FAILED first of two Phase 3 trials July 201107/18/2011
NAVB
2.79RIGScanDetection of solid tumoursPre INDInitiate trials 201211/20/2011
NAVB
2.79LymphoseekLymphatic-tissue tracing agentPDUFAPDUFA Sep 10 2012. Three month extension due to data submitted to FDA within 90 days of original PDUFA date04/04/2012
NBIX
6.55Urocortin 2Cardiovascular diseasesPhase 2Phase 2 data released May 2012. Partner required for further development05/18/2012
NBIX
6.55ElagolixEndometriosisPhase 3Initiate Phase 3 2Q 201205/04/2012
NBIX
6.55ElagolixUterine FibroidsPhase 2Abbott Initiated Phase 2 Sept 13 2011, to be completed late 201202/10/2012
NBIX
6.55VMAT2 NBI-98854Tardive dyskinesiaPhase 2Phase 2b to be initiated mid 2012 with data due end of 201205/04/2012
NBIX
6.55GSK561679Anxiety and DepressionPhase 2Endpoint not met Sept '1009/15/2010
NBY
1.03NVC422Urine infectionPhase 2Phase 2 Topline Data due later in 201205/18/2012
NBY
1.03NVC422Viral conjunctivitisPhase 2Initiated Phase 2b May 2012. Data 1H 201305/18/2012
NBY
1.03NVC422Impetigo skin infection studyPhase 2bStart Ph2b later in 201205/18/2012
NGSX
0.33QutenzaNeuropathic pain associated with HIV-associated peripheral neuropathy (HIV-PN)PDUFAPDUFA Mar 7 2012, Advisory Committee NEGATIVE vote Feb 9 201202/10/2012
NGSX
0.33NGX-1998Neuropathic painPhase 2End of Phase 2 meeting planned for 3Q 2012 with possible Phase 3 initiation late 201205/04/2012
NKTR
6.41NKTR-102Cancer - breastPhase 3Phase 3 initiated Dec 201112/12/2011
NKTR
6.41NKTR-102Cancer - ovarianPhase 2Ongoing04/07/2012
NKTR
6.41NKTR-102Cancer - colorectalPhase 2Ongoing04/07/2012
NKTR
6.41NKTR-118Opioid bowel dysfunctionPhase 3Initiated Mar 2011, plan NDA filing 201311/05/2011
NKTR
6.41NKTR-181Chronic painPhase 2Initiate Phase 2 mid 201204/07/2012
NKTR
6.41Amikacin InhalePhase 2Phase 3 pending04/07/2012
NLNK
11.21HyperAcute PancreasCancer - pancreaticPhase 3Interim Phase 3 data due late 2012, complete enrolment 2013. Second interim read late 201304/07/2012
NLNK
11.21HyperAcute LungCancer - NSCLCPhase 2b/3Initiate Phase 2b/3 1H 201204/07/2012
NLNK
11.21HyperAcute MelanomaCancer - melanomaPhase 2Phase 2 data due 1H 201204/07/2012
NPSP
7.13GATTEXShort Bowel SyndromePDUFAPDUFA date September 30 201202/16/2012
NPSP
7.13NPSP558HypoparathyroidismPhase 3Positive Phase 3 data released Nov 2011. File BLA end of 201202/16/2012
NVAX
1.16VLPSeasonal FluPhase 2Data released Feb 201102/18/2011
NVAX
1.16Seasonal Influenza VaccineSeasonal FluPhase 2Phase 2 initiated Mar 2012. Topline data due 3Q 201203/02/2012
NVGN
2.33GLYC-101 GelWound healingPhase 2Phase 2 completed09/02/2011
NVGN
2.33PhenoxodiolCancer - OvarianPhase 3Endpoints not met June 1 '1006/06/2010
NVGN
2.33Phenoxodiol intravenousCancer - OvarianPhase 2Phase 2 completed09/02/2011
NYMX
7.69NX-1207BPH Phase 3Ongoing04/07/2012
NYMX
7.69NX-1207Cancer - low grade localized prostatePhase 2Phase 2 initiated Mar 201203/02/2012
OGXI
12.73CustirsenCancer - castrate-resistant prostatePhase 3Complete enrolment 2H 201203/11/2012
OGXI
12.73CustirsenCancer - castrate-resistant prostate - trial 2Phase 3Initiate 2nd Phase 3 trial 2H 201203/11/2012
OGXI
12.73CustirsenCancer - NSCLCPhase 3Initiate 2H 201205/04/2012
OGXI
12.73OGX-427Cancer - prostatePhase 2Prelim Phase 2 data released Feb 201202/03/2012
