お知らせ • Aug 13
Acucort Publishes Results from Phase Iv Study with Zeqmelit Oral Film Results from AcuCort's clinical Phase IV study with Zeqmelit has been published in the scientific journal Journal of Market Access & Health Policy following peer review. The study reports positive results for Zeqmelit® oral film and provides valuable insight into how patients prescribed glucocorticoids for moderate to severe acute allergic reactions perceive their treatment, particularly in terms of accessibility, confidence and treatment effectiveness. The published study, ZEQ001, included 50 patients, of whom 44 completed the study, and was conducted as an open-label, low-intervention Phase IV study in a real-world clinical setting. Over a six-month period, patients' experiences with Zeqmelit® oral film were evaluated and compared with betamethasone tablets they had previously been prescribed for their allergic reactions. The study shows that patients not only value the oral film formulation but that it may also help ensure that treatment is more often available when it is actually needed. The aim of AcuCort's Phase IV study ZEQ001 was to collect scientific data from patients who had previously used tablets but were given the opportunity to use Zeqmelit® as part of the study. The study focused on patients' experiences of the medicine's effectiveness, their confidence in the treatment, and how convenient they found it to carry and use in everyday life. Some of the results from the study shows that: 98% of patients reported being satisfied or very satisfied with the availability of Zeqmelit® oral film, compared with 58% for tablets. 77% reported carrying Zeqmelit® with them more often than their corticosteroid tablets. 78% reported feeling more secure when having access to Zeqmelit®. In reported acute allergic reactions, Zeqmelit® was chosen in 16 out of 18 cases, and in 94% of these cases, its effectiveness was rated as good or very good. At the end of the study, a clear majority of patients preferred Zeqmelit® to tablets for future treatment. 24% of patients reported feeling more secure and being less likely to avoid specific situations when they had Zeqmelit® available. The scientific article is entitled A Real-World Clinical Trial Evaluating Satisfaction and Experiences with a Dexamethasone Mouth Film Compared to Corticosteroid Tablets as Rescue Medication for Moderate to Severe Acute Allergic Reactions and has been published in Journal of Market Access & Health Policy. お知らせ • Jul 27
AcuCort Receives Renewed FDA Small Business Waiver Ahead of Planned NDA Submission The U.S. Food and Drug Administration (FDA) has granted AcuCort's application for a renewed Small Business Waiver (SBW). The decision exempts the company from the application fee for its planned New Drug Application (NDA), a fee that would otherwise amount to approximately SEK 16 million. The FDA had previously granted AcuCort a Small Business Waiver (SBW). As the previous waiver had expired, the company applied for a renewal earlier this year, which has now been approved by the FDA. In April 2026, AcuCort also announced that it had reached agreement with the FDA that no additional studies are required prior to submitting its NDA. An NDA is typically reviewed within approximately 12 months. Through the renewed Small Business Waiver, AcuCort is exempt from the application fee of approximately SEK 16 million. お知らせ • Jul 14
AcuCort AB (publ) to Report Q2, 2026 Results on Aug 12, 2026 AcuCort AB (publ) announced that they will report Q2, 2026 results on Aug 12, 2026 お知らせ • Apr 13
AcuCort and the FDA Agree on iPSP - Important Step Towards US Market Approval AcuCort announced that it has agreed an iPSP (Initial Pediatric Study Plan) with the U.S. Food and Drug Administration (FDA) for its product Zeqmelit. This constitutes a prerequisite for AcuCort to submit a New Drug Application (NDA) in the United States, which is planned for later this year. The iPSP process is of central importance ahead of AcuCort's forthcoming NDA submission to the FDA, the world's single largest pharmaceutical market. At the end of March 2026, AcuCort submitted its responses to the FDA's additional questions. The company has now reached agreement with the FDA on the iPSP. The next step is for AcuCort to apply for a renewed Small Business Waiver from the FDA, which would exempt the company from the application fee of approximately SEK 16 million. AcuCort was granted such a waiver in 2022. Following approval, the company can proceed with the submission of the NDA in the United States. お知らせ • Mar 30
AcuCort AB (publ) to Report Q1, 2026 Results on Apr 28, 2026 AcuCort AB (publ) announced that they will report Q1, 2026 results on Apr 28, 2026 お知らせ • Jan 22
AcuCort AB (publ) to Report Fiscal Year 2025 Results on Feb 20, 2026 AcuCort AB (publ) announced that they will report fiscal year 2025 results at 12:00 PM, Central European Standard Time on Feb 20, 2026 
