Cidara Therapeutics : EU Approves Rezzayo For Treatment Of Invasive Candidiasis In Adults

(RTTNews) - Cidara Therapeutics Inc. (CDTX) said that Rezzayo (rezafungin acetate) has been approved in the European Union for the treatment of invasive candidiasis in adults.

In Friday pre-market trade, CDTX was trading at $0.86 up $0.12 or 16.54%.

The approval was based on positive results from the pivotal ReSTORE Phase III clinical trial and supported by the STRIVE Phase II clinical trials and extensive nonclinical development program.

Invasive candidiasis is a severe, life-threatening infection of the bloodstream and/or deep/visceral tissues. It affects seriously ill people, especially those with a weakened immune system and the mortality rate can be 40% or more. It can place a large burden on the healthcare system, with the potential for extended treatment regimens and long hospital stays.

Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan.

Cidara is entitled to receive a milestone payment of approximately $11.14 million from Mundipharma for the European Union (EU) approval of rezafungin in accordance with the terms of the Collaboration and License Agreement, dated September 3, 2019, by and between the Company and Mundipharma.

As per the licensing agreement, Cidara remains eligible to receive additional potential payments of up to approximately $470 million upon achievement of development and regulatory milestones planned over the next several years, as well as double-digit royalties in the teens on tiers of annual net sales.

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