secwatch.observer — SEC 8-K summary
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Issuer:     Galera Therapeutics, Inc. (GRTX)
CIK:        0001563577
Form:       8-K
Filed at:   2022-10-26T23:59:59+00:00
Accession:  0001193125-22-269333
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Galera presents positive Phase 3 ROMAN one-year data; meta-analysis confirms SOM reduction; NDA on track
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- One-year follow-up: avasopasem maintained comparable tumor outcomes and overall survival vs placebo in HNC patients.
- CKD incidence 10% (avasopasem) vs 20% (placebo) at one year (p=0.0043), a 50% reduction.
- Meta-analysis (n=551): avasopasem reduced SOM incidence by 19% (p=0.0053) and median days of SOM by 58% (p=0.0002).
- Meta-analysis also showed 28% delay in SOM onset (p=0.0005) and 32% reduction in Grade 4 incidence (p=0.0102).
- NDA submission for avasopasem for radiotherapy-induced SOM still on track for end of 2022.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1563577/000119312522269333/0001193125-22-269333-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1563577/000119312522269333/d399266d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-269333

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