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 corrected topline data from its Phase 3 ROMAN trial for avasopasem, indicating statistical significance in reducing the incidence of severe oral mucositis (p=0.045) in patients undergoing radiotherapy for head and neck cancer. The trial demonstrated a 16% relative reduction in incidence compared to placebo. The company plans to discuss this data with the FDA in 2022 and will hold a conference call on December 14. The trial results align with earlier Phase 2a EUSOM results, confirming the drug's potential in managing radiotherapy-induced toxicities.
Galera Therapeutics (Nasdaq: GRTX) announced that Mel Sorensen, M.D., CEO, will present at two investor conferences this November. The first event is the Jefferies London Healthcare Conference on November 18, 2021, available on-demand from 8:00 a.m. GMT. The second event is the Piper Sandler Annual Healthcare Conference on November 22, 2021, starting at 10 a.m. ET. Webcasts can be accessed from the investors.galeratx.com page and will be archived for 30 days.
Galera Therapeutics, Inc. (Nasdaq: GRTX) reported its Q3 2021 financial results, showcasing a net loss of $(22.6) million, or $(0.86) per share, compared to $(17.1) million, or $(0.69) per share in Q3 2020. The company maintains a solid cash position of $89 million, expected to last into 2023. Despite the Phase 3 ROMAN trial of avasopasem for severe oral mucositis not meeting its primary endpoint, it demonstrated tolerability and reduced severity duration. Enrollment continues in GRECO-1 and GRECO-2 trials for rucosopasem in lung and pancreatic cancers, with data expected in 2022.
Galera Therapeutics (GRTX) announced results from the Phase 3 ROMAN trial of avasopasem for severe oral mucositis (SOM) in head and neck cancer patients. The primary endpoint of reducing SOM incidence was not met, showing only a 16% reduction (54% vs. 64%) without statistical significance (p=0.113). However, secondary endpoints indicated a 56% reduction in duration of SOM (8 days vs. 18 days, p=0.011) and a 27% reduction in severity (Grade 4 OM). Avasopasem was well tolerated compared to placebo. The company continues to analyze results and explore next steps for its pipeline, including GC4711.
Galera Therapeutics, Inc. (Nasdaq: GRTX) has announced the appointments of Mark J. Bachleda as Chief Commercial Officer and Jennifer Evans Stacey as Chief Legal and Compliance Officer. Both executives bring over 25 years of experience in the biopharmaceutical industry. Bachleda, previously with Bristol Myers Squibb, will focus on the commercialization of avasopasem, a treatment for severe oral mucositis in cancer patients. Stacey, formerly at The Wistar Institute, will lead legal and compliance efforts. These hires come as Galera aims to transition into a commercial-stage company.
Galera Therapeutics (Nasdaq: GRTX) announced a virtual Key Opinion Leader event to discuss radiotherapy-induced severe oral mucositis (SOM) in head and neck cancer patients. The event is scheduled for Thursday, September 23, 2021, at 11:00 a.m. ET, featuring Dr. Carryn Anderson from the University of Iowa, alongside testimonials from survivors and insights from Galera's CEO, Mel Sorensen, M.D. The company’s lead candidate, avasopasem manganese, is in a Phase 3 ROMAN trial, expected to report results in the fourth quarter of 2021. The event will be accessible via Galera’s investor website.
Galera Therapeutics, Inc. (Nasdaq: GRTX) announced promising results from its Phase 1/2 trial evaluating GC4419 in patients with locally advanced pancreatic cancer. The study showed significant improvements in overall survival (HR=0.48), progression-free survival (HR=0.46), local tumor control (HR=0.30), and time to distant metastasis (HR=0.39). Notably, 46% of patients treated with GC4419 were alive at last follow-up compared to 33% in the placebo group. The trial's positive outcomes support the ongoing GRECO-2 Phase 2b trial, which aims to further assess GC4711's efficacy.
Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company, announced that Mel Sorensen, M.D., will present at three virtual investor conferences in September 2021. The events include the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 21, and the Cantor Fitzgerald Global Healthcare Conference on September 29. Live webcasts will be available on Galera's Investors page, with archived versions accessible for 30 days thereafter.
Galera Therapeutics (GRTX) announced the completion of enrollment in its pivotal Phase 3 ROMAN trial for avasopasem, aimed at treating severe oral mucositis in head and neck cancer patients, with topline data expected in Q4 2021. An interim analysis of a 42-patient pancreatic cancer trial showed nearly doubled median overall survival (20.1 months) compared to placebo (10.9 months). Additionally, the company initiated the GRECO-2 trial for pancreatic cancer. Financial results for Q2 2021 included a net loss of $22.4 million and total assets of $115.3 million, boosted by $57.5 million in milestone payments from Blackstone Life Sciences.
Galera Therapeutics (GRTX) announced the completion of enrollment in its pivotal Phase 3 ROMAN trial for avasopasem, aimed at treating severe oral mucositis (SOM) in head and neck cancer patients undergoing radiotherapy. This milestone triggers a $37.5 million payment from Blackstone Life Sciences. Approximately 70% of patients receiving radiotherapy for head and neck cancer develop SOM, and there are currently no approved treatments. Topline data is expected in the second half of 2021, with the potential for regulatory approval and commercialization.