SAN DIEGO, November 24, 2025 — Leads & Copy — Cidara Therapeutics, Inc. (Nasdaq: CDTX) has completed its target enrollment of 6,000 participants in the Northern Hemisphere for its Phase 3 ANCHOR trial.
The trial is designed to assess the safety and efficacy of CD388, a non-vaccine preventative treatment for seasonal influenza, in individuals at high risk for influenza complications, including those who are immune-compromised, have comorbidities, or are over 65.
According to Jeffrey Stein, Ph.D., president and chief executive officer of Cidara, achieving the target enrollment is an important step in evaluating CD388 as a potential single-dose influenza preventative. He also expressed gratitude to the study participants, investigators, and clinical teams.
The ANCHOR trial is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. It will evaluate the safety and efficacy of CD388 administered as a one-time 450-milligram subcutaneous dose in adults and adolescents. An interim analysis is planned for the first quarter of 2026 to assess the trial size and powering assumptions and determine if additional enrollment is needed during the Southern Hemisphere flu season.
If successful, the results from this Phase 3 trial are expected to be sufficient for potential BLA approval in high-risk populations represented in the trial.
Cidara Therapeutics is developing novel DFCs using its Cloudbreak® platform, comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment. CD388, Cidara’s lead DFC candidate, is a long-acting antiviral that aims to provide universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In June 2023, CD388 received Fast Track Designation from the FDA. Cidara announced positive top-line results from its Phase 2b NAVIGATE trial in June 2025 and initiated the Phase 3 ANCHOR trial in September 2025.
Further details on the ANCHOR trial can be found at https://clinicaltrials.gov/study/NCT07159763.
Brian Ritchie, Investor Contact, LifeSci Advisors, (212) 915-2578, britchie@lifesciadvisors.com
Michael Fitzhugh, Media Contact, LifeSci Communications, (628) 234-3889, mfitzhugh@lifescicomms.com
Source: Cidara Therapeutics, Inc.
