--- title: "60 Degrees seeks FDA priority voucher for tafenoquine in babesiosis" url: "https://aibio.space/news/60-degrees-seeks-fda-priority-voucher-tafenoquine-babesiosis/" publisher: "aibio.space (Biotech Investor Relations News)" date: "2026-09-12" section: "Company Updates" tickers: "NASDAQ:SXTP" source: "https://www.sec.gov/Archives/edgar/data/1946563/000121390026099702/ea0305442-8k_60degree.htm" summary: "A September 12, 2026 submission asks FDA for a Commissioner's National Priority Voucher for an efficacy supplement to ARAKODA in babesiosis." --- By the aibio.space news desk. Sources - [60 Degrees Pharmaceuticals, Inc. 8-K (2026-09-14)](https://www.sec.gov/Archives/edgar/data/1946563/000121390026099702/ea0305442-8k_60degree.htm) - [60 Degrees Pharmaceuticals, Inc. 10-K (2026-03-30): business](https://www.sec.gov/Archives/edgar/data/1946563/000155485526000467/sxtp-20251231.htm) - [60 Degrees Pharmaceuticals, Inc. financial data (SEC XBRL)](https://www.sec.gov/Archives/edgar/data/1946563/000155485526000467/) [SXTP](https://aibio.space/companies/60-degrees-pharmaceuticals/) 2026-09-12 # 60 Degrees seeks FDA priority voucher for tafenoquine in babesiosis Tickers [SXTP](https://aibio.space/companies/60-degrees-pharmaceuticals/) A September 12, 2026 submission asks FDA for a Commissioner's National Priority Voucher for an efficacy supplement to ARAKODA in babesiosis. ## Key facts - **Company**: 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP) - **News type**: Company Updates - **Primary source**: [60 Degrees Pharmaceuticals, Inc. 8-K (2026-09-14)](https://www.sec.gov/Archives/edgar/data/1946563/000121390026099702/ea0305442-8k_60degree.htm) *A blood sample drawn into a pipette. CC0, via rawpixel. The picture shows the field, not the companies named.* 60 Degrees Pharmaceuticals, Inc. (NASDAQ: [SXTP](https://aibio.space/companies/60-degrees-pharmaceuticals/)) said in a Form 8-K that on September 12, 2026 it submitted a Statement of Interest to the U.S. Food and Drug Administration (FDA). The company requested a Commissioner's National Priority Voucher (CNPV) designated for an efficacy supplement to NDA 210607 for ARAKODA (tafenoquine) for the treatment of babesiosis. The report is signed September 14, 2026 by Geoffrey Dow, the chief executive officer. ## Why the company says the program matters Babesiosis is an expanding tick-borne parasitic infection in the United States, and no FDA-approved therapy exists for it, the company writes. The disease is especially dangerous for immunocompromised patients, who may have prolonged or relapsing infection despite months of off-label antimicrobial treatment and who face substantially higher mortality. The company says it is the only sponsor with an FDA-authorized randomized placebo-controlled trial and an expanded access study in babesiosis. The filing summarizes an efficacy signal. Published case reports involving tafenoquine added to atovaquone-based therapy report cure in approximately 83% of relapsing patients, and the company says that approaches 100% when treatment is sustained until parasite clearance. In the company's FDA-authorized expanded access study (NCT06478641), all three currently evaluable patients have been cured, as confirmed with an FDA-approved RNA amplification assay. Three patients with no comparison group, and published case reports, are weak evidence, and the 83% and near-100% figures are the company's reading of that literature. The company is also conducting NCT06207370, a randomized, double-blind, placebo-controlled trial of tafenoquine plus standard of care against placebo plus standard of care in hospitalized babesiosis patients at five Northeastern hospitals. Enrollment required for the prespecified interim analysis is complete, and the Data Safety Monitoring Board analysis is scheduled for October 1, 2026. ## The regulatory path The filing says that, depending on the outcome of the interim analysis, the company intends to pursue either regular approval supported by the randomized trial or accelerated approval supported by expanded access and published evidence, with an appropriate confirmatory study. The target supplemental New Drug Application (sNDA) submission is March to April 2027. A Statement of Interest is only a request: the filing does not say the FDA has granted the voucher or agreed that expanded access data could support accelerated approval. The company says CNPV review could permit the first FDA-approved babesiosis treatment to be available at or before the 2027 tick season. It states that standard review timelines would likely extend approval beyond that season, while priority review could place approval near its end. Earlier approval would support incorporation into clinical practice, payer coverage, hospital formularies and prescriber awareness. ## Federal priorities and manufacturing The company says the program advances federal priorities in drug repurposing and tick-borne disease. It has committed to manufacture more than 50% of the value of future CNPV-supported products in the United States and to provide volume-based discounts to federal programs. The filing also lists risks. These include whether the company obtains the CNPV, the outcome of the interim analysis, whether clinical data are sufficient for approval, whether the company can manufacture tafenoquine for commercial distribution, and whether funding is available for clinical development, regulatory activities and commercialization. ## Financial position The annual report filed March 30, 2026 reported revenue of $1.0 million for 2025 and $607,574 for 2024. Research and development expense was $2.1 million in 2025 and $5.0 million in 2024. The net loss was $7.4 million in 2025 and $7.9 million in 2024. Cash from operations was negative $6.8 million in 2025 and negative $5.6 million in 2024. The quarterly report filed August 14, 2026 gives cash and cash equivalents of $1.5 million and short-term investments of $1.2 million at December 31, 2025, and cash and cash equivalents of $1.0 million at June 30, 2026. ## What comes next The DSMB analysis of the randomized trial is scheduled for October 1, 2026, and the filing reports no result from it. The company holds $1.0 million of cash against $6.8 million used in operations in 2025, and its own risk list includes whether funding is available. The company's target sNDA submission is March to April 2027. [Report an error](https://aibio.space/reputation/#correction) ## Companies in this story SXTP 60 Degrees Pharmaceuticals, Inc. 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Cite as: aibio.space, "60 Degrees seeks FDA priority voucher for tafenoquine in babesiosis", 2026-09-12, https://aibio.space/news/60-degrees-seeks-fda-priority-voucher-tafenoquine-babesiosis/