Definium Therapeutics’ DT120 LSD tablet wins FDA breakthrough tag in major depressive disorder after Phase 3 study

• Definium Therapeutics received FDA Breakthrough Therapy designation for DT120 orally disintegrating tablet in major depressive disorder.
• The designation follows results already presented from the Phase 3 Emerge study, which showed meaningful symptom improvement versus placebo.
• Benefits were described as sustained over time, supporting a potential shift toward faster-acting, durable treatment options in depression.
• DT120 is a proprietary, optimized LSD formulation; it previously secured Breakthrough Therapy designation for generalized anxiety disorder.

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