Transcept Pharmaceuticals, Inc. Expects FDA to Reject Insomnia Drug

Transcept Pharmaceuticals Inc.'s (TSPT) shares plunged premarket after the biopharmaceutical company said the Food and Drug Administration is rejecting its new drug application for its Intermezzo insomnia treatment in its present form. Shares were down 41% at $5.11 in recent premarket trading. The stock through Tuesday’s close is up 16% this year. The company, which focuses on nervous-system diseases and disorders, expects to receive a complete response letter from the FDA by Thursday. Such letters from the FDA typically indicate further questions or some sort of hurdle before approval can be granted.

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