FDA Grants Breakthrough Therapy Status to Cidara’s CD388 for Influenza Prevention
Cidara Therapeutics, Inc. received Breakthrough Therapy designation by the U.S. Food and Drug Administration for CD388, a long-acting treatment aimed at preventing influenza A and B.
The designation applies to adults and adolescents at higher risk of flu complications, including those with weakened immune systems, poor response to vaccines, or vaccine contraindications.
The decision follows positive results from the Phase 2b NAVIGATE trial, in which CD388 significantly reduced influenza cases in healthy unvaccinated adults aged 18–64.
A Phase 3 study, the ANCHOR trial, began ahead of schedule in September 2025. It will evaluate CD388’s safety and efficacy in high-risk populations and older adults over 65, following guidance from the FDA to broaden the study group.
Breakthrough Therapy designation is designed to accelerate the development and review of promising treatments for serious conditions.
Benefits include priority review, rolling submission of application sections, and support from senior FDA management to help guide the approval process.
CD388 offers a potential new prevention option for individuals who may not be adequately protected by current flu vaccines.
