Cidara Therapeutics Sets Spotlight on Phase 2 CD388 Data at ID Week 2025—Fast Track Status and Universal Influenza Prevention Drive Attention


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Cidara’s Universal Influenza Prevention Candidate, CD388, to Take Center Stage at ID Week 2025

Late-Breaking Phase 2 Data and FDA Fast Track Drive Focus on CD388

There’s new momentum building around Cidara Therapeutics (NASDAQ:CDTX), as the company is set to present late-breaking clinical Phase 2 results for its antiviral influenza candidate, CD388, during the highly anticipated ID Week 2025 conference. The company’s announcement points to increasing recognition of CD388’s potential as a game-changer in influenza prevention—aiming for universal protection with just a single dose.

CD388 Targets Universal, Single-Dose Flu Protection—Key Details at a Glance

CD388 is Cidara’s leading candidate from its proprietary Cloudbreak® drug-Fc conjugate (DFC) platform, uniquely designed to provide long-acting, universal influenza coverage by directly inhibiting the proliferation of the influenza virus. This novel approach seeks to simplify seasonal and pandemic preparedness by enabling prevention in one step for a broad population.

Presentation Title A Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of CD388, a Novel Drug-Fc-Conjugate, for Prevention of Illness due to Influenza A and B in Healthy Unvaccinated Participants
Conference ID Week 2025
Date & Time Monday, October 20, 2025, 3:15 PM - 4:30 PM ET
Presenter James Alexander MD, MPH, FIDSA
Session Extra, Extra! New Info on Treating and Preventing RSV and Influenza (Room B401-B402)

Positive Phase 2b Results and Fast Track Designation Signal Growing Momentum

In the lead-up to the October presentation, it’s worth noting two key milestones for CD388 in 2025. First, Cidara reported positive topline results from its Phase 2b NAVIGATE trial in June, supporting the safety and efficacy profile for broad influenza prevention. Shortly after, the Phase 3 ANCHOR trial was initiated in September—an ambitious next step toward regulatory approval.

Perhaps most notably, CD388 earned Fast Track Designation from the FDA as early as June 2023, highlighting both the clinical need for better flu prevention and CD388’s potential to fulfill that gap. This designation is designed to accelerate the review and potential availability of promising treatments, often catching the eye of industry watchers and investors alike.

Takeaway: Why CD388’s Presentation Could Shape CDTX’s Outlook

As Cidara steps onto the stage at ID Week 2025, investors and healthcare professionals will be watching closely—not just for data, but for signs that CD388’s single-dose approach can meet the demands of both seasonal and pandemic flu preparedness. With FDA Fast Track, encouraging trial results, and ongoing advancement into Phase 3, CD388 sits at the intersection of innovation and urgent need.

The big question for the months ahead: Will these data points and milestones set a new course for Cidara, and possibly change how influenza is prevented on a global scale? Stakeholders may want to keep a close eye on further updates and clinical progress as CD388’s story unfolds.


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