BPL-003 Demonstrates Rapid and Durable Antidepressant Effects in Treatment-Resistant Depression; Phase 2a Data Published in Journal of Psychopharmacology; Phase 3 Program on Track for Q2 2026 InitiationNEW YORK, March 17, 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 the peer-reviewed publication of results from its ongoing four-part Phase 2a study (NCT05660642) evaluating BPL-003 (mebufotenin benzoate nasal spray) in patients with treatment-resistant depression (TRD). Published in the Journal of Psychopharmacology, the newly reported data come from Cohort 1 – a 12 week, open-label trial of a single 10 mg intranasal dose of BPL-003 in 12 patients with moderate-to-severe TRD who were not taking concomitant antidepressants. BPL-003 produced a mean Montgomery–Åsberg Depression Rating Scale (MADRS) total score reduction of 12.6 points by Day 2 (from a baseline mean of 27.5 to 14.8), which was sustained over 12 weeks to a mean MADRS score of 14.5 at Day 85. A response rate (≥50% MADRS reduction) of 54.5% was observed from the day after dosing through Day 85, and 63.6% of patients achieved remission (MADRS ≤10) at one or more timepoints. Mean Snaith-Hamilton Pleasure Scale (SHAPS) scores also improved from 8.4 at baseline to 1.5 at Day 85, indicating an absence of anhedonia. BPL-003 was well tolerated with no serious adverse events and no treatment withdrawals due to adverse events. Most adverse events were transient and mild-to-moderate in severity.
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 DayNEW 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.
AtaiBeckley Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business and Clinical UpdateNEW YORK, March 06, 2026 (GLOBE NEWSWIRE) -- AtaiBeckley Inc. (
NASDAQ: ATAI) (“AtaiBeckley” or the “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 fourth quarter and full year 2025 financial results and provided key regulatory, clinical and business updates.
