BioXcel Therapeutics' BXCL501 Gains Momentum with FDA Support, Analyst Recommends Buy with $10 Price Target.

BioXcel Therapeutics' BXCL501 has gained momentum with FDA support and positive Phase 3 trial outcomes. Analyst Ram Selvaraju of H.C. Wainwright recommends a Buy rating with a $10 price target, citing positive FDA feedback and the completion of the pivotal Phase 3 SERENITY At-Home trial. The upcoming data readout is perceived as low-risk, supporting the company's strategic plans.

Title: BioXcel Therapeutics Advances with Positive FDA Feedback and Phase 3 Trial Completion

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) has made significant strides in its mission to bring innovative treatments to patients suffering from agitation associated with bipolar disorder or schizophrenia. The company recently announced that it has received positive pre-sNDA meeting responses from the U.S. Food and Drug Administration (FDA), aligning the company's supplemental New Drug Application (sNDA) package to expand the IGALMI label for the at-home (outpatient) setting. This development is a crucial milestone as BioXcel moves closer to its goal of transforming the treatment paradigm for these conditions.

The pre-sNDA meeting, originally scheduled for August 20, 2025, was held to gain alignment with the FDA regarding the content and format of BioXcel's planned sNDA submission for the at-home use of BXCL501. The FDA's feedback confirmed the company's planned regulatory package, which includes data from the pivotal Phase 3 SERENITY At-Home trial. This trial, which concluded recently, 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's topline data is expected this month.

Analyst Ram Selvaraju of H.C. Wainwright has recommended a Buy rating with a $10 price target for BioXcel Therapeutics, citing the positive FDA feedback and the completion of the pivotal Phase 3 SERENITY At-Home trial. The upcoming data readout is perceived as low-risk, further supporting the company's strategic plans.

BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. It has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia. The safety and efficacy of BXCL501 for these investigational uses have not been established.

IGALMI, currently FDA-approved and marketed for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in medically supervised settings, is now being explored for at-home use. The pivotal Phase 3 SERENITY At-Home trial is a significant step towards this goal, as it evaluates the safety and efficacy of BXCL501 in an outpatient setting.

The company's CEO, Vimal Mehta, Ph.D., expressed satisfaction with the FDA's feedback, stating, "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." Mehta added, "This marks an important milestone in our mission to bring a safe and effective outpatient treatment to patients suffering from agitation, potentially transforming the treatment paradigm."

The upcoming sNDA submission, which is on track for the first quarter of 2026, will be subject to the FDA's review. BioXcel Therapeutics is leveraging its artificial intelligence-driven drug re-innovation approach to identify new therapeutic indications and bring transformative medicines to patients in need.

References:
[1] https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-positive-fda-pre-snda-meeting