Shares of BioXcel Therapeutics Inc. (BTAI) are up nearly 20% at $23.81 in premarket trading Wednesday, following FDA approval of Igalmi for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
Igalmi, previously known as BXCL501, is a proprietary, sublingual film formulation of dexmedetomidine, and is expected to be launched in the U.S. in the second quarter of 2022.
Agitation is a common and difficult to manage symptom in schizophrenia and bipolar disorders I and II. In the United States, these two disorders impact an estimated 9 million people, with more than 3 million experiencing agitation each year.
Igalmi becomes the first and only FDA-approved orally dissolving sublingual film for mild, moderate or severe agitation in patients with schizophrenia or bipolar I or II disorder. This product has the potential to achieve peak sales of $1 billion, according to analysts.
BTAI closed Tuesday's trading at $19.88, down 2.98%.
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June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.