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• The approval was led by the positive CHMP opinion & was based on the results from the P-III (ReSTORE) clinical trial evaluating the safety & efficacy of Rezzayo vs SoC (caspofungin) in patients with invasive candidiasis
• The results from the trial depicted a statistical non-inferiority for Rezzayo (QW) vs Soc (BID). These results were supported by the results from the P-II (STRIVE) clinical trial & an extensive nonclinical development program
• Rezzayo, an echinocandin, has received an ODD by the EMA & has been approved by the US FDA. Moreover, as part of its Sep 2019 collaboration with Mundipharma, Cidara will receive a milestone payment of ~$11.14M on Rezzayo’s EU approval

Ref: Cidara Therapeutics | Image: Cidara Therapeutics

Related News:- Cidara Therapeutics & Mundipharma received a Positive opinion from the EU’s CHMP for Rezzayo (Rezafungin) to Treat Invasive Candidiasis

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