AtaiBeckley NV (NASDAQ:ATAI, ETR:9VC) reported continued clinical and operational progress during the third quarter of 2025, advancing multiple programs targeting treatment-resistant depression (TRD) and other mental health conditions. During the quarter, the company's lead candidate BPL-003, a mebufotenin (5-MeO-DMT) benzoate nasal spray, was granted Breakthrough Therapy designation by the US Food and Drug Administration (FDA) for TRD.
Atai Beckley N.V. ( ATAI ) Discusses BPL-003 Phase IIb Open-Label Extension Study Results in Treatment Resistant Depression November 10, 2025 8:00 AM EST Company Participants Ashleigh Barreto Srinivas Rao - Co-Founder, CEO & Executive Director Kevin Craig - Chief Medical Officer Robert Conley - Chief Research & Development Officer Conference Call Participants Lin Tsai - Jefferies LLC, Research Division Ritu Baral - TD Cowen, Research Division Pete Stavropoulos - Cantor Fitzgerald & Co., Research Division Harry Gillis - Joh.
AtaiBeckley NV (NASDAQ:ATAI, ETR:9VC) has unveiled positive topline results from the open-label extension (OLE) study of its Phase 2b clinical trial evaluating BPL-003 in patients with treatment-resistant depression (TRD). The company said that a 12 mg dose of BPL-003 (mebufotenin benzoate nasal spray) administered eight weeks after an initial 0.3 mg, 8 mg, or 12 mg dose produced additional rapid and clinically meaningful antidepressant effects that were sustained for up to eight weeks.
atai Life Sciences (NASDAQ:ATAI, ETR:9VC) announced that its previously annoucned strategic combination with Beckley Psytech has been completed, forming a new clinical-stage biopharmaceutical company focused on developing treatments for mental health disorders called AtaiBeckley. Atai Life Sciences shareholders approved the transaction and a corporate redomiciliation to Delaware at an Extraordinary General Meeting held on November 4, with approximately 98% of votes cast in favor.
atai Life Sciences (ATAI) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).
atai Life Sciences (NASDAQ:ATAI, ETR:9VC) announced that it has priced its registered underwritten offering of 23,725,000 company common shares at $5.48 per share, with expectations of raising about $130 million. The clinical-stage biopharmaceutical company said it intends to use the net proceeds of the offering, together with existing cash, cash equivalents and short-term investments, to advance the clinical development of its product candidates and programs, as well as for working capital and general corporate purposes.
atai Life Sciences (NASDAQ:ATAI, ETR:9VC) and Beckley Psytech announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to BPL-003 (mebufotenin benzoate) nasal spray for adult patients with treatment-resistant depression (TRD). The FDA's Breakthrough Therapy designation is intended to accelerate the development of drugs for serious or life-threatening conditions where preliminary clinical evidence indicates the therapy may offer substantial improvement over existing treatments.
Atai Life Sciences N.V. has surged >275% YTD, driven by promising psychedelic drug candidates targeting treatment-resistant depression and other mental health disorders. ATAI's lead asset, BPL-003, shows strong, durable efficacy in early trials, potentially surpassing Spravato, but regulatory and scheduling hurdles remain significant risks. Despite a tight cash position and upcoming milestones, ATAI's valuation may be fair or slightly overvalued, with major catalysts like Phase 2b/3 data and FDA discussions ahead.
Shares in atai Life Sciences (NASDAQ:ATAI, ETR:9VC) rose 10% on Tuesday after the company and its UK partner Beckley Psytech reported encouraging mid-stage trial results for their experimental nasal spray treatment for depression. The therapy, BPL-003, is a formulation of mebufotenin benzoate delivered via nasal spray.
atai Life Sciences (NASDAQ:ATAI, ETR:9VC) and Beckley Psytech said Tuesday that their experimental nasal spray for depression showed promising results in a mid-stage clinical trial, bolstering hopes for a new treatment option in an area where existing therapies often fall short. The drug, known as BPL-003, is a formulation of mebufotenin benzoate delivered through a nasal spray.
atai Life Sciences (ATAI) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.
atai Life Sciences (ATAI) appears to have found support after losing some value lately, as indicated by the formation of a hammer chart. In addition to this technical chart pattern, strong agreement among Wall Street analysts in revising earnings estimates higher enhances the stock's potential for a turnaround in the near term.