60 Degrees updates investors on tafenoquine babesiosis program ahead of January 2027 readout

60 Degrees Pharmaceuticals disclosed an updated investor presentation on October 6, 2026, tied to a webinar on interim data from its hospital study of tafenoquine for severe babesiosis. The filing accompanied a press release announcing an update to the company's January 2027 hospitalized babesiosis data readout, both furnished as exhibits to an 8-K.

The randomized, placebo-controlled hospital study had 30 patients enrolled as of October 1, 2026, testing tafenoquine plus standard of care versus placebo plus standard of care, with time to sustained clinical resolution as the primary endpoint and follow-up continuing through early January 2027.¹ A separate expanded access study for relapsing immunosuppressed patients had six patients enrolled, with the first three patients NAT-negative after therapy.¹

Following its interim analysis, the Data Safety Monitoring Board recommended that the company complete the study as planned and enroll the originally intended 33 subjects, with no safety signal preventing use of tafenoquine in severe babesiosis as intended, and the study remaining blinded.¹ The company said further enrollment has been suspended, with follow-up to complete in early January 2027, followed by unblinding.¹

The presentation outlined two potential regulatory paths depending on the hospital study outcome: an accelerated approval route using expanded-access cures and refractory-disease case literature with NAT negativity proposed as a potential relapse surrogate, versus a standard sNDA route using the randomized hospital efficacy data as potentially pivotal, both with an FDA discussion targeted for Q1 2027.¹

The company laid out further milestones including disclosure of fourth and fifth expanded-access outcomes in early November 2026, unblinding of hospital study data in January 2027, a pre-sNDA meeting outcome in Q1 2027, sNDA filing in Q2 2027, a potential PDUFA date with priority review in Q4 2027, and potential launch for babesiosis in Q1 2028.¹ Arakoda is not currently approved for babesiosis treatment or prevention.