Cidara Breakthrough Therapy Designation for CD388 in Seasonal Influenza Prevention

Cidara Therapeutics (Nasdaq: CDTX) announced the U.S. FDA has granted Breakthrough Therapy designation for CD388 for prevention of influenza A and B in adults and adolescents at higher risk of complications or for whom vaccines are contraindicated. The designation follows a statistically significant Phase 2b NAVIGATE result in healthy unvaccinated adults and complements an existing Fast Track designation. Cidara initiated the Phase 3 ANCHOR trial at the end of September, six months ahead of schedule, and expanded enrollment to include generally healthy adults >65 based on FDA feedback. Benefits include priority review and rolling submission eligibility.

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