HPTX SLXP PDUFA dates delayed. ACAD Phase 3 data due November. RPRX ARRY ZLCS TGTX NPSP RIGL OREX AVNR BPAX SRPT MNOV news

Sep 06, 2012 No Comments by

Hyperion Therapeutics, Inc. (Nasdaq:HPTX) announced that the PDUFA date for Ravicti (glycerol phenylbutyrate) has been extended by three months to January 23, 2013 following the submission of additional information by the company. ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD)  announced the completion of enrollment in its pivotal Phase 3 trial with pimavanserin in patients with Parkinson’s disease psychosis (PDP). Top-line […]

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BPAX closes offering. PCYC $50m milestone. RGLS pending IPO. ANTH to vote to raise authorized shares

Aug 20, 2012 No Comments by

BioPharmCatalyst is back with daily updates. BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced the closing of the sale of 2,359,932 shares of its common stock and warrants to purchase up to 1,179,966 additional shares for net proceeds of approximately $3.3 million. Pharmacyclics, Inc. (Nasdaq: PCYC) announced that the clinical trial, SPARK (MCL2001), of ibrutinib in patients with relapsed […]

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BIOD reverse split. ZIOP initiates Phase 3 SCLC trial. BPAX plans further LibiGel trials + AVNR PLX news

Jun 12, 2012 No Comments by

Biodel Inc. (Nasdaq:BIOD) announced that it will effect a one-for-four reverse split prior to the start of trading on June 12, 2012. The number of authorized shares of common stock will be adjusted to 25m. ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) announced that has initiated its Phase 3 MATISSE study (Multicenter Adaptive Trial Investigating Small cell lung cancer Survival Endpoints), of palifosfamide for the […]

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BPAX reverse split. AVII proposes name change. MRNA winding down operations + ONTY news

Jun 01, 2012 No Comments

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced it will effect a 1-for-6 reverse split of its common stock on Monday, June 4, 2012. The reverse stock split will reduce the number of shares outstanding from approximately 120.8m to approximately 20.1m shares. The number of authorized shares will remain unchanged. The company had until July 30, 2012 to push […]

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BPAX FDA Approval. SNTS NDA accepted. XNPT VNDA pipeline updates. ALNY prices offering

Feb 15, 2012 No Comments

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 […]

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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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Weekly Summary of key pharma events – week ended 12/16/11

Dec 17, 2011 No Comments

See individual posts made in the last week for more detail. PDUFA/FDA RELATED EVENTS NeurogesX, Inc. (Nasdaq:NGSX) will meet with the FDA Anesthetic and Analgesic Drug Products Advisory Committee on February 9, 2012 to discuss the available efficacy and safety data for sNDA of QUTENZA for the management of neuropathic pain related to HIV-associated peripheral neuropathy. Isis Pharmaceuticals, […]

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BPAX trial failure. ARIA & OREX to raise cash. CERS shelf + ANTH news

Dec 14, 2011 No Comments

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) said today that it failed its two pivotal Phase 3 LibiGel efficacy trials and did not meet the co-primary or secondary endpoints. In the first trial, called BLOOM-1, patients who received LibiGel showed an increase of 1.47 days with a satisfying sexual event compared with 1.26 days for those who received the […]

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BioSante Pharmaceuticals, Inc -BPAX – chart updated

Dec 12, 2011 No Comments

Chart by @VexTrades – EDIT 12/15/11 – This chart is of little significance since following the posting BPAX released data showing it had failed its Phase 3 efficacy trials.   Upcoming Events Phase 3 efficacy data of Libigel for Female sexual dysfunction due 4Q 2011. Stock does tend to sell off following the release of data so trade wisely! […]

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Upcoming Catalysts as of December 9 2011

Dec 11, 2011 No Comments

Some short and long term potential catalysts as of December 9 2011 (share prices as at the close of trading Friday, December 9, 2011). See the links in the FDA Calendar for more details about each catalyst. The possible catalysts listed below represent both short and long opportunities. It is NOT a recommendation to take […]

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Chart – BioSante Pharmaceuticals, Inc – (BPAX)

Dec 04, 2011 No Comments

By @VexTrades – Upcoming Events Phase 3 efficacy data of Libigel for Female sexual dysfunction due 4Q 2011. Safety data due 3Q 2012 and NDA filing due 4Q 2012. PDUFA 2/14/12 of Bio-T-Gel for male hypogonadism partnered with TEVA. Click on chart to enlarge, then click on “expand” icon at top right for a clearer […]

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