GRTX - Galera rises as FDA grants priority review for lead asset

• Clinical-stage biotech Galera Therapeutics ( NASDAQ: GRTX ) gained ~9% pre-market Wednesday after announcing that the FDA accepted and granted priority review for its marketing application for lead product candidate avasopasem.
• Filing the New Drug Application (NDA), Galera ( GRTX ) seeks approval for avasopasem manganese for severe oral mucositis (SOM), the head and neck cancer patients develop due to radiotherapy (RT) they receive as standard-of-care.
• Giving a 6-month priority review designation for the NDA, the FDA has issued August 9, 2023, as the action date for its decision and has indicated that the agency does not plan to conduct an advisory committee meeting for the application.
• The company supports the NDA with data from two randomized, double-blind, placebo-controlled trials for avasopasem, which indicated a clinically significant decline in signs and symptoms of RT-induced SOM.
• In May, Galera ( GRTX ) announced plans to file for avasopasem approval before the end of 2022.

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