Regeneron Rises on FDA Nod for Libtayo in High-Risk Skin Cancer
Approval marks the first immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma, a market estimated to be worth up to $700 million.
Regeneron Pharmaceuticals (NASDAQ: REGN) saw its shares climb nearly 2% Wednesday following the U.S. Food and Drug Administration's (FDA) decision to approve Libtayo (cemiplimab-rwlc) for a new, critical indication. The approval makes Libtayo the first and only immunotherapy available for the adjuvant treatment of adult patients with high-risk cutaneous squamous cell carcinoma (CSCC) following surgery and radiation.
The FDA's decision, which was granted under Priority Review, addresses a significant unmet need for patients at risk of their skin cancer returning post-treatment. The approval was based on compelling results from the Phase 3 C-POST trial, which demonstrated that Libtayo compared to a placebo. This new indication is expected to provide a substantial boost to a drug that already achieved blockbuster status in 2024 with over $1.2 billion in global sales.
Analysts view the approval as a significant growth catalyst, opening up a market niche estimated to be worth between $500 million and $700 million. Regeneron is now positioned to capture a patient population of approximately 10,000 in the U.S. This strategic win is magnified by the fact that a key competitor, Merck's Keytruda, in a similar clinical trial, leaving Libtayo with a clear first-mover advantage in this specific adjuvant setting.
Wall Street has reacted positively to the news, seeing it as a key driver for Regeneron's continued growth. that the new indication could add up to $500 million in incremental sales by 2026. With a regulatory application also under review in the European Union, the global sales trajectory for Libtayo looks increasingly robust, with some forecasts predicting the drug could reach total sales of $2.6 billion by 2031.