secwatch.observer — SEC 8-K summary
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Issuer:     Definium Therapeutics, Inc. (DFTX)
CIK:        0001813814
Form:       8-K
Filed at:   2026-09-14T12:02:40+00:00
Accession:  0001104659-26-107275
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1813814/000110465926107275/0001104659-26-107275-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1813814/000110465926107275/tm2625365d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-107275

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer