AtaiBeckley Reports Q4 and Full-Year 2025 Financial Results, plus FDA and clinical updates and upcoming milestones

mebufotenin benzoate nasal spray (BPL-003) and dimethyltryptamine (DMT) buccal film (VLS-01), along with oral R-MDMA (EMP-01), anchor AtaiBeckley’s updated mental health pipeline as it reports Q4 and full-year 2025 results. AtaiBeckley says its Phase 3 TRD program planning for BPL-003 is on track after a successful End-of-Phase 2 meeting with the FDA, with initiation planned for Q2 2026. The Phase 3 plan includes two pivotal 12-week randomized, double-blind, placebo-controlled core trials followed by a longer open-label extension. The company also reports progress on EMP-01 for social anxiety disorder, including Phase 2a topline results after two administrations, plus business updates following its atai Life Sciences and Beckley Psytech combination and U.S. redomiciliation, and it highlights upcoming topline readouts for both TRD programs through 2026 and beyond.