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Keep up with the regulator's latest rulings on novel drugs and expanded indications, as the second half of 2023 promises some major milestone FDA approvals.
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Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.
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Galera Schedules Type A Meeting with FDA to Discuss Next Steps for Avasopasem
9/18/2023
Galera Therapeutics, Inc. 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).
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Galera to Participate in the H.C. Wainwright 25th Annual Global Investment Conference
9/5/2023
Galera Therapeutics, Inc. 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.
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Galera Reports Second Quarter 2023 Financial Results and Recent Corporate Updates
8/14/2023
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 financial results for the second quarter ended June 30, 2023, and provided recent corporate updates.
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After the regulator rejected avasopasem manganese, its candidate for severe oral mucositis, Galera is implementing a restructuring initiative that involves reducing its headcount by 70%.
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Galera Receives Complete Response Letter from U.S. FDA for Avasopasem Manganese
8/9/2023
Galera Therapeutics, Inc. announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration regarding the Company’s New Drug Application for avasopasem manganese for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment.
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Week in Review: Breakthrough Depression Drug, RSV and GLP-1 Lawsuits, and Earnings Season Shows C...
8/4/2023
A transformational moment in the treatment of depression, GSK takes first shot in a vaccine patent war with Pfizer, a Louisiana woman sues Novo Nordisk and Lilly, and companies face a steep COVID-19 cliff. -
The FDA has three upcoming action dates in the next two weeks, including a highly anticipated decision regarding Biogen and Sage’s depression drug zuranolone.
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Galera Presents Additional Chronic Kidney Disease Data from ROMAN Trial at 2023 ASCO Annual Meeting
6/5/2023
Galera Therapeutics, Inc. (Nasdaq: GRTX) today presented data from the Phase 3 ROMAN trial demonstrating avasopasem manganese (avasopasem) improved preservation of kidney function and reduced cisplatin-related chronic kidney disease (CKD) in patients with head and neck cancer (HNC) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
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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
5/18/2023
Galera Therapeutics, Inc. (Nasdaq: GRTX) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Galera’s second product candidate, rucosopasem manganese (rucosopasem), for the treatment of pancreatic cancer.
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Galera Reports First Quarter 2023 Financial Results and Recent Corporate Updates
5/11/2023
Galera Therapeutics, Inc. announced financial results for the first quarter ended March 31, 2023, and provided recent corporate updates.
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Galera Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - May 04, 2023
5/4/2023
Galera Therapeutics, Inc. 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.
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Galera Expands Commercial Leadership Team
5/1/2023
Galera Therapeutics, Inc. today announced the appointment of accomplished pharmaceutical sales, market access, and commercial operations executives to Galera’s senior commercial leadership team, effective immediately.
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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
4/26/2023
Galera Therapeutics, Inc. (Nasdaq: GRTX) 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.
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Galera Announces Presentation of Supplemental Analysis of Phase 3 ROMAN Trial at European Congress on Head and Neck Oncology
3/10/2023
Galera Therapeutics, Inc. 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.
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Galera Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Corporate Updates
3/8/2023
Galera Therapeutics, Inc. today announced financial results for the fourth quarter and year ended December 31, 2022 and provided recent corporate updates.
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Galera Therapeutics Announces Pricing of Registered Direct Offering of $30 Million of Common Stock and Warrants
2/15/2023
Galera Therapeutics, Inc. 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.
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Galera Announces FDA Acceptance and Priority Review of Avasopasem NDA for Radiotherapy-Induced Severe Oral Mucositis
2/15/2023
Galera Therapeutics, Inc. (Nasdaq: GRTX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted priority review to the New Drug Application (NDA) for avasopasem manganese for radiotherapy (RT)-induced severe oral mucositis (SOM) in patients with head and neck cancer (HNC) undergoing standard-of-care treatment.
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Galera Submits New Drug Application for Avasopasem for Severe Oral Mucositis
12/12/2022
Galera Therapeutics, Inc. (Nasdaq: GRTX) today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avasopasem for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer (HNC) undergoing standard-of-care treatment.