Cidara Therapeutics, Inc. announced that the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has approved REZZAYO (rezafungin acetate) for the treatment of invasive candidiasis in adults. This approval comes after positive results from the ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for weekly-dosed rezafungin compared to the standard of care, daily-dosed caspofungin. Rezafungin?s safety and efficacy are further supported by the STRIVE Phase II clinical trials and an extensive nonclinical development program.

Rezafungin is already approved by the United States Food and Drug Administration (FDA) and European Commission (EC). Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan. The company is entitled to receive a $2.8 million milestone payment from Mundipharma for the MHRA approval.