Cidara gains European approval of Rezzayo for invasive candidiasis

23 December 2023

US drugmaker Cidara Therapeutics’ (Nasdaq: CDTX) shares advanced 12.5% to $0.83 on Friday, after it announced that Rezzayo (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasis in adults.

The approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for rezafungin, dosed once weekly, when compared to the current standard of care, caspofungin, dosed once daily.

These findings are supported by the positive results of the STRIVE Phase II clinical trial and an extensive non-clinical development program.

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