Who's up for a big FDA approval decision in the first half?

Few events can move a biotech stock quite like an FDA decision on a new drug app. And given the agency's rep for somewhat unpredictable behavior, there's no such thing as a sure thing. All of which keeps this guessing game an unending delight for the analysts in the field.

TheStreet's veteran biotech analyst Adam Feuerstein offers up a snapshot of 10 public biotech companies facing crucial, looming decisions likely to either fuel their stock price or douse it with a bucket-load of cold water.

He gets the slide show started off with XenoPort's Horizant, noting that the FDA took the drama out of that one with a rejection this morning, as we report this morning. That's followed by MannKind, which is waiting for final word on its inhaled insulin Afrezza; Salix's Xifaxan for hepatic encephalopathy; Shire's closely-watched Velaglucerase for Gaucher's disease; Amylin and Alkermes' diabetes drug Exenatide; InterMune's Pirfenidone for idiopathic pulmonary fibrosis; Somaxon's insomnia drug Silenor; Cell Therapeutics' Pixantrone for non-Hodgkin's lymphoma; Dendreon's Provenge for prostate cancer (they're already building new manufacturing sites); And Pozen's pain drug Vimovo.

Biotech stock picking has always been one of the most dangerous games on Wall Street. And timing a buy around a regulatory event is like jumping a train--one slip can be fatal. But that's what keeps it interesting.

- here's TheStreet's snapshot, including PDUFA dates for each

Related Articles:
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Somaxon tries again with Silenor
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