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NEW YORK/AMSTERDAM - AtaiBeckley N.V. (NASDAQ:ATAI) announced Monday positive topline results from the open-label extension study of its Phase 2b clinical trial for BPL-003, a mebufotenin benzoate nasal spray being developed for treatment-resistant depression. The announcement comes as the biotech company, currently valued at $934.5 million, has seen its stock surge over 213% in the past six months despite a recent 18.5% pullback last week, according to InvestingPro data.
The study showed that a 12 mg dose of BPL-003 administered eight weeks after an initial dose produced additional rapid antidepressant effects that were sustained for up to eight weeks. Among patients who initially received active doses (8 mg or 12 mg) in the core study, 63% met response criteria and 48% achieved remission at the eight-week mark of the extension study.
Patients who initially received the 8 mg dose showed a mean reduction of 22.3 points in the Montgomery-Asberg Depression Rating Scale (MADRS) score by day 57 of the extension study compared to their baseline at the start of the core study.
The treatment was generally well-tolerated with most adverse events occurring on dosing day and classified as mild or moderate. Common side effects included nausea, headache, and administration site pain. One serious drug-related adverse event was reported.
"Average time to meet readiness-for-discharge criteria was within 2 hours of dosing," according to the company's statement, suggesting potential compatibility with existing psychiatric treatment frameworks.
AtaiBeckley has scheduled an End-of-Phase 2 meeting with the FDA to discuss Phase 3 clinical trial designs. The company expects to provide guidance on its Phase 3 program in the first quarter of 2026, with trial initiation planned for the second quarter, pending FDA feedback.
The announcement follows the FDA's recent granting of Breakthrough Therapy designation to BPL-003 for treatment-resistant depression. Investors should note that AtaiBeckley is scheduled to report earnings in just 8 days on November 18, with analysts maintaining a strong buy consensus and price targets ranging from $8 to $16 per share. While InvestingPro analysis suggests the stock is currently trading above its Fair Value, the company maintains strong financial fundamentals with more cash than debt and liquid assets exceeding short-term obligations. InvestingPro offers 10 additional insights about AtaiBeckley's financial health and growth prospects.
In other recent news, ATAI Life Sciences has completed its public offering of 27.28 million common shares, raising approximately $149.5 million in gross proceeds. This financing effort included the full exercise of the underwriters' option to purchase an additional 3.56 million shares and attracted new investors such as Janus Henderson Investors and Deep Track Capital. Shareholders have also approved the acquisition of Beckley Psytech Limited and the company's planned redomiciliation to Delaware. In connection with this acquisition, a prospectus supplement was filed for the potential resale of over 5.3 million shares by certain securityholders. Canaccord Genuity has raised its price target for ATAI Life Sciences to $14, maintaining a Buy rating, following the FDA's breakthrough therapy designation for a treatment developed by Beckley. These developments highlight significant financial and strategic moves by ATAI Life Sciences.
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