BioXcel Therapeutics, Inc. 8-K

What Happened On April 1, 2026, BioXcel Therapeutics, Inc. announced that the U.S. Food and Drug Administration has accepted its supplemental New Drug Application (sNDA) for IGALMI for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at‑home (outpatient) setting. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 14, 2026. The company disclosed this event in an Item 8.01 (Other Events) Form 8‑K filing.

Key Details

• sNDA accepted by FDA for IGALMI (supplemental New Drug Application).
• Indication: acute treatment of agitation associated with bipolar disorders or schizophrenia in the at‑home/outpatient setting.
• Filing disclosed on April 1, 2026 (Form 8‑K, Item 8.01).
• PDUFA target action date: November 14, 2026.

Why It Matters This is a regulatory milestone for BioXcel: FDA acceptance of the sNDA starts the formal review clock toward a potential label expansion that would permit IGALMI’s use for at‑home treatment of agitation in the specified disorders. The PDUFA date gives investors a clear timeline (Nov 14, 2026) for when the FDA is expected to act.