Regeneron Pharmaceuticals, Inc. Announces U.S. Food and Drug Administration Approves Dupixent for the Treatment of Adult Patients with Bullous Pemphigoid

Published: 2025-06-20 02:05:28 ET REGN

Published on 06/20/2025 at 02:05

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of adult patients with bullous pemphigoid. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees and product candidates being developed by Regeneron and/or's collaborators or licensees and research and clinical programs now underway or planned, including without limitation Dupixent (d) for the treatment of bullous Pemphigoid as discussed in this press release; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the ongoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates a nd new indications for Regeneron's Products, such as Dupixent for the treatment of chronic pruritus of unknown origin, lichen simplex chronicus, and other potential indications; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron's Products (such as Dupixent) and Regeneron's Product Cand candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regener on's Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron's Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other Third parties; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and RegenerON's Product Candidates (including biosimilar versions of Regeneron's Products); the extent to which the results from the research and development programs conducted by Regeneron and/or the collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron To meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi and Bayer (or their agreements with Sanofi and Bayer.