Clinical trial updates for ALKS CYTX RGLS VTVT

Jan 24, 2016 No Comments

Updates to the Company Pipeline Database for January 21-22, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ALKS 36.16 ALKS 5461 Major depressive disorder Phase 2 Phase 3 data from first two trials did not meet their endpoints. Update to be provided later in 1Q 2016 on the projected […]

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SRPT Adcom Meeting postponed. OGXI trial failure and updates for CBAY, AUPH

Jan 21, 2016 No Comments

Updates to the Company Pipeline Database from January 20, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts:   Ticker Price Drug Indication Stage Summary AUPH 1.86 Voclosporin Lupus Phase 2b Enrolment completed January 2015. Data due 3Q 2016 CBAY 1.00 Arhalofenate Gout Phase 3 Phase 3 planned for 2016 OGXI 0.76 Apatorsen and carboplatin and […]

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Database updates for ACOR ACRS AEZS CTIX CYTX DCTH EYEG INCY SYN TGTX TRVN ZGNX

Jan 20, 2016 No Comments

Updates to the Company Pipeline Database from January 19, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ACOR 37.55 Tozadenant Parkinson’s disease Phase 3 Announced January 2016 that it entered into an agreement to acquire Biotie Therapies Corp which is currently in Phase 3 development of Tozadenant for Parkinson’s […]

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SRPT down by over half following release of briefing documents. HRTX PDUFA delay. EBIO trial failure

Jan 16, 2016 No Comments

All updates to the Company Pipeline Database from January 15, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: EBIO Loading… Isunakinra (EBI-005) Moderate to severe allergic conjunctivitis Phase 3 Phase 2 primary endpoint not met October 2014. Phase 3 data released January 2016, endpoint not met HRTX 22.71 APF530 – Sustol Prevention of acute- and […]

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BMRN issued CRL for drisapersen. ADMP PDUFA date set. GERN KPTI initiate trials.

Jan 15, 2016 No Comments

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced on Thursday that the FDA issued a Complete Response Letter for Kyndrisa (drisapersen) for the treatment of Duchenne muscular dystrophy (Duchenne) amenable to exon 51 skipping. Investors now eagerly await the Peripheral and Central Nervous System Drugs Advisory Committee meeting on January 22, 2016 that will review the NDA for eteplirsen by Sarepta Therapeutics, Inc. (NASDAQ:SRPT). […]

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AEZS and GALE give pipeline updates. GTXI and ESPR initiate Phase 2 and 3 trials

Jan 14, 2016 No Comments

Updates to the Company Pipeline Database from January 13, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: AEZS 2.77 Zoptrex Cancer – castration- and taxane-resistant prostate cancer Phase 3 Phase 3 trial to be completed 2H 2016 ESPR 14.11 Bempedoic acid (ETC-1002-040) Hyperlipidemia whose LDL-C is not adequately controlled with low- and moderate-dose statins Phase […]

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TTNP wins positive Advisory Committee vote for Probuphine + updates for ABIO PVCT ESPR IONS

Jan 13, 2016 No Comments

Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the FDA voted 12 to 5 in favor of approving Probuphine, for the maintenance treatment of opioid addiction. Previously, the FDA issued a Complete Response Letter (CRL) in April 2013. The company resubmitted their New Drug Application (NDA) in August 2015 and their PDUFA date […]

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65 pipeline updates predominantly from companies attending the JP Morgan Healthcare Conference

Jan 12, 2016 No Comments

Pipeline updates galore as companies give latest guidance at the JP Morgan Healthcare Conference. Click HERE to register for meeting information and webcasts. Latest updates to the Company Pipeline Database from January 11, 2016. Refer to the FDA Calendar for upcoming catalysts: ACOR 39.98 Dalfampridine Post stroke deficits Phase 2b/3 Phase 3 interim data due 2016 ACOR 39.98 CVT-301 […]

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Pipeline updates from VRTX IMGN ABUS

Jan 10, 2016 No Comments

Latest updates to the Company Pipeline Database from January 10, 2016. Refer to the FDA Calendar for upcoming catalysts: ABUS 4.02 ARB-1467 (TKM-HBV, RNAi) Hepatitis B virus infection (HBV) Phase 2 Phase 2 initiated December 2015.HBsAg reduction results from single dose due 3Q 2016, multiple dose data due 4Q 2016 ABUS 4.02 TKM-PLK1 Hepatocellular carcinoma (HCC) Phase 2 Phase […]

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