By Colin Kellaher

BioXcel Therapeutics Inc. on Wednesday said the U.S. Food and Drug Administration extended its review of the proposed antipsychotic BXCL501 by three months after the clinical-stage biopharmaceutical company provided additional information requested by the agency.

The New Haven, Conn., company, which is seeking approval of BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II, said the delay comes after it responded to the FDA's information request pertaining to analyses of clinical data.

BioXcel said the FDA recently informed the company that it needs more time to review the application and extended the target action date to April 5, 2022, from Jan. 5.

BioXcel said it met with the FDA on Tuesday, and that the agency hasn't requested any additional data.

Shares of BioXcel, which closed Tuesday at $22.93, fell 13% in light premarket trading Wednesday.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

December 01, 2021 07:46 ET (12:46 GMT)

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