With FDA Submission, Cidara Therapeutics Inks US Pact For Bloodstream Infection Candidate

With FDA Submission, Cidara Therapeutics Inks US Pact For Bloodstream Infection Candidate
  • 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.

Posted In: Briefswhy it's movingBiotechNewsPenny StocksHealth CareContractsMoversTrading IdeasGeneral