Cidara Therapeutics Secures Major BARDA Award to Advance CD388 Flu Preventive
cidara therapeutics has announced it will receive federal backing to advance its influenza preventive CD388, following the reacquisition of rights to the asset last year. The U.S. Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA) has awarded Cidara Therapeutics up to $339 million to support development and domestic production of this innovative therapy.
According to , the multi-year arrangement consists of a base contract with additional option periods. The base period provides $58 million in confirmed funding over 24 months. These funds will be directed toward establishing U.S.-based manufacturing for CD388 as part of the company’s initial commercial supply chain.
The BARDA award will also support a clinical trial comparing a higher-concentration formulation and multiple presentations of CD388, additional nonclinical research into the drug’s activity against pandemic influenza strains, and the development of protocols for broader patient population studies.
Cidara Therapeutics May Receive Up to $281 Million in Additional Option Funding
The remaining $281 million in option funding, if exercised by the U.S. government, could support additional studies of CD388 in defined patient groups. This potential funding would complement Cidara Therapeutics’ plans for a future biologics license application (BLA) submission to the U.S. Food and Drug Administration (FDA).
Jeffrey Stein, Ph.D., CEO of Cidara Therapeutics, said, “Clinical and non-clinical data generated to date suggest that CD388 has the potential to be an effective non-vaccine preventative for both pandemic and seasonal influenza.” He added that BARDA’s involvement would help expand supply capacity and ensure U.S. availability of CD388 in the event of an influenza pandemic.
CD388 is a drug-Fc conjugate (DFC) therapeutic developed by Cidara Therapeutics as a non-vaccine alternative for flu prevention. Unlike traditional vaccines or monoclonal antibodies, DFCs are low molecular weight biologics designed to act as long-acting small molecule inhibitors.
The therapy aims to protect against all known strains of seasonal and pandemic influenza. Because it does not rely on stimulating an immune response, Cidara Therapeutics expects it to be effective regardless of a patient’s immune status.
Cidara Therapeutics Reacquired CD388 From Janssen
In April of last year, reacquired CD388 from Janssen, a subsidiary of Johnson & Johnson, after the pharmaceutical giant exited infectious disease and vaccine research. Cidara Therapeutics paid $85 million upfront to regain the rights, with additional future milestone payments tied to development and commercialization.
BARDA Award Follows Clinical Progress of CD388
CD388 has progressed through several stages of clinical development under Cidara Therapeutics. In June, the company reported results from its phase 2b Navigate trial. The highest tested dose of 450 mg provided 76% protection against seasonal influenza in unvaccinated adults compared to placebo. Lower doses showed 61% and 58% protection, respectively.
Cidara Therapeutics has since outlined plans for a single phase 3 trial intended to support FDA approval. The study aims to enroll 6,000 participants who will receive either the 450-mg dose or placebo. Although the company initially expected to start the trial next spring, it later confirmed that dosing had already begun just one day after finalizing its phase 3 strategy.
BARDA’s award to Cidara Therapeutics comes as the agency is reshaping its medical countermeasures portfolio. Earlier this year, HHS ended 22 BARDA-funded mRNA vaccine projects, citing limited effectiveness against respiratory infections. Funding is now being redirected toward platforms with broader and more durable protection—positioning and its CD388 program as a key part of this new strategy.
