60 Degrees Pharma gets FDA comments on tafenoquine babesiosis trial; no material changes needed

60 DEGREES PHARMACEUTICALS, INC.

FDA provided comments on the clinical trial protocol for tafenoquine in treating babesiosis on April 26, 2024.
No material changes to trial design required; company will address FDA questions and recommendations.
Preparatory actions continue; patient enrollment expected to begin later in 2024.
Tafenoquine is FDA-approved for malaria prophylaxis as ARAKODA but not yet for babesiosis.

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