OGXI
12.73OGX-427Cancer - bladderPhase 2Phase 2 enrolling05/04/2012
OGXI
12.73OGX-427Cancer - castrate-resistant prostatePhase 2Initiate Phase 2 later in 201205/04/2012
OMER
9.52OMS103HPACL Phase 3Disappointing Data released Mar 201104/01/2011
OMER
9.52OMS103HPPostoperative joint function Phase 3Data due 2H 201205/11/2012
OMER
9.52OMS302cataract surgeryPhase 3Met primary and secondary endpoints Mar 2012. Additional Phase 3 trial initiated early April 2012 with data 2H 2012. NDA filing due first part of 201304/11/2012
OMER
9.52OMS201UrologyPhase 1/2Interim Data released Dec 201012/29/2010
ONCY
3.48REOLYSIN with paclitaxel Cancer - ovarian, fallopian tube or primary peritonealPhase 2Ongoing04/08/2012
ONCY
3.48REOLYSINCancer - Head and NeckPhase 3First stage of Phase 3 enrolment completed04/03/2012
ONCY
3.48Intravenous REOLYSIN with paclitaxel & carboplatinCancer - Head and NeckPhase 2Data released Nov 201112/13/2011
ONCY
3.48REOLYSIN - intravenous with gemcitabineCancer - PancreaticPhase 2Interim data released Dec 201212/02/2011
ONCY
3.48REOLYSINCancer - NSCLCPhase 2Ongoing04/08/2012
ONCY
3.48REOLYSINCancer - advanced or metastatic colorectal cancerPhase 2Phase 2 planned05/04/2012
ONTY
3.43StimuvaxCancer - NSCLCPhase 3Data due 201303/07/2012
ONTY
3.43PX-866Cancer - metastatic colorectal carcinoma (CRC) & squamous cell carcinoma of the head and neck (SCCHN)Phase 1/2Initiated Phase 2 Oct 201110/20/2011
ONTY
3.43PX-866Cancer - GlioblastomaPhase 2Initiated Phase 2 April 2011. Ongoing04/08/2012
ONTY
3.43StimuvaxCancer - BreastPhase 3Trial cancelled08/06/2010
ONTY
3.43PX-866Cancer - prostatePhase 2Initiated Phase 2 Sept 201109/13/2011
OPTR
14.81FidaxomicinCDI - diarrheaApprovedFDA Approved May 27 201105/27/2011
OPTR
14.81PruvelInfectious diarrheaPhase 3NDA filing on hold due to rash in Ph3 trials05/21/2011
OPTR
14.81OPT-822/821Cancer - metastatic breast cancerPhase 2/3Phase 2/3 initiated Dec 201003/09/2012
OPXA
0.47TovaxinRelapsing Remitting MS (RRMS)Phase 3Phase 3 pending04/08/2012
OPXA
0.47TovaxinSecondary Progressive MS (SPMS)Phase 2Phase 2b pending, possibly by end of 2012, need funding02/28/2012
OREX
3.44EmpaticEpilepsyPhase 2bEvaluate next steps for the Empatic once have had an opportunity to review regulatory outcome for Vivus Qnexa04/08/2012
OREX
3.44ContraveObesityCRLCRL Feb 1, 2011, expect to initiate cardiovascular outcomes trial late 2Q 2012 under SPA with possible NDA filing mid-201405/12/2012
OSIR
5.55ProchymalCrohn’s diseasePhase 3Enrollment re-started May '10.Ongoing04/08/2012
OSIR
5.55ProchymalRefractory GvHDTerminatedTerminated Feb 201204/08/2012
OSIR
5.55ProchymalAcute myocardial infarctionPhase 2Enrolment completed Mar 2011. Ongoing04/08/2012
OSIR
5.55ProchymalDiabetesPhase 2Failed trial Jan 201201/03/2012
OSUR
10.40OraQuickHIV testFDA Blood Products Advisory Committee (BPAC) to met May 15, 2012. Unanimous positive vote 05/16/2012
OXGN
0.88ZYBRESTATCancer - ATC Phase 2/3Hope to initiate Phase 3 in 4Q 201205/10/2012
OXGN
0.88ZYBRESTATCancer - NSCLCPhase 2Concluding development09/01/2011
OXGN
0.88ZYBRESTATCancer - OvarianPhase 2Initiated Apr 2011, data due early 201304/08/2012
PATH
3.03ZelrixMigraineCRLCRL Aug 31 2011, resubmit NDA 1H 201205/11/2012
