Nvidia and TSMC to unveil first domestic wafer for Blackwell chips, Axios reports
NEW YORK/AMSTERDAM - The U.S. Food and Drug Administration has granted Breakthrough Therapy designation to BPL-003, a nasal spray treatment for adults with treatment-resistant depression, atai Life Sciences (NASDAQ:ATAI) and Beckley Psytech announced Thursday. The news comes as ATAI, currently valued at $1.18 billion, has seen its stock surge over 348% year-to-date, according to InvestingPro data.
The designation, which expedites development of drugs for serious conditions showing substantial improvement over existing therapies, follows positive Phase 2b results where a single dose of BPL-003 (mebufotenin benzoate) demonstrated rapid and durable antidepressant effects. Analysts maintain a strong buy consensus on ATAI, with price targets ranging from $7 to $16 per share.
According to the companies, the Phase 2b study showed that single administrations of 8 mg or 12 mg of BPL-003 led to clinically meaningful reductions in depressive symptoms within 24 hours, with effects lasting through the eight-week trial period. Most patients were ready for discharge 90 minutes after treatment.
"Receiving Breakthrough Therapy designation is a significant milestone which highlights the potential of BPL-003 to address the urgent unmet need of patients whose depression is not helped by existing therapies," said Cosmo Feilding Mellen, CEO and Co-Founder of Beckley Psytech.
The designation provides intensive FDA guidance and potentially faster regulatory reviews. Phase 3 trials are expected to begin in the second quarter of 2026, subject to FDA alignment.
BPL-003 is designed to deliver effects from a single dose with a short treatment window. The companies stated the treatment could fit into the established two-hour, in-clinic interventional psychiatry treatment paradigm.
Treatment-resistant depression affects up to 50% of the approximately 300 million people worldwide living with depression, according to information provided in the press release statement.
The announcement comes as atai Life Sciences and Beckley Psytech move forward with their previously announced planned strategic combination.
In other recent news, atai Life Sciences has been active with several significant developments. The company announced a proposed public offering of its common shares, with Jefferies LLC as the lead bookrunner, alongside other financial firms participating in the process. Additionally, atai Life Sciences received Breakthrough Therapy designation from the U.S. Food and Drug Administration for its BPL-003 nasal spray, aimed at treating adults with treatment-resistant depression, which is intended to expedite the drug’s development.
Furthermore, atai Life Sciences has filed updates regarding its planned acquisition of Beckley Psytech Limited, with the transaction expected to close in the fourth quarter of 2025, pending shareholder approval and other conditions. Despite these plans, the company noted that there is no guarantee the acquisition will be completed as scheduled. Meanwhile, H.C. Wainwright has reiterated a Buy rating for atai Life Sciences, setting a price target of $15.00, following positive clinical data on its psychedelic treatment. These recent developments highlight atai Life Sciences’ ongoing efforts in expanding its therapeutic offerings and strategic acquisitions.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.