AtaiBeckleyNASDAQ: ATAI

Actual: Jul 1, 2025

Phase 2b (NCT05870540) primary endpoint met: 8 mg MADRS −12.1 pts vs −5.8 pts control (p=0.0025); 12 mg −11.1 pts (p=0.0038). Rapid onset at Day 2, sustained 8 weeks.

Why it matters: Clear, statistically significant dose-dependent efficacy; rapid onset differentiates BPL-003 from standard TRD treatments

Watch next: BTD, EOP2 meeting, Phase 3 initiation

Likely: Q2 2026

ReConnection 1 and ReConnection 2 Phase 3 programmes targeted Q2 2026 initiation

Why it matters: Phase 3 initiation is the final step before potential NDA; successful trials would position BPL-003 as a novel intranasal TRD therapy

Watch next: ClinicalTrials.gov NCT registration and first patient dosing announcements

Actual: Oct 16, 2025

FDA granted Breakthrough Therapy Designation to BPL-003 for TRD

Why it matters: BTD provides intensive FDA guidance, accelerated review, and rolling NDA submission; reduces Phase 3 programme uncertainty

Watch next: EOP2 meeting and Phase 3 programme design confirmation

Actual: Nov 10, 2025

Phase 2b open-label extension (OLE) positive data: second 12 mg dose at 8 weeks was well-tolerated and provided additional antidepressant effects sustained up to 8 weeks

Why it matters: OLE data supports a multi-dose treatment paradigm and addresses durability questions important for Phase 3 design

Watch next: EOP2 meeting confirmation and Phase 3 launch

Actual: Mar 3, 2026

Successful EOP2 meeting with FDA: FDA supported proposed pivotal Phase 3 programme (ReConnection 1: ~350 pts, 8 mg/4 mg/placebo; ReConnection 2: ~300 pts, two-dose regimen)

Why it matters: FDA alignment on Phase 3 design dramatically de-risks the programme; agency support for registrational endpoints is critical

Watch next: Phase 3 ClinicalTrials.gov registration and first patient dosing (Q2 2026)

Actual: Mar 11, 2025

ELUMINA Phase 2 (NCT06524830) first patient dosed; ~142 patients across multi-site US study, 2 doses 2 weeks apart

Why it matters: First Phase 2 study of a buccal film DMT formulation; novel delivery that avoids IV or inhalation and fits within standard therapy session durations

Watch next: Topline results at Week 4 primary endpoint

Likely: Q1 2026

Topline results expected Q1 2026 per company guidance

Why it matters: Proof-of-concept readout for buccal film DMT in TRD; would differentiate VLS-01 from inhaled competitors

Watch next: MADRS score at Week 4 primary endpoint

Actual: May 13, 2025

Exploratory Phase 2a (NCT06693609) first patient dosed: 71 adults with SAD in UK, 2 doses 225 mg 4 weeks apart

Why it matters: First clinical trial of single-enantiomer R-MDMA in SAD; non-psychotherapy design tests drug-alone effect

Watch next: Topline results at Day 43 primary endpoint

Actual: Feb 26, 2026

Phase 2a topline positive: safety primary met; exploratory efficacy LSAS reduction 11.85 pts (p=0.036 one-tailed, Hedges' g=0.45). No serious AEs, no suicidal ideation.

Why it matters: Safety and early efficacy signals support Phase 2b; SAD is an under-served indication with large patient population

Watch next: Phase 2b design and initiation