PBMD
4.84CVacCancer - ovarianPhase 3Phase 3 initiated Jan 2012. Full patient enrolment should be complete by around Q3-Q4 2013, with data expected in 2015.04/18/2012
PBTH
4.95hGH-CTPAdults - growth hormone deficiencyPhase 2Initiate Phase 3 during 201204/09/2012
PBTH
4.95hGH-CTPChildren - growth hormone deficiencyPhase 2Initiated Phase 204/09/2012
PCRX
10.15EXPARELPostsurgical painApprovedFDA Approved October 201110/31/2011
PCYC
28.60PCI-24781Cancer - lymphomaPhase 2Complete enrolment 1Q 201202/10/2012
PCYC
28.60PCI-32765 (PCYC-1111)Cancer - relapsed/refractory multiple myeloma (MM)Phase 2Initiate Phase 2 Q1 2012. Complete enrolment early 201302/10/2012
PCYC
28.60PCI-32765 in combination with ofatumumab (PCYC-1109)Cancer - Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL/SLL)Phase 2Complete Phase 2 enrolment 1H 2012. Some data to be released mid 201202/10/2012
PCYC
28.60PCI-32765 (PCYC-1102)Cancer - Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL/SLL)Phase 2Phase 2 enrolment complete.Interim data mid 2012. Expect to hear of Phase 3 design in 2Q 201202/10/2012
PCYC
28.60PCI-32765 (PCYC-1104)Cancer - relapsed or refractory MCLPhase 2Interim data presented at ASH 2011 - complete enrolment 1H 2012. Expect to hear of Phase 3 design in 2Q 201202/10/2012
PCYC
28.60PCI-32765 (PCYC-1106)Cancer - Diffuse Large B-cell Lymphoma (DLBCL) Phase 2Complete enrolment 1H 201202/10/2012
PCYC
28.60PCI-27483Cancer - pancreaticPhase 2Interim data due 1H 201202/10/2012
PGNX
7.52RELISTOR pre-filled syringesadvanced-illnessApprovedApproved09/29/2010
PGNX
7.52Subcutaneous RELISTORchronic painsNDAPDUFA Jul 27 2012 - extended by 3 months04/26/2012
PGNX
7.52Oral MethylnaltrexoneChronic, Non-Cancer Pain Subjects with Opioid-Induced ConstipationPhase 3NDA filing due mid 2012 following Phase 3 data release Dec 201112/20/2011
PLX
6.20TaliglueraseGaucher diseaseApprovedApproved May 1 201205/02/2012
POZN
6.49PA32540Cardiovascular patients at risk for developing aspirin-associated gastric ulcersPhase 3Phase3 endpoints met March 2012, intended to file NDA 3Q 2012 but delayed 6 months to 1Q 2014 following FDA meeting04/27/2012
PPHM
0.44CotaraCancer - GlioblastomaPhase 2FDA to provide written feedback regarding Phase 3 design. Needs partner to advance03/11/2012
PPHM
0.44Bavituximab + ribavirinCancer - pancreatic Phase 2Interim data due sometime 201203/11/2012
PPHM
0.44BavituximabHCVPhase 2Phase 2 prelim data released Dec 2012. Seeking partner to advance program03/11/2012
PPHM
0.44BavituximabCancer - LiverPhase 1/2Initiated Dec 2010, ongoing09/09/2011
PPHM
0.44BavituximabCancer - front-line NSCLCPhase 2bPFS disappointing data released Mar 2011. OS data due 2H 201203/11/2012
PPHM
0.44BavituximabCancer - Refractory NSCLCPhase 2Enrolment completed Oct 2011, data 1H 201203/11/2012
PRAN
1.62PBT-2Alzheimer'sPhase 2Phase initiated March 201203/08/2012
PRAN
1.62PBT-2Huntington's DiseasePhase 2Initiated Apr 201205/01/2012
PSDV
2.00IluvienDiabetic macular edemaCRLCRL Nov 2011, two new trials required11/11/2011
PSTI
2.53PLX-PAD (stem cells)CLI - Critical limb ischemia Phase 1Phase 2/3 planned09/16/2011
PSTI
2.53PLX cellsBuerger's DiseasePhase 2Phase 2 planned in India09/16/2011
PTIE
3.78RemoxyChronic painCRLCRL Jun 23, 201106/27/2011
