“We continue to execute our science-led business development strategy, augmenting our pipeline with CD388, a potentially first-in-class, long-acting antiviral designed to prevent influenza in individuals at higher risk of complications,” said Robert M. Davis, chairman and chief executive officer, Merck. “We intend to build on the Cidara team’s remarkable progress and are confident that CD388 has the potential to be another important driver of growth through the next decade, creating real value for shareholders.”
Cidara’s lead candidate, CD388, consists of a small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody designed to prevent influenza A and B. CD388 is currently being evaluated in the Phase 3 ANCHOR study (NCT07159763) among adult and adolescent participants who are at higher risk of developing complications from influenza. Supported by results from the Phase 2b NAVIGATE study (NCT06609460), the U.S. Food and Drug Administration (FDA) granted CD388 Breakthrough Therapy Designation. The NAVIGATE study met all primary and secondary endpoints associated with preventing symptomatic laboratory-confirmed influenza in healthy unvaccinated adults ages 18 to 64. CD388 was previously granted Fast Track Designation by the FDA.
“This milestone represents a transformational moment for Cidara and for our mission to redefine influenza prevention,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “Thanks to the extraordinary dedication of our team, the Phase 2b NAVIGATE study delivered compelling results that demonstrate CD388’s potential to provide an additional option to vaccines and antivirals to help address unmet needs in influenza prevention. Merck’s global development, regulatory and commercial capabilities provide the expertise and resources needed to bring this important innovation to those individuals who need it most.”
“This acquisition expands and complements our respiratory portfolio and pipeline. Influenza continues to pose a significant global health threat, causing widespread illness, morbidity and death each year especially in older adults and immunocompromised individuals, such as those with cancer and chronic diseases,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “CD388 is a novel late-phase candidate with important strain-agnostic properties being evaluated for the prevention of symptomatic influenza in high-risk individuals.”
The transaction has been approved by both Merck’s and Cidara's Boards of Directors. Under the terms of the merger agreement, Merck, through a subsidiary, will acquire all of the outstanding shares of Cidara. The acquisition is subject to a majority of Cidara’s stockholders tendering their shares in a tender offer that will be initiated by a subsidiary of Merck. The closing of the proposed transaction will be subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in the first quarter of 2026 and is expected to be accounted for as an asset acquisition.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.