A big mover to the upside late Wednesday was Transcept Pharmaceuticals (TSPT), whose stock soared after the company announced a plan to resubmit the new drug application for its proposed insomnia drug Intermezzo by the end of the month.
The shares jumped 13.8% to $3.80 on extended-session volume of almost 280,000.
Transcept is seeking approval for the tablet "for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep." The plan to resubmit the application follows the company meeting with the FDA and reaching a general agreement with the regulator to reduce the recommended dosage for women to 1.75 milligrams from 3.5 milligrams, while leaving the 3.5 milligram dosage in place for men.The company added that, based on its discussions with the FDA, it doesn't expect to conduct additional clinical studies of Intermezzo prior to resubmitting the new drug application. It also proposes to include additional instructions on safe usage of the drug. Another stock in action after the close included Ascena Retail Group (ASNA), whose stock lost 8% to $25.96 on volume of more than 30,000 after the Suffern, N.Y.-based company's fiscal fourth-quarter earnings came in a penny short of analyst expectations. --Written by Michael Baron in New York.
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