secwatch.observer — SEC 8-K summary
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Issuer:     Definium Therapeutics, Inc. (DFTX)
CIK:        0001813814
Form:       8-K
Filed at:   2026-08-12T12:05:37+00:00
Accession:  0001104659-26-094528
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Definium DT120 ODT Phase 3 Voyage study hits primary endpoint in GAD; HAM-A diff -5.4
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- Primary endpoint met: HAM-A LS mean change -11.6 vs placebo -6.2, placebo-adjusted -5.4 (p<0.0001, d=0.81).
- Key secondary endpoints met: CGI-S at Week 12 -0.6 (p<0.0001); HAM-A at Week 1 -7.7 (p<0.0001).
- HAM-A response rate (≥50%) 43% vs 16% (p<0.0001); remission rate (≤7) 14% vs 4% (p=0.0222).
- Safety: mild-to-moderate transient AEs, no new signals, no suicidality; mean EoSC time 6.4 hours.
- Panorama GAD topline results expected in September 2026; follows positive Emerge MDD readout in June.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1813814/000110465926094528/0001104659-26-094528-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1813814/000110465926094528/tm2622948d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-094528

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