Cidara Therapeutics Stock Soars 64.51% on Positive Influenza Trial Results

On June 23, 2025, Cidara Therapeutics' stock surged by 64.51% in pre-market trading, driven by the announcement of positive topline results from its Phase 2b NAVIGATE trial evaluating CD388 for the prevention of seasonal influenza.

The Phase 2b NAVIGATE trial, a randomized, double-blind, placebo-controlled study, demonstrated statistically significant prevention efficacy for all three dose groups of CD388. The study met its primary endpoint, showing that single doses of 450mg, 300mg, and 150mg of CD388 conferred 76%, 61%, and 58% protection, respectively, from symptomatic influenza over 24 weeks compared to placebo. The trial also met all secondary endpoints, including efficacy at different temperature thresholds and maintenance of prevention efficacy up to 28 weeks.

CD388 was well-tolerated across all dose groups, with no unexpected dose-limiting treatment-emergent adverse events observed. The safety and tolerability data were similar in all arms, with no safety signals detected. Cidara Therapeutics has submitted an end of Phase 2 meeting request to the FDA to review these results and discuss the Phase 3 trial design and start time.

Jeffrey Stein, Ph.D., president and chief executive officer of Cidara, expressed confidence in the potential of CD388 to offer robust, once-per-season protection against influenza A and B. Nicole Davarpanah, M.D., J.D., chief medical officer of Cidara, highlighted the statistically significant and clinically meaningful results, marking a potential breakthrough for influenza prevention. The company plans to present additional results from the NAVIGATE trial at upcoming scientific conferences in 2025.