AtaiBeckley says BPL-003 Phase 3 on track for Q2 2026 after successful FDA End-of-Phase 2 meeting

AtaiBeckley Inc. (ATAI) — At an investor event, AtaiBeckley said a successful FDA End-of-Phase 2 meeting cleared the way to begin two parallel Phase 3 trials of BPL-003 (intranasal mebufotenin/5-MeO-DMT) in treatment-resistant depression in the second quarter of 2026.

The Breakthrough Therapy-designated candidate is supported by Phase 2b data showing rapid antidepressant effects and durable improvement, with higher response after an optional second dose. Confirmation of the pivotal path is a key de-risking milestone for AtaiBeckley's lead program.

Source: ir.ataibeckley.com

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