AtaiBeckley announces successful end-of-Phase 2 FDA meeting for BPL-003 in treatment-resistant depression and outlines Phase 3 pivotal program

BPL-003, an intranasal mebufotenin benzoate therapy under development by AtaiBeckley for treatment-resistant depression, received positive regulatory feedback after an end-of-Phase 2 (EOP2) meeting with the FDA. The FDA indicated support for AtaiBeckley’s proposed pivotal Phase 3 program design in adults with TRD and provided constructive input on key program elements, including how large the safety database should be for a chronic indication. AtaiBeckley also reaffirmed its Phase 3 initiation plan for Q2 2026 and noted BPL-003’s prior Breakthrough Therapy designation. The Phase 3 plan includes two parallel pivotal studies, ReConnection 1 and ReConnection 2, each with a 12-week randomized double-blind placebo-controlled core period followed by a 52-week open-label extension. ReConnection 1 tests a single dose (8 mg, 4 mg, placebo) while ReConnection 2 tests a two-dose induction model (Day 1 and Day 15; 8 mg vs placebo), with both trials using MADRS change at Week 4 as the primary endpoint.