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Investing.com – BioXcel Therapeutics (NASDAQ:BTAI) rose almost 4% to about $48.86 after securing fast-track development approval from the U.S. Food and Drug Administration for its dementia-related agitation treatment.
The company’s orally dissolving thin film formulation of dexmedetomidine received “Breakthrough Therapy” designation to expedite development and regulatory review of investigational therapies that address serious or life-threatening conditions.
BioXcel shares are up almost 400% since the company went public in 2018. The New Haven, Conn.-based clinical stage biopharmaceutical company has yet to report revenue, and has been losing more money than expected for three of the past four quarters. The stock has five buy ratings and no sells or holds, according to data compiled by Investing.com. Analysts expect shares to continue to rally, with the average price target at $122.
Treating agitation associated with dementia has been a challenge for providers as there are currently no FDA-approved therapies for the treatment of dementia-related agitation, BioXcel said in a filing.
