Cidara Therapeutics’ CD388 Receives FDA Breakthrough Therapy Designation

Cidara Therapeutics’ CD388 Receives FDA Breakthrough Therapy Designation

By, Admin 13 October 2025

Cidara Therapeutics announced that the U.S. FDA has granted Breakthrough Therapy designation for CD388.

The designation targets prevention of influenza A and B in adults and adolescents at increased risk due to immune deficiencies, chronic conditions, or vaccine contraindications.

A Non-Vaccine Approach to Influenza

Unlike traditional vaccines, CD388 does not rely on the body’s immune response.
This makes it a viable option for individuals who cannot receive vaccines or respond inadequately.

The Breakthrough designation follows earlier Fast Track recognition, highlighting CD388’s potential as a next-generation influenza prevention therapy.

Supporting Data from NAVIGATE Phase 2b

Phase 2b NAVIGATE trial results showed significant reduction of seasonal influenza cases in healthy, unvaccinated adults aged 18–64.

  • Initial data were presented in June 2025
  • Full trial findings will be shared at scientific meetings in October

Phase 3 ANCHOR Trial Already Underway

Cidara launched the Phase 3 ANCHOR trial six months ahead of schedule.

  • Enrolling older adults >65, including those without specific co-morbidities
  • Includes immunocompromised participants and individuals with underlying health conditions
  • Evaluates safety and efficacy in high-risk populations

Regulatory Impact

The Breakthrough Therapy designation is intended to accelerate development and FDA review for treatments showing clear potential to improve outcomes in serious conditions.

CD388 may become a transformational non-vaccine option for influenza prevention in vulnerable populations.

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