Galera Therapeutics Receives FDA Complete Response Letter, Announces Corporate Restructuring

Galera Therapeutics, Inc. (Nasdaq: GRTX) has received a Complete Response Letter from the FDA regarding its New Drug Application (NDA) for avasopasem manganese (avasopasem) for radiotherapy-induced severe oral mucositis (SOM).

Mel Sorensen, M.D., Galera’s President and CEO, said, “This response from the FDA is deeply disappointing for Galera and for patients who suffer from severe oral mucositis. We continue to believe in avasopasem’s potential to bring a meaningful benefit to these patients, who currently have no FDA-approved drugs for this debilitating condition.”

Galera anticipates that its current cash will be sufficient to support operations into the second quarter of 2024.

Highlights

The NDA submission for avasopasem included data from a total of 678 patients enrolled in two randomized, double-blind, placebo-controlled trials.

The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy.

The NDA was accepted for priority review, which is granted to applications for therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies.

Galera estimates that its balance of cash, cash equivalents and marketable securities as of June 30, 2023 was $38.8 million.

The company plans to file its Quarterly Report for the quarter ended June 30, 2023 on August 14, 2023.

About Galera Therapeutics

Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera’s selective dismutase mimetic product candidate avasopasem manganese (avasopasem) is being developed for radiation-induced toxicities. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of severe oral mucositis induced by radiotherapy. The Company’s second product candidate, rucosopasem manganese (rucosopasem), is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer. Rucosopasem was granted Orphan Drug Designation by the FDA for the treatment of pancreatic cancer. Galera is headquartered in Malvern, PA.

Share This Article

 

About the Author

Galera Therapeutics Receives FDA Complete Response Letter, Announces Corporate Restructuring

Editor Prism MarketView