Cidara Therapeutics Provides Update on REZZAYO (rezafungin for injection)

Cidara’s U.S. Commercial Partner, Melinta Therapeutics, has Initiated Commercial Launch of REZZAYO

EMA Regulatory Decision for Rezafungin Expected by Year End 2023

SAN DIEGO, July 31, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing therapeutics designed to save lives and improve the standard of care for patients facing serious diseases, today announced an update on REZZAYO (rezafungin for injection) which was approved by the U.S. Food and Drug Administration (FDA) earlier this year. Earlier today, Cidara’s U.S. partner, Melinta Therapeutics, announced the commercial launch of REZZAYO.

“The U.S. launch of REZZAYO recently announced by our partner Melinta is very important for the many patients in need of treatment for deadly fungal infections,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “We look forward to expanding the reach of rezafungin for patients across the world starting in Europe with the upcoming EMA decision and subsequently in Japan where we are currently evaluating potential commercial partnerships. The expected milestone payments and royalties from our current partnerships for rezafungin will further support our Cloudbreak drug-Fc conjugate (DFC) programs, for which we will provide an update at an upcoming R&D Day event.”

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.

About REZZAYO (rezafungin for injection)

INDICATIONS AND USE

REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data.