---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-107275"
form_type: "8-K"
ticker: "DFTX"
cik: "0001813814"
company_name: "Definium Therapeutics, Inc."
filed_at: "2026-09-14T12:02:40+00:00"
generated_at: "2026-09-14T12:05:09.741420+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Definium DT120 Phase 3 in GAD hits primary endpoint; HAM-A -5.1 vs placebo (p<0.0001)

## Summary
- Panorama met primary endpoint: HAM-A LS mean change -9.8 vs placebo -4.7, diff -5.1 (p<0.0001, d=0.64).
- All key secondary endpoints met; rapid onset by Day 2; response rate 32% vs 14% (p<0.05).
- Well tolerated; no new safety signals; discontinuation rates ~10% across arms.
- Pre-NDA meeting scheduled 4Q 2026; NDA filing anticipated 1H 2027.
- Third positive Phase 3 for DT120 ODT following Emerge (MDD) and Voyage (GAD).

## SEC filing metadata
- accession: 0001104659-26-107275
- form_type: 8-K
- ticker: DFTX
- cik: 0001813814
- company_name: Definium Therapeutics, Inc.
- filed_at: 2026-09-14T12:02:40+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1813814/000110465926107275/0001104659-26-107275-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1813814/000110465926107275/tm2625365d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-107275
- JSON: https://secwatch.observer/filing/0001104659-26-107275.json
- Plain text: https://secwatch.observer/filing/0001104659-26-107275.txt

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