This market will resolve YES if, by 11:59 PM ET on December 31, 2029:

1. The U.S. Food and Drug Administration (FDA) grants approval for at least one bacteriophage therapy product through either:

   • New Drug Application (NDA) approval

   • Biologics License Application (BLA) approval

2. The approval must be for a therapeutic application (not diagnostic or other use).

3. The approval must be for use in human patients (not veterinary applications).

4. The approval must be for a marketed product (not limited to investigational or compassionate use).

Clarifications

• Phage therapy definition: For purposes of this market, "phage therapy" refers to any therapeutic approach that uses bacteriophages (viruses that infect bacteria) or their components to treat bacterial infections in humans.

• Qualifying therapies include:

  • Whole, live phage preparations

  • Genetically modified bacteriophages

  • Phage cocktails (multiple phage strains)

  • Phage-derived enzymes (e.g., endolysins) when marketed specifically as phage-based treatments

  • Phage-antibiotic combination products, where the phage component is a key therapeutic element

• Non-qualifying therapies:

  • Products that use phages solely as delivery vectors for other therapies

  • Products where phages are used only in manufacturing but are not present in the final product

  • Diagnostic tests using phages to detect bacteria

  • Phage products approved only for environmental or food safety applications

• Approval status verification: Resolution will be based on publicly available information from the FDA's official website, press releases, or other official FDA communications.

• Temporary authorizations: Emergency Use Authorizations (EUAs) or other temporary approvals will NOT satisfy the resolution criteria.

Ambiguous Cases

In potentially ambiguous cases, the following principles will be applied:

1. The product must be explicitly marketed and approved as a phage therapy or phage-based therapeutic.

2. The FDA must categorize the approval as a full approval (not accelerated, conditional, or temporary).

3. If the approval is for a combination product, the phage component must play a direct therapeutic role in the product's mechanism of action.