Zealand Pharma FIRST LOOK: Submits glepaglutide MAA to the EMA in short bowel syndrome
Zealand announced the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMA) for glepaglutide twice weekly (long-acting GLP-2 analog) in adults with short bowel syndrome (SBS). Looking ahead, we look forward to the initiation of the confirmatory phase 3 trial in the US, expected in 2H25. Beyond glepaglutide, which represents a small fraction of our SOTP, additional phase 1b data (higher dosing and longer treatment) for dapiglutide (long acting GLP-1/GLP-2 analog) for the larger obesity opportunity is expected in 2Q25, and could bring near-term upside for the stock. We reiterate our DKK 1,120 TP and Buy rating.Zealand Pharma is a biotechnology company. Co. is engaged in the discovery development and commercialization of peptide-based medicines. Co.'s pipeline comprises two implementation areas: Cardio-metabolic diseases and Other indications. The Cardio-metabolic diseases area includes medicines for diabetes and obesity treatment, such as Lyxumia (Lixisenatide), Lyxumia/Lantus, ZP2929 and Danegaptide. The Other indications area are ZP1848, Elsiglutide and ZP1480 (ABT-719) drugs for inflammatory bowel disease, chemotherapy-induced diarrhea and acute kidney injury treatment.
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