8-K - BioXcel Therapeutics, Inc. | StockGist

AI Analysis

AI-generated analysis. Always verify with the original filing.

BioXcel Therapeutics announced FDA acceptance of its sNDA for IGALMI in the at-home treatment of agitation in bipolar disorder or schizophrenia, with a PDUFA target date of November 14, 2026.

Key Takeaways

1FDA accepted sNDA for IGALMI for acute agitation in bipolar disorders or schizophrenia in outpatient setting.

2PDUFA target action date set for November 14, 2026.

3Announcement made on April 1, 2026 by BioXcel Therapeutics, Inc.

Current Report Details

Event Type

Other Event

Disclosure

Voluntary

Variant

8-K

Items Reported

8.01

| Other Events. | |---|---| ** ** On April 1, 2026, BioXcel Therapeutics, Inc. (the “Company”) announced that the U.S. Food and Drug Administration has accepted

Other Event

Exhibits (1)

8-K

FORM 8-K