Clinical Trial SuccessThe SERENITY At-Home pivotal Phase 3 trial yielded positive exploratory efficacy data, demonstrating continued effects and consistent benefit with repeat dosing of BXCL501.
Market OpportunitySafety data could pave the way for at-home use of BXCL501, which presents a significant opportunity as the need for safe and efficacious acute treatments for agitation remains very high.
Regulatory ApprovalBXCL501 was previously granted Fast Track Designation, and there are no FDA-approved therapies for the acute treatment of agitation in the at-home setting, suggesting a favorable regulatory outlook.