Regeneron tops quarterly estimates, plans to resubmit Eylea application

Core Insights - Regeneron Pharmaceuticals exceeded Wall Street expectations for Q3 results, driven by strong demand for Dupixent and Libtayo, resulting in an 8% increase in shares [1] - The company plans to resubmit the marketing application for Eylea HD after a previous FDA rejection [1][3] Financial Performance - Total revenue for Q3 reached $3.75 billion, surpassing analysts' average estimate of $3.59 billion [4] - Sales of Dupixent rose 27% to $4.86 billion, exceeding the estimate of $4.54 billion [4] - Libtayo generated sales of $365 million, above the estimated $343.75 million [4] - The company reported a quarterly profit of $11.83 per share on an adjusted basis, compared to expectations of $9.59 [5] Regulatory Challenges - Regeneron has faced regulatory setbacks due to issues at Catalent's Bloomington filling facility, delaying three pending applications for Eylea with the FDA [2] - The company aims to submit a new filler application by January 2026, with potential FDA approval by mid-2026 [3]