Vanda Pharmaceuticals, Inc. (VNDA)

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Vanda shares rise on plans for FDA response
Thursday September 11, 7:08 pm ET
Vanda Pharma rises as company plans response to FDA rejection letter on schizophrenia drug

NEW YORK (AP) -- Shares of Vanda Pharmaceuticals Inc. ticked higher Thursday after the company said it plans to send the Food and Drug Administration a response to the rejection of its experimental schizophrenia drug iloperidone.

The stock gained 4 cents, or 3.9 percent, to end at $1.07. Shares have traded between 76 cents and $19.40 over the last 52 weeks, and are off 84 percent since January.

Shares lost most of their value in July after the FDA rejected the drug candidate, saying it was similar to drugs already on the market, including Pfizer Inc.'s ziprasidone. The agency recommended Vanda conduct additional studies that compared the drug candidate with current treatments such as Johnson & Johnson's Risperdal or Eli Lilly & Co.'s Zyprexa, instead of with just placebo. Also, additional safety data would be needed to consider another application.

Vanda said it met with the FDA on Wednesday to discuss the rejection and has agreed to send the agency a complete response in order to address concerns over the drug candidate.