Cidara Therapeutics Receives $11.14 Million Milestone Payment Following European Approval of REZZAYO
SAN DIEGO, Feb. 12, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced receipt of an $11.14 million milestone payment from Mundipharma following the European approval of REZZAYO™ (rezafungin acetate), a novel, once-weekly echinocandin antifungal approved for the treatment of invasive candidiasis in adults.
This approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for rezafungin, dosed once weekly, when compared to the standard of care, caspofungin, dosed once daily. The drug was previously approved by the United States Food and Drug Administration (FDA) for the treatment of candidemia and invasive candidiasis in patients with limited or no treatment options.
“The European approval of REZZAYO marks a significant milestone for patients who are in need of new treatment options for invasive candidiasis, and we look forward to seeing Mundipharma bring it to the EU market,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “With the payment we’ve received from this milestone, we remain committed to advancing our Cloudbreak platform to develop targeted immunotherapies for cancer patients.”
Cidara is currently advancing its Cloudbreak drug-Fc conjugate (DFC) platform to design targeted immunotherapies that inhibit specific diseases while simultaneously engaging the immune system. Its lead oncology DFC, CBO421, is a potential best-in-class inhibitor of CD73, a validated target highly expressed on tumor cells. An IND is anticipated this year.
About Cidara Therapeutics
Cidara is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO® (rezafungin for injection), which it has licensd to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
About REZZAYO® (rezafungin for injection)
REZZAYO (rezafungin for injection) is a novel once-weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. The structure and properties of REZZAYO are specifically designed to improve upon a clinically validated mechanism.
INDICATIONS AND USE
REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.
IMPORTANT SAFETY INFORMATION
REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion.
REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.
Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy.
Most common adverse reactions (incidence 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.
Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.com.