- Cidara Therapeutics Inc CDTX 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.
- Related: Read Why HC Wainwright Lowered Price Target On This Small Biotech Stock.
- 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.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.