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FDA Grants Breakthrough Therapy Status To Cidara's CD388 For Prevention Of Influenza A And B

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us

Cidara Therapeutics, Inc. (CDTX) on Thursday said that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for CD388 for prevention of influenza A and B
in high-risk adults and adolescents.

The Breakthrough Therapy designation is based on positive results from the Phase 2b NAVIGATE trial in which CD388 provided statistically significant prevention of seasonal influenza in healthy unvaccinated adults aged 18-64.

A Phase 3 study of CD388 dubbed ANCHOR was initiated at the end of September.

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