PTN
0.60Subcutaneous BremelanotideErectile DysfunctionPhase 2Seeking partner for Phase 209/18/2011
PTN
0.60PL-3994Acute exacerbations of asthmaPhase 2Pending, FDA gives thumbs up for Phase 2 initiation03/03/2011
PTN
0.60Bremelanotidefemale sexual dysfunction (FSD)Phase 2bPhase 2b initiated Jun 2011, enrolment completed Mar 2012, data expected 3Q 2012. Phase 3 initiation possible 1H 2013 dependent on funding03/09/2012
QLTI
6.70punctal plug drug deliveryGlaucomaPhase 2Data released Aug 28 2011, further Phase 2 trial data to be released 2H 2012 with Phase 3 commencing 2013 pending positive Phase 2 data02/24/2012
QLTI
6.70punctal plug drug deliveryAllergic conjunctivitisPhase 2aData released Feb 2011, trial failed, study stopped02/09/2011
RGEN
4.48RG1068 - SecreFloPancreatic imagingPhase 3PDUFA June 21 2012 under priority review. Gastrointestinal Drugs Advisory Committee meeting scheduled for May 31,2012 has been cancelled. CRL expected.04/26/2012
RGEN
4.48RG2417BipolarPhase 2bData released Mar 2011. FAIL02/09/2011
RIGL
7.55FostamatinibRA - rheumatoid arthritis Phase 3Interim data due 2H 2012, NDA filing 2H 201303/07/2012
RIGL
7.55R343AsthmaPhase 2Initiate Phase 2 during late summer 201205/17/2012
RIGL
7.55R333Discoid Lupus ErythematosusPhase 2Initiate Phase 2 during summer 201205/02/2012
RNN
0.40ArchexinCancer - pancreaticPhase 2aPhase 2 data due 3Q 201201/17/2012
RNN
0.40SerdaxinMajor Depressive DisorderPhase 2bFailed to display efficacy12/13/2011
RNN
0.40ZoraxelErectile DysfunctionPhase 2bPhase 2b pending04/08/2012
RPRX
7.40ProellexEndometriosisPhase 2Type B meeting to be scheduled with the FDA during 2Q 2012, followed by initiation of Phase 2/3 trial during 3Q 201203/28/2012
RPRX
7.40ProellexUterine fibroidsPhase 2Phase 2 data for uterine fibroids due 4Q 2012, followed by End of Phase 2 meeting with FDA and possible Phase 3 initiation late 2012 or early 201305/01/2012
RPRX
7.40AndroxalType 2 DiabetesPhase 2Topline data released Dec 2011, plans to meet with FDA12/13/2011
RPRX
7.40AndroxalSecondary hypogonadismPhase 2Meet with FDA 1H May 2012 re design of Phase 3 trial with possible NDA filing ealry 201403/28/2012
RPTP
5.33DR CysteamineHuntington's DiseasePhase 2Initiated Nov 201011/09/2010
RPTP
5.33DR CysteamineNASH Phase 2bPhase 2b initiate 1Q 201212/19/2011
RPTP
5.33DR CysteamineCystinosisPhase 3Filed NDA Mar 30, 2012 seeking 6 month priority review04/01/2012
RPTP
5.33ConviviaALDH2Phase 2aPhase 2 completed, seeking partner09/17/2011
RPTP
5.33TezampanelThrombotic DisorderPhase 1Initiate by end of year09/18/2011
RVX
1.36RVX-208 (SUSTAIN trial)Coronary placque removalPhase 2bEnrolment completed Nov 2011. Data due 3Q 201205/10/2012
RVX
1.36RVX-208 (ASSURE trial)Coronary placque removalPhase 2bInitiated Nov 2011. Data due Q1 201305/10/2012
SCLN
5.80SCV-07OM - oral mucositis DiscontinuedDiscontinued Mar 2012 03/03/2012
SCLN
5.80SCV-07Hepatitis C HCVPhase 2b stoppedData released Dec 2010, discontinues development12/15/2010
SCLN
5.80ZADAXINH1N1ClinicalFinal data released June 201006/30/2010
SCMP
8.00Amitiza/ LubiprostoneChronic idiopathic constipationPhase 3Efficacy data released May 2011, MAA filed Aug 2011, expect MAA decision Aug 201203/14/2012
SCMP
