After failing to convince the Food and Drug Administration that there is no need for additional testing for its lead new drug candidate, Malvern-based Galera Therapeutics is busy reviewing “strategic alternatives” with the help of a third party, writes John George for Philadelphia Business Journal. 

The biopharmaceutical company hired Stifel, Nicolaus & Co. to try and find ways to move forward, including through a merger, sale, divestiture of assets, or licensing deals. 

The FDA rejected the company’s new drug application for avasopasem manganese in August. The drug was developed to treat radiotherapy-induced severe oral mucositis in patients undergoing treatment for head and neck cancer. The FDA said that the clinical trial performed by Galera was “not sufficiently persuasive” to establish substantial evidence of the drug’s effectiveness and safety. 

“We are disappointed that the FDA did not find the data from our phase 2b and phase 3 trials sufficient for the approval of avasopasem,” said Dr. Mel Sorensen, Galera’s CEO. 

The company has halted two clinical trials for rucosopasem, a drug candidate being developed as a potential treatment for pancreatic cancer and for non-small cell lung cancer, to conserve funds as it explores its options. 

Read more about Galera Therapeutics trying to save itself from shutting down in the Philadelphia Business Journal. 

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