DT120 ODT (Lysergide (LSD)) - (Emerge)

June 22, 2026: Definium Therapeutics, Inc. (Nasdaq: DFTX) reported positive topline results from Emerge, a randomized, double-blind, placebo-controlled Phase 3 trial of a single 100 µg dose of DT120 (lysergide) orally disintegrating tablet (ODT) in adults with major depressive disorder (MDD). The study met the primary endpoint (MADRS change from baseline at Week 6): LS mean -13.3 with DT120 vs -5.2 with placebo, placebo-adjusted difference -8.1 (p<0.0001). Key secondary endpoints were also met, including MADRS at Week 1 (placebo-adjusted -14.2; p<0.0001) and Week 12 (placebo-adjusted -7.3; p<0.0001), and CGI-S changes at Day 2, Week 6, and Week 12 (all p<0.0001). Week 6 MADRS response rate (≥50%) was 35% vs 7% (p<0.001) and remission rate (≤12) 24% vs 3% (p<0.01).

DT120 ODT was generally well tolerated; 99% of treatment-emergent AEs were mild/moderate, no serious AEs or suicidality signal were observed. The company said results support advancing toward FDA submission and hosted a webcast at 8:00 a.m. EDT. Emerge is one of two pivotal Phase 3 MDD studies; Ascend is ongoing and includes 100 µg, 50 µg, and placebo arms with a Week 6 MADRS primary endpoint.