Cidara Therapeutics Receives U.S. FDA Breakthrough Therapy Designation for CD388 in Seasonal Influenza Prevention

Core Insights - The U.S. FDA has granted Breakthrough Therapy designation to Cidara Therapeutics' CD388 for the prevention of influenza A and B in high-risk adults and adolescents, complementing its previously awarded Fast Track designation [1][2] Company Overview - Cidara Therapeutics is a biotechnology company utilizing its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, with CD388 as its lead candidate aimed at providing long-acting antiviral protection against seasonal and pandemic influenza [5] Clinical Development - CD388 has shown statistically significant prevention of seasonal influenza in healthy unvaccinated adults aged 18-64 during the Phase 2b NAVIGATE trial, with top-line data released in June 2025 and further data to be presented at scientific conferences in October [2][5] - The Phase 3 ANCHOR trial for CD388 was initiated six months ahead of schedule, expanding the study population to include generally healthy adults over 65 years old, in addition to other high-risk groups [3] Regulatory Designation - The Breakthrough Therapy designation is intended to expedite the review of medicines that treat serious conditions and have shown preliminary clinical evidence indicating potential for substantial improvement over existing therapies, providing benefits such as priority review and organizational support from the FDA [4]