With an impending FDA deadline on December 4 for action on the NDA for Silenor (low dose doxepin) in sleep maintenance insomnia, Somaxon (SOMX) was up 88%, rivaling its previous highs. It has been a long and bumpy road for the company whose original NDA was rejected in January 2009 after the FDA raised questions about efficacy as well as concerns over cardiac side effects. The resubmission included additional analyses of clinical data for sleep maintenance and results showing no effect on QT interval even at an exaggerated dose of 50 mg. The compound is approved for depression at doses of 75-300 mg. Targacept, our featured company this month continued up on anticipation of a partnering announcement for their adjunct depression treatment (see story, page 12). Titan Pharmaceuticals (TTNP.PK) also continued upwards. Novartis (NVS) is planning to launch the new antipsychotic Fanapt, on which Titan will earn 8-10% royalties, early next year…

Targacept: Nicotinics Right on Target
NeuroInsights first profiled Targacept (TRGT) in November 2006. At that time, the Winston-Salem company had just completed an IPO in April with about 90 employees. Its stock traded at $7.48 a share and its story was centered around age-associated memory impairment (AAMI), Alzheimer's disease (AD), and cognitive impairment associated with schizophrenia (CIAS). In 2007 and 2008, the company went into something of a tailspin when several clinical trials did not go as planned. Specifically, an Alzheimer’s Phase II was declared inconclusive, a CIAS Phase IIb failed to show efficacy, and development of an early stage pain candidate was discontinued due to lack of projected efficacy. The stock traded as low as $1.40 in November last year. But after a new string of positive results, Targacept is riding high again with an 850% gain in stock price over the last 12 months...