05:01 PM EDT, 10/16/2025 (MT Newswires) -- Atai Life Sciences ( ATAI ) and Beckley Psytech said late Thursday the US Food and Drug Administration has granted Breakthrough Therapy designation to BPL-003 nasal spray formulation for adult patients with treatment-resistant depression.

The label provides intensive FDA guidance to support advancement of BPL-003, the companies said.

"BPL-003 is well-positioned for Phase 3 trials which are expected to initiate in the second quarter of 2026, subject to alignment with the FDA," said atai Chief Executive Officer Srinivas Rao.

Separately, atai said it has started a registered underwritten offering of its shares to raise funds for the clinical development of its product candidates and programs, for working capital and general corporate purposes.

Shares were up about 2% in after-hours trading.