Regeneron Gets FDA Nod for Label Expansion of Oncology Drug Libtayo

Core Insights - Regeneron Pharmaceuticals, Inc. (REGN) has received FDA approval for the label expansion of its PD-1 inhibitor Libtayo (cemiplimab-rwlc) as an adjuvant treatment for adult patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery and radiation [1][9] Group 1: Approval and Efficacy - Libtayo is now approved for high-risk CSCC patients, marking it as the only immunotherapy to show efficacy in this setting [5][9] - The FDA's approval was based on the late-stage C-POST study, which demonstrated a 68% reduction in the risk of disease recurrence or death compared to placebo [4][9] - An additional regulatory application for Libtayo is under review in the European Union, with a decision expected by the first half of 2026 [3] Group 2: Financial Performance - Libtayo's sales reached $661.6 million in the first half of 2025, reflecting an 18% year-over-year increase [5] - REGN's stock has declined by 20.5% year to date, contrasting with the industry's growth of 10.5% [2] Group 3: Portfolio Diversification - REGN is actively working to diversify its portfolio, especially as its lead drug Eylea faces competition from Roche's Vabysmo [12] - Eylea sales in the U.S. increased by 29% in the second quarter due to higher demand for a higher dose version [13] - The oncology franchise has been bolstered by the recent FDA approvals of linvoseltamab-gcpt for relapsed or refractory multiple myeloma and Ordspono for follicular lymphoma, despite setbacks with odronextamab [10][11]