FDA approves expanded label for Krystal Biotech’s DEB treatment

PITTSBURGH, Sept. 15, 2025 — Krystal Biotech, Inc. (NASDAQ: KRYS) announced today that the United States Food and Drug Administration (FDA) has approved a label update for its gene therapy, VYJUVEK® (beremagene geperpavec-svdt). The update expands the eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth and provides greater flexibility for applying the medication and managing wound dressings.

“We believe these changes further reinforce VYJUVEK’s leadership position as the most flexible, convenient, and disease-modifying medicine to treat DEB patients in the United States,” said Krish S. Krishnan, Chairman and CEO of Krystal Biotech.

The updated label allows patients and caregivers to apply VYJUVEK at home. It also gives them more flexibility with wound dressings, permitting them to be removed during the next dressing change rather than after a mandatory 24-hour waiting period.

“The updates to the VYJUVEK label are yet another significant and impactful step forward for all those living with DEB,” said Brett Kopelan, Executive Director of debra of America. “Enabling caretakers to apply VYJUVEK during their standard of care regimen is an enormous positive change allowing for increased convenience without sacrificing safety.”

The label update is based on real-world data collected since VYJUVEK’s launch in the U.S., as well as results from an open-label extension study. These findings collectively reinforce the long-term safety and efficacy of VYJUVEK across all patient ages, including with patient or caregiver application.

About VYJUVEK

VYJUVEK is a non-invasive, topical, redosable genetic medicine designed to deliver two copies of the COL7A1 gene directly to DEB wounds. It is approved in the United States, Europe, and Japan.