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The PDUFA target action date is 7 July 2026

January 13, 2025

REIMAGINE 2 was a 68-week efficacy & safety trial investigating once weekly SC CagriSema, a fixed-dose combination of the Amylin receptor agonist, cagrilintide, & GLP-1RA, Semaglutide, compared to Semaglutide & placebo, the study enrolled 2,728 patients with type 2 diabetes inadequately controlled with metformin with or without an SGLT2I