BioXcel says FDA accepts IGALMI sNDA for at-home agitation treatment

Reuters04-01

FDA accepted BioXcel Therapeutics supplemental NDA for IGALMI for acute agitation in at-home treatment of bipolar disorder or schizophrenia.
PDUFA target action date set for Nov. 14, 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BioXcel Therapeutics Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001104659-26-038174), on April 01, 2026, and is solely responsible for the information contained therein.

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