CDTX Stock Soars 218% YTD on Positive Updates From Influenza Program

Core Insights - Cidara Therapeutics (CDTX) shares have increased by 217.8% in 2025, primarily due to positive developments regarding its clinical-stage candidate CD388 for seasonal influenza prevention [1][6]. Company Overview - CD388 is an investigational drug developed using Cidara's proprietary Cloudbreak platform, designed as a long-acting small molecule inhibitor targeting influenza, offering broad protection against both seasonal and pandemic flu strains [2]. - The drug has the potential to provide season-long protection from a single injection, with efficacy not reliant on an immune response, making it suitable for individuals with varying immune statuses [2]. Clinical Development - The stock price surge began in June 2025 after Cidara reported successful results from its mid-stage study (phase IIb NAVIGATE) of CD388, achieving its primary endpoint with statistically significant prevention efficacy across all three dose groups (150 mg, 300 mg, and 450 mg) [3][4]. - The NAVIGATE study also met all secondary endpoints, demonstrating sustained prevention efficacy through 28 weeks, particularly at the highest dose, with no unexpected adverse events reported [4]. Future Plans - Following a positive End-of-Phase II meeting with the FDA, Cidara has accelerated its late-stage development plan for CD388, initiating the pivotal phase III ANCHOR study six months earlier than planned [8]. - The ANCHOR study will broaden enrollment criteria to include individuals aged 12 and older with high-risk comorbidities, as well as adults over 65 without specific comorbidities, potentially increasing the U.S. patient pool for CD388 from approximately 50 million to over 100 million [9]. - The global phase III ANCHOR study aims to enroll about 6,000 patients, with an interim analysis planned after the Northern Hemisphere flu season [10]. Market Impact - The successful completion of the phase III ANCHOR study could support regulatory filing for CD388 in high-risk populations, contributing to the stock price rally [8].