$GRTX Reports Q4 and FY2022 Results, NDA Granted Priority Review by FDA for Avasopasem
Mar 8th 2023, 12:06 pm
Analyst Summary: Galera Therapeutics, a clinical-stage biopharmaceutical company, reported financial results for Q4 and FY2022, including raising $30 million in gross proceeds from a recent registered direct offering. Galera also provided corporate updates and announced that its NDA had been granted FDA priority review for avasopasem, a product designed to reduce radiotherapy-induced severe oral mucositis in head and neck cancer patients. The PDUFA target date for avasopasem is August 9, 2023. According to Mel Sorensen, Galera’s President and CEO, avasopasem has the potential to be the first FDA-approved drug to reduce SOM. The company intends to build out operations and expand its commercial leadership team in preparation for a potential approval of avasopasem in H2 2023. Galera's other product, rucosopasem manganese, is in clinical-stage development. The company’s forward-looking statements are based on management’s current expectations.