KRYS Gets Positive CHMP Opinion for EU Approval of Skin Disease Drug

Core Viewpoint - Krystal Biotech's Vyjuvek has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the treatment of dystrophic epidermolysis bullosa (DEB), with a final decision expected in Q2 2025 [1][3]. Group 1: Product and Approval Details - Vyjuvek is a non-invasive, topical gene therapy designed to deliver two copies of the COL7A1 gene directly to DEB wounds [2]. - The CHMP's favorable opinion supports administration in healthcare settings or at home, with trained patients or caregivers able to apply it themselves [3]. - The positive opinion is based on results from phase I/II GEM-1 and phase III GEM-3 studies, demonstrating successful gene delivery and durable wound closure [5]. Group 2: Market and Financial Performance - Krystal Biotech's shares have declined 18.3% over the past three months, contrasting with a 0.6% decline in the industry [4]. - In Q4 2024, the company reported total revenues of $91.1 million, a 116% increase year-over-year, solely from Vyjuvek sales [8]. - As of February 2025, the company secured over 510 reimbursement approvals for Vyjuvek in the U.S., with a gross margin of 95% in Q4 2024 and high patient adherence at 85% [9]. Group 3: Future Launch Plans - Krystal Biotech plans to launch Vyjuvek for DEB in Germany around mid-2025, with additional launches in France and other EU countries later in 2025 [7].