BioXcel Therapeutics' BXCL501 Phase 3 Trial Success Supports Suggested Label Expansion for IGALMI in 2026

BioXcel Therapeutics announced its SERENITY Phase 3 trial for BXCL501 met its primary endpoint, demonstrating safety and tolerability for treating agitation in bipolar disorder and schizophrenia patients at home. This successful trial supports the planned sNDA submission for IGALMI label expansion in early 2026, potentially addressing a significant unmet need in the at-home treatment market. The company's stock is rated Underperform by TipRanks' AI Analyst, Spark, due to substantial financial instability, including ongoing losses, high debt, and negative cash flows.

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced today that its SERENITY At-Home Pivotal Phase 3 trial evaluating the safety of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia has met its primary endpoint. The trial, which evaluated the use of BXCL501 in an at-home setting, demonstrated that the 120 mcg dose of BXCL501 was well-tolerated and met the primary objective of being safe for patients with episodes of agitation [1].

The SERENITY At-Home trial involved over 2,600 episodes of agitation, with no discontinuations due to tolerability in the BXCL501 group. The trial's success underscores the potential to address a significant unmet medical need, as there are currently no FDA-approved therapies for at-home agitation treatment [2].

Following the positive results, BioXcel plans to submit a supplemental New Drug Application (sNDA) in Q1 2026 to expand BXCL501's use to outpatient settings. The company aims to provide patients with access to IGALMI® in the home setting, potentially reducing healthcare costs and improving patient safety [1].

However, the company's stock is rated Underperform by TipRanks' AI Analyst, Spark, due to substantial financial instability, including ongoing losses, high debt, and negative cash flows [3].

References:

[1] https://www.ainvest.com/news/bioxcel-therapeutics-shares-rise-16-03-premarket-topline-results-serenity-home-pivotal-phase-3-trial-2508/
[2] https://www.quiverquant.com/news/BioXcel+Therapeutics+Reports+Successful+Results+from+SERENITY+At-Home+Trial+for+BXCL501+as+At-Home+Treatment+for+Agitation+in+Bipolar+Disorders+and+Schizophrenia
[3] https://www.tipranks.com/analysts/bioxcel-therapeutics-inc-btai