AcuCort Reaches FDA Agreement on Pediatric Study Plan for Zeqmelit®, Clearing Path Toward US NDA Submission
Key Insights
AcuCort and the FDA have reached agreement on an Initial Pediatric Study Plan (iPSP) for Zeqmelit® (search), a prerequisite for submitting a New Drug Application in the United States.
The iPSP agreement marks a significant regulatory milestone that had been a prolonged process delaying the company's US application timeline.
AcuCort plans to submit its NDA later in 2026, following an application for a renewed Small Business Waiver to exempt the approximately SEK 16 million filing fee.
AcuCort AB (search) has reached agreement with the U.S. Food and Drug Administration (FDA) on an Initial Pediatric Study Plan (iPSP) for its product Zeqmelit® (search), the company announced on April 13, 2026. The agreement represents a critical regulatory prerequisite for the company to submit a New Drug Application (NDA) in the United States, which AcuCort plans to file later this year.
"We are very pleased to have reached another major and important milestone through our agreement with the FDA on our iPSP, a decision that further strengthens our commercial growth trajectory," said Jonas Jönmark, CEO of AcuCort. "This has been a prolonged process that has delayed our ability to submit an NDA in the United States. It is therefore particularly gratifying that we have now concluded this process and can proceed with the application."
The iPSP process is of central importance ahead of AcuCort's forthcoming NDA submission to the FDA, which governs the world's single largest pharmaceutical market. At the end of March 2026, AcuCort submitted its responses to the FDA's additional questions, culminating in the now-finalized agreement.
Next Steps Toward US Market Entry
With the iPSP agreement secured, AcuCort's immediate next step is to apply for a renewed Small Business Waiver from the FDA. If approved, the waiver would exempt the company from the application fee of approximately SEK 16 million. AcuCort was previously granted such a waiver in 2022. Following approval of the renewed waiver, the company can proceed with the NDA submission in the United States.
European Expansion Underway
The FDA milestone comes alongside AcuCort's growing international footprint. In January 2026, the company entered into a commercial agreement with Glenmark Pharmaceuticals covering six European markets. This agreement expands AcuCort's presence from the Nordic market of approximately 20 million inhabitants to a European market of roughly 200 million people. Preparations for registration under the Repeat Use Procedure (RUP) are currently underway.
"AcuCort has made a strong start to 2026, a year that began with a commercial agreement with Glenmark Pharmaceuticals," Jönmark noted. "Combined with the outcome from the FDA, AcuCort is well positioned for the internationalisation of our medicinal product Zeqmelit® (search)."
BIO International Convention Participation
AcuCort will attend the BIO International Convention in San Diego, June 22–25, 2026, where CEO Jonas Jönmark and Business Development Director Anna Chérouvrier Hansson will engage in strategic partnering discussions. The company will be represented in the Swedish pavilion in the exhibition area.
"The FDA agreement is a concrete step towards the US market and creates a strong foundation for the partnering discussions we are now conducting," said Jönmark. "We are seeing a clear and growing interest in AcuCort from potential international partners."
The BIO International Convention is one of the world's largest biotechnology gatherings, bringing together approximately 20,000 leading figures from across research, development, industry, and investment.