Study met primary and all key secondary efficacy endpoints; Panorama is the second positive Phase 3 trial for DT120 ODT in GAD and the third positive Phase 3 trial for DT120 ODT

Participants receiving DT120 ODT 100 µg achieved a statistically significant reduction in Hamilton Anxiety Rating Scale (HAM-A) score, with a placebo-adjusted change of 5.1 points from baseline at Week 12 (p<0.0001, Cohen’s d=0.64)

DT120 ODT 100 µg was generally well tolerated, with a safety profile consistent with prior clinical experience

Pre-NDA meeting scheduled in 4Q 2026; NDA filing anticipated in 1H 2027

Company to host webcast today at 8 am EDT

Definium Therapeutics, Inc. (NASDAQ:DFTX) ("Definium" or the "Company"), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders, today announced positive topline results from Panorama, the Company’s second Phase 3 study of DT120 (lysergide) Orally Disintegrating Tablet (ODT) in adults with generalized anxiety disorder (GAD). This is the Company’s third positive Phase 3 readout for DT120 ODT, following the positive Emerge results in major depressive disorder (MDD) announced in June and the positive Voyage results in GAD announced in August.

Panorama met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement from baseline compared with placebo, as measured by the change in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12. The Least Squares (LS) mean change from baseline in HAM-A total score at Week 12 in participants who received DT120 ODT 100 µg was -9.8 compared with -4.7 for participants who received placebo, an LS mean difference of -5.1 points (p<0.0001), corresponding to a standardized effect size of d=0.64. Efficacy was rapid, with changes seen as early as Day 2 and sustained at all post-baseline timepoints in Part A.