StockNews.AI

BioXcel Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for IGALMI® Label Expansion in the At-Home Setting

StockNews.AI • 2 days

BTAI
High Materiality8/10

Information

sNDA submission supports the acute treatment of agitation associated with bipolar disorders or schiz...

Original source

AI Summary

BioXcel Therapeutics submitted an sNDA to expand IGALMI's use to outpatient care for agitation associated with bipolar disorders and schizophrenia. This could lead to approval by year-end 2026, addressing a significant unmet need in the treatment landscape, which may substantially boost market access and revenue for BTAI.

Sentiment Rationale

Previous label expansions in pharma often lead to stock price increases; sNDA results bolster investor confidence.

Trading Thesis

BTAI is a buy due to an upcoming pivotal regulatory decision enhancing revenue visibility in 2026.

Market-Moving

  • FDA approval of IGALMI label could dramatically increase patient access and market size.
  • 7.3 million diagnosed in the U.S. for applicable conditions boosts potential market demand.
  • Positive SERENITY trial data supports likelihood of successful sNDA approval.

Key Facts

  • BioXcel submitted sNDA for IGALMI® expansion to outpatient use.
  • Potential approval could come by the end of 2026.
  • Approximately 7.3 million U.S. individuals suffer from schizophrenia or bipolar disorders.
  • Agitation episodes number 57-77 million annually in the U.S.
  • Results from the Phase 3 SERENITY trial backed the sNDA submission.

Companies Mentioned

  • BioXcel Therapeutics (BTAI): Potential label expansion of IGALMI could significantly increase revenue.

Corporate Developments

This fits under 'Corporate Developments' as it involves a strategic regulatory submission for product expansion, enhancing market positioning.

BioXcel Therapeutics Submits Supplemental New Drug Application for IGALMI® in Outpatient Settings

On January 14, 2026, BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company focused on innovative neuroscience solutions, submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA). This application seeks to expand the labeling for IGALMI® to support the acute treatment of agitation associated with bipolar disorders and schizophrenia in at-home settings.

Significance of the sNDA Submission

The recent sNDA submission aims to make IGALMI® available for outpatient treatment, addressing a critical gap in care where no FDA-approved options currently exist. This outreach is particularly vital for the estimated 7.3 million individuals in the U.S. diagnosed with schizophrenia or bipolar disorders, who collectively experience approximately 57 to 77 million annual episodes of agitation.

Background on IGALMI®

Approved by the FDA in April 2022, IGALMI® is the first orally dissolving sublingual film designed for managing agitation in adults under healthcare supervision. The new sNDA seeks to extend its usage to less supervised environments, enhancing patient access to effective treatment options.

“The successful submission of this sNDA for IGALMI represents an important milestone in expanding access to patients who are experiencing acute agitation episodes in the at-home setting,” stated Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “This expansion fulfills a clear unmet medical need in an area where agitation often originates.”

Clinical Trial Support and Market Preparation

The submission of the sNDA is underpinned by promising results from the Phase 3 SERENITY At-Home safety trial, which demonstrated that BXCL501, the active component of IGALMI®, is well-tolerated. Furthermore, the FDA provided positive feedback during the pre-sNDA meeting, enhancing optimism for potential approval.

Dr. Mehta added, “We are advancing our pre-commercialization efforts, including a market opportunity assessment, under the guidance of our newly appointed Interim Chief Commercial Officer, Mark Pavao. We aim to collaborate closely with the FDA for a potential approval by the end of this year.”

Safety Information and Usage

IGALMI® (dexmedetomidine) is prescribed for managing agitation associated with schizophrenia and bipolar disorder. It should be administered under the supervision of healthcare professionals. Important safety information includes:

  • Potential for decreased blood pressure and heart rate changes, especially in individuals with underlying health conditions.
  • Patients are advised against operating heavy machinery or driving for at least 8 hours post-administration due to potential drowsiness.
  • Withdrawal symptoms may occur if IGALMI is used longer than 24 hours.

About BioXcel Therapeutics, Inc. (Nasdaq: BTAI)

BioXcel Therapeutics, Inc. utilizes artificial intelligence to create transformative medicines in neuroscience. Alongside its subsidiary OnkosXcel Therapeutics, the company focuses on developing innovative therapies across various healthcare domains. For more information, please visit bioxceltherapeutics.com.

Conclusion

The submission of the sNDA for IGALMI® marks a significant step toward improving treatment accessibility for patients experiencing agitation linked to schizophrenia and bipolar disorders. The potential approval, targeted for late 2026, underscores BioXcel's commitment to addressing critical healthcare needs.

Related News