FDA delays response to 60 Degrees Pharma's babesiosis trial protocol to April 2024

60 DEGREES PHARMACEUTICALS, INC.

FDA communicated intention to respond to babesiosis trial protocol in April 2024, not March 2024 as anticipated.
Company maintains preparations for June 1, 2024 start date as previously communicated.
Protocol submission is under existing IND; FDA has no specified response timeframe.
Tafenoquine (ARAKODA) is FDA-approved for malaria prophylaxis since 2018.

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