Posted by Michael Wonder on 10 Oct 2025
Cidara Therapeutics receives US FDA breakthrough therapy designation for CD388 in seasonal influenza prevention
9 October 2025 - Cidara Therapeutics today announced that the US 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 contra-indicated.
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.
