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 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.