MindMed reaches alignment with FDA on Phase 3 plan for MM120 in GAD

Definium Therapeutics, Inc.

Constructive End-of-Phase 2 meeting with FDA; aligned on Phase 3 requirements for MM120 (LSD D-tartrate) in generalized anxiety disorder.
Phase 3 program initiation remains on schedule for second half of 2024.
Phase 2b MMED008 trial results: MM120 100 µg cohort showed 65% clinical response rate and 48% remission rate on HAM-A at Week 12.
Last new FDA approval for GAD was in 2007; no robust treatment options have emerged since.

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