RTTNews | Dec 1, 2021 08:03AM EST

08:03 Wednesday, December 1, 2021 (RTTNews.com) - BioXcel Therapeutics, Inc. (BTAI) said the FDA has extended the PDUFA date for its review of the New Drug Application of BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II. The company responded to the information request by FDA pertaining to analyses of clinical data, and was informed the application would require additional time for review.

The company and the FDA met on November 30. The FDA extended the previously disclosed PDUFA date of January 5, 2022 to April 5, 2022.

Shares of BioXcel Therapeutics were down 17% in pre-market trade on Wednesday.

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