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 Insights - Novavax announced positive results from a late-stage study of its COVID-19-influenza combination (CIC) and standalone influenza vaccine candidates, showing robust immune responses in adults aged 65 and older [1][2][8] - The study's findings will guide the design of another late-stage trial that could support regulatory submissions if successful [3][8] - Novavax is seeking strategic collaborations to finance further development and commercialization of both vaccine candidates as part of a strategic shift to expand its pipeline [4][8] Stock Performance - Novavax shares have underperformed the industry year to date [5] Recent Developments - The announcement followed the FDA's approval of Nuvaxovid for older adults, with a narrower label than expected, restricting use in individuals aged 12-64 with high-risk conditions [7][8] - Sanofi has acquired exclusive global marketing rights for Nuvaxovid, part of a multi-billion-dollar deal, and will receive tiered royalties on future sales [10] Competitive Landscape - Other companies like Pfizer and Moderna are also developing COVID-flu combination vaccines, with Moderna ahead in its investigational candidate mRNA-1083, despite a recent setback [11][12] - Pfizer faced challenges in its phase III study for its combination vaccine, missing one of its primary immunogenicity objectives [13] - Sanofi is testing multiple COVID-19/flu combination vaccine candidates, with two receiving fast-track designation from the FDA [14]

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]