Benzinga | Mar 15, 2021 09:06AM EDT

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 (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.