other_material
confidence high
sentiment neutral
materiality 0.65
BioXcel completes enrollment (last patient last visit) in SERENITY At-Home Phase 3 trial for BXCL501
BioXcel Therapeutics, Inc.
- SERENITY At-Home Phase 3 safety trial for BXCL501 120 mcg to treat acute agitation in bipolar/schizophrenia.
- Enrolled >200 patients across 22 sites; no single site >11% of total patients.
- Patient distribution balanced between bipolar disorders and schizophrenia.
- Collected data from >2,200 agitation episodes; topline results expected in August 2025.
- Topline results expected to be announced this month.
item 8.01