AtaiBeckley Announces Positive Topline Data from the Phase 2b Open-Label Extension Study of BPL-003, Supporting Safety and Efficacy of a Second Dose in Patients with Treatment-Resistant De...
Atai Beckley N.V - Common Shares (ATAI)
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Source: GlobeNewswire
A 12 mg dose of BPL-003 (mebufotenin benzoate nasal spray) administered eight weeks after an initial 12 mg, 8 mg or 0.3 mg dose in the core study of the Phase 2b clinical trial produced additional rapid, clinically meaningful antidepressant effects that were sustained for up to eight weeksPatients who received an active dose of BPL-003 in the core study of the Phase 2b clinical trial (either 8 mg or 12 mg) met response and remission criteria for depression at increased rates after receiving a 12 mg dose in the OLE study, with 63% in response and 48% in remission at Week 8 in the OLE study (Week 16 of the Phase 2b clinical trial)An End-of-Phase 2 meeting has been scheduled with the U.S. Food and Drug Administration (FDA) to align on clinical trial designs and other aspects of the BPL-003 Phase 3 development program. Anticipate providing guidance on the Phase 3 clinical program in the first quarter of 2026Readout follows announcement that the FDA granted Breakthrough Therapy designation
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News
- H.C. Wainwright Maintains Buy on Atai Beckley (ATAI) Following Breakthrough Therapy and Merger Completion [Yahoo! Finance]Yahoo! Finance
- Enhanced Fortifies Executive Leadership Team & Board of DirectorsPR Newswire
- Atai Beckley N.V. (ATAI) Receives Buy Rating on BPL-003 Edge against Spravato [Yahoo! Finance]Yahoo! Finance
- AtaiBeckley to Participate in the Jefferies Global Healthcare Conference in LondonGlobeNewswire
- ATAI Life Sciences GAAP EPS of -$0.28 misses by $0.17, revenue of $0.75M beats by $0.69M [Seeking Alpha]Seeking Alpha
ATAI
Earnings
- 11/12/25 - Miss
ATAI
Sec Filings
- 12/5/25 - Form 8-K
- 12/5/25 - Form 424B7
- 11/26/25 - Form 4
- ATAI's page on the SEC website