Core Insights - Cidara Therapeutics, Inc. (CDTX) stock surged over 90% following the release of positive topline results from its Phase 2b NAVIGATE trial for CD388, aimed at preventing seasonal influenza in healthy unvaccinated adults aged 18 to 64 [1][6] Study Results - The NAVIGATE trial met its primary endpoint, showing statistically significant prevention efficacy (PE) across all three dose groups, with evaluations conducted over 24 weeks [2] - The highest dose group (450 mg) achieved a 76.1% prevention efficacy, while the 300 mg and 150 mg doses demonstrated 61.3% and 57.7% efficacy, respectively, all statistically significant compared to placebo [3] - Secondary endpoints were also met, including efficacy at specific temperature thresholds and maintenance of PE for up to 28 weeks [2] Safety and Tolerability - CD388 was well-tolerated across all doses, with no unexpected dose-limiting treatment-emergent adverse events reported [3][4] - No serious drug-related adverse events were observed, and injection site reaction rates were consistent across all dose groups [4] Regulatory Actions - Cidara has submitted a request to the FDA for an end of Phase 2 meeting to discuss the results and the design of the upcoming Phase 3 trial [5]

Core Viewpoint - Novavax, Inc. announced positive results from the initial cohort of its COVID-19-Influenza Combination (CIC) and stand-alone trivalent hemagglutinin nanoparticle seasonal influenza (tNIV) Phase 3 trial, indicating that both vaccine candidates induced immune responses comparable to licensed vaccines Nuvaxovid® and Fluzone HD [1][2][3] Group 1: Trial Results - The Phase 3 trial involved approximately 2,000 adults aged 65 and older, focusing on the safety and immunogenicity of the CIC and tNIV compared to Nuvaxovid and Fluzone HD [3] - Both vaccine candidates demonstrated robust immune responses, with neutralizing antibody responses increasing by 2.4 to 5.7 times over baseline [2][6] - The trial results showed that nearly all solicited adverse events (>98%) were mild or moderate, indicating good tolerability [2][6] Group 2: Future Development - The data from this trial will inform future discussions with potential partners regarding the registrational Phase 3 program for the CIC and tNIV vaccines [2][3] - Novavax continues to seek partnerships to advance the development of these vaccine programs [6]