Zealand Pharma FDA issues rejection letter for glepaglutide in SBS
Zealand announced that the FDA has issued a complete response letter (CRL) for the company's NDA for glepaglutide (long acting GLP-2 analog) in SBS, and recommended an additional confirmatory phase 3 trial. We are keen to learn more about what the additional study will look like, which should become clearer following the company's type A meeting with the FDA expected in 1Q25. We expect some pressure on the shares today, though note that glepaglutide represents just ~4% in our SOTP, with the majority of value coming from the company's obesity programs. We adjust our model shifting glepaglutide's US market entry and potential out-licencing deal to 2027 (from 2025), which brings us to a new TP of DKK 970 (from DKK 980). With multiple differentiated assets in the obesity space we reiterate our BUY rating for Zealand.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.
We are a financial services provider for several types of professional clients, each with distinct needs.
Unfortunately, this report is not available for the investor type or country you selected.
Browse all ResearchPool reportsReport is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.