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Somaxon Pharmaceuticals (Nasdaq: SOMX) $2.66, Up $1.33. Today announced an update on the status of its New Drug Application (NDA) for Silenor (doxepin) for the treatment of insomnia.
Somaxon held a meeting with senior leadership 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. The only remaining efficacy issue was related to the robustness of sustained subjective sleep maintenance efficacy in non-elderly adults with primary insomnia. In the meeting, the FDA and the company discussed this issue, and the agency instructed Somaxon to resubmit the contents of its January 20, 2010 pre-meeting briefing package to the FDA. The agency acknowledged that this resubmission would be considered a complete response to the Complete Response Letter Somaxon received in December. The FDA also agreed that this would be considered a Class 1 resubmission with a two-month review cycle. 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. As a result, the company anticipates a decision from the FDA by March 21, 2010.
What They Do: Somaxon Pharmaceuticals, Inc. is a 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.
Lodgian, Inc. (NYSE: LGN) Trading at $2.46, Up $0.68. Today announced it has entered into a definitive agreement to be acquired by an affiliate of Lone Star Funds ("Lone Star"), in a transaction valued at approximately $270 million, including assumed debt.
Under the terms of the agreement, Lone Star will acquire all of the outstanding common stock of Lodgian for $2.50 per share in an all-cash transaction. The price represents a premium of approximately 67.2 percent over Lodgian's average closing share price during the trading period of one calendar month prior to January 15, 2010 and 64.3 percent over Lodgian's average closing share price during the trading period of six calendar months prior to January 15, 2010.
What They Do: Lodgian is one of the nation's largest independent hotel owners and operators. The company currently owns and manages a portfolio of 34 hotels with 6,401 rooms located in 20 states. Of the company's 34-hotel portfolio, 16 are InterContinental Hotels Group brands (Crowne Plaza, Holiday Inn, and Holiday Inn Express), 12 are Marriott brands (Marriott, Courtyard by Marriott, SpringHill Suites by Marriott, Residence Inn by Marriott and Fairfield Inn by Marriott), two are Hilton brands, and four are affiliated with other nationally recognized franchisors including Starwood, Wyndham and Carlson.
GenVec, Inc. (Nasdaq: GNVC) Trading at $2.91, Up $0.52, Today announced 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.
What They Do: GenVec, Inc. is a biopharmaceutical company developing novel therapeutic drugs and vaccines. GenVec's lead product, TNFerade™, is currently in a pivotal clinical study (PACT) in locally advanced pancreatic cancer.
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