atai Life Sciences and Beckley Psytech Announce U.S. FDA Breakthrough Therapy Designation Granted to BPL-003, Underscoring its Potential in Treatment-Resistant Depression

Breakthrough Therapy designation recognizes the potential of BPL-003 to deliver substantial improvement over existing therapies for patients with treatment-resistant depressionFDA designation follows previously announced Phase 2b topline data which showed rapid and durable antidepressant outcomes following a single dose of BPL-003Breakthrough Therapy designation provides intensive FDA guidance to support advancement of BPL-003 NEW YORK and AMSTERDAM, Oct. 16, 2025 (GLOBE NEWSWIRE) -- atai Life Sciences (NAS ...