BioXcel Submits IGALMI Application for FDA Review: A Catalyst for BTAI Stock

BioXcel Therapeutics has submitted a pre-supplemental New Drug Application to the FDA for IGALMI, seeking to expand its label for outpatient use in treating agitation linked to bipolar disorders and schizophrenia. The meeting with the FDA is scheduled for August 20, 2025, potentially impacting the company's market positioning. BioXcel's stock is rated as Underperform by Spark's AI Analyst due to substantial financial instability and ongoing losses.

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) has submitted a pre-supplemental New Drug Application (pre-sNDA) meeting package to the U.S. Food and Drug Administration (FDA) for IGALMI®. The application seeks to expand the label for outpatient use in the acute treatment of agitation associated with bipolar disorders or schizophrenia. The meeting with the FDA is scheduled for August 20, 2025, and is aimed at aligning the company's plans with regulatory expectations.

The primary purpose of the pre-sNDA meeting is to gain alignment with the FDA regarding the content and format of the planned sNDA submission, which the company is preparing. The meeting will also serve to reconfirm the understanding reached during the Type C meeting with the FDA on March 6, 2024, that FDA views the company’s current development plans as a reasonable approach to support expanding the label to include at-home (outpatient) use of 120 mcg BXCL501 for the acute treatment of agitation associated with schizophrenia or bipolar disorders.

Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, stated, "We are on track with our clinical development and regulatory submission plan for BXCL501 (IGALMI®). Our clear focus continues to be bringing for the first time to patients an at-home treatment for acute agitation associated with schizophrenia or bipolar disorders. We have received two favorable recommendations from the Data Safety Monitoring Board (DSMB), are nearing completion of the SERENITY At-Home Pivotal Phase 3 trial, and expect to report top-line results from the study this quarter."

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 associated with bipolar disorders or schizophrenia in the at-home setting. The trial is designed to evaluate 200 patients with a history of agitation episodes residing at home either alone or with caregivers/informants.

IGALMI® (dexmedetomidine) sublingual film is a prescription medicine administered under the supervision of a healthcare provider. It is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI have not been studied beyond 24 hours from the first dose.

BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The company's drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications.

The stock of BioXcel Therapeutics, Inc. is currently rated as Underperform by Spark's AI Analyst due to substantial financial instability and ongoing losses.

References:
[1] https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-submits-pre-supplemental-new-drug