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(CHARTPOPPERS.COM, December 08, 2009 ) Point Roberts, WA - Chartpoppers.com announces an investment report featuring company Somaxon Pharmaceuticals Inc. (NASDAQ: SOMX)
Somaxon Pharmaceuticals, Inc. (Somaxon) is a specialty pharmaceutical company focused on the in-licensing and development of product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area.
Recent News on Somaxon Pharmaceuticals Inc. (NASDAQ: SOMX)
Co says FDA has requested for amended REMS
* Co intends to schedule meeting with FDA for guidance
* Shares tank 71.7 pct
Somaxon Pharmaceuticals Inc (SOMX.O) said U.S. health regulators declined to approve its insomnia drug Silenor for the second time this year, sending its shares down 72 percent before the bell.
The company had previously received a complete response letter in February from the U.S. Food and Drug Administration, which raised issues regarding efficacy data.
Somaxon resubmitted the new drug application (NDA) for Silenor in June.
In the most recent complete response letter, the FDA stated that the Silenor NDA did not meet the approval standard for efficacy.
The letter did not raise any clinical safety issues but the FDA has requested the company submit an amended risk evaluation and mitigation strategy (REMS), including a medication guide to be distributed with the product, in any resubmission, the company said.
To view the Consolidated Investment Analysis on Somaxon Pharmaceuticals Inc. (NASDAQ: SOMX) Please visit the stock pulse page at www.chartpoppers.com/stock%20pulse/
In the report chartpoppers.com covers a recent Financial Summary, Analyst Consensus, Technical Analysis, Comparative Analysis and Insider Trading Activity.
The full report is available at www.chartpoppers.com
Chartpoppers.com is a market research and investment commentary provider. Chartpoppers.com aims to bring undervalued, up and coming companies into the sight of both experienced and non-experienced investors. We try to help investors, at whatever stage in their careers, to get a grasp on the necessary financial data that they need in order to make a educated investment decision. From our daily trading ideas to a in depth coverage of whatÂ’s going on in the markets, we are sure that chartpoppers.com is exactly what you need in order succeed.
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Chartpoppers.com Disclosure
DO NOT BASE ANY INVESTMENT DECISION UPON ANY MATERIALS FOUND ON THIS REPORT. We are not registered as a securities broker-dealer or an investment adviser either with the U.S. Securities and Exchange Commission (the "SEC") or with any state securities regulatory authority. We are neither licensed nor qualified to provide investment advice. ChartPoppers.com nor its affiliates have a beneficial interest in the mentioned company; nor have they received compensation of any kind for any of the companies listed in this communication. The information contained in our report is not an offer to buy or sell securities. We distribute opinions, comments and information free of charge exclusively to individuals who wish to receive them.
CHARTPOPPERS.COM
Paul Marek
6047245332
info@chartpoppers.com
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