|RxNews Recap for Friday 01-22-10. Somaxon (Nasdaq:SOMX), Poniard (Nasdaq:PARD) and GenVec (Nasdaq:GNVC) up sharply. Late day rumors launch IR Biosciences (OTC:IRBS)|
|By Mary Davila|
|Friday, 22 January 2010 18:49|
Below is a list of the companies that made news in the healthcare sector on Friday, January 22, 2010.
Shares of IR Biosciences (OTC BB: IRBS) rose dramatically late Friday afternoon on speculation that the company will be announcing either a partnership or that they have been awarded one of the multi-million dollar grant submissions which have been made to the NIH and BARDA (Biomedical Advanced Research and Development Authority) , as well as to the Armed Forces Institute of Pathology and Walter Reed Army Medical Center through their Combat Wound Initiative Program. According to a recent press release, NIH-funded studies in areas related to Idiopathic Pulmonary Fibrosis, where the Company has filed its first IND (Investigational New Drug application) with the U.S. Food and Drug Administration (FDA), are being pursued at the University of Rochester. Successful research studies have garnered the interest of potential partners, among them the world-renowned peptide manufacturer Bachem Inc. Shares rallied 55% on the day.
Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), saw its shares rocket over 80% as the specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today provided an update on the status of its New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia.
Somaxon met with senior leaders at the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the issues raised by the FDA in the Complete Response Letter Somaxon received in December 2009 relating to the Silenor NDA. No additional safety or efficacy data was required to be included in the resubmission, and the company filed the resubmission with the FDA on January 21, 2010. The company anticipates a decision from the FDA by March 21, 2010.
“We believe that the dialogue we had with the FDA was constructive,” said Richard W. Pascoe, Somaxon’s president and chief executive officer. “We intend to continue to work diligently with the FDA during the two-month review cycle toward a potential approval for Silenor.”
GenVec, Inc. (Nasdaq: GNVC) announced today that data from the Company's trial in esophageal cancer were presented at the American Society of Clinical Oncology's 2010 Gastrointestinal Cancer Symposium in Orlando, Florida on January 22, 2010.
The poster, titled, "Long term survival analysis of multicenter clinical trial using endoscopy (END) and endoscopic ultrasound (EUS) guided fine needle injection (FNI) of antitumor agent (TNFerade Biologic (TNF)) in patients with locally advanced esophageal cancer," reports on updated efficacy and survival data. In the 24 patients receiving TNFerade in combination with chemoradiation, the median survival was 47.7 months. Median survival from other historical clinical trials in similar stage disease ranged from 9.7 to 34 months.
Research presented in the poster received a prestigious ASCO Foundation Merit Award. In addition, the poster received focused attention at the oral review session on esophageal cancer on January 22, 2010.
"This symposium brings together the greatest thought leaders in this area of oncology and we are pleased to be presenting this analysis at this event," stated Mark Thornton, Ph.D., GenVec's Senior Vice President of Product Development. "The encouraging increases in survival versus historical controls will warrant additional evaluation."
Shares of GenVec,which have been rising over the last few trading session, shot up 25% on the news and continued to rally in after-hours trading.
Other news makers on Friday:
Access Pharmaceuticals, Inc. (OTC Bulletin Board: ACCP), today announced that it has entered into definitive agreements with accredited investors to sell in a registered direct offering an aggregate of 2.10 million shares of its common stock at a price of $3.00 per share for aggregate gross proceeds of $6.3 million.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) late Friday announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for AMPYRA™ (dalfampridine), an oral treatment to improve walking in patients with multiple sclerosis (MS).
Shares of Acorda closed up nearly 10% on the day.
Biovail Corporation (NYSE/TSX: BVF) today commented on a proposed clinical trial recently announced by Teva Pharmaceutical Industries Ltd. According to Teva, the trial it intended to address reports of inefficacy and adverse events by consumers who switched from Wellbutrin XL® 300 mg, Biovail’s FDA-approved brand of the antidepressant, bupropion hydrochloride, to Budeprion XL, Teva’s generic formulation of the drug.
Sanomedics International Holdings (Pink Sheets:SIMH) announced a significant donation to Haiti earthquake relief efforts today, consisting of over $35,000 worth of the company’s Non-Contact Infrared Thermometers.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.