AcuCort receives marketing authorization for the drug Zeqmelit by the Danish Medicines Agency

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AcuCort AB (publ) (Spotlight Stock Market: ACUC) today announces that the Danish Medicines Agency, Laegemiddelstyrelsen, has approved the company’s first drug under the name Zeqmelit in Denmark. The same drug is already approved in Sweden, but under the brand name ISICORT®.

In the development of the drug Zeqmelit/ISICORT®, AcuCort has managed to combine the benefits of the well-proven substance dexamethasone and the patented user-friendly oral film for quick accessibility and relief in acute situations such as severe and acute allergic reactions.

The registration process for the Nordic market is ongoing and the drug is now approved in Denmark and Sweden. Intensive work is underway on registration applications for other priority markets.  AcuCort’s goal is to commercialize Zeqmelit/ISICORT® globally, i.e. in the EU, the US and in selected key markets.

“AcuCort has passed another important milestone as the company’s first innovative drug is now approved also in Denmark. This is very gratifying and creates good conditions for a continued positive development of the company.
I am optimistic about the upcoming commercialization and our continued growth journey,” says Jonas Jönmark, CEO of AcuCort AB.

This information is information that AcuCort AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person below, on August 16, 2022.

For more information, please contact:

Jonas Jönmark, CEO, AcuCort AB

Telephone: + 46 (0)70 365 5400

Email: jonas.jonmark@acucort.se

About AcuCort AB (publ)

AcuCort has developed and commercializes Zeqmelit/ISICORT®, a new fast-dissolving oral film to put on the tongue, based on the well-known cortisone substance dexamethasone. The drug is a smart product in a new, innovative, patented, and user-friendly dosage form primarily for the treatment of severe and acute allergic reactions, croup in children and chemotherapy-induced nausea and vomiting (CINV) and for the treatment of patients with COVID-19 who need supplemental oxygen therapy. The product is approved in Sweden and Denmark. Altogether, this strengthens the company’s assessment that the time to commercialization may be relatively short. AcuCort (ticker: ACUC) is listed on the Spotlight Stock Market in Sweden. Please visit www.acucort.se.

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