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BioXcel Therapeutics Announces SERENITY At-Home Pivotal Phase 3 Safety Trial Met its Primary Endpoint in Support of sNDA Submission for Label Expansion of IGALMI®
GlobeNewswire News Room· 2025-08-27 11:00
BXCL501 achieved SERENITY At-Home’s primary endpoint of being well tolerated in the at-home treatment of agitation episodes in patients with bipolar disorders or schizophrenia No discontinuations for tolerability in the BXCL501 arm While not the primary objective of the SERENITY At-Home trial, the preliminary results demonstrate continued effects and consistent benefit with repeat dosing across the course of the trial Following previously disclosed positive FDA feedback, BioXcel plans to submit a sNDA in Q1 ...