Published: 4/13/2026 8:27:56 AM

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Finwire about AcuCort AB: Acucort reaches milestone toward approval of Zeqmelit in the USA

The life science company Acucort has reached an agreement with the US Food and Drug Administration (FDA) on an IPSP, Initial Pediatric Study Plan, regarding the drug Zeqmelit. This is a prerequisite for Acucort to apply for marketing approval in the USA, which is planned to take place during the current year. This is stated in a press release.- It is very gratifying that we have reached yet another major and important milestone by reaching an agreement with the FDA on our IPSP, a decision that further strengthens our commercial growth journey. It has been a protracted process that has delayed our ability to submit an application for marketing approval in the USA. It is therefore especially gratifying that we have reached the finish line and can move forward with the application, says Acucort's CEO Jonas Jönmark.The next step is for Acucort to apply for a renewed Small Business Waiver from the FDA, which means that the company can be exempted from the application fee of SEK 16 million. Acucort was granted such a waiver in 2022. After the approval, the company can move forward with the application for marketing approval in the USA.

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