BioXcel Therapeutics Stock Surges on FDA Positive Meeting Comments

BioXcel Therapeutics Inc (BTAI) shares rose 14.59% on Monday after the company announced positive meeting comments from the US FDA, giving it confidence in its planned sNDA submission for BXCL501, a treatment for agitation associated with bipolar disorders or schizophrenia. The FDA agreed on the content and format of the sNDA submission, which is expected to be submitted in Q1 2026.

BioXcel Therapeutics Inc. (BTAI) shares experienced a significant surge, rising by 14.59% on Monday, following the company's announcement of positive meeting comments from the U.S. Food and Drug Administration (FDA). The feedback, received during a pre-sNDA meeting, has bolstered BioXcel's confidence in its planned supplemental New Drug Application (sNDA) submission for BXCL501, a treatment aimed at managing agitation associated with bipolar disorders or schizophrenia.

The FDA's positive response indicates alignment on the content and format of the sNDA submission, which is now on track for submission in the first quarter of 2026. The pre-sNDA meeting, originally scheduled for August 20, 2025, was deemed unnecessary after receiving the preliminary comments from the FDA on August 14, 2025. The feedback will serve as the official record for the meeting.

The primary focus of the pre-sNDA meeting was to gain alignment with the FDA regarding the content and format of the sNDA submission for the at-home (outpatient) use of BXCL501. The FDA's approval of the planned submission reflects a shared commitment to addressing the urgent needs of patients suffering from agitation.

BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. It is under investigation for the acute treatment of agitation associated with Alzheimer's dementia and bipolar disorders or schizophrenia in the at-home setting. The company recently completed the last patient last visit (LPLV) of its pivotal Phase 3 SERENITY At-Home trial, with topline data expected soon.

The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation in the at-home setting. The trial will assess 200 patients with a history of agitation episodes residing at home, either alone or with caregivers/informants. The study protocol was agreed with the FDA at a Type C Meeting held in March 2024.

The positive FDA feedback is a significant milestone for BioXcel Therapeutics, as it brings the company closer to bringing a safe and effective outpatient treatment to patients suffering from agitation. This development has the potential to transform the treatment paradigm for bipolar disorder and schizophrenia.

References:
[1] https://www.marketscreener.com/news/bioxcel-therapeutics-announces-positive-fda-pre-snda-meeting-comments-for-snda-submission-for-bxcl50-ce7c51dcd888f524
[2] https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-positive-fda-pre-snda-meeting