Galera Therapeutics

Galera Therapeutics, Inc. operates as a clinical-stage biotechnology company. It focuses on developing and commercializing a pipeline of novel, proprietary therapeutics for cancer. The firm is involved in the prevention of radiation-induced toxicity, including mucositis and the treatment of fibrosis and cancer. Its product candidate, GC4419, reduces severe oral mucositis in patients with head and neck cancer undergoing radiation therapy and receiving cisplatin, a chemotherapy drug. The company was founded by Robert A. Beardsley, Randy W. Weiss, and Dennis P. Riley in 2009 and is headquartered in Malvern, PA.

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Galera Therapeutics, Inc. is a clinical stage biotechnology company, which engages in developing and commercializing a pipeline of novel, proprietary therapeutics for cancer. It is also involved in the prevention of radiation-induced toxicity, including mucositis and the treatment of fibrosis, and cancer. The company was founded by Robert A. Beardsley, Randy W. Weiss, and Dennis P. Riley in 2009 and is headquartered in Malvern, PA.

Company continues to evaluate strategic options to maximize shareholder value Company continues to evaluate strategic options to maximize shareholder value

Galera Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Updates

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 cancer, today announced financial results for the third quarter ended September 30, 2023 and provided recent corporate updates.

Galera Reports Third Quarter 2023 Financial Results and Recent Corporate Updates

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, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that it has received official meeting minutes from the Type A meeting with the United States Food and Drug Administration (FDA) held September 28, 2023 in which the FDA reiterated the need for an additional Phase 3 trial of avasopasem manganese (avasopasem) for radiotherapy-induced SOM.

Galera Announces Receipt of Type A Meeting Minutes and Strategic Update

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 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 Schedules Type A Meeting with FDA to Discuss Next Steps for Avasopasem

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Galera Therapeutics, Inc. (GRTX) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

All You Need to Know About Galera Therapeutics, Inc. (GRTX) Rating Upgrade to Buy

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Company received Complete Response Letter from FDA for avasopasem and intends to request Type A meeting with FDA to discuss potential next steps

Galera Reports Second Quarter 2023 Financial Results and Recent Corporate Updates

Galera Therapeutics shares plunged by almost 85% after the clinical-stage biopharmaceutical company revealed its New Drug Application for its investigational therapeutic avasopasem manganese (avasopasem) for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment was not approved by the Food and Drug Administration (FDA).  The company said that the FDA had informed it that the data from its Phase 3 ROMAN trial and supporting data from its GT-201 trial were “not sufficiently persuasive to establish substantial evidence of avasopasem's effectiveness and safety for reducing severe oral mucositis in patients with head and neck cancer.

Galera Therapeutics shares plummet after FDA rejects drug for cancer treatment side effect

Galera Therapeutics (NASDAQ: GRTX ) stock is falling hard on Thursday following a drug rejection by the FDA! In a Complete Response Letter ( CRL ), the FDA rejected the company's New Drug Application (NDA) for avasopasem manganese.

Why Is Galera Therapeutics (GRTX) Stock Down 83% Today?

Galera Therapeutics Inc said the U.S. health regulator declined to approve its drug to treat radiotherapy-induced severe mouth inflammation in patients with advanced head and neck cancer undergoing standard-of-care treatment.

Galera shares tank after US FDA declines to approve inflammation disease drug

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 Receives Complete Response Letter from U.S. FDA for Avasopasem Manganese

As previously reported, avasopasem reduced cisplatin-related chronic kidney disease by 50% compared to placebo at one-year follow-up

Galera Presents Additional Chronic Kidney Disease Data from ROMAN Trial at 2023 ASCO Annual Meeting

Avasopasem NDA granted FDA priority review for radiotherapy-induced severe oral mucositis (SOM); PDUFA target date of August 9, 2023

Galera Reports First Quarter 2023 Financial Results and Recent Corporate Updates

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 Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Company appoints leading sales, market access and operations executives with decades of experience successfully launching and commercializing new oncology products

Galera Expands Commercial Leadership Team

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 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 to Present One-Year Reductions in Cisplatin-Related Chronic Kidney Disease Data from ROMAN Trial at 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

Galera Therapeutics: A Possible Solution To Severe Oral Mucositis In Head And Neck Cancer Patients.

Galera Therapeutics: A Possible Solution To Severe Oral Mucositis In Head And Neck Cancer Patients

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 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 Announces Presentation of Supplemental Analysis of Phase 3 ROMAN Trial at European Congress on Head and Neck Oncology

Galera Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Corporate Updates

On February 21, 2023, Piper Sandler initiated coverage of Galera Therapeutics with a Overweight recommendation.

Piper Sandler Initiates Coverage of Galera Therapeutics With Overweight Recommendation

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 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 Therapeutics Announces Pricing of Registered Direct Offering of $30 Million of Common Stock and Warrants

NDA based on two positive randomized, double-blinded, placebo-controlled trials which enrolled a total of 678 patients NDA based on two positive randomized, double-blinded, placebo-controlled trials which enrolled a total of 678 patients

Galera Submits New Drug Application for Avasopasem for Severe Oral Mucositis

MALVERN, 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.

Galera to Present at Piper Sandler Annual Healthcare Conference

Company on track to submit NDA to U.S. FDA for avasopasem by end of 2022

News for Galera Therapeutics Stock (GRTX)