---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-384403"
form_type: "8-K"
ticker: "DFTX"
cik: "0001813814"
company_name: "Definium Therapeutics, Inc."
filed_at: "2026-09-08T12:00:15+00:00"
generated_at: "2026-09-08T12:05:19.283058+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Definium gets second FDA Breakthrough Therapy designation for DT120 in MDD

## Summary
- FDA granted Breakthrough Therapy designation for DT120 ODT in major depressive disorder; second BTD for program after GAD.
- Phase 3 Emerge: single 100 µg dose showed 8.1-point placebo-adjusted MADRS improvement at Week 6 (p<0.0001), durable to Week 12.
- MDD affects >21M US adults annually; fewer than one-third of patients reach remission with current treatments.
- CEO Rob Barrow says designation underscores DT120's potential to transform treatment for serious mental health disorders.

## SEC filing metadata
- accession: 0001193125-26-384403
- form_type: 8-K
- ticker: DFTX
- cik: 0001813814
- company_name: Definium Therapeutics, Inc.
- filed_at: 2026-09-08T12:00:15+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1813814/000119312526384403/0001193125-26-384403-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1813814/000119312526384403/dftx-20260908.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-384403
- JSON: https://secwatch.observer/filing/0001193125-26-384403.json
- Plain text: https://secwatch.observer/filing/0001193125-26-384403.txt

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