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, Inc. (GRTX) is a clinical-stage biopharmaceutical company pioneering therapies to reduce radiotherapy complications and enhance cancer treatment efficacy. This dedicated news hub provides investors and researchers with timely updates on clinical developments, regulatory milestones, and strategic initiatives.
Access comprehensive coverage of GRTX's dismutase mimetic pipeline, including avasopasem manganese for severe oral mucositis and rucosopasem manganese for radiation sensitization. Track progress across Phase 2/3 trials, partnership announcements, and scientific presentations while staying informed about financial updates and corporate strategies.
Our curated news collection features verified press releases on trial results, FDA designations (Fast Track/Breakthrough Therapy), intellectual property developments, and management commentary. Regular updates ensure stakeholders maintain current insights into GRTX's oncology-focused research and market positioning.
Bookmark this page for centralized access to GRTX's latest advancements in radiotherapy toxicity reduction and anti-cancer therapeutic development. Check back frequently for authoritative reporting on this innovative biopharmaceutical company's progress in transforming cancer care paradigms.
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.
Galera Therapeutics (GRTX) announced a pivotal year ahead with FDA's Priority Review for its NDA on avasopasem, aimed at reducing radiotherapy-induced severe oral mucositis (SOM) in head and neck cancer patients. The PDUFA target date is set for August 9, 2023. The company raised $30 million through a direct offering to support operations and upcoming commercial efforts. Financially, Q4 2022 showed research and development expenses of $8.1 million, with a net loss narrowing to $(16.2) million. For the entire year, 2022's net loss was $(62.2) million, a significant improvement from $(80.5) million in 2021.
Galera Therapeutics (GRTX) announced a registered direct offering of 14,320,000 shares of common stock and accompanying warrants at an offering price of $2.095 per share. The gross proceeds are expected to be approximately $30 million before fees and expenses. The warrants are set to expire five years from issuance and have an exercise price of $1.97 per share. This offering is slated to close around February 17, 2023, pending customary conditions. Galera is actively pursuing the development of innovative cancer therapeutics, with avasopasem under priority review by the FDA for treating radiation-induced oral mucositis.
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