AtaiBeckley (ATAI) to Initiate Phase 3 Depression Study Following Positive FDA Meeting

This milestone follows the Breakthrough Therapy designation granted in late 2025, with the company remaining on track to initiate the Phase 3 program in the second quarter of 2026. The Phase 3 program consists of two parallel pivotal studies, ReConnection 1 and ReConnection 2, followed by a 52-week open-label extension to assess long-term safety and individualized retreatment. ReConnection 1 will evaluate single doses of 8 mg and 4 mg against a placebo to characterize the dose-response relationship, while ReConnection 2 will investigate a two-dose induction model on Day 1 and Day 15.

Designed to fit within existing interventional psychiatry workflows, BPL-003 aims to offer a rapid and durable treatment option with an approximately two-hour in-clinic experience. AtaiBeckley Inc. (NASDAQ:ATAI) believes that this model addresses significant barriers for patients and providers by requiring only a few treatments per year.

AtaiBeckley Inc. (NASDAQ:ATAI) is a clinical-stage biopharmaceutical company that researches, develops, and commercializes mental health treatments in the US, Germany, and Canada.

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