Cidara Therapeutics, Inc. CDTX stock is trading over 90% higher on Monday with a session volume of 3.2 million compared to the average volume of 181.7K.
On Monday, the company released topline results from its randomized, double-blind, placebo-controlled Phase 2b NAVIGATE trial evaluating CD388 for preventing seasonal influenza in healthy unvaccinated adults aged 18 to 64.
The study met its primary endpoint, demonstrating a statistically significant prevention efficacy (PE) for each of three dose groups in individuals who received a single dose of CD388 at the beginning of the flu season and were evaluated for laboratory and clinically confirmed influenza over 24 weeks.
The study also met all secondary endpoints, including efficacy at 37.8 and 37.2 degrees Celsius temperature thresholds and maintenance of PE for up to 28 weeks with statistical significance.
Over the same period, CD388 was well-tolerated at all doses, and no unexpected dose-limiting treatment-emergent adverse events were observed.
The highest dose group (450 mg) showed 76.1% prevention efficacy against laboratory and clinically confirmed influenza over 24 weeks, while the 300 mg and 150 mg doses demonstrated 61.3% and 57.7% efficacy, respectively.
All results were statistically significant compared to placebo.
Safety and tolerability data were similar in all arms ,but no safety signals were observed. No drug-related serious adverse events were observed, and treatment-emergent adverse events showed no dose-dependent pattern between CD388 and placebo groups.
Injection site reaction rates were similar across all CD388 dose groups and placebo.
Cidara expects to present additional results from the NAVIGATE trial at upcoming scientific conferences in 2025.
Cidara has submitted an end of Phase 2 meeting request to the FDA to review the Phase 2b results and further discuss the Phase 3 trial design and start time.
In June, Novavax Inc NVAX announced the results of the initial cohort of its COVID-19-Influenza Combination (CIC) and standalone trivalent hemagglutinin nanoparticle seasonal influenza (tNIV) Phase 3 trial.
The study showed that the CIC and flu vaccine candidates induced immune responses similar to those of licensed comparators Nuvaxovid and Sanofi SA‘s SNY Fluzone HD, respectively.
Both standalone flu and CIC vaccine candidates induced robust immune responses to the vaccine strains (2.4-5.7-fold over baseline).
Price Action: CDTX stock is up 90.7% at $40.08 at last check on Monday.
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