An Extreme FDA Trade that Paid: Vanda Pharma (NASDAQ:VNDA)
LOS ANGELES - May 07, 2009 - Shares of Vanda Pharma (NASDAQ:VNDA) soared by nearly nine-fold in after-hours trading Wednesday evening as Fanapt (iloperidone) was approved by the FDA for the acute treatment of adult patients with schizophrenia. The approval was supported by two placebo-controlled Phase 3 clinical studies comparing Fanapt to placebo and active control in patients with schizophrenia, as well as safety data in more than 3,000 patients.
Vanda was one of twelve companies which were profiled by BiomedReports in a special report about “Extreme FDA trades.” The report highlighted companies with market caps below $200M which have pending new drug product decisions at the FDA. Those companies are expected to have a major impact on each of the underlying stock prices as the PDUFA decision dates approach and the decision is ultimately announced.
Hemispherx Biopharma (AMEX:HEB) is another profiled company. Their Ampligen (Poly I: Poly C12U) New Drug Application was originally delayed, but the drug has an Orphan Drug Status with a PDUFA decision date later this month (5/25/09).
Ampligen is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments). During the last few days, share prices have been climbing steadily in anticipation of that upcoming FDA decision.
Acusphere (OTC:ACUS) is a small cap with an FDA decision expected at the end of the month. The company amended their New Drug application for Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension as a cardiac imaging agent for the detection of coronary artery disease.
The amended indication would be limited to subsets of patients undergoing pharmacologic stress techniques compared to original request for more widespread use.
Share prices for Acusphere were trading for $.75 a share in December before falling to as low as $.02 in mid March. At the end of Wednesday’s session, the price per share stood at $.06. The company is expecting a PDUFA (Prescription Drug User Fee Act III) decision date at the end of this month (5/31/09).
A full special report detailing the FDA decision dates for several other companies including BioDelivery Sciences (NASDAQ:BDSI) appears today at:
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