8.00Amitiza/ LubiprostoneOpioid-induced bowel dysfunctionPhase 3Met endpoint, sNDA filing due mid-201205/10/2012
SCMP
8.00CobiprostoneGastric ulcersPhase 2aCompleted, data reported08/13/2011
SCMP
8.00Unoprostone isopropyl - resculaDry age-related macular degeneration (dry AMD) Phase 2Initiate late 201203/14/2012
SGEN
20.06LintuzumabCancer - Acute myeloid leukemia AMLPhase 2bFAIL - Data Sept 13 201009/13/2010
SGEN
20.06Brentuximab Vedotin -ADCETRISCancer - Anaplastic large cell lymphomaApprovedAPPROVED Aug 19 201108/20/2011
SGEN
20.06Brentuximab Vedotin -ADCETRISCancer - Relapsed & Refractory Hodgkin lymphomaApprovedAPPROVED Aug 19 201108/20/2011
SGEN
20.06Brentuximab Vedotin -ADCETRISCancer - CD30-positive non-Hodgkin lymphomaPhase 2Initiated Aug 201108/23/2011
SGEN
20.06Brentuximab Vedotin -ADCETRISCancer - CD30-positive non-lymphomaPhase 2Initiated Phase 2 Oct 201110/26/2011
SGEN
20.06Brentuximab Vedotin -ADCETRISCancer - cutaneous T-cell lymphomaPhase 3Initiated May 201205/08/2012
SGEN
20.06Brentuximab Vedotin -ADCETRISCancer - front-line advanced stage Hodgkin lymphomaPhase 3Plan to initiate Phase 3 late 2012/early 201305/08/2012
SGEN
20.06Brentuximab Vedotin -ADCETRISCancer - front-line mature T-cell lymphomas, including sALCLPhase 3Plan to initiate Phase 3 late 2012/early 201305/08/2012
SGMO
4.35SB-728-902HIV/AIDSPhase 2Phase 2 initiated Jan 201201/09/2012
SGMO
4.35SB-728-1101HIV/AIDSPhase 2Phase 2 initiated Jan 201201/09/2012
SGMO
4.35SB-509-901Diabetic NeuropathyPhase 2bData 4Q 2011 - FAILED10/04/2011
SGYP
4.32PlecanatideChronic idiopathic constipation (CIC)Phase 2 / 3Initiated Phase 2/3 trial Nov 2011. Topline data due 4Q 201204/10/2012
SGYP
4.32PlecanatideIBS-CPhase 2Initiate sometime during 201204/08/2012
SNSS
2.63VoreloxinCancer - Acute myeloid leukemia AMLPhase 3Initiated Dec 2010, interim analysis 3Q 201205/16/2012
SNSS
2.63VoreloxinCancer - OvarianPhase 2Completed 2010
SNTA
3.80ElesclomolCancer - ovarianPhase 2Ongoing04/08/2012
SNTA
3.80STA-9090 GanetespibCancer - NSCLCPhase 2b /3Interim Phase 2b results due 2Q. Final PFS data and preliminary OS data from Phase 2b portion is expected in 2H 2012 and initiation of the Phase 3 portion expected during 2H 2012.05/04/2012
SNTA
3.80STA-9090 GanetespibCancer - breastPhase 2Phase 2 pending04/08/2012
SNTA
3.80STA-9090 GanetespibCancer - gastrointestinal stromal tumorsPhase 2Data presented at ASCO 201109/17/2011
SNTA
3.80STA-9090 GanetespibCancer - hepaticPhase 1/2Ongoing04/08/2012
SNTA
3.80STA-9090 GanetespibCancer - small cell lungPhase 2Ongoing04/08/2012
SNTA
3.80STA-9090 GanetespibCancer - AMLPhase 2bPending04/08/2012
SNTA
3.80STA-9090 GanetespibCancer - rectalPhase 1b/2Initiate Phase 1b/2 trial 1Q 201211/11/2011
SNTA
3.80ElesclomolCancer - AMLPhase 2Ongoing09/17/2011
SNTA
3.80ElesclomolCancer - NSCLCPhase 2Initiate Ph2b sometime during 201201/05/2012
SNTS
5.64Budesonide - USUlcerative colitis diseasePhase 3Filed NDA Dec20 2011, NDA accepted. PDUFA Oct 16 201203/06/2012
SNTS
5.64RifamycinTravelers’ diarrheaPhase 3Initiated June 2010, ongoing. Aim to complete 2H 201204/08/2012
SNTS
5.64RHUCINHereditary Angioedema (HAE) attacksPhase 3Expects to be completed 3Q 201202/14/2012
SOMX
0.32SilenorInsomniaApproved1Q 2010
SPEX
0.76D-TagatoseDiabetesPhase 3Development stopped04/08/2012
