FDA Pushes Review Of BioXcel's Candidate For Agitation Associated With Neuropsychiatric Disorders
- The FDA has extended the review period for BioXcel Therapeutics Inc's (NASDAQ: BTAI) marketing application seeking approval for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II.
- In connection with the FDA's ongoing review, BioXcel Therapeutics responded to the agency's information request about analyses of clinical data.
- The Company was recently informed that the application would require additional time for review.
- As a result, the FDA extended the previously disclosed PDUFA date of January 5, 2022, to April 5, 2022.
- BioXcel Therapeutics and the FDA met on November 30. No additional data has been requested.
- BXCL501 is an orally dissolving thin film formulation of dexmedetomidine, a selective alpha-2a receptor agonist for agitation associated with neuropsychiatric disorders.
- See here Benzinga's Full FDA Calendar.
- Price Action: BTAI shares are down 12.40% at $20.08 during the market session on the last check Wednesday.
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