Core Insights - Zealand Pharma A/S announced positive topline results from a 28-week Phase 1b trial of dapiglutide, a dual GLP-1/GLP-2 receptor agonist, indicating significant weight loss and safety [2][3][4] Group 1: Trial Results - In the Phase 1b trial, 30 participants (approximately 93% male) experienced an estimated mean body weight decrease of 11.6% from baseline after 28 weeks of dapiglutide treatment, compared to a 0.2% decrease in the placebo group [3][8] - The trial showed that dapiglutide was safe and well-tolerated, with no severe treatment-emergent adverse events reported, and the majority of adverse events were mild gastrointestinal issues [4][8] Group 2: Trial Design - The Phase 1b trial was a single-center, randomized, double-blind, placebo-controlled study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of dapiglutide in participants with overweight or obesity [5][6] - Part 1 of the trial included 54 participants and demonstrated placebo-adjusted weight reductions of up to 8.3% after 13 weeks, while Part 2 involved 30 participants receiving 28 weekly doses of dapiglutide [6][7] Group 3: Drug Mechanism and Target Population - Dapiglutide is designed to leverage a dual mechanism involving GLP-1 and GLP-2, targeting obesity-related comorbid conditions driven by low-grade inflammation [9][10] - The drug aims to improve intestinal barrier function and address comorbidities associated with obesity, such as cardiovascular disease and liver disease [10]

Group 1 - The MSCI Nordic Countries Index declined by 1.0%, marking its worst single-day performance since May 22, when it fell by 1.8%, closing at 361.81 points [1] - The healthcare sector in the Nordic region led the decline [2] - Zealand Pharma A/S experienced the largest drop among constituents, falling by 9.2% [3]

Core Viewpoint - The MSCI Nordic Countries Index experienced a significant decline of 0.8%, marking the largest single-day drop since May 22, when it fell by 1.8%, closing at 364.60 points [1] Financial Sector Performance - The Nordic financial sector led the decline in the index [1] Company-Specific Performance - Zealand Pharma A/S recorded the worst performance among the constituents, with a drop of 4.9% [1]

Core Viewpoint - Zealand Pharma has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for glepaglutide, a long-acting GLP-2 analog aimed at treating short bowel syndrome (SBS) in adults [1][2]. Company Overview - Zealand Pharma A/S is a biotechnology company focused on developing innovative peptide-based medicines, with more than 10 drug candidates in clinical development, including two that have reached the market [12][13]. Product Development - Glepaglutide is designed as a liquid product for subcutaneous administration, intended to reduce or eliminate the need for parenteral support in SBS patients [4]. - The MAA submission is based on results from the pivotal Phase 3 trial (EASE-1) and interim results from ongoing long-term extension trials (EASE-2 and EASE-3) [2][3]. Clinical Trial Results - EASE-1 trial involved 106 SBS patients, showing that glepaglutide administered twice weekly significantly reduced weekly parenteral support volume by 5.13 liters compared to 2.85 liters in the placebo group [6]. - In EASE-1, 9 patients treated with glepaglutide achieved enteral autonomy, while no patients in the placebo group were able to discontinue parenteral support [6]. - EASE-2 continues to evaluate the efficacy of glepaglutide, with interim analyses indicating maintained or improved clinical responses [8]. Future Plans - Zealand Pharma plans to initiate the EASE-5 Phase 3 trial in the second half of 2025 to gather further confirmatory safety and efficacy data for regulatory submission in the U.S. [3][11].

Zealand Pharma A/S涨10%，领跑一众成分股。 明晟公司MSCI北欧国家指数涨1.4%，创5月12日以来最大单日涨幅，报360.29点，北欧医疗保健板块领 跑。 ...

