Definium’s LSD-Based Therapy Posts Third Positive Phase 3 Result in GAD

Overview

• The Panorama Phase 3 trial met its primary endpoint for generalized anxiety disorder with the 100 microgram DT120 ODT dose producing a 9.8-point fall in HAM-A at 12 weeks versus 4.7 points for placebo, a placebo-adjusted difference of 5.1 and an effect size of 0.64.
• The Panorama readout, announced Monday, is the third positive Phase 3 result for DT120 ODT following the Voyage GAD study and the Emerge major depressive disorder study, and the company reported efficacy differences as early as Day 2.
• Safety and tolerability were consistent with earlier trials: most adverse events were mild to moderate and transient, overall discontinuation was 10.4% on drug versus 10.3% on placebo, and 97% of participants met end-of-session criteria by eight hours across more than 1,000 program treatment sessions.
• The 245-patient Panorama design included a 50 microgram arm to limit functional unblinding but patients still tended to identify active treatment, a data quality issue regulators will examine when reviewing subjective efficacy measures.
• Investors reacted strongly with the stock up about 20% in premarket trading and Definium has a pre-NDA meeting scheduled for Q4 2026 and plans to file an NDA in the first half of 2027, though final approval will depend on full data review by the FDA and regulator questions about blinding and measurement.