SXTP News & Events

60 Degrees Pharmaceuticals announced it submitted a New Dietary Ingredient Notification, or NDIN, to the FDA for Australian Chestnut Extract on March 11. FDA has until May 25 to object to the notification, after which the Company will be free to market its planned dietary supplement containing Australian Chestnut Extract. The Company has also signed an option agreement to license Florida State University's ownership rights related to new capsule formulation methods for Australian Chestnut Extract, which FSU jointly owns with the Company. This expands on the Company's January 2026 exercise of a license option with FSU for exclusive rights to large-scale purification of Castanospermine for non-prescription uses. Australian Chestnut Extract is derived from the seeds of Castanospermum australe. The dominant molecular constituent of Australian Chestnut Extract is castanospermine. According to recent scientific literature, at low doses, castanospermine modulates carbohydrate metabolism, altering glycogen, glucose levels, and other clinical markers. In animal models, high doses have been shown to impact disease outcomes in several therapeutic areas through immunomodulation. Castanospermine is also a metabolite of celgosivir, a product evaluated in clinical trials in more than 500 patients against HIV and Hepatitis C, but which is no longer in commercial development for those indications. That safety record suggests castanospermine is safe at achievable doses in humans and is active against the same pharmacological targets as in animal studies.

60 Degrees Pharmaceuticals announced that three of three enrolled patients have been cured of babesiosis after completing the tafenoquine regimen in the Company's trial of relapsing babesiosis in immunosuppressed patients. The Company's expanded use trial is an open-label, expanded access, multi-site study evaluating the safety and efficacy of the ARAKODA regimen of tafenoquine combined with atovaquone and other antimalarials/antibiotics administered to patients with risk factors for severe disease with relapsing babesiosis who have previously failed conventional antimicrobial regimens. It aims to confirm the high cure rate from the addition of tafenoquine in these patients, as reported by the Yale School of Public Health in a 2024 Clinical Infectious Diseases publication. For this study, tafenoquine treatment is continued for up to one year until two consecutive negative PCR tests for Babesia parasites are recorded and symptoms of babesiosis are resolved. Sixty to ninety days following clinical resolution and cessation of study drug administration, the study protocol calls for a follow-up visit at which two molecular tests are administered to assess parasite infection status. One test is an RT-PCR from Mayo Clinic. The second is a U.S. Food and Drug Administration-approved RNA amplification test used for blood donation screening that is at least 1,000 times more sensitive than standard commercial RT-PCRs such as the Mayo test. A patient is considered cured if no evidence of infection is detected following treatment. The Yale study reported an apparent treatment success rate of 100 percent in four patients when an atovaquone-containing standard of care regimen was combined with weekly tafenoquine administered until two sequential non-reactive conventional PCRs were noted. The fifth patient in the Yale study was administered weekly tafenoquine monotherapy, then azithromycin/atovaquone; the triple regimen was not sustained until consecutive negative PCRs were noted, and so was not successful. That same final patient in the Yale study was the third patient in the Company's expanded access study, and a quadruple combination of atovaquone/azithromycin/proguanil and weekly tafenoquine sustained until two negative PCRs were noted was ultimately curative as demonstrated through a non-reactive RNA amplification test following treatment. Cure was achieved with a triple combination of tafenoquine, atovaquone, and an antibiotic for the first two patients enrolled in the study. Collectively, in the seven patients evaluated, the data suggest that the cure rate for relapsing babesiosis in immunosuppressed patients approaches 100 percent when weekly tafenoquine is added to a patient's background atovaquone-containing combination regimen and sustained until two negative PCRs are noted. Given the rarity of relapsing immunosuppressed patients and the high cure rate associated with adding tafenoquine, the Company believes it is an appropriate time for widely accepted treatment guidelines to be reviewed in light of the new data.

60 Degrees Pharmaceuticals (SXTP) announced a partnership with GoodRx (GDRX) to offer eligible consumers savings of up to 30% on Arakoda. Starting February 2, 2026, eligible patients can use GoodRx to access a self-pay price for ARAKODA at more than 70,000 pharmacies nationwide, or can have the medication delivered to their home.

60 Degrees Pharmaceuticals announced it has exercised the option in its agreement with Florida State University, FSU, to negotiate an exclusive license to use large-scale purification techniques to extract castanospermine from the seeds of Castanospermum australe. Castanospermum australe grows primarily in the Australian states of Queensland and New South Wales, but also in Florida, Hawaii, and California.