- The FDA accepted Cidara Therapeutics Inc’s CDTX marketing application seeking approval for rezafungin for candidemia and invasive candidiasis.
- Under the priority review designation, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 22, 2023. The agency currently plans to hold an advisory committee meeting to discuss the application.
- Related: With FDA Submission, Cidara Therapeutics Inks US Pact For Bloodstream Infection Candidate.
- Rezafungin is a novel, once-weekly echinocandin antifungal being developed for the treatment of candidemia and invasive candidiasis, as well as for the prophylaxis of invasive fungal infections in patients undergoing allogeneic blood and marrow transplant.
- The submission was supported by positive data from the global ReSTORE Phase 3 and STRIVE Phase 2 clinical trials.
- Rezafungin dosed once weekly demonstrated statistical non-inferiority versus caspofungin, the current standard of care, dosed once daily.
- Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma Medical in all other geographies.
- Price Action: CDTX shares are down 1.04% at $0.76 on the last check Wednesday.
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