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FDA Gives Accelerated Review Tag To BioXcel's BXCL501 In Dementia-Related Agitation

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The FDA has designated Breakthrough Therapy status to BioXcel Therapeutics Inc's (NASDAQ: BTAI) BXCL501, to treat agitation associated with dementia.

  • The designation intends to expedite the development and review of certain product candidates.
  • After a routine review of TRANQUILITY study data, a lower 30 mcg dose showed numerical improvements compared to the placebo.
  • Earlier this year, the company announced positive topline data from the Phase 1b/2 TRANQUILITY study.
  • Price Action: BTAI shares gained 8.53% at $51 in premarket on the last check Monday.
 

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Posted-In: dementiaBiotech News Health Care Small Cap FDA General

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