07:55 AM EDT, 09/24/2025 (MT Newswires) -- Cidara Therapeutics ( CDTX ) said Wednesday it will start enrolling patients for a phase 3 trial of CD388 by the end of September following its end-of-phase 2 meeting with the US Food and Drug Administration.

The company said it is accelerating and expanding its development plan, seeking biologics license application approval based on a single phase 3 trial.

The company said it expects to enroll about 6,000 participants for the study and will test a single 450-milligram injection of CD388 or placebo at the start of flu season.

The study has been moved up by six months and will now include adults over 65 years of age as well as patients aged 12 and above with high-risk comorbidities or immune compromised status, Cidara said.

CD388 is a long-acting antiviral for seasonal influenza prevention.

Shares of Cidara Therapeutics ( CDTX ) were up past 10% in recent Wednesday premarket activity.