Cidara Therapeutics Stock Slides Despite Acing Rezafungin Trial In Fungal Infection

Cidara Therapeutics Stock Slides Despite Acing Rezafungin Trial In Fungal Infection

Cidara Therapeutics Inc 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.

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