---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-075317"
form_type: "8-K"
ticker: "DFTX"
cik: "0001813814"
company_name: "Definium Therapeutics, Inc."
filed_at: "2024-06-20T23:59:59+00:00"
generated_at: "2026-06-01T03:38:02.070849+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0000950170-24-075317
- form_type: 8-K
- ticker: DFTX
- cik: 0001813814
- company_name: Definium Therapeutics, Inc.
- filed_at: 2024-06-20T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1813814/000095017024075317/0000950170-24-075317-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1813814/000095017024075317/mnmd-20240620.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-075317
- JSON: https://secwatch.observer/filing/0000950170-24-075317.json
- Plain text: https://secwatch.observer/filing/0000950170-24-075317.txt

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