60 Degrees Pharmaceuticals updates tafenoquine babesiosis data in Oct. 23 8-K presentation

60 Degrees Pharmaceuticals, Inc. filed an 8-K on October 23, 2026, furnishing an investor presentation given at the ILADS Annual Scientific Conference, covering progress on tafenoquine for babesiosis across three clinical settings. The company said a statement of interest submitted in September 2026 asks FDA for national-priority review¹, and it is targeting a potential sNDA filing in 2027 alongside that priority-review request¹.

In the randomized hospital study of hospitalized patients, 30 subjects were randomized 2:1 to tafenoquine plus standard of care, dosed at 200 mg on Days 1 through 4 then 200 mg weekly for four weeks, versus placebo plus standard of care, with the primary endpoint being time to sustained clinical resolution¹. The company said blinded follow-up is expected to complete in early January 2027, with unblinding to follow¹, and a DSMB interim review recommended completing the originally planned study after finding no safety signal that prevented continued use of tafenoquine as intended¹.

In the relapsing-disease program, a reanalysis of 45 reconstructed cases found that each time uninterrupted conventional treatment duration doubled, patients had a 27% lower rate of needing retreatment in the 12 weeks after therapy stopped¹. Separately, the first three expanded-access patients were NAT-negative after treatment, with results for two more cases pending disclosure¹.

On the chronic-disease side, the B-FREE study has enrolled slowly; early screening has produced a genus-level signal in 2 of 9 patients but no species-specific B. microti signal¹. The company outlined plans for a meeting with FDA ahead of a potential sNDA submission, planned for late January 2027, to occur after the hospital study unblinds and the expanded-access data package is updated¹.