BioXcel’s Stock Plummets 24.43% on 310.96% Volume Surge, Ranks 488th in Market Activity Following Positive Phase 3 Trial Results for BXCL501

On August 27, 2025, BioXcel Therapeutics (BTAI) fell 24.43% with a trading volume of $0.19 billion, surging 310.96% from the previous day, ranking 488th in market activity. The stock’s sharp decline followed the release of pivotal Phase 3 trial results for BXCL501, its lead asset for treating agitation in bipolar disorder and schizophrenia. The SERENITY At-Home trial demonstrated the drug’s safety for outpatient use, meeting its primary endpoint of tolerability in home settings. The company plans to submit a supplemental New Drug Application (sNDA) in Q1 2026 to expand IGALMI’s label for at-home administration, a move that could address a $57–77 million annual episode market previously constrained by lack of approved therapies.

The trial, involving 246 patients, recorded 2,628 agitation episodes, with 81% completing the 12-week study. Adverse events aligned with IGALMI’s existing label, with no serious drug-related adverse events reported. Early efficacy data suggested consistent benefits with repeated dosing, though full analyses remain pending. BioXcel’s CEO emphasized the potential to transform treatment paradigms, noting the unmet need for rapid, at-home solutions. Analysts highlight the trial’s alignment with FDA feedback and the absence of competing therapies, positioning BXCL501 as a first-of-its-kind option in outpatient care.

Backtest results indicate the stock closed at a 24.43% loss on the day, with trading volume surging 310.96% compared to the prior session.