AtaiBeckley posts positive Phase 2b open-label extension data for BPL-003 in treatment-resistant depression

AtaiBeckley Inc. (ATAI) — AtaiBeckley reported that a second, 12 mg dose of its intranasal mebufotenin (5-MeO-DMT) candidate BPL-003, given roughly eight weeks after an initial dose, was well tolerated and produced additional rapid, durable antidepressant effects.

Pooled active-core patients (n=60) showed a mean MADRS reduction of 19.0 points with a 63% response and 48% remission rate at Day 57. The company said the data support a two-dose regimen heading into a planned Phase 3 program, with an FDA End-of-Phase 2 meeting scheduled and Phase 3 guidance expected in Q1 2026.

Source: ir.ataibeckley.com

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