Group 1 - Krystal Biotech announced FDA approval for an updated label for its gene therapy, Vyjuvek (beremagene geperpavec) [6] - The new approval expands patient eligibility to include individuals with dystrophic epidermolysis bullosa from birth [6] - The updated label allows for broader access to the therapy for affected patients [6]

Core Insights - Abeona Therapeutics Inc. received FDA approval for Zevaskyn, the first autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) [1][3] - Zevaskyn is a single-application treatment that utilizes genetically modified skin cells to produce functional Type VII collagen, allowing for significant coverage of wounds [2][3] - The list price for Zevaskyn is set at $3.1 million per treatment, significantly higher than previous estimates, with projected sales of over $30 million by the end of 2025 [5][6] Market Potential - HC Wainwright estimates peak U.S. sales for Zevaskyn could reach around $600 million, with a potential market opportunity exceeding $2 billion if all 750 identified patients are treated [6] - The updated revenue forecast for Abeona is $31.6 million in 2025, increasing to $130.4 million in 2026 [5][6] Competitive Landscape - Zevaskyn may be used in conjunction with other treatments, such as Krystal Biotech's Vyjuvek, which was recently approved in Europe for similar indications [3][4] - Analyst Raghuram Selvaraju maintains a Buy rating for Abeona, raising the price target from $15 to $20 per share, reflecting increased confidence in Zevaskyn's market position [6]