Cidara Therapeutics IncCDTX has submitted a marketing application to the FDA seeking approval for rezafungin for candidemia and invasive candidiasis.
The company has also entered into a license agreement with Melinta Therapeutics granting it an exclusive license to commercialize rezafungin in the U.S.
Rezafungin is a novel, once-weekly echinocandin antifungal being developed for candidemia and invasive candidiasis and for preventing invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation.
Cidara expects to be assigned a Prescription Drug User Fee Act (PDUFA) target action date in Q1 of 2023, if the application is accepted for review following application validation.
Under the terms of the agreement with Melinta, Cidara will receive a $30 million upfront payment and is eligible to receive $60 million in regulatory milestone payments and up to $370 million in commercial milestone payments.
Cidara will be responsible for completing the ongoing global Phase 3 ReSPECT prophylaxis study, CMC, and other activities required by the FDA to obtain approval for rezafungin.
Cidara retains the rights to rezafungin in Japan, while Mundipharma retains the commercial rights to rezafungin outside the U.S. and Japan.
Price Action: CDTX shares are up 19.90% at $0.82 during the market session on the last check Wednesday.
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