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Regulatory Timeline and Expectations CagriSema (Cagrilintide + Semaglutide): FDA review ongoing for obesity indication European Medicines Agency (EMA) submission completed Potential approval expected in late 2026 or early 2027 Would represent first approved amylin analogue combination therapy Cagrilintide Monotherapy: Less likely to be pursued as standalone therapy Combination approaches show superior efficacy May remain primarily a research tool Emerging Research Questions Key questions driving current research include: Optimal combination partners Beyond semaglutide, which peptides pair best with cagrilintide