60 Degrees Pharma Submits Statistical Plan for Tafenoquine Trial, Eyes Priority Review Voucher

summarizeSummary

60 Degrees Pharmaceuticals filed a statistical analysis plan with the FDA for its tafenoquine babesiosis trial, setting the stage for a potential interim analysis by October 2026. The company also announced plans to seek a Priority Review Voucher if the data supports an sNDA submission.

check_boxKey Events · Product Development and Regulatory · SXTP

• Statistical Analysis Plan Submitted to FDA

  On July 7, 2026, the SAP for the tafenoquine babesiosis trial was submitted, outlining the interim analysis methodology and stopping rules.

• Interim Analysis Trigger Set

  The interim analysis will occur at the earlier of October 30, 2026 or after 24 of 33 planned patients are randomized with 50-day follow-up. Conditional power ≥80% may allow early reporting of positive results.

• Priority Review Voucher Application Planned

  If trial results support an sNDA submission, the company intends to apply for a Commissioner's National Priority Review Voucher, a potentially valuable asset.

• Enrollment Progress: 23 of 33 Patients

  As of the filing date, 23 patients have been enrolled, nearing the 24-patient threshold that could trigger the interim analysis.

auto_awesomeAnalysis · SXTP · Life Sciences

A statistical analysis plan has been submitted to the FDA for the interim analysis of the tafenoquine trial in severe babesiosis, setting clear triggers: an interim look by October 30, 2026 or after 24 patients are randomized with 50-day follow-up. If conditional power reaches at least 80%, the trial could stop early for success — a potential catalyst. The company also disclosed its intent to pursue a Priority Review Voucher, which could be worth tens of millions if granted. With 23 patients already enrolled and a cash runway of only four months, this trial represents a critical value driver. Positive interim data could unlock financing or partnership opportunities, while failure would be a major setback.