BNET Industries

Somaxon Pharmaceuticals Inc.

(SOMX) is in the Pharma Industry

Market Cap:$52.9M
Last Fiscal Year Sales:$1.4M
  • Public
  • US
Dow Jones Description

We are a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area. We submitted our New Drug Application, or NDA, for Silenor ® (doxepin) for the treatment of insomnia to the U.S. Food and Drug Administration, or FDA, on January 31, 2008. The FDA accepted the NDA for filing effective March 31, 2008. Pursuant to Prescription Drug User Fee Act, or PDUFA, guidelines, the FDA was expected to complete its review and provide an action letter with respect to the NDA by December 1, 2008. However, in November 2008, the FDA indicated that its review of the NDA would be extended for up to three additional months, resulting in a new PDUFA date of February 28, 2009. On February 25, 2009, we received a Complete Response Letter from the FDA relating to the NDA. In the Complete Response Letter, the FDA stated that the NDA could not be approved in its then-current form. The FDA raised a number of issues relating to the interpretation of the efficacy data contained in the NDA and indicated that the FDA was open to a discussion of these concerns. The FDA did not request us to conduct additional clinical trials of Silenor. ...

Number of Employees 22
Contact Information

3721 Valley Centre Dr Ste 500

San Diego, California 92130

somaxon.com

1 858 480 0400

NAICS Code Pharmaceutical Preparation Manufacturing: 325412

Recent Events

  • Somaxon Pharmaceuticals Posts 2009 3Q Financial Results

    11/10/09 - Financial Announcement - View Story

  • Biotie Therapies terminates agreement with Somaxon Pharmaceuticals for Nalmefene

    9/25/09 - Joint Venture / Alliance - View Story

  • Somaxon Pharmaceuticals Reports 2009 Second Quarter Financial Results

    8/06/09 - Financial Announcement - View Story

News & Analysis

somaxon pharmaceuticals inc. - All News and Analysis

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     SOMX $2.24 +0.03 (1.36% )
Intraday | 3 Month | 6 Month | 1 Year
Average Volume 403,980
Shares Outstanding 23.64M
Market Cap 53.0M
Year High 4.78
Year Low 0.175
Earnings Per Share -1.18
P/E Ratio -1.90
Dividend N/A
Yield N/A
IndustryTop Rated
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