60 DEGREES PHARMACEUTICALS, INC. 8-K

What Happened

• 60 DEGREES PHARMACEUTICALS (SXTP) filed an 8‑K on July 9, 2026 disclosing a statistical analysis plan (SAP) agreed with the FDA for an interim analysis of its randomized, placebo‑controlled tafenoquine trial in hospitalized severe babesiosis patients (NCT0627370). As of the filing date the company had enrolled 23 patients in the study. The SAP sets timing and decision rules for early reporting, sample‑size reassessment, and DSMB review.

Key Details

• Interim analysis timing: earlier of (i) October 30, 2026 or (ii) after 24 of the planned 33 patients have been randomized and followed for ≥50 days.
• Endpoints and conditional power (CP): CP will be calculated independently for time to sustained clinical resolution (TTSCR) and time to molecular cure (TTMC).
• Early reporting rule: if CP ≥ 80% then a log‑rank test will be performed; a one‑sided significance ≤ 0.02137 for TTSCR would allow early reporting.
• Sample size reassessment: if CP is 50%–80% for either endpoint, the study may increase enrollment by up to 33 additional patients (capped at 66 total). DSMB will review interim results; sponsor and investigators remain blinded to calculated clinical power if the study continues.
• Regulatory plan: the company intends to apply for a Commissioner’s National Priority Review Voucher if interim/final results support an sNDA submission to the FDA before the end of Q1 2028.

Why It Matters

• The SAP defines clear criteria and timelines that could enable early reporting or expansion of the trial, which may accelerate or alter the path to a potential supplementary New Drug Application (sNDA). For investors, the enrollment status (23 of 33 planned) and the October 30, 2026 interim timing are immediate milestones to watch. The company’s stated intent to seek a Priority Review Voucher if trial data support an sNDA adds a potential regulatory/financial upside, but the filing also includes standard forward‑looking cautions about risks and uncertainties.