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BioXcel seeks FDA nod for at‑home agitation treatment; shares fall

ReutersJan 20, 2026 12:16 PM

Shares of drugmaker BioXcel Therapeutics BTAI.O fall 3.3% to $1.78 premarket

Company says it has asked U.S. FDA to allow at‑home use of Igalmi for agitation tied to bipolar disorder and schizophrenia

BTAI says Igalmi, an orally dissolving film cleared in 2022 for supervised use, will become the first approved at‑home option if the FDA agrees

Company filed the request on January 14 via a supplemental application

Agitation is a state of restlessness and intense irritability that can cause sudden outbursts; current treatment options require medical supervision - BTAI

As of last close, shares down ~73% over the past year

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