ALXA issued CRL. SGYP offering. Pipeline updates for OGXI NGSX ANTH ZIOP THLD EXEL DRRX

May 04, 2012 No Comments by

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has received a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for ADASUVE. In its press release the company said the CRL was issued due to medical device deficiencies and plans to meet with the FDA to resolve the issues. Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) […]

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Upcoming PDUFA dates, Adcom meetings and clinical catalysts as of January 12 2012

Jan 12, 2012 No Comments by

Some short and long term potential catalysts as of January 12, 2012 (share prices as at the close of trading Wednesday, January 11, 2012). 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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Weekly Summary of key pharma events – week ended 12/16/11

Dec 17, 2011 No Comments by

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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NGSX Adcom meeting date set. ISIS NDA delay + OREX ARIA CORT STEM news

Dec 15, 2011 No Comments

NeurogesX, Inc. (Nasdaq:NGSX) – The FDA Anesthetic and Analgesic Drug Products Advisory Committee will meet on February 9, 2012 to discuss the available efficacy and safety data for the supplemental new drug application (sNDA) of QUTENZA (capsaicin 8%) Patch, for the proposed indication of management of neuropathic pain (nerve pain) related to HIV-associated peripheral neuropathy (nerve pain in the periphery […]

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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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PATH to resubmit NDA. NGSX March PDUFA date. CADX offering. Updates for DYAX CYCC GERN PCYC

Nov 15, 2011 No Comments

NuPathe Inc. (NASDAQ: PATH) announced that it intends to resubmit its NDA in 1H 2012 for its migraine patch that was issued a CRL in August 2011. NeurogesX, Inc. (Nasdaq:NGSX) announced that the FDA has accepted for review the its supplemental new drug application (sNDA) for Qutenza (capsaicin) 8 percent, for the management of neuropathic […]

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Shelf filed by ARNA and ZIOP. NGSX Phase 2 data. Pipeline updates from ACHN OREX OMER CYTR ASTM LGND HALO ISIS

Nov 08, 2011 No Comments

Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) filed a $50m shelf today. Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) said today it is on track to release interim early virologic response (EVR) results by the end of 2011. Orexigen Therapeutics, Inc. (Nasdaq: OREX) maintained previous guidance that it intends to initiate a cardiovascular outcomes trial (CVOT) in 1H 2012 for its […]

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EXEL to initiate Phase 3 CRPC without SPA + NGSX ARRY NBIX ASTX news

Nov 01, 2011 No Comments

Exelixis, Inc. (NASDAQ:EXEL) announced after hours yesterday that it has decided to initiate its Phase 3 306 trial, its first pivotal trial of cabozantinib in patients with metastatic castration-resistant prostate cancer (CRPC). Pain will be the primary efficacy endpoint for the 306 trial. The company did not reach a timely agreement under a special protocol […]

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RPTP offering. NGSX files sNDA. EXEL data soon + PPHM ALKS

Sep 08, 2011 No Comments

Raptor Pharmaceutical Corp. (Nasdaq:RPTP), today announced the pricing of its previously announced underwritten public offering of 10m shares of its common stock at a price to the public of $4 per share for net proceeds of approximately $37,250,000. NeurogesX, Inc. (Nasdaq:NGSX), today announced it submitted a supplemental new drug application (sNDA) to the FDA seeking […]

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IPO for Horizon Pharma HZNP next week + NEOP NGSX MYRX news

Jul 22, 2011 No Comments

NeurogesX, Inc. (Nasdaq: NGSX), annuounced a private placement of approximately $20m in gross proceeds from the sale of 11,749,552 shares of its common stock and the issuance of five-year warrants to purchase 5,874,782 additional shares of NGSX common stock at an exercise price of $1.65 per share. The purchase price per unit of shares and […]

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SGEN Adcom July 14. AEGR PCYC offerings + ANX ASTM CTIC NGSX news

Jun 17, 2011 No Comments

ADVENTRX Pharmaceuticals, Inc (AMEX: ANX) shareholders yesterday approved the issuance of up to 13,478,050 shares pursuant to merger agreement with SynthRx, Inc. Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR) announced that it has filed a registration statement relating to the underwritten public offering of 3,250,000 shares of its common stock and 1,000,000 shares of its common stock by […]

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