Cidara Therapeutics, Inc. announced on September 24, 2025, updates to its planned Phase 3 registrational trial of CD388 following its End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA). The company is proceeding with an expanded and accelerated development plan, seeking biologics license application (BLA) approval based on a single Phase 3 study.
Based on FDA feedback, the study population will be expanded to include adults over 65 years of age without specific co-morbidities, in addition to individuals over 12 years of age with high-risk co-morbidities or immune-compromised status. This expansion substantially increases the initial number of potentially eligible patients in the U.S. from approximately 50 million to well over 100 million people.
The planned Phase 3 study, a global, multicenter, randomized, double-blind, placebo-controlled trial, will evaluate a single 450-milligram dose of CD388. Enrollment is set to begin by the end of September 2025 in the Northern Hemisphere, accelerating the study start by six months from the prior plan, with a target enrollment of 6,000 subjects. The company confirmed that its planned Phase 3 development program is fully funded through completion following its successful financing earlier in the summer.
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