secwatch.observer — SEC 8-K summary
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Issuer:     Galera Therapeutics, Inc. (GRTX)
CIK:        0001563577
Form:       8-K
Filed at:   2023-02-15T23:59:59+00:00
Accession:  0001193125-23-039798
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 2.02, 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Galera Therapeutics announces FDA priority review of NDA for avasopasem in SOM; PDUFA date Aug 9, 2023
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- FDA accepted NDA for avasopasem manganese for radiotherapy-induced severe oral mucositis in head/neck cancer.
- Priority review assigned; PDUFA target action date of August 9, 2023; no advisory committee meeting planned.
- Company estimates total US market opportunity for SOM exceeds $1 billion.
- Preliminary cash and investments balance of ~$31.6M as of Dec 31, 2022; audited results pending.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1563577/000119312523039798/0001193125-23-039798-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1563577/000119312523039798/d419811d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-039798

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