On September 12, 2026, 60 Degrees Pharmaceuticals submitted a Statement of Interest to the FDA requesting a Commissioner’s National Priority Voucher for tafenoquine (ARAKODA) as a treatment for babesiosis. The company cites compelling efficacy signals from published case reports and an expanded access study where all three evaluable patients were cured. A randomized controlled trial is complete, with Data Safety Monitoring Board analysis scheduled for October 1, 2026. If successful, the company targets supplemental New Drug Application submission in March–April 2027, aiming for approval before the 2027 tick season. This biopharmaceutical company develops and commercializes pharmaceutical products.
