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AtaiBeckley Announces Successful End-of-Phase 2 Meeting for BPL-003 in Treatment-Resistant Depression
Aligned with FDA on dual-trial design Phase 3 program that aims to demonstrate robust efficacy and long-term safety and that allows for flexible dosingPhase 3
About this update from Ataibeckley Inc.
[{"type":"text","content":"Aligned with FDA on dual-trial design Phase 3 program that aims to demonstrate robust efficacy and long-term safety and that allows for flexible dosingPhase 3 program initiation remains on track for Q2 2026BPL-003 was previously granted Breakthrough Therapy designation by the FDA for treatment-resistant depressionVirtual Investor Day scheduled on March 6, 2026, to provide further detail on the BPL-003 Phase 3 clinical strategy NEW YORK, March 03, 2026 (GLOBE NEWSWIRE) -- AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or “Company”), a clinical-stage biotechnology company on a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments, today announced a successful End‑of‑Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of BPL‑003, the Company’s proprietary intranasal formulation of mebufotenin benzoate, for treatment‑resistant depression (TRD). Minutes from the meeting show that the FDA indicated support for AtaiBeckley’s proposed BPL-003 pivotal program and the compound’s advancement into Phase 3 studies in adults with TRD. The FDA also provided constructive feedback on the overall design and key components of the proposed program, including the overall size of the safety database for this chronic indication. “Receiving clear guidance from the FDA at this stage is a major milestone for AtaiBeckley and for the BPL‑003 program,” said Srinivas Rao, M.D., Ph.D., Co-Founder and Chief Executive Officer at AtaiBeckley. “This feedback builds on our compelling Phase 2b data as well as the Breakthrough Therapy Designation granted to BPL-003 in October 2025 and firmly positions us to advance a robust Phase 3 clinical program designed to maximize the probability of regulatory and commercial success. With this development, we maintain our conviction that BPL-003 has the potential to offer a rapid, durable and convenient treatment option for the millions of people living with treatment-resistant depression.” Phase 3 Program DesignThe Phase 3 program is designed to include two pivotal studies, ReConnection 1 and ReConnection 2, conducted in parallel. Both will include a 12-week, randomized, double-blind, placebo-controlled core study followed by a 52-week open-label extension (OLE) in which participants may receive individualized retreatment ...