Atai Beckley Inc's stock soared 5.01% during intraday trading on Tuesday, following the company's announcement that its experimental depression treatment is advancing to late-stage clinical trials.
The clinical-stage biotechnology company reported a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration for BPL-003 (mebufotenin benzoate nasal spray), clearing the path for Phase 3 initiation in the second quarter of 2026. BPL-003 holds Breakthrough Therapy Designation for treatment-resistant depression and demonstrated rapid antidepressant effects at Day 2 with durable improvements through eight weeks in Phase 2b studies.
Atai Beckley also reaffirmed its cash runway into early 2029, providing financial stability through the planned Phase 3 readouts. The company highlighted additional pipeline progress, including positive Phase 2a results for EMP-01 and expected Phase 2 topline data for VLS-01 in the second half of 2026.
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