Regeneron shares fell by almost 9% after the US Food and Drug Administration (FDA) rejected the company’s proposal for an 8mg dose of its injection, Eylea, for patients with wet age-related macular degeneration and two other eye diseases that are common in people with diabetes. The rejection was due to an ongoing review of inspection findings at a third-party filler. Regeneron said the decision was not related to the drug’s efficacy, safety, trial design, labeling or drug substance manufacturing, but the delay could harm the company’s Eylea drug franchise, which is facing competition from Roche Holdings’ eye drug, Vabysmo.
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