Positive Phase IIb NAVIGATE Clinical Trial Results
Cidara Therapeutics announced positive top line results from its Phase IIb NAVIGATE clinical trial, demonstrating statistically significant efficacy of CD388 with 76%, 61%, and 58% protection rates at 450mg, 300mg, and 150mg doses respectively, all with p-values indicating strong statistical significance compared to placebo.
$400 Million Financing Secured
Cidara secured $400 million in financing, providing a strong financial position to fund the completion of the planned Phase III study and additional supportive clinical and nonclinical studies.
Potential FDA and BARDA Support
Cidara advanced discussions with the FDA for Phase III development and submitted a proposal to BARDA which, if funded, could provide significant support for manufacturing and clinical development of CD388.
Fast Track and Priority Review Designations
CD388 has received Fast Track and Priority Review designations from the FDA, and an application for Breakthrough Therapy Designation has been submitted.