Cidara Therapeutics Receives $11.14 Million Milestone Payment Following European Approval of REZZAYO
- 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
- None.
Insights
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.
- 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
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 is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data.
REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.
IMPORTANT SAFETY INFORMATION
REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.
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
Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.com.
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether an unmet medical need exists for rezafungin, 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.
INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
212-915-2578
britchie@lifesciadvisors.com
MEDIA CONTACT:
Veronica Eames
LifeSci Communications
646-970-4682
veames@lifescicomms.com
FAQ
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