Trouble With Somaxon (SOMX)
Somaxon Pharmaceuticals (SOMX) collapsed today, with shares down over two-thirds. It will be interesting to see if the company can recover from a major blow to its prospects.
The company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Silenor (doxepin) for the treatment of insomnia. Based on its review, the FDA has determined that the NDA cannot be approved in its present form. Somaxon previously received a Complete Response Letter for the NDA in February 2009, and it resubmitted the NDA in June 2009.
In the most recent Complete Response Letter, the FDA stated that the Silenor NDA did not meet the approval standard for efficacy due to a lack of robustness of sustained subjective sleep maintenance efficacy in adults with primary insomnia.
For the third quarter of 2009, net loss applicable to common stockholders was $1.8 million, or $0.08 per share, compared with $10.3 million, or $0.56 per share, for the third quarter of 2008. The company had no revenue and had only $5.4 million in revenue at the end of the quarter.
The firm’s share price is down to $1.80 and its market cap down to $31 million.
Douglas A. McIntyre
