atai and Beckley Psytech announce positive Phase 2b results for treatment-resistant depression

atai and Beckley Psytech plan to meet with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to finalize the Phase 3 trial design.

atai Life Sciences, a clinical-stage biopharmaceutical company focused on improving mental health, and Beckley Psytech, a private company developing next-generation psychedelic therapies, today announced positive topline results from their Phase 2b clinical trial of BPL-003 in patients with treatment-resistant depression (TRD).

The eight-week, quadruple-blinded, dose-finding trial tested the safety and effectiveness of a single dose of BPL-003, an intranasal formulation of mebufotenin (5-MeO-DMT) benzoate. The study met its primary goal and all key secondary goals.

atai and Beckley Psytech plan to meet with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to finalize the Phase 3 trial design. These results also meet the pre-agreed success criteria for the strategic merger between atai and Beckley Psytech, announced in June 2025.  The merger will now move forward to atai shareholder approval.

The combined company, to be named atai Beckley, is expected to become a global leader in short-duration, clinic-based psychedelic mental health therapies.