Beckley’s intranasal psychedelic BPL-003 clears Phase II readout for treatment-resistant depression, with data supporting late-stage plans and a Beckley-atai merger

Beckley Psytechs intranasal psychedelic BPL-003 shows statistically significant symptom easing in patients with treatment-resistant depression in a Phase II readout, advancing the programs late-stage path. After 29 days, the 12 mg dose produced an 11.1 point reduction on the MADRS scale versus a 5.8 point reduction with the 0.3 mg control, with a reported p-value of 0.0038. The 8 mg dose also outperformed control, with a 12.1 point improvement, and benefits were reported to persist out to eight weeks, with improvements maintained through 57 days. Jefferies characterized the readout as robust, noting the effects after a single dose and projecting potential peak sales. The results are also described as meeting the success criteria needed to complete a proposed merger between Beckley and atai Life Sciences, with further data planned for a future scientific congress and FDA alignment for a Phase III study design. The drug was reported to be well tolerated, with no serious adverse events linked to the study drug and no cases of suicidal intent or behaviors.