VRTX issued CRL for KALYDECO + updates for BOTA CEMP DPRX IMMU OGXI SPHS

Feb 05, 2016 No Comments by

Updates to the Company Pipeline Database for February 4 and 5, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary BOTA 1.51 Vapendavir – SPIRITUS trial Human rhinovirus (HRV) Phase 2b Phase 2b top-line data due 2H 2016 BOTA 1.51 BTA074 5% topical gel Condyloma Phase 2 Phase 2 patient […]

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HTBX Phase 2 bladder cancer trial placed on clinical hold + updates for IMMU OXGN

Feb 04, 2016 No Comments by

Updates to the Company Pipeline Database for February 3, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary HTBX 2.02 HS-410 Cancer – bladder cancer Phase 2 Phase 2 initiated Oct 2014. Data due 4Q 2016. Trial placed on partial clinical hold in early February 2016. IMMU 1.72 Clivatuzumab tetraxetan […]

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CANF data due by end of March. IMMU lupus data due 1H + pipeline updates for GWPH BIND IRWD MSTX

Feb 05, 2015 No Comments by

Latest updates to the Company Pipeline Database for February 4, 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Link Text Updated BIND 6.34 BIND-014 Cancer – KRAS mutant Non-small cell lung cancer (NSCLC) Phase 2 Preliminary data due 2H 2015 2/5/2015 BIND 6.34 BIND-014 Cancer – Squamous histology NSCLC […]

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Upcoming data for CUR KBIO NKTR. AVNR approval delay likely. DVAX reverse split + AEZS RMTI GNCA HRTX IMMU TLOG OPK DSCO ANAC IMMU HPTX SPPI RPTP CMRX VSAR

Nov 08, 2014 No Comments

Neuralstem, Inc. (NYSE MKT: CUR) announced that the Phase 2 data lock of NSI-566 spinal cord-derived stem cell therapy for the treatment of amyotrophic lateral sclerosis (ALS) is scheduled to conclude in late January 2015 at which time the company anticipates providing its Phase 2 ALS results. The company also noted that a Phase 2 trial of NSI-189 for […]

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ECYT Phase 3 trial halted + pipeline updates for ACOR MACK TRVN ITMN NBY VTL

May 04, 2014 No Comments

Merck (NYSE:MRK) and Endocyte, Inc. (NASDAQ:ECYT) announced that the Data Safety Monitoring Board (DSMB) of the PROCEED trial has recommended that the trial be stopped because vintafolide did not demonstrate efficacy on the pre-specified outcome of Progression-Free Survival (PFS) in patients with platinum-resistant ovarian cancer. Acorda Therapeutics, Inc. (Nasdaq:ACOR) announced that the FDA has issued […]

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ICPT wows the biotech world. ITMN Ph3 data due early 2Q. IMMU initiates Ph3 pancreatic trial + SNTA AEGR BOTA XLRN news

Jan 10, 2014 No Comments

Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT $257.87) announced that the Phase 2 FLINT trial of obeticholic acid (OCA) for the treatment of nonalcoholic steatohepatitis (NASH) has been stopped early for efficacy based on a planned interim analysis showing that the primary endpoint of the trial has been met. They also noted that data from their Phase 3 POISE trial of obeticholic […]

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CPRX receives Breakthrough Designation. RIGL fails Phase 2 trial. OREX NDA due end of 2013 + updates for SGMO QRXPY OGXI ONXX AMGN IMMU

Aug 28, 2013 No Comments

Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX $2.01)  announced that Firdapse, currently in Phase 3 development, has received “Breakthrough Therapy Designation” by the FDA for the treatment of patients with Lambert-Eaton Myasthenic Syndrome (LEMS). Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL $3.11) announced that R343, for patients with allergic asthma, did not meet the primary or secondary endpoints in a Phase 2 […]

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Pipeline updates for YMI OREX IMMU BDSI FOLD

May 11, 2012 No Comments

YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM) provided an update today on CYT387 for the treatment of myelofibrosis. It intends to initiate its Phase 3 trial during 2H 2012. By the end of 2012 both final data from its Phase 1/2 Core trial and interim data from the Phase 1/2 Extension trial are expected to be reported. Interim […]

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NBIX VICL EXEL IMMU CRIS pipeline updates + numerous companies raising cash

Feb 09, 2012 No Comments

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) gave a pipeline update today noting that it expects to initiate its Phase 3 trial of elagolix for endometriosis during 1H 2012. It also expects data from its second Phase 2 trial of NBI-98854 in tardive dyskinesia patients during March 2012. A larger Phase 2b program is planned to be initiated during 2012. Topline data […]

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ALXA panel vote.YMI CYT387 data + PCYC CYTR IMMU GERN NKTR OPTR news

Dec 12, 2011 No Comments

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) appeared before the Psychopharmacologic Drugs Advisory Committee (PDAC) today where the committee was divided on whether Adasuve should be approved as a single dose when used with FDA proposed REMS, with 9 votes FOR, 8 votes AGAINST and one abstention. It had earlier voted that Adasuve had been shown to be effective […]

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VVUS PDUFA announced. MELA approval + INHX MDVN IMMU AVNR LGND RGRX

Nov 05, 2011 No Comments

Inhibitex, Inc. (NASDAQ:INHX) today reported top-line safety and antiviral data from the first cohort of its ongoing clinical trial of INX-189, for HCV. In this study, 200 mg INX-189, dosed once-daily for seven days, continued to demonstrate potent and dose-dependent antiviral activity with a median HCV RNA reduction from baseline of -4.25 log10 IU-mL. Further, […]

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