MAA - Cidara drops 5% despite 'positive' Phase 3 rezafungin data in candidemia/invasive candidiasis

Cidara Therapeutics (NASDAQ:CDTX) announces positive topline data from the Phase 3 ReSTORE trial evaluating the efficacy and safety of its once-weekly antifungal candidate rezafungin as a potential first-line treatment for candidemia and invasive candidiasis. Shares down 4.9% premarket at $1.55. The trial met FDA and EMA-pre-specified primary endpoints of of all-cause mortality at Day 30 and and global cure at Day 14, respectively versus daily standard of care. Both results demonstrated statistical non-inferiority of rezafungin  dosed once-weekly versus caspofungin dosed once-daily. Rezafungin was generally well tolerated and had a similar safety profile to caspofungin. CDTX intends to file its NDA with the FDA and other regulators outside the U.S., in mid-2022. Cidara has partnered with Mundipharma who has commercial rights to rezafungin outside the U.S. and Japan.

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Cidara drops 5% despite 'positive' Phase 3 rezafungin data in candidemia/invasive candidiasis