Update: Small Cap Biotech Important FDA/ Action Dates for October

Here are the biotech ticker action dates for October, enjoy and now go play!

Oct. 8th

The FDA accepted Spectrum Pharma’s (biotech ticker: SPPI)supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for injection on 3/26/09 in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The user fee goal (PDUFA) date for the sNDA is October 8 2009.

Oct. 13
Presentation at the American Neurological Association meeting of detailed data from the phase III study of Avanir Pharmaceuticals’ (biotech ticker: AVNR) Zenvia, an experimental drug for the treatment of uncontrollable laughing and crying episodes — a condition known medically as pseudobulbar affect.

Oct. 14
The FDA’s Peripheral and Central Nervous System Drug Advisory Committee will convene to review Acorda Therapeutics’ (biotech ticker: ACOR) fampridine (brand name Amaya). The proposed indication for Amaya is to improve the walking ability of patients with multiple sclerosis.

Oct 22

Acorda Therapeutics, Inc. (ACOR). The U.S. Food and Drug Administration (FDA) is currently reviewing a New Drug Application (NDA) for Fampridine-SR. The NDA was assigned Priority Review and a Prescription Drug User Fee Act (PDUFA) date of October 22, 2009.

Oct. 24-28
The Obesity Society annual meeting convenes in Washington, D.C. Detailed data from phase III studies of three closely watched weight-loss drugs will be presented at the meeting: Arena Pharmaceuticals’ (biotech ticker: ARNA) lorcaserin, Vivus (biotech ticker: VVUS) Qnexa and Orexigen Therapeutics’ (biotech ticker: OREX) Contrave

Oct. 30
FDA approval decision date for GTXI Inc. (biotech ticker: GTXI) Acapodene for the reduction of bone fractures in prostate cancer patients undergoing androgen deprivation therapy.
FDA approval decision date for Transcept Pharmaceuticals’ (biotech ticker: TSPT) Intermezzo for insomnia.

Tagged with: Biotech Ticker Clinical Trials, FDA Approval, GTXI, TSPT, ARNA, VVUS, SPPI, AVNR, ACOR, OREX,