Shares of ATAI Life Sciences (NASDAQ:ATAI) skyrocketed 29% on Tuesday after the biotech company and its partner, Beckley Psytech, reported encouraging topline results from a Phase 2b trial evaluating their investigational depression treatment BPL-003 in patients with treatment-resistant depression.
The clinical trial successfully met its primary endpoint along with all key secondary measures. Both the 8mg and 12mg single intranasal doses of BPL-003 (mebufotenin) produced statistically significant reductions in depressive symptoms compared to a low-dose control group. On Day 29, participants receiving the 12mg dose showed an average reduction of 11.1 points on the Montgomery-Åsberg Depression Rating Scale (MADRS), while the 8mg group saw an even greater drop of 12.1 points. In contrast, the control group showed a 5.8-point reduction.
The treatment demonstrated a favorable safety profile, with nearly all reported adverse events categorized as mild or moderate in severity. Importantly, no serious adverse events tied to the drug were reported. A standout observation from the trial was that the majority of participants were ready for discharge within 90 minutes of administration—an indication the treatment could be administered under existing two-hour clinic 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 trial involved 193 participants across 38 sites in six countries, making it the most comprehensive controlled study of mebufotenin to date. It is also the first blinded Phase 2 trial of the compound to include U.S. patients.
Following the promising results, ATAI and Beckley Psytech intend to move forward with Phase 3 development of the 8mg dose, pending discussions with regulatory agencies.
Additionally, the outcome of the study fulfills key success conditions outlined in the companies’ planned merger agreement announced in June 2025. This milestone paves the way for the deal to move ahead toward shareholder approval.