$DFTX (DEFINIUM THERAPEUTICS) — 8-K: FDA grants second Breakthrough Therapy designation to DT120 ODT, now in MDD

The FDA granted Breakthrough Therapy designation for DT120 (lysergide) ODT in major depressive disorder, supported by Phase 3 Emerge study results. A single 100 µg dose showed an 8.1-point placebo-adjusted MADRS improvement at Week 6 (p<0.0001), with durable efficacy through Week 12. This is the second Breakthrough Therapy designation for DT120, following the designation for generalized anxiety disorder.

The FDA granted Breakthrough Therapy designation for DT120 (lysergide) ODT in major depressive disorder, supported by Phase 3 Emerge study results. A single 100 µg dose showed an 8.1-point placebo-adj