Krystal Biotech Stock Up on FDA Nod to Vyjuvek Label Update

Core Insights - Krystal Biotech received FDA approval to update the label of Vyjuvek to include dystrophic epidermolysis bullosa (DEB) patients from birth, leading to an 8.4% increase in share price following the announcement [1][7]. Product Update - The label update allows for greater flexibility in the use of Vyjuvek, enabling patients and caregivers to administer the treatment at home and manage wound dressings more conveniently [2][7]. - The FDA's decision was based on data from an open-label extension study and real-world experience, confirming the long-term safety and efficacy of Vyjuvek across all ages [2]. Market Context - Vyjuvek was previously approved in 2023 as the first revocable gene therapy for DEB patients aged six months or older, a rare and severe genetic condition caused by mutations in the COL7A1 gene [3]. - Year-to-date, Krystal Biotech's shares have decreased by 0.7%, while the industry has seen a 3.6% increase [4]. Sales Performance - Vyjuvek recorded sales of $184.2 million in the first half of 2025, with expectations for further sales growth due to the recent label update and approvals in Europe and Japan [10]. - The company has secured over 575 reimbursement approvals for Vyjuvek in the U.S. since its launch, indicating steady progress in market access [8]. Expansion Plans - Krystal Biotech plans to launch Vyjuvek in Germany in Q3 and in France in Q4 of 2025, following its approval in Japan for DEB patients from birth [9].