Definium DT120 Phase 3 in GAD hits primary endpoint; HAM-A -5.1 vs placebo (p<0.0001)

Definium Therapeutics, Inc.

Panorama met primary endpoint: HAM-A LS mean change -9.8 vs placebo -4.7, diff -5.1 (p<0.0001, d=0.64).
All key secondary endpoints met; rapid onset by Day 2; response rate 32% vs 14% (p<0.05).
Well tolerated; no new safety signals; discontinuation rates ~10% across arms.
Pre-NDA meeting scheduled 4Q 2026; NDA filing anticipated 1H 2027.
Third positive Phase 3 for DT120 ODT following Emerge (MDD) and Voyage (GAD).

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