Regeneron Pharmaceuticals announced robust second-quarter earnings with revenues surpassing forecasts by 11% and significant earnings per share gains. However, three high-dose Eylea drug applications have experienced FDA approval delays linked to manufacturing issues at Catalent’s facility, with updated decision timelines pending resolution. Additionally, the FDA issued a complete response letter for Regeneron’s odronextamab for follicular lymphoma, partly attributed to these manufacturing challenges. Despite these setbacks, leadership remains optimistic about eventual FDA approvals. The stock initially spiked on earnings before retreating to prior levels.