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Cidara Therapeutics (CDTX) shares have surged by 217.8% in 2025, bolstered by successful progress in the clinical development of its pipeline candidate, CD388, aimed at preventing seasonal influenza. The stock’s rally began in June 2025, following positive data from its mid-stage NAVIGATE study involving healthy unvaccinated adults aged 18 to 64, demonstrating statistically significant prevention efficacy with all three doses (150 mg, 300 mg, and 450 mg) over 24 weeks.
The company recently announced the initiation of the pivotal phase III ANCHOR study, which will enroll about 6,000 participants and aims to broaden eligibility to include individuals over 65 and those without comorbidities. The FDA indicated this study could support a regulatory filing if successful, expanding the potential U.S. patient population from 50 million to over 100 million.
Investors are particularly optimistic about CD388’s unique mechanism, which aims to provide season-long protection from influenza with a single injection, not relying on immune response. The study is expected to carry significant implications for its marketability, aligning dosing with the Northern Hemisphere flu season.
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