Cidara Therapeutics, Inc. announced on September 25, 2025, that the first participants have been dosed in its Phase 3 ANCHOR trial. This trial evaluates the safety and efficacy of CD388, a non-vaccine preventative of seasonal influenza, in populations at high-risk for complications.
The study population has been expanded, based on FDA feedback, to include generally healthy adults over 65 years old, in addition to individuals with high-risk co-morbidities and immune-compromised status. The company plans to enroll a minimum of 10% of participants with immune-compromised status.
The Phase 3 ANCHOR trial is a global, multicenter, randomized, double-blind, placebo-controlled study, administering a one-time 450-milligram subcutaneous dose of CD388. Results from this single Phase 3 trial, if successful, are expected to be sufficient for potential Biologics License Application (BLA) approval in the high-risk populations, with over $500 million in cash as of Q2 expected to fund the program through completion.
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