Galera Therapeutics completes acquisition of Nova PharmaceuticalsGalera’s development strategy shifts from toxicity reduction to anti-cancer therapeutics, with three trials in patients with highly resistant subsets of advanced breast cancer.
Galera Reports First Quarter 2024 Financial Results and Recent Corporate UpdatesCompany’s evaluation of potential strategic alternatives progresses with goal to maximize stockholder value
Galera Adopts Limited Duration Stockholder Rights AgreementMALVERN, Pa., May 03, 2024 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that its Board of Directors (the “Board”) has unanimously resolved to adopt a limited duration stockholder rights agreement (the “Rights Agreement”) to protect stockholder interests.
Galera Reports Third Quarter 2023 Financial Results and Recent Corporate UpdatesFDA confirms need for new trial for avasopasem; GRECO trials with rucosopasem to be discontinued
Galera Announces Receipt of Type A Meeting Minutes and Strategic UpdateFDA confirms need for new trial for avasopasem for severe oral mucositis (SOM)
Galera Schedules Type A Meeting with FDA to Discuss Next Steps for AvasopasemMALVERN, Pa., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that a Type A Meeting has been scheduled for September 28, 2023 with the U.S. Food and Drug Administration (FDA) regarding the Complete Response Letter (CRL) received for the Company’s New Drug Application (NDA) for avasopasem manganese (avasopasem). The FDA is expected to issue written meeting minutes approximately 30 days following the meeting.
Galera to Participate in the H.C. Wainwright 25th Annual Global Investment ConferenceMALVERN, Pa., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that Mel Sorensen, M.D., President and Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 25th Annual Global Investment Conference on Monday, September 11, 2023, at 4:30 p.m. E.T.
Galera Reports Second Quarter 2023 Financial Results and Recent Corporate UpdatesCompany received Complete Response Letter from FDA for avasopasem and intends to request Type A meeting with FDA to discuss potential next steps
Galera Receives Complete Response Letter from U.S. FDA for Avasopasem ManganeseThe Company remains committed to its goal of bringing avasopasem to patients and intends to meet with FDA as soon as possible to discuss potential next steps
Galera Presents Additional Chronic Kidney Disease Data from ROMAN Trial at 2023 ASCO Annual MeetingAs previously reported, avasopasem reduced cisplatin-related chronic kidney disease by 50% compared to placebo at one-year follow-up
Galera Announces FDA Orphan Drug Designation Granted to Rucosopasem for Pancreatic CancerRucosopasem in clinical development to augment the anti-cancer efficacy of stereotactic body radiation therapy
Galera Reports First Quarter 2023 Financial Results and Recent Corporate UpdatesAvasopasem NDA granted FDA priority review for radiotherapy-induced severe oral mucositis (SOM); PDUFA target date of August 9, 2023
Galera Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)MALVERN, Pa., May 04, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that on May 1, 2023, the Compensation Committee of Galera’s board of directors granted inducement equity grants consisting of stock options to purchase an aggregate of 315,000 shares of its common stock to three new employees.
Galera Expands Commercial Leadership TeamCompany appoints leading sales, market access and operations executives with decades of experience successfully launching and commercializing new oncology products
Galera to Present One-Year Reductions in Cisplatin-Related Chronic Kidney Disease Data from ROMAN Trial at 2023 American Society of Clinical Oncology (ASCO) Annual MeetingMALVERN, Pa., April 26, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that a prespecified analysis from the Phase 3 ROMAN trial detailing one-year reductions in cisplatin-related chronic kidney disease in patients with head and neck cancer treated with avasopasem will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, 2023, in Chicago, IL.
Galera Announces Presentation of Supplemental Analysis of Phase 3 ROMAN Trial at European Congress on Head and Neck OncologyMALVERN, Pa., March 10, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced the presentation of a net treatment benefit analysis of Phase 3 ROMAN results at the 10th European Congress on Head and Neck Oncology (ECHNO), taking place March 8-11, 2023, in Lisbon, Portugal. The analysis further demonstrates the overall impact of avasopasem manganese (avasopasem) in reducing the burden of severe oral mucositis (SOM). Galera’s New Drug Application (NDA) in the U.S. for avasopasem is currently under U.S. Food and Drug Administration (FDA) priority review for radiotherapy (RT)-induced SOM in patients with head and neck cancer undergoing standard-of-care treatment.
Galera Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Corporate UpdatesAvasopasem NDA granted FDA priority review for radiotherapy-induced severe oral mucositis (SOM); PDUFA target date of August 9, 2023
Galera Therapeutics Announces Pricing of Registered Direct Offering of $30 Million of Common Stock and WarrantsMALVERN, Pa., Feb. 15, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that it has agreed to sell 14,320,000 shares of common stock and warrants to purchase up to 14,320,000 shares of common stock in a registered direct offering at a combined offering price of $2.095 per share and accompanying warrant. The warrants have an exercise price of $1.97 per share of common stock. The gross proceeds of the offering are expected to be approximately $30 million, before placement agent fees and offering expenses. All shares of common stock and warrants to purchase common stock to be sold in the offering will be sold by Galera. The warrants will be exercisable immediately following their issuance and will expire five years from the date of issuance. The offering is expected to close on or about February 17, 2023, subject to customary closing conditions.
Galera Submits New Drug Application for Avasopasem for Severe Oral MucositisNDA based on two positive randomized, double-blinded, placebo-controlled trials which enrolled a total of 678 patients
Galera to Present at Piper Sandler Annual Healthcare ConferenceMALVERN, Pa., Nov. 22, 2022 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that Mel Sorensen, M.D., President and Chief Executive Officer, will present at the Piper Sandler 34th Annual Healthcare Conference on Tuesday, November 29, 2022 at 11:10 a.m. E.T.
