other material
confidence high
sentiment positive
materiality 0.65
AtaiBeckley provides 2026 milestones; BPL-003 Phase 3 start Q2'26, VLS-01 data H2'26
AtaiBeckley Inc.
- BPL-003 (mebufotenin) Phase 2b TRD trial met primary and all key endpoints; Phase 3 guidance Q1'26, trial start Q2'26 pending FDA End-of-Phase 2 meeting.
- Additional BPL-003 Phase 2a cohort evaluating two-dose induction in TRD starts Q1'26; initial data expected Q4'26.
- VLS-01 (DMT buccal film) Phase 2 Elumina trial topline data from 142 TRD patients expected H2'26.
- EMP-01 (oral R-MDMA) SAD Phase 2a topline data expected Q1'26; new patent provides exclusivity through 2043.
- Redomiciliation to Delaware completed Dec 2025; added to NASDAQ biotech index (NBI) Dec 2025; cash runway into 2029.