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Cidara Therapeutics Receives $20M Milestone Payment Following FDA Approval of REZZAYO

Eligible to receive up to an additional $47 million in milestones from multiple existing partnerships based on successful completion of activities.

Cidara Therapeutics Inc., a biotechnology company developing long-acting therapeutics designed to improve the standard of care for serious diseases, received a $20 million milestone payment from Melinta Therapeutics following the U.S. FDA approval of REZZAYO (rezafungin for injection), a novel, once-weekly echinocandin antifungal approved for the treatment of candidemia and invasive candidiasis.

Last month, REZZAYO became the first new FDA-approved echinocandin in over a decade for once weekly use in adults with limited or no alternative treatment options. The approval was based on positive data from Cidara’s global ReSTORE Phase 3 trial and supported by the STRIVE Phase 2 clinical trial and extensive non-clinical development program. Last year, Melinta acquired exclusive rights to commercialize REZZAYO in the U.S. from Cidara.

“We look forward to Melinta bringing REZZAYO to the U.S. market, which is in urgent need of new treatment options for patients with often deadly fungal infections,” said Jeffrey Stein, President and CEO of Cidara. “Receipt of this milestone payment is an important next step in redirecting Cidara’s focus to our Cloudbreak drug-Fc conjugate (DFC) programs in oncologic and autoimmune indications.”

Stein added: “With the $20 million milestone payment from Melinta, Cidara remains eligible to receive additional non-dilutive capital of up to approximately $47 million in development and regulatory milestones from our existing partnerships based on successful completion of activities planned for the next year.”

Meanwhile, Cidara is currently advancing its Cloudbreak DFC program in an ongoing Phase 2a trial being conducted in collaboration with Janssen that is evaluating the pre-exposure prophylactic activity of CD388 against the H3N2 influenza A virus strain. The Company recently announced positive interim efficacy and safety data from the Phase 2a study. Cidara is additionally advancing its first oncology DFC candidate, CD421, a first-in-class inhibitor of CD73, with an IND anticipated in 2024.

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