NEW YORK and AMSTERDAM, Aug. 14, 2025 - atai Life Sciences $(ATAI)$ announced today that they are on track to submit an End-of-Phase 2 meeting request to the U.S. Food and Drug Administration (FDA) in the third quarter of 2025. This submission is a critical step in the regulatory review of BPL-003, an intranasal psychedelic treatment for patients with treatment-resistant depression $(TRD.UK)$. The company recently reported positive topline data from the core, blinded stage of the Phase 2b clinical trial of BPL-003, demonstrating rapid, robust, and durable antidepressant effects for up to 8 weeks with a single dose. The anticipated regulatory milestone is part of atai's ongoing efforts to advance innovative mental health therapies.
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