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Definium Therapeutics said its DT120 fast-dissolving LSD formulation met the Phase 3 Panorama primary endpoint in GAD with rapid effects and mostly mild adverse events, received FDA Breakthrough Therapy status, and is pushing an NDA toward H1 2027.
The company says its Phase 3 Panorama study for DT120 ODT 100 µg met all primary and key secondary endpoints for reducing anxiety symptoms in GAD, with rapid, sustained efficacy and a favorable safety profile. The company plans an NDA submission for 2027.