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Cidara Therapeutics Receives U.S. FDA Breakthrough Therapy

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October 9, 2025↗ source

Cidara Therapeutics has received U.S. FDA Breakthrough Therapy designation for CD388, a long-acting antiviral conjugate designed for the prevention of seasonal influenza A and B. This regulatory milestone is supported by Phase 2b data showing statistically significant prevention of flu in healthy adults and targets high-risk populations who respond poorly to vaccines. The company is accelerating the development of CD388, with a Phase 3 trial now underway ahead of schedule.

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