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.
Galera Therapeutics (GRTX) announced its progress in clinical trials and financial results for Q2 2022. The company aims to submit a New Drug Application for avasopasem by year-end 2022. An oral presentation at the ASCO Annual Meeting highlighted positive outcomes from the Phase 3 ROMAN trial for treating radiotherapy-induced oral mucositis. Phase 1 data from the GRECO-1 trial demonstrated that rucosopasem combined with SBRT was well tolerated, with signs of anti-cancer activity. The company reported a net loss of $(14.6) million for the quarter.
Galera Therapeutics (GRTX) announced promising Phase 1 results from the GRECO-1 trial of rucosopasem combined with stereotactic body radiation therapy (SBRT) for non-small cell lung cancer. Safety was confirmed, with common adverse effects, including fatigue and cough. Of seven patients, six showed tumor response or stability, with significant tumor reductions. Notably, no Grade 2-4 declines in pulmonary function were observed, contrasting previous studies. The ongoing Phase 2 stage aims to evaluate efficacy in a larger group, with enrollment expected to complete in late 2023.
Galera Therapeutics (Nasdaq: GRTX) announced that Dr. Mel Sorensen, CEO, will present at the 2022 Jefferies Healthcare Conference on June 9 at 2:00 p.m. E.T. The presentation will highlight the company's innovative therapies aimed at transforming cancer radiotherapy. Investors can access a live webcast on Galera's investor page, and an archived version will be available for 30 days post-event. Galera's leading products include avasopasem manganese and rucosopasem manganese, focused on mitigating radiotherapy-induced toxicities and enhancing treatment efficacy in specific cancers.
Galera Therapeutics (GRTX) announced positive results from its Phase 3 ROMAN trial of avasopasem, demonstrating a significant reduction in severe oral mucositis (SOM) in patients undergoing radiotherapy for head and neck cancer. The trial involved 455 patients and showed over a 50% reduction in the median duration of SOM. Avasopasem has received Breakthrough Therapy and Fast Track Designations from the FDA, with a New Drug Application submission expected by the end of 2022. Results will be presented at the ASCO Annual Meeting on June 3, 2022.
Galera Therapeutics (GRTX) plans to submit a New Drug Application (NDA) for avasopasem, targeting radiotherapy-induced severe oral mucositis, by the end of 2022. The Phase 3 ROMAN trial results will be presented at the ASCO Annual Meeting. Positive topline data from the Phase 2a AESOP trial showed avasopasem significantly reduced the incidence of severe esophagitis in lung cancer patients undergoing chemoradiotherapy. Financially, Galera reported a net loss of $15.4 million for Q1 2022, down from $18.7 million in Q1 2021, with cash reserves of $60.9 million expected to sustain operations into late 2023.
Galera Therapeutics (GRTX) announced plans to file a New Drug Application (NDA) for avasopasem by the end of 2022 to treat severe oral mucositis (SOM) resulting from radiotherapy in patients with head and neck cancer. This follows positive data from the Phase 3 ROMAN trial and the Phase 2b trial. There are currently no FDA-approved treatments for SOM, affecting over 40,000 patients annually in the U.S. The FDA has granted Fast Track and Breakthrough Therapy Designations for avasopasem.
Galera Therapeutics (GRTX) announced promising topline results from the Phase 2a AESOP trial of avasopasem, aimed at reducing severe acute radiation-induced esophagitis in lung cancer patients undergoing chemoradiotherapy. Out of 29 patients evaluated, only 2 (7%) experienced Grade 3 esophagitis, with no reports of Grade 4 or 5. This is a significant improvement compared to the 20-30% incidence reported in literature. Avasopasem was well tolerated, suggesting a potential breakthrough in treating radiation-induced toxicities.
Galera Therapeutics (GRTX) announced that clinical data from its Phase 3 ROMAN trial of avasopasem for severe oral mucositis will be presented at the 2022 ASCO Annual Meeting from June 3-7, 2022, in Chicago, Illinois.
The oral presentation, led by Dr. Carryn M. Anderson, is titled 'ROMAN: Phase 3 trial of avasopasem manganese for severe oral mucositis in patients receiving chemoradiotherapy for locally advanced head and neck cancer.' The abstract number is 6005.
Additionally, the Phase 2 GRECO-2 study of rucosopasem will also be included in a poster session on June 4, 2022.
Galera Therapeutics (Nasdaq: GRTX) announced successful Phase 3 ROMAN trial results for avasopasem, aiming at severe oral mucositis in head and neck cancer patients. The trial met key endpoints, leading to an upcoming FDA meeting regarding a New Drug Application (NDA). 2021 saw a net loss of $80.5 million, or $3.12 per share, with a cash reserve of $71.2 million expected to last into 2H 2023. The firm plans to report additional data in 2022 from ongoing trials for esophagitis and lung cancer treatments.
Galera Therapeutics, Inc. (Nasdaq: GRTX) announced that its President and CEO, Mel Sorensen, M.D., will present at the H.C. Wainwright BioConnect Conference from January 10-13, 2022. The presentation will be available via webcast on January 10 at 7:00 a.m. ET on Galera's Investors page. This event highlights the company's focus on developing novel therapeutics aimed at transforming cancer radiotherapy. Galera's lead product candidates include avasopasem manganese and rucosopasem manganese, which target radiotherapy-induced toxicities and enhance treatment efficacy.