BioXcel Therapeutics, Inc. 8-K

What Happened
BioXcel Therapeutics, Inc. announced on January 20, 2026 that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration on January 14, 2026. The sNDA requests approval of IGALMI® for at‑home use to treat acute agitation associated with bipolar disorders or schizophrenia. IGALMI was originally approved by the FDA in April 2022 as the first and only orally dissolving sublingual film for acute agitation in adults when used under a healthcare provider’s supervision.

Key Details

• sNDA submitted to FDA: January 14, 2026; announcement filed via Form 8-K on January 20, 2026.
• Drug: IGALMI® (orally dissolving sublingual film).
• Current approval: April 2022 for acute agitation in adults with schizophrenia or bipolar I/II disorder under provider supervision.
• Proposed expansion: label to include broader at-home patient population where no FDA‑approved options currently exist.

Why It Matters
This filing seeks to broaden IGALMI’s approved use from supervised, in‑clinic administration to at‑home treatment, addressing a stated unmet need for FDA‑approved at‑home options for acute agitation in bipolar disorder and schizophrenia. For investors, the sNDA represents a potential avenue to expand the product’s addressable market and patient access if the FDA accepts and approves the label change; the 8‑K reports the submission but does not provide a regulatory timeline or guarantees of approval.