REGN Gets EC Nod for Libtayo Label Expansion, FDA Clears Monthly Eylea HD

Core Insights - The European Commission has approved the label expansion of Regeneron Pharmaceuticals' PD-1 inhibitor Libtayo for use as an adjuvant treatment for adult patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery and radiation [1][9]. Group 1: Libtayo Approval and Efficacy - The recent approval expands Libtayo's indications to include patients at high risk of disease recurrence, complementing its existing approvals for advanced CSCC, advanced basal cell carcinoma, advanced non-small cell lung cancer, and recurrent or metastatic cervical cancer [2][9]. - The approval is based on data from the global late-stage C-POST study, which demonstrated a 68% reduction in the risk of disease recurrence or death when Libtayo was compared to placebo [3][5]. - CSCC is one of the fastest-growing forms of skin cancer, and the approval highlights the need for earlier intervention in patients who are at significant risk of recurrence despite effective management through surgery or radiation [4][5]. Group 2: Financial Performance and Market Position - Libtayo has shown strong sales performance, totaling $1.03 billion in the first nine months of 2025, reflecting a 21% year-over-year increase [5]. - Regeneron is also evaluating Libtayo for use as a monotherapy and in combination with other therapies for various solid tumors and blood cancers [6]. Group 3: Eylea Developments - The FDA has approved Eylea HD for the treatment of macular edema following retinal vein occlusion, allowing for dosing up to every eight weeks after an initial monthly period [7][9]. - Eylea remains a significant contributor to Regeneron's revenue, although it faces competition from Roche's Vabysmo, which has impacted Eylea's sales [10][11]. - Eylea HD sales in the U.S. increased by 10% in Q3 2025 due to higher demand, and further label expansions are expected to boost sales [10]. Group 4: Portfolio Diversification and New Approvals - Regeneron is actively working to diversify its portfolio in response to declining Eylea sales, with a year-to-date stock performance of -1.4% compared to the industry's growth of 16.5% [12]. - Recent FDA approvals for linvoseltamab-gcpt and Ordspono have strengthened Regeneron's oncology franchise, targeting relapsed or refractory multiple myeloma and certain types of lymphoma, respectively [14][15].