BioXcel: FDA inspection closed with VAI; SERENITY trial enrolling; Nasdaq compliance regained; CMO resigns

BioXcel Therapeutics, Inc.

FDA closed TRANQUILITY II site inspection with 'Voluntary Action Indicated'; no regulatory action taken.
SERENITY At-Home Phase 3 trial: 23 sites open, enrolling; topline data expected H2 2025 for sNDA.
Regained compliance with Nasdaq minimum bid price rule; notice received Feb 28, 2025.
Vincent J. O'Neill, M.D. resigned as EVP, Chief of Product Development and Medical Officer.

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