San Diego, California — October 2, 2025 — Leads & Copy — Cidara Therapeutics, Inc. (Nasdaq: CDTX) has received an award valued up to $339 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), the biotechnology company announced.
The multi-year agreement consists of a Base contract with Option periods. The Base period funding of $58 million over 24 months supports the onshoring of CD388 manufacturing to the United States as an addition to the initial commercial supply chain.
This initial funding will also be used to conduct a clinical trial to demonstrate the comparability of a higher-concentration formulation and different presentations of CD388, further characterize its activity against pandemic influenza strains in non-clinical models and initiate the development of clinical trial protocols for expanded populations.
The Option periods funding up to $281 million, if requested by Cidara and exercised by the U.S. government, would support additional clinical and non-clinical studies of CD388 in specific populations, as a complement to the company’s plans for potential Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA).
Jeffrey Stein, Ph.D., president and chief executive officer of Cidara, said that 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 also said that a long-acting, universal influenza preventative that confers broad protection against all strains of influenza across all populations is critical for pandemic preparedness, especially for the millions of Americans who are immune-compromised, have comorbidities that can lead to severe complications from influenza infection, or the elderly who have diminished response to vaccines.
Stein also said that the company welcomes BARDA’s partnership that will enable them to accelerate domestic supply options for CD388 production and that this will both expand their commercial supply capacity, as well as ensure U.S. supply of CD388 in the event of an influenza pandemic.
CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics designed to function as long-acting small molecule inhibitors. CD388 was designed to provide universal protection against all known strains of seasonal and pandemic influenza with the potential to provide season-long protection with a single subcutaneous or intramuscular administration. Importantly, because CD388 is not a vaccine, its activity is not reliant on an immune response and thereby is expected to be efficacious in individuals regardless of immune status.
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. Cidara is headquartered in San Diego, California.
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