RegulatoryCompany release

60 Degrees: All Five Completed Babesiosis Expanded-Access Patients Improve on Tafenoquine Regimens

🇺🇸 60 Degrees Pharmaceuticals, Inc. (SXTP) · Tue 27 Oct 2026

The company says all five patients tested PCR-negative after tafenoquine-based combination therapy, and plans a pre-sNDA FDA meeting after unblinding its randomised hospital study in January 2027.

60 Degrees Pharmaceuticals reported on 27 October 2026 results from the first five patients to complete tafenoquine-containing combination treatment in its expanded access study. The study involves immunosuppressed patients with relapsing babesiosis.

According to the company, all five patients improved clinically and tested negative on conventional PCR. Four of the five were also negative on a highly sensitive nucleic acid test (NAT) of the type used to screen blood donors.

Tafenoquine is not approved by the US Food and Drug Administration for babesiosis. The data come from a small expanded access series, so they do not replace controlled trial evidence.

The company intends to request a pre-sNDA meeting with the FDA once it has unblinded its randomised hospital study in January 2027. It may then seek accelerated approval, using NAT nonreactivity as a surrogate endpoint. Accelerated approval is an FDA pathway that can rely on a surrogate endpoint reasonably likely to predict clinical benefit, usually with confirmatory studies required afterwards.

What it means for your team

  • Regulatory teams should watch whether the FDA accepts NAT nonreactivity as a surrogate endpoint for babesiosis; the company has only said it may seek this route.
  • The January 2027 unblinding of the randomised hospital study is the next key milestone, followed by the planned pre-sNDA meeting.
  • Tafenoquine remains unapproved for babesiosis, so any use is limited to expanded access or trial settings, and the five-patient dataset is too small to settle questions of efficacy or safety.

Company's press release (SEC filing): 60 Degrees Pharmaceuticals, Inc. ↗

Article written by VigiEye from the official source (60 Degrees Pharmaceuticals, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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