● 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 standard 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
COVER DFUS II (NCT06140303) is a Pivotal Phase III Multicenter Randomized Controlled Trial (RCT) investigating SkinTE® in the treatment of Wagner Grade 1 Diabetic Foot Ulcers (DFUs). COVER DFUS II is a registrational study to support the filing of a Biologics License Application (BLA) of a first-in-class autologous cutaneous multicellular therapy, SkinTE®.

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
PolarityBio, headquartered in Salt Lake City, Utah, is a biotechnology company developing regenerative multicellular biologics. PolarityBio’s lead product is SkinTE®, a first-in-class autologous cutaneous multicellular therapy. PolarityBio has submitted a Biologics License Application (BLA) to the FDA for SkinTE® for the treatment of Wagner Grade 1 diabetic foot ulcers (DFUs) — a program that holds Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy designations. Beyond DFUs, PolarityBio is advancing SkinTE® for additional chronic wound indications, including venous leg ulcers (VLUs) and pressure injuries. SkinTE® is currently available for investigational use only through an Expanded Access Program. Learn more at www.polaritybio.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the anticipated timing and outcome of the FDA’s review of the SkinTE BLA, the potential approval of SkinTE, the reimbursement landscape for skin substitute products, and PolarityBio’s commercial readiness activities. Forward-looking statements are based on management’s current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. PolarityBio undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Company Contact
connect@polaritybio.com

Investor Relations Contact
Parker Scott
IR@polaritybio.com
801-455-1440

Media Contact
Jessica Starman
media@elev8newmedia.com
888-461-2233


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