Cidara Therapeutics has received a funding award worth up to $339 million from the US Biomedical Advanced Research and Development Authority (BARDA) to support expanded manufacturing and clinical development of CD388, its investigational, long-acting, non-vaccine influenza preventative.
The multi-year agreement, part of the US Department of Health and Human Services’ Administration for Strategic Preparedness and Response (ASPR), will provide $58 million in base funding over the first 24 months.
This initial tranche will fund the onshoring of CD388 manufacturing to the US, bolstering domestic production capacity and pandemic preparedness. It will also support a new clinical trial to compare a higher-concentration formulation of CD388, evaluate new product presentations, and further characterize its activity against pandemic influenza strains in non-clinical models.
Should additional funding be exercised, BARDA could provide up to $281 million more through optional extensions, supporting further clinical and non-clinical studies, and advancing regulatory preparations toward a potential Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA).
“This collaboration with BARDA represents an important step forward in ensuring both domestic supply and clinical advancement of CD388,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara Therapeutics.
“A long-acting, universal influenza preventative that protects against all strains—regardless of immune status—is critical for pandemic readiness, particularly for the elderly and those who are immune-compromised.”
CD388 development
The BARDA award builds upon a challenging year of strategic realignment for Cidara. In 2024, the company reacquired the rights to CD388 from Johnson & Johnson for $85 million after J&J deprioritized the program. To finance the buyback and upcoming trials, Cidara secured $240 million through a private investment round and sold its rezafungin program to Mundipharma. These moves refocused the company squarely on advancing its influenza prevention candidate.
CD388 is part of Cidara’s proprietary Cloudbreak platform, which creates drug-Fc conjugates (DFCs)—a class of long-acting biologics that combine the potency of small molecules with the stability and extended half-life of antibody fragments. Unlike vaccines or monoclonal antibodies, DFCs are designed to function as long-acting small-molecule inhibitors that do not depend on eliciting an immune response.
CD388 couples multiple copies of a potent neuraminidase inhibitor to a human Fc fragment, creating a therapeutic capable of broad, universal protection against all known influenza strains. Its mechanism is aimed at directly inhibiting viral proliferation rather than stimulating immunity, potentially offering protection for individuals who respond poorly to vaccines—such as the elderly, those with weakened immune systems, or patients with chronic health conditions.
Preclinical data and early clinical studies have shown promising results. In Phase I (NCT05285137 and NCT05619536) and IIa (NCT05523089) studies, CD388 demonstrated reduced influenza incidence rates compared to placebo, though results were not statistically significant. The company’s Phase IIb NAVIGATE trial (NCT06609460), announced in June 2025, reported positive top-line findings, paving the way for larger pivotal trials.
Cidara plans to advance CD388 through additional Phase II and III studies with BARDA’s support, exploring its efficacy across diverse populations and pandemic strains. The company also aims to establish US-based manufacturing to ensure rapid scalability in the event of an influenza pandemic.
