AtaiBeckley’s BPL-003 Shows Rapid, Durable Antidepressant Response in Treatment-Resistant Depression Patients on SSRIs; Phase 2a Data Published in CNS Drugs
AtaiBeckley Inc. (ATAI)
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Source: GlobeNewswire
66.7% of participants achieved an antidepressant response by Day 2 following a single intranasal dose of BPL-003 in both the 10 mg (n=6) and 12 mg (n=6) cohortsDurable responses observed at Day 85: 83% (5/6) (10 mg) and 66.7% (4/6) (12 mg)BPL-003 received FDA Breakthrough Therapy Designation in October 2025Phase 3 initiation on track for Q2 2026 NEW YORK, April 08, 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 peer-reviewed Phase 2a results (NCT05660642) in CNS Drugs demonstrating that a single intranasal dose of BPL-003 (mebufotenin benzoate), which holds FDA Breakthrough Therapy Designation, achieved rapid and sustained reductions in MADRS scores from baseline in participants with treatment-resistant depression (TRD) who remained on stable SSRI therapy throughout the
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News
- AtaiBeckley Joins $3 Trillion CRSP Index and S&P Benchmark Indices Adding Mandatory Passive Fund Ownership to Phase 3 Pipeline CatalystGlobeNewswire
- AtaiBeckley: BPL-003 Phase 3 Momentum Keeps Me Bullish [Seeking Alpha]Seeking Alpha
- 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 InitiationGlobeNewswire
- 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 DayGlobeNewswire
- CNS Drug Developers Add Pharma Veterans as Sector Nears First FDA DecisionsPR Newswire
ATAI
Earnings
- 11/12/25 - Miss
ATAI
Sec Filings
- 3/24/26 - Form 4
- 3/20/26 - Form 144
- 3/13/26 - Form 4
- ATAI's page on the SEC website