Phase 3 Panorama Study Topline Data Readout

Definium Therapeutics presents topline results from the Phase 3 Panorama study evaluating DT120 (lysergide ODT) 100 Γg in generalized anxiety disorder (GAD). The study met its primary endpoint, showing a statistically significant 5.1-point HAM-A improvement over placebo at week 12. Rapid onset was observed as early as week 1, alongside significant improvements across secondary endpoints including CGI-S. Treatment with DT120 was well tolerated with no new safety signals or drug-related serious adverse events reported. Standardized treatment sessions averaged 6.2 hours to clearance on the End of Session Checklist, with over 94% of participants cleared by hour 8. Interim analysis from Part B showed sustained and further improved response and remission rates through week 28 with flexible open-label retreatment. These findings support plans for a pre-NDA meeting in Q4 2026 and an anticipated NDA submission in the first half of 2027. DT120 aims to provide a novel, highly differentiated interventional treatment paradigm for millions of patients living with GAD.