60 Degrees Pharmaceuticals Seeks FDA Priority Voucher for Babesiosis

What Happened
60 Degrees Pharmaceuticals, Inc. announced on Sept. 12, 2026 that it submitted a Statement of Interest to the U.S. Food and Drug Administration requesting a Commissioner’s National Priority Voucher (CNPV) for an efficacy supplement to NDA 210607 for ARAKODA® (tafenoquine) to treat babesiosis. The company says there is currently no FDA‑approved therapy for babesiosis and that tafenoquine has shown a compelling efficacy signal in treatment‑refractory cases (published reports ~83% cure; near‑100% when treatment continued until parasite clearance). In the company’s FDA‑authorized expanded access study (NCT06478641), all three currently evaluable patients were cured per an FDA‑approved RNA amplification assay. 60P is also running a randomized, double‑blind, placebo‑controlled trial (NCT06207370); enrollment for the prespecified interim analysis is complete and a Data Safety Monitoring Board review is scheduled for Oct. 1, 2026. Depending on results, the company plans either a regular approval path or accelerated approval with a confirmatory study, targeting an sNDA submission in March–April 2027. The company has committed to manufacture >50% of the value of future CNPV‑supported products in the U.S. and to provide volume‑based discounts to federal programs.

Key Details

• CNPV request submitted: Sept. 12, 2026 for an efficacy supplement to NDA 210607 (ARAKODA/tafenoquine).
• Randomized trial: NCT06207370 — DSMB interim analysis scheduled Oct. 1, 2026; enrollment for that analysis is complete.
• Expanded access: NCT06478641 — 3 of 3 currently evaluable patients cured (confirmed by FDA‑approved RNA assay).
• Regulatory timing: target supplemental NDA (sNDA) submission March–April 2027; CNPV review could accelerate approval toward or before the 2027 tick season.
• Manufacturing commitment: >50% of value of future CNPV‑supported products to be manufactured in the U.S.; discounts to federal programs.

Why It Matters
If granted, a CNPV could speed FDA review and make tafenoquine the first FDA‑approved treatment for babesiosis—potentially improving access, hospital formulary placement, payer coverage, and physician awareness ahead of the 2027 tick season. For investors, key upcoming catalysts are the DSMB interim analysis (Oct. 1, 2026) and the planned sNDA submission (Mar–Apr 2027). The filing also highlights important risks: the CNPV is not guaranteed, trial results and FDA review may not support approval, and manufacturing, funding, or other factors could delay or prevent commercialization. The company’s forward‑looking statements note these uncertainties and reference its SEC filings for additional risks.