COPENHAGEN - Zealand Pharma A/S (NASDAQ:ZEAL) has revealed that its licensing partner Boehringer Ingelheim is set to present positive results from a Phase 2 trial of survodutide for treating metabolic dysfunction-associated steatohepatitis (MASH) at the upcoming European Association of the Study of Liver Congress (EASL). The data, which was inadvertently released on the congress website ahead of its official presentation scheduled for tomorrow, supports the efficacy of survodutide in improving liver health.
The double-blind, placebo-controlled trial assessed the impact of three different doses of survodutide on patients with MASH. The primary endpoint, which was histological improvement of MASH without worsening fibrosis, was met after 48 weeks of treatment. Additionally, a key secondary endpoint was achieved, demonstrating a significant reduction in liver fibrosis without exacerbating MASH. This improvement was observed across stages F1 to F3, which range from mild to advanced scarring.
Survodutide, a glucagon/GLP-1 receptor dual agonist, has been recognized by the U.S. Food and Drug Administration with Fast Track Designation for MASH and fibrosis treatment since May 2021. It has also been accepted into the European Medicines Agency's Priority Medicine (PRIME) scheme for the same conditions as of November 2023.
The safety profile of survodutide aligns with that of other GLP-1 based molecules, showing no new safety concerns. These results bolster the therapeutic potential of survodutide, which is also undergoing investigation in five Phase 3 trials for overweight and obesity, conditions commonly associated with MASH.
Zealand Pharma, a biotechnology firm specializing in peptide-based medicines, has invented more than 10 drug candidates that have progressed to clinical development. The company holds co-promotion rights for survodutide in the Nordic countries, while Boehringer Ingelheim is responsible for its global development and commercialization.
The information regarding the Phase 2 trial results of survodutide is based on a press release statement.
In other recent news, Zealand Pharma has been making significant strides in the healthcare sector. The company received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its dasiglucagon solution, a treatment for severe hypoglycemia in diabetes patients. This recommendation paves the way for potential marketing authorization by the European Commission for the European Union market.
In another development, Zealand Pharma reported topline results from its DREAM trial, which evaluated the effects of its investigational drug dapiglutide in individuals with obesity. The 12-week study showed an average weight loss of up to 4.3% with low doses of the dual GLP-1/GLP-2 receptor agonist. The company is also conducting a Phase 1b trial to assess higher doses of dapiglutide, with results expected later in the year.
Furthermore, Zealand Pharma received an Overweight rating from Cantor Fitzgerald and a Buy rating from BTIG, reflecting optimism about the company's potential in the obesity treatment market. Both firms highlighted Zealand's year-to-date performance and anticipate further growth driven by forthcoming clinical data. The company's obesity pipeline, which includes a range of incretins and an amylin analog named petrelintide, is considered to have best-in-class features.
In addition to these developments, Zealand Pharma is also working on two near-commercial rare disease therapies with little competition, which are expected to be highly successful and potentially reach $1.9 billion in combined peak sales. The company's partnership with Boehringer Ingelheim on a GLP-1/GCG agonist is seen as a strong player in the obesity market with payor support.
InvestingPro Insights
As Zealand Pharma A/S (NASDAQ:ZEAL) garners attention with the promising results of survodutide, InvestingPro data provides a snapshot of the company's financial health and market performance. With a market capitalization of $5.88 billion, the company is maintaining a significant presence in the biotech sector. Despite a negative P/E ratio of -51.56, indicating that the company is not currently profitable, the substantial revenue growth over the last twelve months as of Q1 2024, at 222.76%, suggests a strong potential for future profitability.
Investors keeping a close eye on Zealand Pharma's stock performance will note the impressive 138.29% one-year price total return, signaling robust investor confidence and market momentum for ZEAL. However, the company's fair value estimations present a mixed picture; while analyst targets suggest a fair value of $118.95, InvestingPro's fair value assessment is $63.66, hinting at divergent views on the company's valuation.
For those interested in a deeper dive into Zealand Pharma's prospects, InvestingPro offers additional analysis and metrics. There are 7 more InvestingPro Tips available, which could provide valuable insights for investors considering ZEAL. For access to these exclusive tips, consider subscribing to InvestingPro with a special offer using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
The upcoming European Association of the Study of Liver Congress presentation and subsequent developments will likely play a crucial role in shaping the investment landscape for Zealand Pharma. With such dynamic growth and market activity, keeping informed with the latest data and expert tips can be pivotal.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.