60 Degrees Pharmaceuticals, Inc. (SXTP) · Oct 27, 2026 · Other events
80% NAT-negative — 4 of 5 patients nonreactive on post-treatment blood-donor NAT
60 Degrees’ babesiosis study update adds two patients to the molecular-cure signal, but one remains NAT-positive and the surrogate is unvalidated.
60 Degrees is trying to repurpose its approved malaria drug, tafenoquine, into a babesiosis treatment—using the relapsing-immunosuppressed program and a separate randomized hospital study as its near-term regulatory evidence base. The direction was partly known: on October 6, 2026, the company had already disclosed molecular cure in the first three expanded-access patients and said two additional outcomes were expected in early November.
The update broadens the cure signal rather than changing the thesis. All five completed patients improved and had negative conventional PCR results, while four were also negative on the much more sensitive blood-donor NAT assay. 〔0〕 〔1〕 That is a meaningful step up from the previously disclosed three-patient molecular-cure signal, and it arrives before the company’s earlier “early November” timing for the remaining cases.
The fifth patient keeps this from being a clean validation. One patient remained NAT-reactive despite a negative follow-up conventional PCR result, so the key question is not whether the regimen can clear disease in some difficult cases—it can—but whether NAT nonreactivity consistently predicts durable freedom from relapse. The filing itself says the study is small and uncontrolled and that this surrogate relationship has not been established. 〔2〕 〔3〕
Regulatory optionality improves, but approval is still the next hurdle. The company now has four of five patients with the molecular result it wants to use for a potential accelerated-approval case, while two patients remain on treatment and the study is still open. 〔4〕 Management plans to use the January 2027 randomized hospitalized-babesiosis readout and a planned FDA pre-sNDA meeting to determine whether this expanded-access evidence can support a filing. 〔5〕
Bottom line: This is a narrow positive update to an already-known thesis: the relapsing-babesiosis data set is larger and still favorable, but one discordant NAT result and the lack of controlled evidence leave the FDA case unproven until the randomized study and regulatory meeting.
January 2027 hospital-study unblinding and FDA pre-sNDA meeting
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