announced the receipt of a $20m milestone payment from following the US Food and Drug Administration (FDA) approval of its antifungal treatment Rezzayo.
Rezzayo (rezafungin for injection) is a once-weekly echinocandin for the treatment of invasive candidiasis and candidemia. In July 2022, Cidara gave Melinta US licensing rights for rezafungin following submission to the FDA. In March 2023, the based on positive results from a ReSTORE Phase 3 trial (NCT03667690) and STRIVE Phase 2 clinical trial (NCT02734862), making it the first approved treatment for invasive candidiasis and candidemia in over a decade.
The treatment is indicated in patients above the age of 18 years who have limited, if any, treatment options for the aforementioned fungal infections. Candidemia is the . Rezafungin works by inhibiting an enzyme complex specific to the wall of fungal cells which results in osmotic instability and ultimately, cellular death.
The $20m received by Cidara is part of . Cidara is also in line to scoop $370m in commercial payments, to add to the $30m received upfront when the deal was signed. It puts the total potential transaction value at $460m.
鈥淐idara 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,鈥� said Cidara鈥檚 president and CEO Jeffrey Stein, Ph.D.
鈥淩eceipt of this milestone payment is an important next step in redirecting Cidara鈥檚 focus to our Cloudbreak drug-Fc conjugate (DFC) programs in oncologic and autoimmune indications,鈥� Stein added.
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By GlobalDataIn 2019, Mundipharma acquired the rights to commercialise rezafungin outside the US. Cidara鈥檚 submitted marketing authorisation application to the European Medicines Agency has been accepted and is undergoing review.
