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

Breakthrough Therapy designation comes in addition to previously awarded Fast Track designation

SAN DIEGO, Oct. 09, 2025 (GLOBE NEWSWIRE) -- 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.