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PolarityBio Announces FDA Acceptance for Filing of SkinTE® BLA with Priority Review in Diabetic Foot Ulcers? PDUFA Target Action Date Set for March 16, 2027 SALT LAKE CITY, Sept. 15, 2026 (GLOBE NEWSWIRE) -- PolarityBio®, a late-stage biotechnology company addressing unmet needs in wound healing through innovation in regenerative multicellular biologics, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s Biologics License Application (BLA) for SkinTE® (autologous cutaneous multicellular units) for the treatment of Wagner Grade 1 diabetic foot ulcers (DFUs). The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 16, 2027. Priority Review establishes an FDA goal of taking action on an application within six months, compared with 10 months under standard review. The FDA grants Priority Review to applications for products that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment of a serious condition. SkinTE previously received Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy designations from the FDA for the treatment of Wagner Grade 1 DFUs. “FDA acceptance of our BLA and the grant of Priority Review reflect both the strength of the COVER DFUS II data package and the urgency of the need for patients living with chronic, non-healing diabetic foot ulcers,” said Nikolai Sopko, M.D., Ph.D., President, Chief Operating Officer, and Chief Scientific Officer of PolarityBio. “Our focus now is on supporting an efficient review and on preparing to serve patients well if SkinTE is approved. We have built manufacturing, medical affairs and market access capabilities in parallel with the clinical program, and that work continues.” The BLA is supported by positive results from COVER DFUS II, PolarityBio’s pivotal Phase III randomized controlled trial evaluating SkinTE with standard of care compared with standard of care alone. The study met its primary efficacy endpoint of complete wound closure within 12 weeks. Additional COVER DFUS II findings, including infection and safety data, are being prepared for peer-reviewed publication. “A six-month review timeline matters in a population where every week that an ulcer stays open carries risk of infection, hospitalization and amputation,” said Robert Kirsner, M.D., Ph.D., chair of the COVER DFUS II trial. “In COVER DFUS II, adding SkinTE to stndard of care both improved complete wound closure at 12 weeks and reduced adverse events. Closure paired with better overall outcomes for patients is the combination clinicians managing difficult-to-heal diabetic foot ulcers need.” With a definitive PDUFA target action date established, PolarityBio is advancing its market access and commercial readiness strategy. Following Medicare payment changes that took effect on January 1, 2026, a product’s FDA regulatory pathway has become an increasingly important consideration in the reimbursement landscape for skin substitute products. 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 payment methodologies. SkinTE is an investigational product and has not been approved by the FDA for any indication. About COVER DFUS II The trial enrolled 120 patients across multiple U.S. clinical sites over 14 months. Participants were randomized 1:1 to receive either SkinTE with standard of care (SOC) or SOC alone. Study participants were followed for 24 weeks following randomization. The study’s primary efficacy endpoint was the incidence of complete wound closure within 12 weeks. Eligible participants were required to have a diabetic foot ulcer that had persisted for at least four weeks despite prior treatment. Participants also completed a two-week run-in period with rigorous standard of care. About PolarityBio Forward-Looking Statements Company Contact Investor Relations Contact Media Contact 
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