Posted by Michael Wonder on 16 Oct 2025
atai Life Sciences and Beckley Psytech announce US FDA breakthrough therapy designation granted to BPL-003, underscoring its potential in treatment-resistant depression
16 October 2025 - FDA designation follows previously announced Phase 2b topline data which showed rapid and durable anti-depressant outcomes following a single dose of BPL-003.
atai Life Sciences and Beckley Psytech today announced that the US FDA has granted breakthrough therapy designation to BPL-003 (mebufotenin benzoate) nasal spray for adult patients with treatment-resistant depression.
