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60 Degrees Pharmaceuticals Says The First Patient Who Completed The Regimen In Expanded Access Study Of Arakoda (Tafenoquine) Combined With Conventional Treatments For Relapsing Babesiosis In Immunosuppressed Patients Has Tested Negative For Babesiosis

Benzinga·10/15/2025 11:16:23
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  • Breakthrough Therapy Designation request has been submitted to FDA
  • Company to request a Type B meeting with FDA in early 2026 to discuss requirements for a supplementary New Drug Application (sNDA)
  • Results obtained using highest sensitivity test available; licensed by FDA for blood donation screening
  • Remaining enrolled patients will complete the study between January and October 2026
  • Study intended to confirm the high cure rate for tafenoquine in immunosuppressed patients with relapsing babesiosis, as reported by Yale in a 2024 publication