SPPI
11.08BelinostatCancer - Carcinoma of Unknown Primary (CUP)Phase 2Completed enrolment Dec 2010, data due 2H 201203/03/2012
SPPI
11.08ZEVALIN and Motexafin Gadolinium (MGd)Non-Hodgkin's lymphoma (NHL)Phase 2Phase 2 Initiated May 2012
SPPI
11.08FusilevCancer - ColorectalApprovedApproved April 29 201105/01/2011
SPPI
11.08FusilevCancer - Removal of BioscanApprovedApproved Nov 20, 201111/21/2011
SPPI
11.08BelinostatCancer - Peripheral T-Cell LymphomaPhase 3Enrolment completed Sept 2011. Data expected 4Q 201204/26/2012
SPPI
11.08ApaziquoneCancer - BladderPhase 3Failed to meet primary endpoint in Phase 3 trial - Apr 2012. Some secondary endpoints met04/06/2012
SQNM
4.25SensiGene T21 Laboratory Developed Test (LDT) - MaterniT21Prenatal test for Down SyndromeR&DLaunched Oct 201110/17/2011
STEM
0.80HuCNS-SC cellsNCLPhase 1Discontinued due to lack of patient enrolment04/09/2011
STEM
0.80HuCNS-SC cellsPelizaeus-Merzbacher disease (PMD)Phase 1/2Prelim data from 4 patients released Apr 201204/03/2012
STEM
0.80HuCNS-SC cellsSpinal cord injury Phase 1/2Interim data released May 201205/18/2012
STEM
0.80Age-Related Macular DegenerationPhase 1Phase I/II to be initiated early 201207/29/2011
SUPN
6.30SPN-538EpilepsyPDUFAPDUFA July 201204/27/2012
SUPN
6.30SPN-804Adjunctive therapy for epilepsyPDUFAPDUFA October 201204/27/2012
SUPN
6.30SPN-810Impulsive Aggression in ADHDPhase 2bPhase 2b data due 2H 201204/27/2012
SUPN
6.30SPN-810ADHDPhase 2aCompleted 1Q 201104/27/2012
SVNT
0.85KRYSTEXXAChronic goutApprovedFDA Approved. MAA submitted May 4 2011, expect approval 2Q 2012 est05/04/2011
SYN
2.25TrimestaMultiple sclerosisPhase 2Enrolment completed Mar 201203/15/2012
SYN
2.25TrimestaMultiple sclerosisPhase 2Phase 2 initiated Jan 201201/19/2012
SYN
2.25FlupirtineFibromyalgiaPhase 2Ongoing04/08/2012
SYN
2.25AEN-100ALSPhase 2/3Planning04/08/2012
TELK
3.67TELINTRAMyelodysplastic SyndromePhase 2Phase 2b initiated Oct 201110/13/2011
TELK
3.67TELINTRALenalidomidePhase 2Phase 2 Initiated June 2011, interim data due early 201309/03/2011
THLD
6.11TH-302Cancer - soft tissue sarcoma (406 trial)Phase 3Initiated Ph3 Sept 2011, under SPA, interim data due early 201303/09/2012
THLD
6.11TH-302Cancer - PancreaticPhase 2bPhase 2b data released Feb 2012. Primary endpoint PFS met. Overall survival data due 2H 201205/04/2012
THLD
6.11TH-302Cancer - multiple myeloma (408 trial)Phase 1/2Phase 1/2 topline data due by end of 201205/04/2012
THLD
6.11TH-302 in Combination with SunitinibCancer - renal cell carcinoma, gastrointestinal stromal tumors or pancreatic neuroendocrine tumors (410 trial)Phase 1/2Phase 1/2 topline data due by end of 201205/04/2012
THRX
20.33RelovairAsthmaPhase 3Phase 3 Data released Jan 2012. MAA to filed mid 2012. NDA finding pending following further discussions04/27/2012
THRX
20.33RelovairChronic Obstructive Pulmonary Disease (COPD)Phase 3Phase 3 Data released Jan 2012. MAA and NDA to filed mid 2012. 04/27/2012
THRX
20.33GSK961081Chronic Obstructive Pulmonary Disease (COPD)Phase 2bPhase 2 completed04/27/2012
THRX
20.33TD−1211Opioid-induced constipation (OIC)Phase 2bPhase 2b data due mid 201204/27/2012
THRX
20.33TD-9855Attention deficit/hyperactivity disorder (ADHD)Phase 2Phase 2 ongoing04/27/2012
