BPAX FDA Approval. SNTS NDA accepted. XNPT VNDA pipeline updates. ALNY prices offering
BioSante Pharmaceuticals Inc. (NASDAQ: BPAX) - The FDA said today that it approved Bio-T-Gel, a once-daily transdermal testosterone gel in development for the treatment of male hypogonadism, or low testosterone levels.
Santarus, Inc. (NASDAQ: SNTS) today announced the FDA has accepted for filing its New Drug Application (NDA) for UCERIS for the induction of remission of mild to moderate active ulcerative colitis. It expects the FDA will complete its review or otherwise respond to the UCERIS NDA by mid-October, 2012.
XenoPort, Inc.(Nasdaq:XNPT) gave a pipeline update noting that it expects top-line results from its Phase 3 safety and efficacy trial of Arbaclofen placarbil in multiple sclerosis patients near the end of 2012.
Vanda Pharmaceuticals Inc.(Vanda) (NASDAQ: VNDA) also gave a pipeline update as it released results for the latest quarter. It noted that it intends to submit a New Drug Application (NDA) mid-2013 for Tasimelteon in patients with insomnia, with its two Phase 3 trials due to be completed by the end of 2012. It also mentioned that it is due to release data from its Phase 2b/3 trial for Major Depressive Disorder (MDD) during 1H 2013. The company also noted that it has been given until mid-May 2012 to respond to the 120-day list of questions provided by the European Medicines Agency (EMA) in response to its Marketing Authorization Application (MAA) for oral iloperidone tablets in the European Union.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) announced the pricing of its public offering of 7.5m shares of its common stock at a public offering price of $10.75 per share with a 30-day option to issue a further 1.125m shares to cover overallotments.
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- SNTS NDA filing soon. ISTA due 1Q 2012 + DEPO CYTK VICL ALNY:
- Pipeline updates for THLD DRRX BCRX CLDX AVEO VNDA ANTH ZIOP SCMP NKTR
- News from AMRN CLSN SNTS CHTP ALXA CBRX CHTP SGEN HZNP ALNY CXM ZIOP
- Pipeline updates for XNPT GTXI OSIR QLTI NPSP ARIA POZN ITMN SGEN
- VRTX FDA Approval. NPSP NDA accepted. BDSI VTUS shelf filings. MNKD offering
