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NEW YORK/AMSTERDAM/OXFORD - Beckley Psytech and atai Life Sciences (NASDAQ:ATAI), a $440 million market cap biotech company that has seen its stock surge over 64% in the past six months according to InvestingPro data, announced positive results from their Phase 2b trial evaluating BPL-003, an intranasal mebufotenin treatment for treatment-resistant depression (TRD).
The study met its primary endpoint with a single 12 mg dose of BPL-003 reducing Montgomery-Åsberg Depression Rating Scale (MADRS) scores by 11.1 points from baseline compared to 5.8 points in the control group at Day 29. The 8 mg dose showed similar efficacy with a 12.1-point reduction. With analyst price targets ranging from $6 to $12 and a strong "Buy" consensus, InvestingPro data suggests significant upside potential for investors. The platform offers 11 additional exclusive insights about ATAI’s financial health and growth prospects.
Both dosage strengths demonstrated rapid onset of action, with statistically significant improvements observed as early as Day 2 and effects maintained through Week 8. The 193-patient study is the largest controlled trial of mebufotenin to date.
BPL-003 was generally well-tolerated with 99% of treatment-emergent adverse events being mild or moderate. No drug-related serious adverse events or suicide-related safety signals were reported. Most patients were ready for discharge within 90 minutes of administration.
"The 8 mg and 12 mg doses of BPL-003 demonstrated equivalent efficacy, suggesting the 8 mg dose may be sufficient to achieve therapeutic benefit," said Cosmo Feilding Mellen, CEO of Beckley Psytech. Based on these results, the companies plan to advance the 8 mg dose to Phase 3 development following regulatory consultation.
The positive results satisfy pre-agreed criteria for the strategic combination between atai and Beckley Psytech announced in June 2025, which is now expected to progress to shareholder approval. ATAI approaches this combination from a position of financial strength, with InvestingPro data showing a healthy current ratio of 4.07 and more cash than debt on its balance sheet, though the company is currently burning through cash as it advances its clinical programs.
Follow-up in the eight-week open-label extension stage is ongoing, with data expected in the third quarter of 2025. According to the press release, this will provide additional insights into repeat dosing safety and durability of antidepressant effects.
In other recent news, atai Life Sciences announced positive topline data from a Phase 2a study of BPL-003 for treatment-resistant depression. The study revealed that a single dose of BPL-003, combined with SSRIs, was well-tolerated and produced rapid antidepressant effects lasting up to three months. No serious adverse events were reported, and patients were dischargeable within two hours post-dosing. In a strategic move, atai Life Sciences is merging with Beckley Psytech, combining their mental health pipelines and focusing on the development of BPL-003. This merger, expected to close in the second half of 2025, aims to create a global leader in psychedelic mental health therapies. The combined entity, atai Beckley, will leverage both companies’ expertise in CNS drugs and psychedelic therapies. Lucid Capital Markets recently initiated coverage on atai Life Sciences with a Buy rating and a $12 price target, emphasizing the company’s extensive drug portfolio. H.C. Wainwright maintained its Buy rating and a $10 price target following the merger announcement. Additionally, atai Life Sciences held its annual general meeting, approving key proposals and appointing new directors, which are expected to streamline its governance structure.
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