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

Reuters01-20 20:16
BUZZ-BioXcel seeks FDA nod for at‑home agitation treatment; shares fall

** 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

(Reporting by Sahil Pandey in Bengaluru)

((Sahil.Pandey@thomsonreuters.com))

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