regulatory
confidence high
sentiment positive
materiality 0.85
FDA grants Breakthrough Therapy Designation to MindMed's MM120 for GAD; Phase 2b shows durable 12-week effect
Definium Therapeutics, Inc.
- FDA breakthrough designation for MM120 (lysergide d-tartrate) to treat generalized anxiety disorder.
- Phase 2b met key secondary endpoint: MM120 100 µg showed 7.7-point HAM-A improvement vs placebo at Week 12 (p<0.003).
- 65% clinical response rate and 48% clinical remission rate sustained to Week 12 from a single dose.
- Plans End-of-Phase 2 meeting with FDA in H1 2024, Phase 3 initiation in H2 2024.
- Terminated ATM prospectus for up to $100M of common shares; no new sales until new prospectus filed.