Shares of Galera Therapeutics Inc. jumped more than 10% in premarket trading Wednesday after the U.S. Food and Drug Administration granted priority review to its application seeking approval of its lead product candidate for a common complication of radiotherapy in cancer patients.
The Malvern, Pa., clinical-stage biopharmaceutical company said the application covers avasopasem manganese for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. Galera said the agency set a target action date of Aug. 9 for the application.
Galera said about 70% of patients receiving radiotherapy for head and neck cancer develop severe oral mucositis, defined by the inability to eat solid food or drink liquids, and that there are currently no FDA-approved drugs to reduce the condition in those patients.
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