60 Degrees Pharmaceuticals Plans January 2027 Hospitalized Babesiosis Data Readout; Will Seek Pre-sNDA Meeting with FDA
60 Degrees Pharmaceuticals plans to conclude enrollment in its severe babesiosis study at 30 patients and proceed with unblinding; primary and secondary endpoint results are expected in January 2027. The company also plans to request a pre-sNDA meeting with the FDA that month.
Why it matters — The readout and planned FDA discussion will provide updates on clinical results and the company’s proposed regulatory pathway for tafenoquine in severe or treatment-refractory babesiosis.