GRTX - Galera plans to file for US approval of avasopasem by end of year

Galera Therapeutics (NASDAQ:GRTX) said it intends to file a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) by the end of 2022 for avasopasem manganese (avasopasem) to treat radiotherapy-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer. Oral mucositis is characterized by an swelling in the mouth. "The NDA will be based on the positive and clinically meaningful data from our Phase 3 ROMAN trial and our randomized Phase 2b trial," said Galera's President and CEO Mel Sorensen. The company said FDA has already granted breakthrough therapy and fast track designations to avasopasem for reducing SOM induced by radiotherapy. Galera (GRTX) noted that detailed results from the phase 3 trial called ROMAN will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting on June 3. Earlier in May, the company reported data from a phase 2a trial, called AESOP, showing avasopasem helped

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Galera plans to file for US approval of avasopasem by end of year