TLON
0.75Marqibo2nd line adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL)PDUFAPDUFA extended to Aug 12 2012. ODAC voted 7 yes, 4 no, and 2 abstain - Mar 21 201205/08/2012
TRGT
4.12TC-5214Major depressive disorder (MDD)Phase 3Phase 3 (RENAISSANCE 2 and RENAISSANCE 3 missed primary endpoint02/22/2012
TRGT
4.12TC-5214Major depressive disorder (MDD)Phase 3(RENAISSANCE 4 and RENAISSANCE 5) - failed to meet primary endpoint Mar 2012. Discontinue development03/21/2012
TRGT
4.12TC-5214Switch monotherapyPhase 2bDiscontinued Mar 201203/27/2012
TRGT
4.12TC-5214SchizophreniaPhase 2bPhase 2b Ongoing02/22/2012
TRGT
4.12TC-5214Attention deficit/hyperactivity disorder (ADHD)Phase 2Phase 2 topline data due 2H 201202/22/2012
TRGT
4.12TC-6987Type 2 DiabetesPhase 2Phase 2 topline data released Mar 2012. Failed trial. Will not further development03/28/2012
TRGT
4.12TC-6987AsthmaPhase 2Phase 2 data released Mar 2012, originally met co-primary endpoints BUT revised data showed that it failed to meet one of the two endpoints04/11/2012
TRGT
4.12AZD3480Alzheimer’s diseasePhase 2bPhase 2b Ongoing02/22/2012
TRGT
4.12AZD1446Alzheimer’s diseasePhase 2Phase 2 planned02/22/2012
TSPT
6.99IntermezzoInsomniaApprovedApproved Nov 201111/23/2011
TSPT
6.99Ondansetron TO-2061Obsessive Compulsive DisorderPhase 2Data due 1Q 201304/03/2012
TSRX
4.99Oral torezolid phosphateAcute bacterial skin and skin structure infections (ABSSSI)Phase 3Topline data of first Phase 3 trial released Dec2011. SPA for second Ph3 initiated Sept 2011 data due early 201312/19/2011
TTHI
1.90TT-223DiabetesPhase 2Endpoints NOT met Sept '10, development stopped11/12/2010
TTHI
1.90ELND005Alzheimer'sPhase 2Plan Ph3 despite average Ph212/02/2011
TZYM
3.00Ulimorelin ULISES 007To accelerate GI recovery in subjects who have undergone partial bowel resectioPhase 3Failed to meet primary and secondary endpoints03/13/2012
TZYM
3.00Ulimorelin ULISES 008To accelerate GI recovery in subjects who have undergone partial bowel resectioPhase 3Data from second Phase 3 trial due by end of June 201205/11/2012
TZYM
3.00TZP-102Diabetic gastroparesisPhase 2bPhase 2b data due by end of 201205/11/2012
VICL
2.84TemusiIschemia Phase 3Endpoint not met11/20/2010
VICL
2.84TransVax(TM) vaccineHematopoietic cell transplantPhase 3Initiate Phase 3 2H 201205/04/2012
VICL
2.84TransVax(TM) vaccinesolid organ transplant (SOT)Phase 2Initiate Phase 2 2H 2012 or shortly after05/04/2012
VICL
2.84CollategenePeripheral arterial diseasePhase 2Initiate Phase 3 201211/02/2011
VICL
2.84Allovectin-7Cancer - melanomaPhase 3Topline data late 201205/04/2012
VNDA
4.02TasimelteonInsomniaPhase 3Data end 2012, poss NDA filing mid- 201305/09/2012
VNDA
4.02TasimelteonDepressionPhase 2bPhase 2b/3 trial initiated Sept 2011. Data due 1H 201305/09/2012
VNDA
4.02Fanapt (Injectable) SchizophreniaPhase 2MAA filed July 2011, expects to respond to 120day questions by mid May 201202/15/2012
VPHM
19.24Subcutaneous Delivery of Cinryze with HyaluronidaseHereditary angioedemaPhase 2Phase 2 initiated Sept 2011, prelim data released Dec 201112/06/2011
VPHM
19.24VP 20621C. difficile infection (CDI)Phase 2Phase 2 initiated May 201109/01/2011
VPHM
19.24BuccolamPediatric epilepsyMAACHMP issued positive opinion June 201109/01/2011
