AtaiBeckley N.V. $(ATAI)$, a clinical-stage biopharmaceutical company, announced positive topline results from the open-label extension (OLE) study of its Phase 2b clinical trial of BPL-003 in patients with treatment-resistant depression (TRD). The study found that a 12 mg dose of BPL-003, administered eight weeks after an initial dose, was generally well-tolerated and provided additional rapid and clinically meaningful antidepressant effects sustained for up to eight weeks. These results are consistent with previously reported findings from the blinded core study, which showed statistically significant reductions in depressive symptoms for both 8 mg and 12 mg single doses compared to a low-dose control. The company plans to discuss Phase 3 clinical trial designs with the U.S. Food and Drug Administration and anticipates providing guidance on the Phase 3 program in the first quarter of 2026, with trial initiation expected in the second quarter of 2026, pending regulatory alignment. The topline results have already been presented.
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