60 DEGREES PHARMACEUTICALS, INC. — Form 8-K

60 Degrees Pharmaceuticals presented October 2026 clinical updates on tafenoquine (ARAKODA) for babesiosis at ILADS conference. The randomized hospital study enrolled 30 subjects (2:1 tafenoquine+SOC vs. placebo+SOC); blinded follow-up completes January 2027 with unblinding planned. Expanded-access program reports 3 confirmed NAT-negative cures in relapsing disease; 2 additional cases pending disclosure. Chronic outpatient study (B-FREE) screening identified 2/9 genus-level positives but 0/9 species-specific B. microti NAT positives, revealing diagnostic bottlenecks. Company submitted September 2026 statement of interest requesting FDA national-priority review (CNPV) for a potential sNDA filing in 2027. Pre-sNDA meeting planned late January 2027 post-unblinding; regulatory path (standard sNDA vs. accelerated approval) contingent on hospital study efficacy result.