Cidara Therapeutics Inc. shares jumped 7.1% to 83 cents in after-hours trading Tuesday after it said the Food and Drug Administration granted priority review for rezafungin.
The biotechnology company said the FDA assigned a Prescription Drug User Fee Act target action date of March 22 due to the drug’s designation as a qualified infectious disease product. The FDA has indicated that it is planning to hold an advisory committee meeting to discuss the application, Cidara said.
Rezafungin is a once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis.
Cidara said it retains the rights to rezafungin in Japan and has licensed the commercial rights to antibiotics-focused company Melinta Therapeutics Inc. in the U.S. and Mundipharma International Ltd. in all other geographies.