AcuCort newsletter spring 2026

CEO’s Message

2026 has got off to a strong start. In January, we entered into a commercial agreement with Glenmark Pharmaceuticals, one of the world’s top 100 biotech companies. This is an important milestone and a clear validation that Zeqmelit® is ready for the global market. In this newsletter, you will find an update on our current position. We also highlight an important step in the company’s development: that our pharmacovigilance system is now managed in-house, as well as the indication areas – beyond acute allergic reactions – where Zeqmelit® has the potential to make a difference for patients.

Below is a status update on our ongoing processes.

Glenmark Pharmaceuticals
Converting an LOI into a final commercial agreement with a global company of Glenmark’s size takes time and requires careful attention. We are pleased with the outcome and view the agreement as confirmation that Zeqmelit® has clear value for a global player such as Glenmark. Glenmark will be the Market Authorisation Holder (MAH) for the product. Glenmark expects to submit the application towards the end of 2026.

Lunatus – Middle East and the Gulf States
In June 2025, we signed an LOI with Lunatus for the Middle East and the Gulf States. Negotiations are at an advanced stage, but we are still evaluating different business models to ensure that the agreement structure is suitable for a market that is both large and complex.

USA
During 2025, Zeqmelit® was registered as a trademark in the United States. We also submitted responses to the questions raised by the FDA regarding our iPSP application. We have recently received feedback on some, but not all, of our responses. We will shortly revert to the agency and then await the FDA’s reply. To accelerate the process, we are working on several fronts in parallel, including securing a planning meeting as soon as possible. Our ambition is to submit an application for market approval during 2026.

Additional partner agreements
France, the United Kingdom and Poland are priority markets where we are actively seeking the right partner. The Glenmark agreement has strengthened our position in these discussions, as it sends a clear signal to the market that Zeqmelit® is a product that global players want in their portfolios. We are also in discussions regarding markets outside Europe and the United States.

In our home market, the Nordic region, we are seeing clear progress. Awareness of our product among healthcare professionals is increasing, which, among other things, resulted in an additional order at the end of last year. Overall, work is progressing on several fronts simultaneously. The development of a strong international commercial network continues in line with our strategic plan. I look forward to continuing to update you, our shareholders, as this work progresses.

Jonas Jönmark
CEO, AcuCort

Zeqmelit® – a medicine with potential beyond allergy

AcuCort’s initial target group for Zeqmelit® is the treatment of acute allergic reactions, but the active substance, dexamethasone, has a significantly broader range of applications.

Dexamethasone, the active substance in Zeqmelit®, is a highly potent corticosteroid. It is effective and used, among other things, to treat respiratory conditions. The ODF formulation of dexamethasone (Zeqmelit®) may be advantageous in severe or acute situations where patients or healthcare professionals need to initiate treatment quickly.

AcuCort sees opportunities in, among others, two areas:

  • Croup in children is a respiratory infection that causes swelling and breathing difficulties. The condition is caused by a virus. In moderate to severe croup, dexamethasone has been shown to be effective (2). It can be difficult for children to swallow tablets during croup, and some corticosteroids may also trigger vomiting. Dexamethasone has been shown to trigger vomiting to a lesser extent (1).
  • Acute exacerbations of COPD and asthma (rapid and sudden deterioration in breathing). COPD is a relatively common condition often treated with corticosteroids (3). Some of these patients may also have difficulty swallowing tablets, which can be problematic during exacerbations or severe throat swelling.

(1) Cai KJ, Su SQ, Wang YG, Zeng YM. Dexamethasone versus prednisone or prednisolone for acute pediatric asthma exacerbations in the emergency department: a meta-analysis. Pediatr Emerg Care 2021; 37:e1139–e1144.
(2) Prednisolone versus dexamethasone in croup: a randomised equivalence trial, A Sparrow, G Geelhoed. Archives of Disease in Childhood 2006; 91 580-583 Published Online First: 19 Apr 2006. doi: 10.1136/adc.2005.089516
(3) GINA-2024-Strategy-Report-24_05_22

Why an oral film is advantageous
The format of Zeqmelit® is not only about the convenience of an oral film. In acute situations where the patient has difficulty breathing, is distressed, or lacks access to water, the ability to administer medication without aids can be crucial.

What this means for AcuCort
By demonstrating, together with its commercial partners, the advantages of the oral film format within these indications, AcuCort can address patient groups that are significantly larger than the current market for acute allergic reactions.

AcuCort strengthens control and scalability – brings pharmacovigilance in-house

Pharmacovigilance is a regulatory requirement for pharmaceutical companies and includes the detection, assessment, understanding and prevention of adverse effects or other medicine-related problems. By establishing an internal pharmacovigilance system, AcuCort strengthens operational control, increases flexibility, and creates a more cost-efficient structure for continued commercial development.

The internal pharmacovigilance system is designed to be scalable and adapted to increased volumes as the company grows. At the same time, it reduces dependence on external providers and gives the company full visibility into its processes.

“Bringing pharmacovigilance in-house is a strategically important step for AcuCort. We are strengthening our control over a regulatory core function, improving cost efficiency, and building an organisation that is well prepared for future expansion,” says AcuCort CEO Jonas Jönmark.

The internal pharmacovigilance system is designed to efficiently monitor and evaluate the benefit-risk balance of the company’s product. The implementation of the pharmacovigilance system is part of the company’s long-term strategy to gradually strengthen its internal structure as operations develop.
 

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