VTUS
10.50VEN 307 (diltiazem cream)Anal fissuresPhase 3Phase 3 positive data released May 2012. Phase 3 US trial to be initiated 2H 201205/15/2012
VTUS
10.50VEN 308 (phenylephrin)Fecal incontinence Phase 2Does not expect to further development in short term12/20/2011
VTUS
10.50VEN 309 (iferanserin)Symptomatic hemorrhoidsPhase 3First of two Phase 3 trials initiated Aug 2011. Data due late June, early July 2012.05/10/2012
VVUS
22.40QnexaObesityPDUFAPDUFA Apr 17 2011. Advisory Committee Meeting Feb 22 2012 voted 20-2 in favour02/23/2012
VVUS
22.40AvanafilErectile dysfunctionApprovedApproved April 27 201204/27/2012
VVUS
22.40QnexaObstructive sleep apneaPhase 2Completed08/08/2010
XNPT
5.83Arbaclofen placarbilSpasticity in multiple sclerosis (MS)Phase 3Initiated under SPA, topline data due near end of 201202/15/2012
XNPT
5.83Arbaclofen placarbilGERDPhase 2bFAIL - endpoints not met Mar 201103/22/2011
XNPT
5.83HorizantRestless LegsApprovedFDA Approved Apr 6 201104/07/2011
XNPT
5.83HorizantPostherpetic NeuralgiaPDUFAPDUFA June 9 201211/05/2011
XNPT
5.83XP21279Parkinson's DiseasePhase 2bData released Dec 2011, no statistical improvement over Sinemet12/06/2011
XNPT
5.83HorizantMigrainePhase 2bFailed07/07/2010
XOMA
2.37XOMA 052DiabetesPhase 2bData released Mar 22, 2011. Endpoint not met12/22/2011
XOMA
2.37XOMA 052DiabetesPhase 2aPrelim data released Jan '10, full data released 2Q 201106/09/2011
XOMA
2.37XOMA 052 GevokizumabBehcet's uveitisPhase 3Initiate 2Q 201203/15/2012
XOMA
2.37XOMA 052 GevokizumabModerate to Severe Acne VulgarisPhase 2Initiated Phase 2 Dec 2011. Data due 201203/15/2012
XOMA
2.37XOMA 052 GevokizumabCardiovascular diseasePhase 2Initiate Phase 2 during 201204/08/2012
YMI
1.97CYT387MyelofibrosisPhase 2Phase 3 planned 3Q 2012. Final data of Phase 1/2 Core trial due by end 2012. Interim data from Phase 1/2 Extension trial due by end of 2012. Interim data from the BID (twice-daily dosing) Phase 2 trial also due by end of 2012.05/12/2012
YMI
1.97CYT997Cancer - GliomaPhase 1/2Prelim data expected 1H 201109/23/2011
YMI
1.97NimotuzmabCancer - NSCLCPhase 2Discontinued09/18/2011
YMI
1.97NimotuzmabCancer - pancreaticPhase 2b/3Enrolment ongoing09/23/2011
YMI
1.97NimotuzmabCancer - Glioma (adult)Phase 3Phase 3 efficacy data due 2H 201109/23/2011
YMI
1.97NimotuzmabCancer - GastricPhase 2Data released Jan 201101/21/2011
YMI
1.97NimotuzmabDiffuse intrinsic pontine glioma (DIPG)Phase 2Prelim Data released Oct 201110/31/2011
ZGNX
1.79ZX002Moderate to severe painPhase 3NDA filed May 2 201205/04/2012
ZIOP
4.44DarinaparsinCancer - MyelomaPhase 2Complete07/30/2010
ZIOP
4.44IL12 DNACancerPhase 2Initiate Phase 2 2H 201203/01/2012
ZIOP
4.44PalifosfamideCancer - sarcoma Phase 3Data due 2H 201205/04/2012
ZIOP
4.44PalifosfamideCancer - small cell lung SCLCPhase 3Plan to initiate Phase 3 early 3Q 201205/04/2012
ZLCS
0.77SynaviveRheumatoid arthritisPhase 2bInitiated June 2011, enrolment completed Apr 2012, topline data due 3Q 201205/01/2012
ZLCS
0.77Z160Neuropathic painPhase 2Initiate Phase 2 during 2H 201203/08/2012

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.

2 Responses to “Clinical 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!

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