SALT LAKE CITY, Utah — September 15, 2026

PolarityBio announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for SkinTE®, an investigational autologous cutaneous multicellular therapy for Wagner Grade 1 diabetic foot ulcers (DFUs). The FDA granted Priority Review and established a PDUFA target action date of March 16, 2027, moving SkinTE into a defined regulatory review timeline. Priority Review establishes an FDA goal of taking action within six months rather than the standard 10-month review period for applications meeting the agency’s criteria for potentially significant improvements in the treatment of serious conditions. SkinTE previously received Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy designations for Wagner Grade 1 DFUs. The regulatory milestone strengthens PolarityBio’s transition from late-stage clinical development toward potential commercialization in a major chronic wound-care indication.

COVER DFUS II Supports SkinTE Regulatory Filing

The SkinTE BLA is supported by positive results from the pivotal Phase 3 COVER DFUS II trial, a multicenter randomized controlled study evaluating SkinTE combined with standard of care against standard of care alone. The study met its primary efficacy endpoint of complete wound closure within 12 weeks, providing the central clinical evidence supporting the regulatory submission. COVER DFUS II enrolled 120 patients across multiple U.S. clinical sites, with participants randomized 1:1 and followed for 24 weeks after randomization. Eligible patients had Wagner Grade 1 diabetic foot ulcers that had persisted for at least four weeks despite prior treatment and completed a two-week rigorous standard-of-care run-in period before randomization. Additional findings from the study, including infection and safety data, are being prepared for peer-reviewed publication. For PolarityBio, the successful pivotal program provides the clinical foundation for FDA review while highlighting the company’s regenerative multicellular approach to chronic wounds that can be difficult to heal..

SkinTE Targets Chronic Diabetic Foot Wounds

SkinTE is designed as an autologous cutaneous multicellular therapy intended to support regenerative wound healing, with the company developing the product for patients with chronic diabetic foot ulcers. Diabetic foot ulcers represent a significant clinical burden because wounds that remain open can increase the risk of infection, hospitalization and amputation. PolarityBio said COVER DFUS II demonstrated that adding SkinTE to standard of care improved complete wound closure at 12 weeks and reduced adverse events, although the product remains investigational and has not been approved by the FDA for any indication. The company is also developing SkinTE for additional chronic wound indications, including venous leg ulcers and pressure injuries. The FDA’s Priority Review and previous RMAT and Breakthrough Therapy designations provide regulatory recognition for the potential importance of the program, while the upcoming review will determine whether the clinical and manufacturing package supports approval for Wagner Grade 1 DFUs.

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PolarityBio Prepares for Potential SkinTE Commercialization

The March 16, 2027 PDUFA date gives PolarityBio a defined regulatory milestone as the company advances its commercial and market-access preparations. PolarityBio said it has been building manufacturing, medical affairs and market access capabilities in parallel with SkinTE’s clinical development. The company is also evaluating the reimbursement environment for skin substitute and wound-care products following Medicare payment changes that took effect in January 2026. Under current Centers for Medicare & Medicaid Services policy, wound therapies regulated under a BLA continue to receive separate payment as biological products under established Medicare Part B methodologies. This reimbursement framework could become strategically important if SkinTE receives FDA approval. With the BLA now under Priority Review, a March 2027 FDA decision ahead, and a pivotal Phase 3 study supporting the application, PolarityBio is moving SkinTE toward a potential first commercial approval while expanding its broader regenerative wound-healing strategy.

Source:PolarityBio press release