CD-388

Oct. 09, 2025 -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for CD388 for prevention of influenza A and B in adults and adolescents who are at higher risk of influenza complications due to underlying immunodeficiency, are at higher risk of severe influenza despite influenza vaccination, or those for whom vaccines are contraindicated. “This Breakthrough Therapy designation, in addition to the previously awarded Fast Track designation, underscores the importance of CD388 as a potential new non-vaccine prophylactic for seasonal influenza,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “Individuals who have chronic medical conditions, advanced age, or are immune compromised may not be adequately protected by current vaccines, leaving them at higher risk for infection and complications from flu. As a long-acting prophylactic drug, CD388’s activity does not rely on an immune response, making it a potential prevention option for high-risk individuals as well as those for whom vaccines are contraindicated. We look forward to advancing CD388 through our ongoing Phase 3 ANCHOR trial and submission of a Biologic License Application.” The Breakthrough Therapy designation is based on positive results from the Phase 2b NAVIGATE trial in which CD388 provided statistically significant prevention of seasonal influenza in healthy unvaccinated adults aged 18-64. Top line data from the NAVIGATE study was announced in June 2025 and additional data will be presented at upcoming scientific conferences later in October. A Phase 3 trial to evaluate the safety and efficacy of CD388, the ANCHOR Trial, was initiated at the end of September, six months ahead of schedule, in populations at high-risk for complications of influenza. Based on feedback from the FDA, the study population has been expanded to include generally healthy adults over 65 years old with no specific co-morbidities in addition to other high-risk populations with certain comorbidities and immune compromised status. Breakthrough Therapy designation is intended to expedite the review of medicines that treat a serious or life-threatening condition and have shown preliminary clinical evidence indicating the potential for substantial improvement over available therapies. The benefits of Breakthrough Therapy designation include the eligibility for priority review, rolling submission of portions of the application, and FDA’s organizational commitment to involving senior management to provide guidance to the company to help determine the most efficient route to approval. Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel DFCs comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment. Cidara’s lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In June 2023, CD388 was granted Fast Track Designation by the FDA. Cidara announced positive top-line results from its Phase 2b NAVIGATE trial in June 2025 and initiated its Phase 3 ANCHOR trial in September 2025. Cidara is headquartered in San Diego, California. The content above comes from the network. if any infringement, please contact us to modify.

The study met its primary and all secondary efficacy endpoints for all dose groups Single doses of 450mg, 300mg and 150mg of CD388 conferred 76%, 61% and 58% protection, respectively, from symptomatic influenza over 24 weeks compared to placebo CD388 was well-tolerated with no safety signals observed End of Phase 2 meeting request has been submitted to the U.S. Food and Drug Administration (FDA) Cidara will host a conference call at 8:30 am ET on Monday, June 23rd, 2025 June 23, 2025 -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company applying its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced positive topline results from its randomized, double-blind, placebo-controlled Phase 2b NAVIGATE trial evaluating CD388 for the prevention of seasonal influenza in healthy unvaccinated adults aged 18 to 64. The study met its primary endpoint, demonstrating a statistically significant prevention efficacy (PE) for each of three dose groups in individuals who received a single dose of CD388 at the beginning of the flu season and were evaluated for laboratory and clinically confirmed influenza over 24 weeks. The study also met all secondary endpoints, including efficacy at 37.8 and 37.2 degree Celsius temperature thresholds, as well as maintenance of PE up to 28 weeks with statistical significance. Over the same period, CD388 was well-tolerated at all doses with no unexpected dose-limiting treatment-emergent adverse events observed. Primary Efficacy Analysis: Key Secondary Endpoints: Safety and tolerability data were similar in all arms with no safety signals observed. No drug-related serious adverse events were observed, and treatment-emergent adverse events showed no dose-dependent pattern between CD388 and placebo groups. Injection site reaction rates were similar across all CD388 dose groups and placebo. Cidara expects to present additional results from the NAVIGATE trial at upcoming scientific conferences in 2025. “Results such as these are unprecedented in influenza and support our confidence in the potential of CD388 to offer robust, once-per-season protection against influenza A and B,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “As a long-acting antiviral drug, CD388 was designed to provide once per season protection against all strains of influenza in all people, irrespective of immune status. These results provide us with continued conviction in the remarkable opportunity CD388 presents to deliver broad influenza protection. We thank all of our collaborating partners for their dedication and hard work to reach this milestone. Cidara is grateful to the individuals whose participation helped us to generate these important results.” Nicole Davarpanah, M.D., J.D., chief medical officer of Cidara added, "The statistically significant and clinically meaningful results shown with CD388 mark a potential breakthrough for patients and the future of influenza prevention. These Phase 2b results support the potential of CD388 to be a highly effective and well-tolerated seasonal prophylactic for high-risk individuals, such as those with compromised immune systems or those at a heightened risk of severe illness due to underlying health conditions. We look forward to engaging with the FDA and expanding on these results in our planned Phase 3 trial." Cidara has submitted an end of Phase 2 meeting request to the FDA to review the Phase 2b results and further discuss the Phase 3 trial design and start time. CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics which are designed to function as long-acting small molecule inhibitors. CD388 was designed to provide universal protection against all known strains of seasonal and pandemic influenza with the potential to provide season-long protection with a single subcutaneous or intramuscular administration. Importantly, because CD388 is not a vaccine, its activity is not reliant on an immune response and thereby is expected to be efficacious in individuals regardless of immune status. The Phase 2b NAVIGATE clinical trial (NCT06609460) is a randomized, double-blind, controlled trial in more than 5,000 healthy, unvaccinated adult participants across clinical sites in the U.S. and U.K. who are not at risk of complications from influenza. The objective of the study was to evaluate safety, pharmacokinetics and the rates of laboratory and clinically confirmed influenza in participants receiving single doses of CD388 (150mg, 300mg, 450mg) or placebo administered once at the beginning of the flu season. Participants were followed for the remainder of the influenza season to monitor for breakthrough cases. Protocol-defined PE was determined by the percentage by which the CD388 treated groups reduced the rates of symptomatic influenza infection compared to the placebo group. Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs) comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment (Fc). Cidara’s lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In June 2023, CD388 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA), and the Company announced completion of enrollment of its Phase 2b NAVIGATE trial in December 2024. Additional DFCs have been developed for oncology and in July 2024 Cidara received investigational new drug application clearance for CBO421 which is intended to target CD73 in solid tumors. Cidara is headquartered in San Diego, California. The content above comes from the network. if any infringement, please contact us to modify.