The Biomedical Advanced Research and Development Authority (BARDA), within the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), has issued a Request for Information (RFI) to better understand the current development landscape for antifungal medical countermeasures. BARDA plays a central role in advancing the United States Government’s preparedness for chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases. Through this RFI, BARDA is seeking input from current and prospective development partners to inform potential future acquisitions and programs focused on drug-resistant fungal infections, including infections that may arise secondary to public health emergencies, illness, or injury.
The RFI focuses specifically on first-in-class antifungal candidates in development for the treatment of drug-resistant Candida species, including Candida auris, and/or drug-resistant Aspergillus species. These pathogens represent a growing public health concern because resistance to existing antifungal therapies can limit treatment options, particularly for invasive fungal infections. BARDA is interested in understanding the capabilities of both small businesses and other-than-small businesses that are developing antifungals capable of overcoming known and emerging forms of resistance.
For the purposes of this RFI, BARDA is seeking information on first-in-class small molecule or peptide-based antifungals that are currently in Phase 2 clinical trials or beyond, including candidates that may already be approved by the Food and Drug Administration (FDA) or European Medicines Agency (EMA). Desired candidates may have treatment and prophylaxis indications, or treatment-only indications, for drug-resistant invasive fungal infections. BARDA notes that broad-spectrum candidates effective against both yeasts and molds, and available in both oral and intravenous formulations, are especially desirable.
Respondents are asked to provide a concise overview of their antifungal candidate, including targeted pathogens, differentiation from currently FDA-approved antifungals, clinical indications sought or approval status, commercial formulation, FDA correspondence, intellectual property status, and timelines for a supplemental New Drug Application (sNDA) or New Drug Application (NDA) submission. BARDA is also requesting information on clinical development progress across Phase 1, Phase 2, and, where applicable, Phase 3 trials, including trial design, endpoints, safety data, enrollment targets, interim analyses, and clinical study report timelines. In addition, respondents should summarize relevant nonclinical data, manufacturing readiness, procurement and stockpiling approaches, commercialization plans, and provide a Target Product Profile (TPP).
Key Date and Submission Information
Responses to the RFI are due electronically to [email protected] and [email protected] on June 21, 2026, at 5:00 PM Eastern Time.
Because this notice is an RFI issued strictly for planning purposes, it does not include funding levels, an expected number of awards, anticipated award size, or a defined period of performance. BARDA makes clear that the notice does not obligate the U.S. Government to award a contract, and respondents will not be reimbursed for costs associated with preparing or submitting information. After reviewing responses, the Government may publish a pre-solicitation synopsis or solicitation on SAM.gov under Contract Opportunities, but responses to this RFI will not be considered responses to a future solicitation.
Drug-resistant fungal infections pose an increasing challenge to public health preparedness, particularly when treatment options are limited during emergencies involving severe illness, injury, or immunocompromised patients. By gathering information on advanced antifungal candidates, BARDA is working to strengthen the nation’s ability to respond to invasive fungal threats and support the development of medical countermeasures that could improve patient outcomes in future public health emergencies. Organizations developing first-in-class antifungal candidates should consider whether their programs align with BARDA’s areas of interest.
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