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Investing.com -- ATAI Life Sciences (NASDAQ:ATAI) stock surged 29% after the company and its partner Beckley Psytech announced positive topline results from a Phase 2b study of BPL-003 in patients with treatment-resistant depression.
The study met its primary and all key secondary endpoints, with both 8mg and 12mg single doses of BPL-003 (intranasal mebufotenin) showing statistically significant reductions in depressive symptoms compared to a low-dose control. At Day 29, the 12mg dose demonstrated an 11.1-point reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) versus 5.8 points for the control group, while the 8mg dose showed a 12.1-point reduction.
The treatment was generally well-tolerated, with 99% of adverse events being mild or moderate and no drug-related serious adverse events reported. Notably, the majority of patients were deemed ready for discharge just 90 minutes after dosing, suggesting the treatment could fit within existing two-hour in-clinic treatment protocols.
"These findings strengthen our confidence in the potential of BPL-003 to be a transformative psychedelic therapy, offering rapid and durable antidepressive effects with minimal in-clinic time for patients with treatment-resistant depression," said Srinivas Rao, Chief Executive Officer and Co-Founder of atai.
The Phase 2b study, which enrolled 193 patients across 38 sites in six countries, is the largest controlled study of mebufotenin to date and the only blinded Phase 2 study to include U.S. participants. Based on the results, the companies plan to advance the 8mg dose into Phase 3 development after consulting with regulatory authorities.
The positive results also satisfy pre-agreed success criteria for the strategic combination between atai and Beckley Psytech announced in June 2025, allowing the merger to progress to shareholder approval.
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