Cidara Therapeutics Receives Breakthrough Therapy Designation for CD388 in Preventing Seasonal Influenza
Friday, October 10, 2025
Cidara Therapeutics has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for CD388.
The designation applies to the prevention of influenza A and B in adults and adolescents at increased risk of severe influenza or complications due to immune deficiencies, chronic health conditions, or vaccine contraindications.
The recognition follows earlier Fast Track designation and reflects the potential of CD388 as a non-vaccine option for influenza prevention. Unlike traditional vaccines, CD388’s mechanism of action does not depend on the body’s immune response, positioning it as a suitable alternative for individuals who may not respond adequately to vaccines or cannot receive them.
The FDA’s decision was supported by data from the Phase 2b NAVIGATE trial, which demonstrated that CD388 significantly reduced cases of seasonal influenza in healthy, unvaccinated adults aged 18–64. Initial findings from the trial were shared in June 2025, with further details expected to be presented at scientific meetings later in October.
Cidara has also initiated the Phase 3 ANCHOR trial to assess the safety and efficacy of CD388 in populations at high risk for influenza-related complications. The trial, launched six months ahead of schedule, now includes older adults over 65 without specific co-morbidities as well as immunocompromised individuals and those with underlying health conditions.
The FDA’s Breakthrough Therapy designation aims to accelerate the development and review of treatments that demonstrate clear potential to improve outcomes in serious or life-threatening conditions.
Source: globenewswire.com
