Somaxon Awaiting FDA Decision

Somaxon Pharmaceuticals (SOMX) is a specialty pharmaceutical company focused on the development and in-licensing of product candidates in the fields of psychiatry and neurology. The company is focused on advancing the clinical development of existing product candidates, with a long-term strategy designed to build a portfolio suite by sourcing and in-licensing products where Somaxon believes they can expand upon significant untapped demand.

The company filed the new drug application (NDA) for insomnia drug Silenor in late January 2008. The FDA accepted the application in April 2008. The PDUFA [Prescription Drug User Fee Act] is now set for December 1, 2008. Somaxon is currently in discussion with several interested parties for commercialization of the drug in early 2009. Management is looking for a co-promotion agreement in the U.S. However, we do not believe a deal will be reached until after the FDA's decision.

In the meantime, all investors can do is wait. We expect little in stock price movement over the next few months. We are keeping our rating at Hold, and maintaining our $5 price target. This target may prove entirely too low if Silenor is approved in December 2008.

Read the full analyst report on SOMX

Read the full analyst report on SOMX