---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-061361"
form_type: "8-K"
ticker: "DFTX"
cik: "0001813814"
company_name: "Definium Therapeutics, Inc."
filed_at: "2024-03-07T23:59:59+00:00"
generated_at: "2026-06-05T01:49:11.294679+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA grants Breakthrough Therapy Designation to MindMed's MM120 for GAD; Phase 2b shows durable 12-week effect

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-24-061361
- form_type: 8-K
- ticker: DFTX
- cik: 0001813814
- company_name: Definium Therapeutics, Inc.
- filed_at: 2024-03-07T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1813814/000119312524061361/0001193125-24-061361-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1813814/000119312524061361/d682854d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-061361
- JSON: https://secwatch.observer/filing/0001193125-24-061361.json
- Plain text: https://secwatch.observer/filing/0001193125-24-061361.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.