SNY and REGN's Dupixent sBLA for Skin Disease Gets FDA's Priority Tag

Core Viewpoint - Sanofi and Regeneron announced that the FDA has accepted their supplemental biologics license application for Dupixent to treat bullous pemphigoid, with a decision expected by June 20, 2025 [1][2]. Company Overview - Dupixent is currently approved for six type II inflammatory diseases and is a key revenue driver for both Sanofi and Regeneron [6][8]. - In 2024, Dupixent generated global product sales of approximately $14.15 billion for Sanofi, reflecting a growth of 23.1% at a constant exchange rate [10]. Market Dynamics - Dupixent's sales growth is driven by strong demand across various geographies and newly approved indications, with expectations for continued growth in future quarters [8]. - If approved for bullous pemphigoid, Dupixent will be the first targeted treatment for this condition in the United States, addressing a significant unmet medical need [5]. Financial Performance - Sanofi's stock has increased by 18% over the past year, contrasting with a 7.9% decline in the industry [3]. - Regeneron reported collaboration revenues of $4.53 billion from Dupixent in 2024, marking a 19% year-over-year increase [10]. Future Prospects - Sanofi anticipates Dupixent will achieve around €22 billion in sales by 2030 [10]. - An additional sBLA for Dupixent targeting chronic spontaneous urticaria is under review, with a decision expected on April 18 [9].