Vanda Pharma plummets 62% on 'not-approvable' letter from FDA
Vanda Pharmaceuticals Inc. (Nasdaq:VNDA) has plunged 62% today after announcing the U.S. Food and Drug Administration had issued a not approvable letter for Vanda’s drug iloperidone. Iloperidone is an investigation-stage antipsychotic treatment for schizophrenia. The FDA said it needed additional trials, and Vanda must obtain more safety data for patients at a dose range of 20 to 24 milligrams per day. The company said in a statement it plans to meet with the FDA to discuss iloperidone.
Shares of the Rockville, Md.-based company are at $1.28 at 10:47 a.m. ET, down $2.08 from Friday’s close. Trading volume is more than 13 times the average at 13.5 million shares. The stock has ranged between today’s after-the-opening low of $1.20 to a high of $19.62.
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