Cidara Therapeutics announces updates to its planned Phase 3 registrational trial of CD388 following its End-of-Phase 2 meeting with the U.S. Food and Drug Administration
- Update based on FDA End-of- Phase 2 meeting outcome.
- Phase 3 study start accelerated by six months, in time for the fall 2025 Northern Hemisphere flu season.
- A single Phase 3 trial of CD388, if successful, may be sufficient for BLA approval.
- Phase 3 study population expanded to include adults over 65 years of age in addition to subjects with high-risk co-morbidities and immune compromised status.