Cidara Therapeutics Announced Updates To Its Planned Phase 3 Registrational Trial Of CD388 Following Its End-Of-Phase 2 Meeting With FDA

Author: Benzinga Newsdesk | September 24, 2025 07:09am

Cidara 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 with no specific co-morbidities in addition to subjects over 12 years of age with high-risk comorbidities or immune compromised status, substantially increasing the initial number of patients potentially eligible to receive CD388 from approximately 50 million to well over 100 million people in the U.S.

Posted In: CDTX