Priority Review Granted for PolarityBio’s SkinTE for Treatment of Diabetic Foot Ulcers
September 24, 2026
PolarityBio, a biotechnology company based in Salt Lake City, Utah, announced today that the FDA has accepted its Biologics License Application (BLA) and granted Priority Review for SkinTE, an autologous multicellular therapy designed to treat Wagner Grade 1 diabetic foot ulcers (DFUs). Ahead of its target PDUFA date of March 16, 2027, PolarityBio continues to advance its market access and commercial readiness strategy. DFUs affect ~18.6 million people worldwide each year, including ~1.6 million people annually in the US. Given the risk of hospitalization and infection associated with chronic, non-healing wounds and limited treatment options, SkinTE could expand treatment offerings for a difficult-to-treat condition that affects a substantial population.
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