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60 DEGREES PHARMACEUTICALS, INC.
60 Degrees Pharmaceuticals updated its investor presentation on October 23, 2026, detailing the development progress of tafenoquine for the treatment of babesiosis. The company is targeting an sNDA submission and a request for national-priority review in 2027, while continuing ongoing clinical trials and expanded-access programs. While tafenoquine is FDA-approved for malaria, it is not yet approved for the treatment or prevention of babesiosis.…more
60 DEGREES PHARMACEUTICALS, INC.
60 Degrees Pharmaceuticals will conclude enrollment in its severe babesiosis clinical trial at 30 patients and expects to report primary and secondary endpoint results in January 2027. Regardless of the trial outcome, the company plans to request a pre-sNDA meeting with the FDA in January 2027 to discuss regulatory pathways for tafenoquine in treating babesiosis.…more
60 DEGREES PHARMACEUTICALS, INC.
60 Degrees Pharmaceuticals has submitted a Statement of Interest to the FDA for a Commissioner's National Priority Voucher (CNPV) regarding the expansion of ARAKODA for the treatment of babesiosis. The company is scheduled to conduct an interim analysis of its randomized controlled trial on October 1, 2026, with a target sNDA submission date between March and April 2027.…more
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60 Degrees Pharmaceuticals to Report Babesiosis Study Data in January 2027…more
60 Degrees Pharmaceuticals plans to conclude enrollment for its severe babesiosis study and release primary and secondary endpoint results in January 2027. The company intends to request a pre-sNDA meeting with the FDA to discuss potential regulatory pathways for the treatment.…more
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60 Degrees Pharmaceuticals shares fell in pre-market trading as the company prepares to release interim clinical trial results for its babesiosis treatment, tafenoquine. Investors are closely monitoring the upcoming data release and the scheduled investor webinar.…more
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60 Degrees Pharmaceuticals will disclose interim analysis results from its clinical study evaluating tafenoquine for severe babesiosis on October 6, 2026. The company will also host an investor webinar featuring medical experts to discuss the clinical data and potential therapeutic role of the drug.…more
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