Welcome to our dedicated page for Galera Therapeutics news (Ticker: GRTX), a resource for investors and traders seeking the latest updates and insights on Galera Therapeutics stock.
Galera Therapeutics develops clinical-stage oncology therapeutics and reports corporate updates under the GRTX symbol. Company news has centered on its shift toward anti-cancer therapeutics following the completed acquisition of Nova Pharmaceuticals, including a pan-inhibitor of Nitric Oxide Synthase program studied in advanced breast cancer settings.
Recurring updates also cover Galera’s portfolio and capital structure, including the disposition of its dismutase mimetics assets such as avasopasem and rucosopasem, financing activity, stockholder voting matters, governance actions, and operating and financial results. Earlier company disclosures addressed clinical and regulatory matters for cancer-related product candidates and strategic alternatives for the business.
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Galera Therapeutics (Nasdaq: GRTX) announced a significant finding from the Phase 3 ROMAN trial that focuses on reductions in cisplatin-related chronic kidney disease (CKD) in patients with head and neck cancer. This analysis will be presented at the 2023 ASCO Annual Meeting scheduled for June 2-6, 2023 in Chicago, IL. The presentation, titled One-year reductions in CKD in patients with HNC cancer treated with avasopasem manganese, is set for June 5, 2023, from 1:15 PM to 4:15 PM ET. Avasopasem is currently under priority review by the FDA for severe oral mucositis, with a decision expected by August 9, 2023.
Galera Therapeutics, Inc. (Nasdaq: GRTX) announced a net treatment benefit analysis of the Phase 3 ROMAN trial results at the 10th ECHNO conference in Lisbon, Portugal, highlighting its drug avasopasem manganese's impact on severe oral mucositis (SOM) in head and neck cancer patients. The company’s New Drug Application (NDA) for avasopasem is currently under priority review by the FDA with a PDUFA date set for August 9, 2023. Galera is in discussions with European regulatory authorities for potential approval in Europe, emphasizing the drug's first-in-class potential to improve patient quality of life following radiotherapy.