Cidara Therapeutics Reaches Target Enrollment of Phase 3 ANCHOR Trial Evaluating CD388 for Prevention of Seasonal Influenza in High-Risk Populations

Rhea-AI Summary

Cidara Therapeutics (Nasdaq: CDTX) announced completion of target enrollment for its Phase 3 ANCHOR trial with 6,000 participants across the US and UK to evaluate CD388, a one-time 450-milligram subcutaneous, non-vaccine preventative for seasonal influenza in high-risk populations.

An interim analysis in Q1 2026 will assess trial powering and the potential need for further enrollment during the Southern Hemisphere flu season. If successful, results from this single Phase 3 trial are expected to be sufficient to support a potential BLA for the high-risk populations studied.

Positive

• Target enrollment of 6,000 participants completed
• Interim analysis scheduled in Q1 2026
• One-time 450 mg subcutaneous dosing regimen
• Single Phase 3 could support a potential BLA

Negative

• Possible additional enrollment during Southern Hemisphere flu season
• Regulatory outcome hinges on a single Phase 3 trial
• Efficacy and safety results still pending from interim and final analyses

Insights

Clinical Trials Strategist

Enrollment of 6,000 in a Phase 3 influenza prevention trial reached; interim read planned in Q1 2026.

Cidara advanced its ANCHOR Phase 3 program by completing target enrollment of 6,000 participants across the US and UK to test CD388, a one‑time 450‑milligram subcutaneous dose intended as a non‑vaccine influenza preventative for high‑risk groups. Completing enrollment before the Northern Hemisphere peak secures patient exposure and preserves timely event accrual for the planned interim analysis.

Key dependencies remain the interim analysis in Q1 2026 to assess powering and whether additional enrollment during the Southern Hemisphere season is needed, and the eventual single Phase 3 readout intended to support a potential BLA for the represented high‑risk populations. The trial is randomized, double‑blind and placebo‑controlled, which supports regulatory relevance but still depends entirely on safety and efficacy outcomes.

Watch the interim analysis outcome in Q1 2026, any announcement about added enrollment in the Southern Hemisphere, and the final efficacy/safety readout and its sufficiency for a BLA. These milestones set the near‑term timeline for regulatory feasibility and program value.

Target enrollment of 6,000 participants completed in the Northern Hemisphere

Planned interim analysis in Q1 2026 will determine potential need for additional enrollment during Southern Hemisphere flu season

SAN DIEGO, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak^® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced it has reached target enrollment in its Phase 3 ANCHOR trial of 6,000 participants across clinical trial sites in the US and UK. The trial is designed to evaluate the safety and efficacy of CD388, a non-vaccine preventative of seasonal influenza, in populations at high-risk for complications of influenza. These populations include individuals who are immune compromised, have certain comorbidities, or are over 65 years of age.

“Achieving our target enrollment of 6,000 participants ahead of the peak of flu season in the Northern Hemisphere is an important step in our efforts to evaluate CD388 as a potential single-dose, non-vaccine influenza preventative for those at high risk of complications from influenza,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “We thank the ANCHOR study participants and are grateful for the continued commitment of our investigators and clinical teams as the flu season unfolds in the Northern Hemisphere.”

ANCHOR is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial designed to evaluate the safety and efficacy of CD388 administered as a one-time 450-milligram subcutaneous dose in adults and adolescents. The study will include an interim analysis in the first quarter of 2026 to assess the trial size and powering assumptions and determine the potential need for enrollment during the Southern Hemisphere flu season. Results from this single Phase 3 trial, if successful, are expected to be sufficient for potential BLA approval in the high-risk populations represented in the Phase 3 trial.

Further information on the ANCHOR trial can be found at https://clinicaltrials.gov/study/NCT07159763.

About Cidara Therapeutics
Cidara Therapeutics is using its proprietary Cloudbreak^® platform to develop novel DFCs comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment. Cidara’s lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In June 2023, CD388 was granted Fast Track Designation by the FDA. Cidara announced positive top-line results from its Phase 2b NAVIGATE trial in June 2025 and initiated its Phase 3 ANCHOR trial in September 2025. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “intends,” “believes,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to the potential benefits of and future plans for CD388, the target enrollment and expected timing of the Phase 3 ANCHOR study of CD388 and the interim analysis, and whether the single Phase 3 study will be sufficient to support BLA approval. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s clinical studies and other risks related to clinical development, delays in or unanticipated action by regulatory authorities, other obstacles associated with the enrollment of participants or other aspects of CD388 or other DFC development, risks related to government contracts, having to use cash in ways other than as expected and other risks and uncertainties associated with Cidara’s business in general. These and other risks are identified under the caption “Risk Factors” in Cidara’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025 and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com

MEDIA CONTACT:
Michael Fitzhugh
LifeSci Communications
(628) 234-3889
mfitzhugh@lifescicomms.com

FAQ

What did Cidara announce about the ANCHOR trial enrollment for CDTX on November 24, 2025?

Cidara announced completion of the target enrollment of 6,000 participants in the Phase 3 ANCHOR trial.

When is the planned interim analysis for the CDTX ANCHOR trial and what will it assess?

An interim analysis is planned in Q1 2026 to assess trial size, powering, and potential need for more enrollment.

What dose and administration does the ANCHOR trial use for CD388 (CDTX)?

CD388 is administered as a one-time 450-milligram subcutaneous dose in the ANCHOR trial.

Could the ANCHOR Phase 3 results lead to FDA approval for CD388 (CDTX)?

If successful, results from this single Phase 3 trial are expected to be sufficient to support a potential BLA in the high-risk populations studied.

Which populations are included in Cidara's ANCHOR trial for CD388 (CDTX)?

The trial enrolls adults and adolescents at high risk, including the immune compromised, certain comorbidities, and those over 65 years.

Will ANCHOR require more participants after the Northern Hemisphere flu season?

The interim analysis will determine whether additional enrollment is needed during the Southern Hemisphere flu season.