Cidara Therapeutics reports Q1 EPS ($1.66) vs. ($2.28) last year

“Coinciding with the end of the 2024-2025 flu season in the Northern Hemisphere, we have established April 30, 2025 as the data cutoff for the primary efficacy analysis of the 5,041 subjects dosed in the Phase 2b NAVIGATE clinical trial. We are expecting top-line results in late June of this year. The severity of the 2024-2025 flu season has provided an opportunity to discuss changes to the study’s statistical analysis plan with the U.S. FDA to evaluate the potential statistical significance of CD388 versus placebo,” said Jeffrey Stein, president and chief executive officer of Cidara. “We believe CD388 is highly differentiated from vaccines and monoclonal antibodies and we believe these differences can significantly improve upon the protective efficacy against influenza in healthy, high-risk, and immunocompromised patients with a single dose per flu season.”