BXCL501 decision

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[I do not remember this but decision could be this week.]

Can BioXCel Push Psychiatric Disorder-Associated Agitation Drug Past Finish Line?

  • Company: BioXcel Therapeutics, Inc. (NASDAQ: BTAI)
  • Type of Application: new drug application
  • Candidate: dexmedetomidine (BXCL501)
  • Indication: agitation associated with schizophrenia and bipolar disorders I and II.
  • Date: April 5

BXCL501 is an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation associated with neuropsychiatric disorders. The original PDUFA date of Jan. 5, 2022 was pushed back by three months, with BoXcel communicating that the FDA needed three more months to review data.

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BioXcel Therapeutics Inc

shares are trading higher Wednesday after the company announced that the U.S. Food and Drug Administration approved IGALMI (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

IGALMI is the first new acute treatment for schizophrenia or bipolar disorder-associated agitation in nearly a decade. It can be self-administrated by patients under the supervision of a healthcare provider.

BioXcel said it expects to launch IGALMI in the U.S. in the second quarter.

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