Cidara Therapeutics Receives $11.14 Million Milestone Payment Following European Approval of REZZAYO
Cidara Therapeutics, Inc. (CDTX) receives an $11.14 million milestone payment from Mundipharma following the European approval of REZZAYO™ for the treatment of invasive candidiasis. The approval was based on positive results from the ReSTORE Phase III clinical trial, demonstrating statistical non-inferiority to the standard of care. Cidara plans to advance its Cloudbreak platform for the development of targeted immunotherapies, with a focus on cancer patients.
Positive
Cidara receives $11.14 million milestone payment from Mundipharma for the European approval of REZZAYO™
Positive results from the ReSTORE Phase III clinical trial led to the approval
REZZAYO™ is a novel, once-weekly echinocandin antifungal for invasive candidiasis
Cidara aims to advance its Cloudbreak platform for targeted immunotherapies
Lead oncology DFC, CBO421, is a potential best-in-class inhibitor of CD73
The recent approval of REZZAYO by the European Commission represents a pivotal advancement in the treatment of invasive candidiasis, a serious infection that can be life-threatening, particularly in immunocompromised individuals. The milestone payment to Cidara Therapeutics underscores the potential of their Cloudbreak platform, which integrates drug and antibody-like functions to enhance the immune response against infections and, potentially, cancer.
From a medical research perspective, the non-inferiority of rezafungin to caspofungin, a current standard of care, indicates that patients could benefit from a less frequent dosing schedule without compromising efficacy. This can significantly improve patient compliance and quality of life. Furthermore, the development of CBO421, targeting CD73, is noteworthy as CD73 is an enzyme implicated in tumor evasion of immune surveillance. Inhibiting CD73 can potentially enhance anti-tumor immunity, making CBO421 a promising candidate in oncology.
An $11.14 million milestone payment is a strong financial endorsement for Cidara Therapeutics, reflecting confidence in the company's proprietary technology and pipeline. The approval of REZZAYO in the European market could open up new revenue streams for Cidara and its partners. The milestone payment will likely be reinvested to further advance the Cloudbreak platform, particularly in oncology with the anticipated Investigational New Drug (IND) application for CBO421.
Investor attention may be drawn to the company's strategic positioning in both antifungal and oncology markets, which could influence the company's stock valuation. The dual focus on infectious diseases and cancer immunotherapy may diversify the company's risk profile and enhance its growth potential. It is important to monitor the company's burn rate and future funding needs, especially in the capital-intensive phase of clinical development.
The European approval of REZZAYO not only validates Cidara's Cloudbreak platform but also reflects a growing trend in the pharmaceutical industry towards novel biologic drugs that offer improved dosing regimens. The once-weekly dosing of rezafungin could position it favorably in the market against daily treatments, potentially increasing its adoption and market share.
Market dynamics for antifungal treatments are shifting towards drugs that offer better patient adherence, reduced hospital stays and fewer side effects. Cidara's strategic partnership with Mundipharma for the commercialization of REZZAYO in the EU market is a critical factor in the drug's potential success. The collaboration combines Cidara's innovative technology with Mundipharma's established market presence and commercial expertise, potentially accelerating market penetration and uptake of REZZAYO.
02/12/2024 - 08:00 AM
Approval triggered by positive results from ReSTORE Phase III clinical trial Payment will advance Cidara’s Cloudbreak platform for the development of drug-Fc conjugates (DFCs) 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 licensed 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
Forward-Looking Statements , and the likelihood that rezafungin will be prescribed by physicians in the EU or approved for reimbursement by member state authorities. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.
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What triggered the approval for Cidara Therapeutics, Inc. (CDTX)?
The approval was triggered by positive results from the ReSTORE Phase III clinical trial.
What is the purpose of the $11.14 million milestone payment received by Cidara Therapeutics, Inc. (CDTX)?
The payment will advance Cidara's Cloudbreak platform for the development of drug-Fc conjugates (DFCs).
What is the focus of Cidara Therapeutics, Inc. (CDTX) in developing immunotherapies?
Cidara aims to develop targeted immunotherapies that inhibit specific diseases while engaging the immune system.
What is the lead oncology DFC being developed by Cidara Therapeutics, Inc. (CDTX)?
The lead oncology DFC, CBO421, is a potential best-in-class inhibitor of CD73, a validated target highly expressed on tumor cells.
