Ambit Biosciences Falls on Slower Path for Drug

NEW YORK, Dec. 4, 2013 (AP) — Shares of Ambit Biosciences tumbled Wednesday after the company said it won't file for accelerated approval of its leukemia drug quizartinib, and will run a late-stage clinical trial instead.

The company has been meeting with the Food and Drug Administration to discuss quizartinib, a potential treatment for acute myeloid leukemia. The company said it will proceed with a late-stage trial of the drug that measures the overall survival of patients. Ambit wanted to file for accelerated approval based on a different measurement taken from studies it has already completed, but the FDA told Ambit that the measurement was not clinically meaningful.

Ambit Biosciences Inc. shares sank $4.43, or 34.6 percent, to $8.37 in morning trading. The company went public in May at $8 per share. It has traded between $6.22 and $21.44 since its initial public offering.

The San Diego company does not have any approved drugs, and quizartinib is its most advanced experimental product.

Ambit is conducting mid-stage trials of quizartinib as a treatment for acute myeloid leukemia that has recurred or not responded to other therapies. It is also studying the drug as part of a chemotherapy regimen and as a maintenance regimen following stem cell therapy.

Posted: December 2013

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