Regeneron Pharmaceuticals reported stronger-than-expected second-quarter results, with revenue rising 4% year on year to $3.68 billion and adjusted earnings climbing 12% to $12.89 a share. Dupixent continued to power growth, while sales of the newer high-dose formulation of Eylea rose 29% to $393 million. Nonetheless, combined U.S. revenue for the Eylea franchise fell 25% to $1.14 billion as patients shifted away from the original 2-mg version and competition intensified. The earnings beat was overshadowed by fresh regulatory trouble. The U.S. Food and Drug Administration issued a second complete response letter for odronextamab, Regeneron’s bispecific antibody for relapsed or refractory follicular lymphoma, after citing deficiencies found during a July inspection of Catalent’s fill-finish plant in Bloomington, Indiana, recently acquired by Novo Nordisk. The same observations are expected to push back three separate August decision dates for Eylea HD, including a pre-filled syringe presentation. Chief Executive Officer Leonard Schleifer said the shortcomings are process-related and ‘have a good chance of being resolved expeditiously.’ In a separate setback for the sector, Allogene Therapeutics removed its conditioning antibody ALLO-647 from a pivotal CAR-T trial after a patient died from infection-related liver failure. The disclosure sent Allogene shares down roughly 11% and prompted JPMorgan to cut its rating to neutral.
US FDA declines to approve Regeneron's blood cancer therapy for second time https://t.co/fqq7iROKfM https://t.co/fqq7iROKfM
Fluor Reports Second Quarter 2025 Results https://t.co/GkXwrwgynP https://t.co/jHupisW5Uu
Regeneron said on Friday the U.S. Food and Drug Administration has once again declined to approve its blood cancer therapy, this time in relation to observations from the regulator's inspection at a third-party manufacturing site. https://t.co/35SPuRGgET