secwatch.observer — SEC 8-K summary
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Issuer:     Galera Therapeutics, Inc. (GRTX)
CIK:        0001563577
Form:       8-K
Filed at:   2023-05-30T23:59:59+00:00
Accession:  0001193125-23-156074
Event type: litigation
Sentiment:  neutral
Materiality: 0.60
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Galera Therapeutics sues CROs over Phase 3 ROMAN trial statistical error
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- Filed lawsuit in Pennsylvania against Alira Health Clinical and IQVIA Biotech for breach of contract and negligence.
- Error in 2021 statistical program for Phase 3 ROMAN trial corrected; yielded statistically significant p-values for primary and key secondary endpoints.
- Litigation is in early stages; company cannot predict outcome at this time.
- FDA accepted NDA for avasopasem with Priority Review; PDUFA target date August 9, 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1563577/000119312523156074/0001193125-23-156074-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1563577/000119312523156074/d465209d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-156074

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