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

The FDA has designated Breakthrough Therapy status to BioXcel Therapeutics Inc's 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.