Cidara Therapeutics reported strong progress in Q3 2025, marked by the early initiation of its Phase III ANCHOR trial for CD388 and receipt of Breakthrough Therapy Designation from the FDA.

• CD388 has entered Phase III development, expanding the potential patient population from 50 million to over 100 million in the U.S. by including healthy adults over 65.
• The ongoing ANCHOR trial, now over 50% enrolled, aims for completion in the Northern Hemisphere by December, leveraging a targeted participant group at high risk for influenza complications.
• Cidara secured a $45 million milestone payment from Johnson & Johnson for the trial initiation and was awarded $339 million from BARDA for expanded manufacturing and clinical development.
• CD388 has received Breakthrough Therapy Designation, promising expedited regulatory pathways and enhanced FDA guidance.
• The Phase IIb NAVIGATE study demonstrated a 76.1% protective efficacy against influenza, underpinning the drug's differentiated profile and bolstering confidence for Phase III success.