MALVERN, 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... Read More

MALVERN, Pa., March 28, 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 financial results for the fourth quarter and year ended December 31, 2023 and provided recent corporate updates. "As a result of last year’s FDA request for a... Read More

FDA confirms need for new trial for avasopasem; GRECO trials with rucosopasem to be discontinued Company evaluating potential strategic options to optimize shareholder value MALVERN, Pa., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in... Read More

FDA confirms need for new trial for avasopasem for severe oral mucositis (SOM) GRECO-2 trial did not pass futility analysis; Company will discontinue both GRECO trials Company reviewing potential strategic alternatives to maximize shareholder value MALVERN, Pa., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel,... Read More

MALVERN, 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... Read More

MALVERN, 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... Read More

Company received Complete Response Letter from FDA for avasopasem and intends to request Type A meeting with FDA to discuss potential next steps Cash runway extended into Q2 2024 in connection with reduction in workforce FDA granted orphan drug designation to rucosopasem for the treatment of pancreatic cancer Enrollment in GRECO trials with rucosopasem remains ongoing MALVERN, Pa., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Galera... Read More

The 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 will take actions to extend its cash runway and continue enrolling its rucosopasem clinical trials Conference call tomorrow, August 10, 2023 at 8:30 a.m. ET MALVERN, Pa., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage... Read More

As previously reported, avasopasem reduced cisplatin-related chronic kidney disease by 50% compared to placebo at one-year follow-up Additional data demonstrated improved preservation of kidney function at month 3 through one year in avasopasem-treated patients Based on ROMAN oral mucositis data, avasopasem NDA under FDA priority review for radiotherapy-induced SOM; PDUFA target date of August 9, 2023 MALVERN, Pa., June 05,... Read More

MALVERN, Pa., May 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 the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Galera’s second product candidate,... Read More

Avasopasem NDA granted FDA priority review for radiotherapy-induced severe oral mucositis (SOM); PDUFA target date of August 9, 2023 Company raised $30 million in gross proceeds from registered direct offering Company expanded commercial team and appointed leading biopharmaceutical executives with decades of experience successfully launching and commercializing new oncology products MALVERN, Pa., May 11, 2023 (GLOBE... Read More

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... Read More

Company appoints leading sales, market access and operations executives with decades of experience successfully launching and commercializing new oncology products New Drug Application (NDA) for avasopasem is currently under priority review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee (PDUFA) target date of August 9, 2023 MALVERN, Pa., May 01, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics,... Read More

MALVERN, 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... Read More

MALVERN, 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 10 th European Congress on Head and Neck... Read More

Avasopasem NDA granted FDA priority review for radiotherapy-induced severe oral mucositis (SOM); PDUFA target date of August 9, 2023 Company raised $30 million in gross proceeds from registered direct offering MALVERN, Pa., March 08, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary... Read More

MALVERN, 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... Read More

PDUFA target date of August 9, 2023 Avasopasem would be first drug approved for SOM in patients with head and neck cancer MALVERN, 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 the... Read More

NDA based on two positive randomized, double-blinded, placebo-controlled trials which enrolled a total of 678 patients MALVERN, Pa., Dec. 12, 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 the... Read More