Launched in the Nordics, European deal secured – AcuCort now targets the US market
AcuCort has made significant commercial progress in a relatively short period of time – moving from product launch and initial sales in the Nordic region to strengthening its position internationally. Most recently, the Swedish pharmaceutical company signed a commercial agreement with global pharmaceutical group Glenmark Pharmaceuticals covering several European markets. At the same time, AcuCort is preparing to submit an application for market approval to the US Food and Drug Administration (FDA) before the end of the year.
Based in Lund, AcuCort has developed a patented oral film designed for conditions requiring anti-inflammatory and immunosuppressive treatment, including acute allergic reactions. The product was launched in the Nordic market in autumn 2024, and the company has since received four orders across the region.
“We have successfully transitioned from a development-focused company to a commercial-stage pharmaceutical business, which marks a major milestone for us. At the same time, we have established a solid platform for continued international expansion,” says AcuCort’s CEO Jonas Jönmark.
Building momentum in the Nordic market
The Nordic launch represents the first step in AcuCort’s broader international expansion strategy. According to Jonas Jönmark, the company is using its commercial progress in the Nordics as proof of concept in discussions with prospective partners in other markets. This was an important factor behind the agreement announced earlier this year with Glenmark Pharmaceuticals, one of the world’s leading pharmaceutical companies.
The agreement covers Germany – one of Europe’s most important pharmaceutical markets – as well as the Netherlands, Austria, the Czech Republic, Slovakia and Ukraine. As a result, AcuCort’s potential market has expanded from around 20 million people in the Nordic region to close to 200 million across Europe.
“Germany is one of the most strategically important pharmaceutical markets in Europe, and this agreement validates both the commercial potential of our product and the long-term strategy we are executing,” says Jonas Jönmark.
Advancing towards the US market
Alongside its European expansion, AcuCort is continuing preparations for entry into the United States. The company recently reached an agreement with the FDA regarding the regulatory pathway forward through an initial Pediatric Study Plan (iPSP).
The agreement means AcuCort can proceed with its application for market approval without conducting additional studies prior to submission.
“Our ongoing dialogue with the FDA is a key part of our strategy. Our ambition is to submit the application for market approval later this year,” says Jonas Jönmark.
Entering the next phase of growth
With a commercially launched product in the Nordics, strategic partnerships in Europe and a defined regulatory pathway in the United States, AcuCort is now entering a new phase of development in which several parts of its growth strategy are progressing simultaneously.
Going forward, the company’s focus will be on strengthening its position in existing markets, establishing additional commercial partnerships and continuing to advance the regulatory process in the US.
“We have built a strong foundation and are now beginning to see tangible results from our efforts. At the same time, we are still only in the early stages of our international growth journey,” says Jonas Jönmark.
Watch Jonas Jönmark present Q1 2026 (Swedish)
BioStock highlights the iPSP news and interviews Jonas Jönmark
Read article from BioStock here (swedish – translate in browser)
Watch Jonas Jönmark discuss the Glenmark agreement, Zeqmelit’s broader indications, and the company’s pharmacovigilance work.
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