Cidara Therapeutics announced that it has achieved its target enrollment of 6,000 participants in the Phase 3 ANCHOR trial for its lead antiviral, CD388. The trial enrolls high‑risk adults and adolescents across the United States and the United Kingdom and evaluates a single 450‑milligram subcutaneous dose of CD388 for seasonal influenza prevention.
The enrollment milestone was reached ahead of the peak of the Northern Hemisphere flu season, positioning the company to complete the trial and conduct its interim analysis in the first quarter of 2026. The data from ANCHOR will support a potential Biologics License Application in the high‑risk populations represented in the study.
The milestone is especially significant in the context of Merck’s recent acquisition of Cidara for approximately $9.2 billion, announced on November 14 2025. Merck’s purchase is a strategic move to diversify its portfolio and offset the impending patent cliff for its blockbuster cancer drug Keytruda. The acquisition validates the value of CD388, which has received FDA Fast Track and Breakthrough Therapy designations and is positioned as a strain‑agnostic, long‑acting antiviral that could complement or replace current influenza vaccines for high‑risk groups.
Management emphasized that reaching enrollment ahead of schedule demonstrates operational efficiency and strengthens the company’s pipeline. CEO Jeffrey Stein noted, “Achieving our target enrollment of 6,000 participants ahead of the peak of flu season is a critical step in evaluating CD388 as a single‑dose, non‑vaccine influenza preventative for those at high risk of complications.”
Analysts view the enrollment achievement as a key driver of investor enthusiasm for the Merck acquisition, which offered a premium of over 100% to Cidara shareholders. The market reaction reflected confidence in CD388’s potential to become a first‑in‑class product and in Merck’s strategy to secure future revenue streams beyond Keytruda.
The ANCHOR trial’s design, which includes healthy adults over 65 in addition to other high‑risk groups, aligns with FDA feedback and positions CD388 to potentially secure a Biologics License Application with a single pivotal study. Successful interim results would accelerate the drug’s path to commercialization and could open a substantial market opportunity for Merck and its partners.
In summary, the enrollment milestone not only marks a pivotal moment for Cidara’s CD388 program but also reinforces the strategic rationale behind Merck’s acquisition, underscoring the potential for a high‑impact influenza prevention product in a growing market.
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