BioXcel Therapeutics Stock Surges 105% On Positive FDA Update

(RTTNews) - BioXcel Therapeutics, Inc. (BTAI) is up 156.94 percent, rising $3.39 to trade at $4.44 during Monday's trading after the company announced that the FDA has closed its inspection of a site involved in the TRANQUILITY II Phase 3 trial and issued an Establishment Inspection Report with a Voluntary Action Indicated designation.

The stock opened at $2.37 and has traded between $2.37 and $6.82 today. Volume has soared to 120.23 million shares, significantly above its average of 1.91 million. BioXcel's 52-week range is $1.72 to $52.80.

This report, combined with positive findings from an independent audit in October 2023, further supports the integrity of the trial data and the clinical evidence expected for a potential supplemental New Drug Application.

BioXcel also received FDA feedback on the protocol for its TRANQUILITY In-care Phase 3 trial and plans to advance the program with its lead asset, BXCL50.