Swedish pharmaceutical company AcuCort AB (Spotlight Stock Market: ACUC), developer of the rapidly dissolving dexamethasone oral film Zeqmelit, said on Monday it has received a renewed Small Business Waiver from the US Food and Drug Administration.

The decision exempts the company from the approximately SEK16m application fee for its planned New Drug Application.

The FDA had previously granted AcuCort a waiver, which had since expired. The renewal follows the company's application earlier this year and comes after an April 2026 agreement confirming that no additional studies are required before submitting the NDA.

AcuCort expects to file the NDA later in 2026, with the CEO stating that the waiver and initial paediatric study plan agreement keep the timeline on track.

Zeqmelit is approved and marketed in Sweden, Denmark, Norway and Finland for severe and acute allergic reactions, croup in children, chemotherapy-related nausea and vomiting, and COVID-19 patients requiring supplemental oxygen.