Regeneron's Manufacturing Missteps Lead to FDA Rejection and Stock Slump

The US Food and Drug Administration (FDA) rejected Regeneron Pharmaceuticals' application for a stronger formulation of its eye medicine Eylea due to ongoing inspection findings at a Catalent Inc. production facility in Bloomington, Indiana. Catalent confirmed that its facility was the one in question and stated that it is taking the observations seriously and working on proposed corrective actions. This is the latest setback for Catalent, which has faced previous inspection-related issues impacting the supply of Moderna's Covid booster shot and Novo Nordisk's weight-loss drug Wegovy. The delay in approval could be costly for Regeneron, as it faces potential competition from cheaper versions of Eylea next year.