Regeneron's Fianlimab and Cemiplimab Combination Therapy in NSCLC: Promising Clinical Trial Update

Regeneron Pharmaceuticals is conducting a Phase 2 clinical trial to evaluate the safety and efficacy of combining fianlimab with cemiplimab and chemotherapy in treating non-small cell lung cancer (NSCLC). The study aims to determine if this combination improves treatment outcomes for NSCLC patients. The trial began on July 16, 2024, and the latest update was submitted on July 31, 2025. Positive results could enhance Regeneron's stock performance and influence industry dynamics.

Regeneron Pharmaceuticals (REGN) reported its Q2 2025 earnings on August 1, 2025, showcasing a mix of financial performance and strategic challenges. The company's non-GAAP earnings per share (EPS) reached $12.89, significantly surpassing the consensus estimate of $8.43 [1]. GAAP revenue hit $3.68 billion, up 3.6% year-over-year (YoY), driven by collaboration income and high-margin products [1].

Key highlights include a 29.7% increase in collaboration revenue, largely driven by the company's partnership with Sanofi on Dupixent, an immunology biologic drug [1]. The company's share of Dupixent profits rose 30% to $1.28 billion [1]. Regeneron also reported strong growth in its oncology segment, with Libtayo, an immunotherapy, delivering global net product sales up 27% [1].

However, the quarter was marred by several challenges. The U.S. ophthalmology franchise faced significant erosion, with legacy EYLEA U.S. net product sales down 39% compared to Q2 2024 [1]. This decline was attributed to competition from compounded alternatives like repackaged Avastin and shifting insurance reimbursement trends [1]. Regeneron committed $200 million in matching funds through the end of 2025 to re-establish patient assistance [1].

Moreover, the company's gross margin on net product sales fell to 86% on a Non-GAAP basis, down 4 percentage points compared to Q2 2024 [1]. This was due to higher manufacturing investment and inventory write-offs driven by more complex product launches and upgrades at external manufacturing suppliers [1]. Despite these challenges, Regeneron maintained disciplined control over selling, general, and administrative expenses, which decreased 19% Non-GAAP [1].

Looking ahead, management highlighted external regulatory and manufacturing variables, continued pressure on the ophthalmology business, and rising competition across therapy areas as key risks [1]. The company's Phase 2 clinical trial evaluating the combination of fianlimab, cemiplimab, and chemotherapy for non-small cell lung cancer (NSCLC) could potentially enhance its stock performance and influence industry dynamics [2].

References:
[1] https://www.nasdaq.com/articles/regeneron-regn-q2-eps-jumps-53
[2] https://www.ainvest.com/news/regeneron-pharmaceuticals-navigating-q2-2025-earnings-pipeline-advances-long-term-growth-2508/