$DFTX (DEFINIUM THERAPEUTICS) — 8-K: Definium's DT120 ODT Hits Phase 3 GAD Endpoint With 5.1-Point HAM-A Reduction

In the Phase 3 Panorama study, DT120 ODT 100 g produced an LS mean HAM-A change of -9.8 versus -4.7 for placebo at Week 12, a placebo-adjusted difference of -5.1 points (p<0.0001, Cohen's d=0.64). Panorama is the second positive Phase 3 trial for DT120 ODT in generalized anxiety disorder and the third positive Phase 3 readout for the program. A pre-NDA meeting is scheduled for 4Q 2026, with NDA filing anticipated in 1H 2027.

In the Phase 3 Panorama study, DT120 ODT 100 g produced an LS mean HAM-A change of -9.8 versus -4.7 for placebo at Week 12, a placebo-adjusted difference of -5.1 points (p<0.0001, Cohen's d=0.64). Pan