The accompanying table [click to enlarge or download] includes an updated calendar of 75 expected FDA decision dates, which includes a full slate of expected action before year-end outline in my previous article. The last few days have been busy for antibiotics at the agency, resulting in sharply lower stock prices for Targanta Therapeutics (TARG) and Theravance (THRX).
An FDA panel voted against Targanta's oritavancin, which has an upcoming decision in early December and sent shares crashing from 8 bucks before the decision to around $1.30 in trading today. Despite the panel endorsement for telavancin, shares of Theravance are losing about 25% today and the Company is still waiting for the FDA to issue a formal PDUFA date.
Vanda Pharma (VNDA) received word yesterday from the FDA that its resubmission for iloperidone was accepted with a decision date expected by 5/6/09. Some other recent filings include Ista Pharma's (ISTA) NDA for eye drop Bepreve and two new filings by Johnson & Johnson (JNJ) for Comfyde and trabectedin.
$55.2135 (11/21/08)
