Cidara Therapeutics announces expanded, accelerated Phase 3 plan for CD388

Cidara Therapeutics (CDTX) announced 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. Cidara is proceeding with an expanded and accelerated development plan seeking biologics license application, BLA, approval based on a single Phase 3 study. The company intends to begin enrollment by the end of September 2025 in the Northern Hemisphere with continuation into the spring of 2026 in the Southern Hemisphere, with a target enrollment of 6,000 subjects. This represents a six-month acceleration from the prior plan to initiate the Phase 3 study in the spring of 2026 in the Southern Hemisphere. The study will include an interim analysis following the Northern Hemisphere flu season, to assess the trial size and powering assumptions and determine enrollment for the Southern Hemisphere flu season