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In its Complete Response Letter, the FDA pointed to facility-related deficiencies discovered last month during an inspection of a third-party manufacturer as the reason for the rejection

CagriSema is the investigational fixed-combination of cagrilintide with the GLP-1 receptor agonist semaglutide studied across the Phase 2 and Phase 3 REDEFINE trials

A landmark 2012 study published in Behavioural Brain Research administered 0.04mg/kg subcutaneously to rats with scopolamine-induced cognitive deficits and observed complete reversal of spatial memory impairments within 48 hours

It includes a clinically proven combo of probiotics and inulin (fibre) to improve gut function, reduce bloating, and enhance nutrient absorption