Regeneron Pharmaceuticals reported delays in FDA approval of its high-dose Eylea applications due to manufacturing issues at a Catalent facility, now owned by Novo Nordisk. These setbacks postponed FDA decisions originally expected in August 2025. Additionally, the FDA issued a complete response letter rejecting odronextamab for relapsed/refractory follicular lymphoma, also citing manufacturing concerns among other potential issues. Despite strong Q2 financials, these regulatory challenges cloud the company's near-term outlook.