Core Viewpoint - Zealand Pharma strengthens its leadership in innovation for obesity and related conditions with the appointment of Steven Johnson as Chief Development Officer [2][4] Company Overview - Zealand Pharma A/S is a biotechnology company focused on the discovery and development of innovative peptide-based medicines, with more than 10 drug candidates in clinical development, including two that have reached the market and three in late-stage development [5][6] Leadership Appointment - Steven Johnson brings nearly 30 years of experience in drug development and regulatory strategy, previously serving at UCB Biopharma and holding senior roles at Medpace, Inc. and Novo Nordisk [3][4] - His role will involve leading regulatory and development strategies, enhancing the company's R&D leadership alongside CMO David Kendall and CSO Utpal Singh [4][7] Strategic Focus - The appointment comes as Zealand Pharma collaborates with Roche to co-develop and co-commercialize petrelintide, aimed at addressing obesity and related complications [4][7] - The leadership team aims to align human-centered innovation with world-class science to develop new therapies that could redefine the standard of care for obesity [4]

Zealand Pharma A/S涨3.7%，领跑一众成分股。 明晟公司MSCI北欧国家指数微幅上涨，报357.39点，北欧电信服务板块领跑，本周累计上涨超过 2.65%。 ...

Core Insights - Zealand Pharma has successfully closed a collaboration and license agreement with Roche, which is now effective following the satisfaction of all closing conditions, including regulatory requirements [1] - The partnership is aimed at advancing Zealand Pharma's vision in obesity management, with a focus on the potential of petrelintide to benefit individuals who are overweight or obese [2] Company Overview - Zealand Pharma A/S is a biotechnology company specializing in the discovery and development of peptide-based medicines, with over 10 drug candidates in clinical development, including two that have reached the market and three in late-stage development [3] - Founded in 1998 and headquartered in Copenhagen, Denmark, Zealand Pharma also has a presence in the United States [4]

Core Insights - Zealand Pharma has reported significant progress in its clinical pipeline and has established a transformative partnership with Roche for petrelintide, positioning the company for accelerated growth [1][3]. Financial Performance - For Q1 2025, Zealand Pharma reported revenue of DKK 8.1 million, a decrease from DKK 15.1 million in Q1 2024 [4]. - Operating expenses increased to DKK 393.1 million from DKK 266.3 million year-over-year [4]. - The operating result was a loss of DKK 385.5 million compared to a loss of DKK 255.8 million in the same quarter last year [4]. - The net financial items improved to DKK 70.3 million from DKK 25.8 million [4]. - The cash position as of March 31, 2025, was DKK 8,544.5 million, down from DKK 9,022.0 million at the end of 2024 [4]. Strategic Developments - Zealand Pharma entered a collaboration and license agreement with Roche to co-develop and co-commercialize petrelintide, sharing profits and losses on a 50/50 basis [4][5]. - The partnership aims to establish a leading amylin-based franchise for weight management and related indications [5]. - Zealand Pharma completed enrollment in the Phase 2 ZUPREME-1 trial for petrelintide three months after initiation [5][9]. Corporate Updates - Utpal Singh was appointed as Chief Scientific Officer to lead the next wave of innovative medicines [5][10]. - Steven R. Smith was appointed as Senior Global Medical Advisor in Obesity to support obesity research and clinical development programs [8]. Upcoming Milestones - Zealand Pharma expects to submit a Marketing Authorization Application for glepaglutide in the second half of 2025 and initiate a Phase 3 clinical trial [12]. - The company anticipates reporting topline results from the Phase 2 ZUPREME-1 trial in the first half of 2026 [14]. - Zealand Pharma plans to host a Capital Markets Day in London on December 11, 2025 [17]. Financial Guidance - The financial guidance for 2025 remains unchanged, with net operating expenses expected to be between DKK 2,000 million and DKK 2,500 million [18][19].

Core Points - Zealand Pharma A/S will host a conference call on May 8, 2025, at 2:00 pm CET (8:00 am ET) to present its financial results for the first quarter of 2025 [1] - The call will feature key executives including the President and CEO, CFO, CMO, and CCO, followed by a Q&A session [2] - A live audio webcast and slide presentation will be available for participants, with a recording accessible afterward on the company's investor website [3] Company Overview - Zealand Pharma A/S is a biotechnology company focused on the discovery and development of peptide-based medicines, with over 10 drug candidates in clinical development, including two that have reached the market and three in late-stage development [4] - The company has established development and commercial partnerships with various pharmaceutical companies for its marketed products [4] - Founded in 1998 and headquartered in Copenhagen, Denmark, Zealand Pharma also has a presence in the U.S. [5]