Positive European Opinion for Zealand Pharma Drug, With Commission Decision Still Pending
Key Facts
Final approval from the European Commission for Zeydovio had not been confirmed as of November 13, despite the European Medicines Agency’s Committee for Medicinal Products for Human Use issuing a positive opinion on the drug, according to the agency’s live page. The application concerns glepaglutide for the treatment of short bowel syndrome, a condition that may require patients to depend on intravenous support. This means the positive opinion is a regulatory step in the application process, but is not equivalent to a Commission decision granting marketing authorization. Zealand Pharma said in September that a final decision was expected within about 67 days of the committee’s opinion. If authorization is granted, it will be valid in European Union countries as well as Iceland, Liechtenstein and Norway.
The committee’s opinion, according to the European Medicines Agency, was based on results from a trial that compared glepaglutide administered twice weekly with placebo over 24 weeks. The results showed a greater reduction in weekly intravenous support volume among recipients of the drug, the measure the trial used to assess the treatment’s effect on patients’ need for nutrition and fluids through a vein. This result provides a clinical basis for the positive opinion, while the final regulatory decision remains with the European Commission. The available information does not support describing the opinion as final approval or as an announcement of an effective authorization.
In the EASE-1 trial, Zealand Pharma said 65.7% of patients who received glepaglutide twice weekly achieved a clinical response, compared with 38.9% in the placebo group. The company defined a response as a reduction of at least 20% in weekly intravenous support volume compared with baseline, at both weeks 20 and 24. The result therefore combined the share of patients who responded with the prespecified level of improvement in their need for intravenous support. The company said the difference between the groups was statistically significant, with a p-value of 0.0243. These results are among the clinical evidence supporting the drug’s evaluation, not part of the final European authorization decision.
Zealand Pharma’s third-quarter 2023 report said 14% of the twice-weekly dose group, or five patients, completely stopped intravenous support in the EASE SBS-1 trial. No patient in the placebo group achieved the same outcome, according to the report. Complete cessation of intravenous support is a different indicator from the response defined as a reduction of at least 20% in its volume, as it describes a more pronounced outcome among a group of participants. The comparison between the groups shows that this outcome was recorded among recipients of the twice-weekly dose and was not recorded in the placebo group. These figures relate to the drug’s clinical background and do not by themselves determine the outcome of the marketing application.
In the market, EL7 data showed ZLDPF closing at $35.5 on November 12, 2026, after closing at $36.75 on November 11. This places the two closing prices in their time context, without establishing that the November 12 price preceded or reacted to an announcement of European approval. The available facts include no other data on the stock’s movement in the November 13 session or on investors’ interpretation of the price change. The closing-price reading therefore remains limited to the two recorded figures and the dates cited.
On the U.S. clinical path, Zealand Pharma had been recruiting patients in Europe and the United States since January 2026 for EASE-5, an additional Phase 3 trial of the drug. The study aims to confirm its efficacy and safety over 52 weeks of treatment at a dose of 10 mg twice weekly, according to the company. Reuters reported on November 12 that the trial is being conducted to support a new U.S. application. Clinical development therefore continues alongside the European review, while the Commission’s final decision on the European marketing application remains pending.