Somaxon’s FDA Hurdle, Again (SOMX)

Posted in pre-market 
December 7th, 2009

Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX) was halted after it received a Complete Response Letter from the FDA for its New Drug Application for Silenor for the treatment of insomnia.  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.  The FDA claimed 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.  At 8:23 AM EST under a share trading halt from NASDAQ we have shares down 5% at $3.35 on 21,000 shares.  The 52-week range is $0.18 to $4.80.

UPDATED AFTER HALT RELEASE: SOMX at 8:47 AM EST is now down a whopping 67% at $1.16 on 1.15 million shares.  Average volume is only 900,000 shares.

JON C. OGG

Comments are closed

-->