Regeneron Pharmaceuticals Inc. (REGN) is seeking to expand the label of Libtayo as adjuvant therapy in patients with high-risk cutaneous squamous cell carcinoma after surgery, and a decision is expected in October 2025.Cutaneous Squamous Cell Carcinoma (CSCC) is the second most common type of skin cancer in the United States, with an estimated annual incidence of approximately 1.8 million cases according to the Skin Cancer Foundation.In a phase III trial, Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death in patients with high-risk cutaneous squamous cell carcinoma after surgery compared to placebo.The drug is already approved in the U.S. for the treatment of certain adult patients with cutaneous squamous cell carcinoma, basal cell carcinoma, and non-small cell lung cancer.For cutaneous squamous cell carcinoma (CSCC) in particular, the current indication covers patients with either metastatic CSCC (mCSCC) or locally advanced CSCC (laCSCC) who are not suitable candidates for curative surgery or radiation.Libtayo, approved in more than 30 countries for one or more indications, generated global net sales of $1.22 billion in full-year 2024 and $662 million in the first half of 2025.REGN closed Friday’s (September 26, 2025) trading at $563.90, up 1.51%.