- Wednesday, October 16, 2024
Cidara Therapeutics, a pharmaceutical company, experienced a 12% surge in its shares (up to 83 cents) following the approval of its drug, Rezzayo (rezafungin acetate), by the European Union. Rezzayo has been specifically designated as an orphan drug for the treatment of invasive candidiasis in adults within the EU. Cidara Therapeutics has formed a partnership with Mundipharma, granting them commercial rights to the drug outside of the United States and Japan.
Mundipharma will provide Cidara Therapeutics with a significant milestone payment of $11.1 million due to the approval of rezafungin in the EU. Additionally, as part of the licensing agreement, Cidara remains eligible for potential payments of up to $470 million upon achieving development and regulatory milestones over the next few years. Furthermore, the company will receive double-digit royalties based on tiers of annual net sales.
The approval from the European Commission is the result of positive findings from a Phase 3 clinical trial, which demonstrated that rezafungin, administered once weekly, is statistically non-inferior to the current standard of care, caspofungin. These results are supported by promising outcomes from a Phase 2 clinical trial and an extensive nonclinical development program.
Invasive candidiasis is a severe infection that affects the bloodstream and/or deep/visceral tissues.
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