Cidara Therapeutics, Inc. announced an update on REZZAYO? (rezafungin for injection) which was approved by the U.S. Food and Drug Administration (FDA) earlier this year. Earlier on July 31, 2023, Cidara?s U.S. partner, Melinta Therapeutics, announced the commercial launch of REZZAYO.

The total potential transaction value of the Melinta License Agreement is $460.0 million, including a $30.0 million upfront payment and up to $430.0 million in regulatory and commercial milestones. In addition, Cidara is eligible to receive tiered royalties on U.S. sales in the low double digits to mid-teens. As of June 30, 2023, Cidara has received the $30.0 million up-front payment and a $20.0 million regulatory milestone payment for U.S. FDA approval.

The European Medicines Agency (EMA) accepted the marketing authorization application (MAA) for rezafungin in August 2022 with Cidara?s EU partner, Mundipharma, and it is currently under review, with a decision timeline on track for year-end 2023. Cidara retains the rights to rezafungin in Japan, and the company is currently evaluating potential commercial partnership opportunities in that country.