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BPL-003 Phase 3 Program Initiation on Track for Q2 2026 Following Successful FDA End-of-Phase 2 Meeting; AtaiBeckley Highlights Key Pipeline Milestones at 2026 Investor Day
BPL‑003 holds Breakthrough Therapy Designation and is supported by positive Phase 2b results in treatment-resistant depressionCash runway reaffirmed through
About this update from Ataibeckley Inc.
[{"type":"text","content":"BPL‑003 holds Breakthrough Therapy Designation and is supported by positive Phase 2b results in treatment-resistant depressionCash runway reaffirmed through the planned early-2029 topline readouts from both parallel Phase 3 pivotal studiesCommercial readiness advancing with scalable treatment model aligned to existing interventional psychiatry workflowsContinued pipeline progress, including positive Phase 2a results for EMP‑01 and expected Phase 2 topline for VLS-01 in H2 2026Replay and presentation materials available on AtaiBeckley’s investor website NEW YORK, March 10, 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 highlighted key clinical, regulatory, and operational milestones from its 2026 Virtual Investor Day, including the advancement of BPL‑003 (mebufotenin benzoate nasal spray) toward Phase 3 initiation in Q2 2026 following a successful End-of-Phase 2 meeting with the FDA. BPL-003, which holds Breakthrough Therapy Designation, is supported by positive Phase 2b results in treatment-resistant depression (TRD), demonstrating rapid antidepressant effects at Day 2, durable improvements through eight weeks, and higher response and remission rates following an optional second dose in the open-label extension. The Company also reaffirmed its cash runway into early 2029, provided updates on its commercial readiness strategy, and outlined continued pipeline progress, including recently announced positive Phase 2a results for EMP‑01 and its expectation that VLS-01 will deliver Phase 2 topline data in H2 2026. Advancing BPL-003 Towards Phase 3 in Treatment-Resistant DepressionA central focus of the event was the continued advancement of BPL‑003 toward Phase 3 studies in TRD. Following a successful End‑of‑Phase 2 meeting with the FDA, the Company remains on track to initiate two parallel Phase 3 studies – ReConnection-1 and ReConnection-2 - in Q2 2026. These pivotal trials will include a 12‑week randomized, double‑blind, placebo‑controlled core study, followed by a 52‑week open‑label extension allowing individualized retreatment based on pre‑specified criteria. “BPL-003 has demonstrated rapid, durable antidepressant effects, and t...