secwatch.observer — SEC 8-K summary
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Issuer:     Immunome Inc. (IMNM)
CIK:        0001472012
Form:       8-K
Filed at:   2025-12-15T23:59:59+00:00
Accession:  0001193125-25-318429
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Immunome Phase 3 RINGSIDE trial of varegacestat meets primary endpoint with 84% risk reduction
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- Progression-free survival HR=0.16 (95% CI 0.071-0.375, p<0.0001) vs placebo in desmoid tumors.
- Confirmed ORR 56% with varegacestat vs 9% with placebo (p<0.0001); median tumor volume change -83% vs +11%.
- All key secondary endpoints met; safety consistent with GSI class (most common AEs: diarrhea 82%, fatigue 44%, rash 43%).
- NDA submission to FDA planned for Q2 2026; additional data to be presented at upcoming medical conference.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1472012/000119312525318429/0001193125-25-318429-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1472012/000119312525318429/d793961d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-318429

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