60 Degrees Pharmaceuticals plans to report results from its hospitalized severe babesiosis study in January 2027 and seek FDA feedback that month on a potential supplemental New Drug Application pathway for tafenoquine.
Key Investor Takeaways
- 60 Degrees Pharmaceuticals (NASDAQ:SXTP) plans a January 2027 babesiosis data readout from its randomized study of tafenoquine in hospitalized patients.
- The company will conclude enrollment at 30 subjects rather than the initially planned 33, citing the limited statistical impact of three additional patients and the risk of a seasonal enrollment delay.
- An interim DSMB review identified no safety issues but does not indicate whether the study met its primary or secondary endpoints.
- SXTP intends to request a pre-sNDA meeting with the FDA in January to discuss the evidence needed to seek approval of tafenoquine for babesiosis.
- The company may ask the FDA to consider NAT-based molecular clearance as a surrogate endpoint supporting an accelerated approval pathway if its submission relies on literature and expanded-access cases.
Why SXTP Stock Is in Focus
60 Degrees Pharmaceuticals is moving toward a defined January 2027 clinical and regulatory catalyst for tafenoquine in babesiosis.
The company has enrolled 30 patients in its double-blind, randomized and placebo-controlled study evaluating tafenoquine plus standard of care against placebo plus standard of care in hospitalized patients with severe babesiosis.
An independent Data Safety Monitoring Board reviewed interim data covering time to sustained clinical resolution, the trial’s primary endpoint, and time to molecular parasite clearance, a key secondary endpoint. The DSMB recommended completing the originally planned enrollment of 33 patients and found no safety issues.
60 Degrees instead intends to stop enrollment at the 30 patients already recruited. The company said adding three patients would have only a marginal effect on the statistical power to detect differences and could potentially delay unblinding by a year because of the seasonal nature of babesiosis.
The trial will now be unblinded, with primary and secondary endpoint results expected in January.
Why This Matters for Investors
The decision establishes a near-term data catalyst but also puts greater importance on results from a relatively small 30-patient study.
Crucially, the DSMB recommendation provides no indication of efficacy. Investors will therefore have to wait until January’s unblinding to determine whether tafenoquine demonstrated differences on the study’s clinical and molecular endpoints.
60 Degrees is also pursuing a potential regulatory route that may not depend entirely on the hospitalized severe babesiosis trial.
The company reported molecular cure in the first three patients enrolled in a separate expanded-access study involving tafenoquine combined with atovaquone-containing regimens for relapsing, treatment-refractory babesiosis. Final screening data from another two patients are expected in early November.
Management believes an approval pathway based on published case reports and expanded-access evidence could be possible even if the severe babesiosis trial does not ultimately provide the desired results. That remains subject to FDA review.
The regulatory strategy could include asking the FDA to accept NAT-based molecular clearance as a surrogate endpoint reasonably likely to predict clinical benefit, potentially allowing an accelerated approval approach accompanied by a post-approval confirmatory study.
For investors, that means the next several months contain separate clinical and regulatory milestones that could help define tafenoquine’s development pathway in babesiosis.
What to Watch Next
The first upcoming catalyst is final screening data from two additional expanded-access patients, expected in early November 2026.
January 2027 is more consequential, with the hospitalized babesiosis study scheduled to be unblinded and its primary and secondary endpoint results reported.
60 Degrees also intends to request a pre-sNDA meeting with the FDA that month. Regulatory feedback will be important in determining whether the available clinical evidence could support an sNDA and whether an accelerated approval strategy based on molecular clearance is potentially viable.
Tafenoquine is already FDA-approved for malaria prevention but is not approved for treating or preventing babesiosis.