Definium gets second FDA Breakthrough Therapy designation for DT120 in MDD

Definium Therapeutics, Inc.

FDA granted Breakthrough Therapy designation for DT120 ODT in major depressive disorder; second BTD for program after GAD.
Phase 3 Emerge: single 100 µg dose showed 8.1-point placebo-adjusted MADRS improvement at Week 6 (p<0.0001), durable to Week 12.
MDD affects >21M US adults annually; fewer than one-third of patients reach remission with current treatments.
CEO Rob Barrow says designation underscores DT120's potential to transform treatment for serious mental health disorders.

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