NEW YORK — Definium Therapeutics, Inc. (“Definium” or the “Company”), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for DT120 (lysergide) ODT. The designation was supported by the significant unmet medical need in MDD and results from the Company’s Phase 3 Emerge study, in which a single 100 µg dose of DT120 ODT demonstrated a statistically significant 8.1-point placebo-adjusted improvement in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 (p<0.0001), with durable efficacy through Week 12. Read More
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Definium Therapeutics Receives Breakthrough Therapy Designation for DT120 (lysergide) Orally Disintegrating Tablet (ODT) in Major Depressive Disorder (MDD) Following Positive Phase 3 Results
Second FDA Breakthrough Therapy designation for DT120 reinforces its potential across MDD and generalized anxiety disorder (GAD), two disorders with significant unmet need NEW YORK — Definium Therapeutics, Inc. (“Definium” or the “Company”), a late-stage clinical biopharmaceutical company developing a new generation…