Shares of BioXcel Therapeutics, Inc. (NASDAQ:BTAI) surged 32% after the U.S. Food and Drug Administration provided positive responses during a pre-sNDA meeting regarding the potential at-home use of BXCL501 for managing agitation in patients with bipolar disorder or schizophrenia.
The company announced that, based on feedback received from the FDA on August 14, 2025, it believes its planned supplemental New Drug Application (sNDA) package will meet regulatory expectations, keeping the submission on track for the first quarter of 2026. BioXcel noted that the previously scheduled August 20, 2025 meeting is no longer necessary, as the objectives were addressed through the FDA’s written responses.
“We are pleased with the pre-sNDA meeting feedback we received from the FDA, which confirmed agreement on the content and format for our planned sNDA submission, and reflects a shared commitment to addressing the urgent needs of patients living with bipolar disorder or schizophrenia,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics.
BXCL501, marketed as IGALMI, is currently FDA-approved for acute agitation related to bipolar I or II disorder or schizophrenia, but only in supervised medical settings. The company is pursuing an expansion to allow at-home use, which could significantly alter the treatment landscape for these conditions.
The upcoming sNDA submission will feature results from the pivotal Phase 3 SERENITY At-Home trial, a 12-week, double-blind, placebo-controlled study assessing the safety of a 120 mcg dose of BXCL501 in the home setting. BioXcel recently completed the last patient last visit for this trial, with topline results expected later this month.
BXCL501 has been awarded Fast Track Designation by the FDA, underscoring the unmet need for acute agitation treatments in at-home environments, where no FDA-approved therapies currently exist.
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