On Oct. 10, 2025, Cidara Therapeutics announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to its drug‑Fc conjugate, CD388, for the prevention of influenza A and B in adults and adolescents at higher risk of complications. The designation applies to individuals with underlying immunodeficiency, those at higher risk of severe influenza despite vaccination, and patients for whom vaccines are contraindicated.
The Breakthrough Therapy status is grounded in the positive results of the Phase 2b NAVIGATE study, which demonstrated statistically significant prevention of seasonal influenza in healthy, unvaccinated adults aged 18‑64. In addition to the existing Fast‑Track designation, the new status provides eligibility for priority review, rolling submission of application portions, and a dedicated FDA organizational commitment to expedite the approval process.
This regulatory advance supports Cidara’s ongoing Phase 3 ANCHOR trial, which began in September 2025 and has expanded its enrollment to include healthy adults over 65. By accelerating the review pathway, the Breakthrough Therapy designation positions CD388 as a potential non‑vaccine prophylactic for high‑risk populations and strengthens the company’s commercial prospects.
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