Regeneron Pharmaceuticals reported second-quarter revenue of $3.68 billion, a 4 percent increase from a year earlier, and adjusted earnings of $12.89 a share, outpacing analyst expectations. Net income reached $1.39 billion as strong demand for high-dose Eylea and continued expansion of Dupixent helped offset weakness in the legacy macular-degeneration formulation. U.S. sales of Eylea HD climbed 29 percent to $393 million, accounting for roughly one-third of the $1.15 billion generated by the overall Eylea franchise, whose total fell 25 percent amid price pressure and patient shifts to compounded bevacizumab. Sanofi-recorded Dupixent revenue rose 22 percent to $4.34 billion, while Regeneron’s oncology portfolio was bolstered by the early-July U.S. approval of Lynozyfic, a BCMA-targeting bispecific for heavily pre-treated multiple-myeloma patients. Regulatory headwinds tempered the quarter’s gains. On 30 July the Food and Drug Administration issued a complete response letter for odronextamab, Regeneron’s CD20×CD3 bispecific for relapsed or refractory follicular lymphoma, citing manufacturing deficiencies at a Catalent facility in Indiana that Novo Nordisk recently acquired. The same inspection findings are expected to delay August FDA decisions on a pre-filled syringe and additional indications for Eylea HD. Regeneron said it is working with alternate contractors and with Novo Nordisk on corrective actions and expects a “prompt resolution” that would allow it to re-file odronextamab and clear the path for the pending Eylea HD supplements. Since the start of the year the company has authorised more than $7 billion in manufacturing investments, capital expenditures and business-development deals while continuing share buybacks, underscoring its confidence in long-term growth despite near-term regulatory setbacks.