Galera Therapeutics Inc.’s (GRTX) lead drug candidate Avasopasem manganese is at the FDA altar, with a decision due on August 9, 2023.Avasopasem manganese is proposed for treating radiotherapy (RT)-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment. Severe oral mucositis (SOM) is a common and burdensome toxicity of radiotherapy, which is the standard-of-care treatment for head and neck cancer. This condition involves the acute inflammation of the mucous membranes in the mouth and throat, which can hinder a patient's ability to consume solid foods or liquids.In clinical trials, it was observed that Avasopasem manganese reduced both the frequency and duration of severe oral mucositis (SOM), while also delaying the onset of the condition and reducing its overall severity.There are currently no FDA-approved drugs to reduce SOM for head and neck cancer patients.Amgen’s severe oral mucositis drug Kepivance, approved by the FDA in 2004, is indicated for patients with hematologic (blood) cancers undergoing high-dose chemotherapy, with or without radiation, followed by a bone marrow transplant. GRTX closed Friday’s (Jul.28, 2023) trading at $2.68, up 13.08%.