Cidara Therapeutics Inc (NASDAQ:CDTX) and Mundipharma posted topline data from the ReSTORE Phase 3 trial of rezafungin for candidemia and invasive candidiasis.
- Rezafungin met the FDA primary endpoint of all-cause mortality at Day 30 and the primary endpoint for the European Medicines Agency (EMA) submission of global cure at Day 14.
- Both results demonstrated statistical non-inferiority of rezafungin dosed once-weekly versus caspofungin dosed once-daily, the current standard of care.
- Rezafungin was generally well tolerated and had a similar safety profile to caspofungin.
- Investors seem to be bearish, although the trial met the endpoints.
- Day 30 All-Cause Mortality (FDA), 23.7% achieved the goal in rezafungin once-weekly regime, compared to 21.3% in caspofungin once-daily dosing.
- On the Day 14 Global Cure (EMA), 59.1% of patients achieved Day 14 Global Cure (EMA) for rezafungin versus 60.6% in caspofungin arm.
- The Company plans to file its marketing application with the FDA and other regulators outside the U.S. in mid-2022.
- Price Action: CDTX shares are down 31.20% at $1.12 during the market session on the last check Tuesday.
