Cidara Therapeutics, Inc. CDTX has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead asset Rrezafungin for the treatment of candidemia and invasive candidiasis.
The regulatory submission for rezafungin was based on positive results from its global ReSTORE Phase 3 and STRIVE Phase 2 trials.
The company expects to be assigned a target action date in the first quarter of 2023, if the application is accepted for review following validation.
Jeffrey Stein, President and Chief Executive Officer, said, “The NDA submission for rezafungin for the treatment of candidemia and invasive candidiasis is an important milestone for Cidara. If approved, rezafungin would represent an important new treatment option for patients at risk of these potentially deadly diseases.
The FDA has previously granted Qualified Infectious Disease Product (QIDP) designation and orphan designation to rezafungin for injection which ensures priority review of the NDA.
Additionally, the company has entered into a license agreement with Melinta Therapeutics under which Cidara has granted Melinta an exclusive license to commercialize rezafungin in the United States.
Price Action : Cidara shares are trading around 16 percent higher on Wednesday at the time of publication.
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