atai Life Sciences and Beckley Psytech Announce U.S. FDA Breakthrough Therapy Designation Granted to BPL-003, Underscoring its Potential in Treatment-Resistant Depression
Atai Beckley N.V - Common Shares (ATAI)
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Source: GlobeNewswire
Breakthrough Therapy designation recognizes the potential of BPL-003 to deliver substantial improvement over existing therapies for patients with treatment-resistant depressionFDA designation follows previously announced Phase 2b topline data which showed rapid and durable antidepressant outcomes following a single dose of BPL-003Breakthrough Therapy designation provides intensive FDA guidance to support advancement of BPL-003 NEW YORK and AMSTERDAM, Oct. 16, 2025 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), and Beckley Psytech Limited (“Beckley Psytech”), who previously announced a planned strategic combination to create a global leader in transformative mental health therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to BPL-003 (mebufotenin benzoate) nasal spray for adult patients with treatment-resistant depression (TRD). BTD is granted to expedite development of drugs ta
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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