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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