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SAN DIEGO – Cidara Therapeutics, Inc. (NASDAQ:), a biotechnology firm specializing in immunotherapies, has received an $11.14 million payment from Mundipharma following the European Commission’s approval of its antifungal treatment, REZZAYO™ (rezafungin acetate). This milestone comes after the drug demonstrated non-inferiority to the standard of care in the ReSTORE Phase III clinical trial.
REZZAYO, a once-weekly echinocandin antifungal, is now approved in the European Union for treating invasive candidiasis in adults. It offers a new treatment option for patients, complementing its prior approval by the U.S. Food and Drug Administration for similar indications.
The European approval is based on the ReSTORE trial outcomes, which showed that rezafungin, administered weekly, was as effective as daily doses of caspofungin, the current standard treatment. Jeffrey Stein, Ph.D., president and CEO of Cidara, expressed optimism about the drug’s EU market prospects and reiterated the company’s commitment to advancing its Cloudbreak platform, which aims to develop targeted immunotherapies for cancer patients.
Cidara’s lead oncology drug-Fc conjugate (DFC), CBO421, targets CD73, a protein often found on tumor cells. The company expects to file an Investigational New Drug (IND) application for it within the year.
REZZAYO’s structure and properties are designed to enhance the clinically validated mechanism of echinocandins. While approved for invasive candidiasis treatment, it is also being studied as a preventative measure for invasive fungal diseases in patients undergoing allogeneic blood and marrow transplantation.
The drug is indicated for adults with limited or no alternative treatment options, and the company cautions that it has not been studied in patients with Candida-induced endocarditis, osteomyelitis, and meningitis. Potential side effects include infusion-related reactions, photosensitivity, and liver test abnormalities.
This news is based on a press release statement from Cidara Therapeutics, Inc.
InvestingPro Insights
As Cidara Therapeutics, Inc. (NASDAQ:CDTX) celebrates the European Commission’s approval of REZZAYO™ and the subsequent payment from Mundipharma, the financial health of the company remains a critical factor for investors. According to InvestingPro data, Cidara has a market capitalization of approximately $65.84 million and a notably high Price / Book ratio of 8.19 as of the last twelve months ending in Q3 2023. Despite the challenges, the company holds more cash than debt, an InvestingPro Tip that suggests a degree of financial stability in its balance sheet.
The company’s revenue over the last twelve months as of Q3 2023 stands at $56.54 million, with a negative revenue growth of 7.75%. While this indicates a contraction, another InvestingPro Tip highlights that 2 analysts have revised their earnings upwards for the upcoming period, providing a glimmer of optimism for future financial performance. However, it’s important to note that analysts do not expect the company to be profitable this year, and Cidara has not been profitable over the last twelve months.
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