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The rejection is related to the timing of the FDA’s reinspection of Zealand’s third-party manufacturer, which previously had deficiencies.

Zealand Pharma A/S, a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced the interim report for the three months ended March 31, 2024, and provided a corporate update.

Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that Adam Steensberg, President and CEO, will participate in fireside chats at the following healthcare investor conferences in June.

Zealand Pharma announces that Boehringer Ingelheim’s survodutide demonstrates breakthrough improvement in liver fibrosis with no worsening of MASH in 64.5% of patients with F2 and F3 fibrosis

Zealand Pharma said on Thursday that partner Boehringer Ingelheim will present the results from the study on Friday at the European Association of the Study of Liver Congress.

Zealand Pharma announces that Boehringer Ingelheim will present positive results from Phase 2 trial with survodutide in MASH at EASL

Zealand Pharma A/S announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending granting marketing authorization for dasiglucagon solution for injection in the treatment of severe hypoglycemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus.

Zealand Pharma’s petrelintide cut body weight by more than 8% on average, with a good overall safety and tolerability profile.

Zealand Pharma announces positive topline results from the Phase 1b 16-week multiple ascending dose clinical trial with long-acting amylin analog petrelintide