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Investing.com -- atai Life Sciences (NASDAQ:ATAI) stock initially rose 10% but later traded flat after announcing FDA Breakthrough Therapy designation for its depression treatment, followed by a proposed public offering of common shares.
The company revealed that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to BPL-003 (mebufotenin benzoate) nasal spray for adult patients with treatment-resistant depression. This designation is designed to expedite development of drugs targeting serious conditions where preliminary clinical evidence suggests substantial improvement over existing therapies.
The designation follows positive topline results from Beckley Psytech’s Phase 2b study, which showed a single administration of BPL-003 led to clinically meaningful reductions in depressive symptoms within 24 hours, with effects sustained through the eight-week trial period. Most patients were deemed ready for discharge at the 90-minute post-dose assessment.
Shortly after this announcement, atai launched a proposed registered underwritten offering of its common shares, with plans to grant underwriters a 30-day option to purchase additional shares. The company intends to use proceeds to advance clinical development of its product candidates and for working capital.
The Breakthrough Therapy designation provides intensive FDA guidance to support advancement of BPL-003, potentially expediting development timelines and regulatory reviews. Phase 3 trials are expected to begin in the second quarter of 2026, subject to FDA alignment.
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