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Through this choice of new partner AcuCort ensures a high quality, experienced and cost-effective performer of the bioequivalence studies who can help us with one of the most important steps towards market approval, according to the schedule that we have communicated.
Mats Lindfors, CEO of AcuCort
Dexa ODF is now another step closer to a registration application.
Mats Lindfors, CEO of AcuCort AB
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AcuCort to attend BIO International Convention in San Diego – focus on strategic partnering discussions

Pharmaceutical company AcuCort will attend the BIO International Convention, 22–25 June 2026 in San Diego, USA. The participation comes at a strategically important juncture, following the company's recent agreement with the FDA as it actively prepares its New Drug Application (NDA) submission.In April 2026, AcuCort announced that it had reached an agreement with the FDA regarding its Initial Pediatric Study Plan (iPSP) for Zeqmelit®. The agreement represents a significant regulatory milestone and a prerequisite for the NDA submission in the United States that the company plans to file

AcuCort publishes newsletter with CEO update

Pharmaceutical company AcuCort has published its newsletter for May 2026. In the newsletter, the company highlights key milestones, including the launch and sales in the Nordic market, the commercial agreement with Glenmark Pharmaceuticals, and the ongoing work towards a future market approval application in the United States.The newsletter also includes recorded presentations, including the Q1 presentation. The newsletter is available here: https://bit.ly/4uyczVu Would you like to receive future newsletters directly in your inbox? Sign up here:https://www.acucort.se/EN/media/

AcuCort publishes newsletter with CEO update

AcuCort has published its April 2026 newsletter. The newsletter includes a CEO statement from Jonas Jönmark, in which he comments on the agreement with the FDA regarding the company’s iPSP. The newsletter is available here: https://bit.ly/42929Pl For further information: Jonas Jönmark, CEO, AcuCort ABPhone: 070 365 5400E-mail: jonas.jonmark@acucort.se About AcuCort AB (publ)AcuCort has developed and is commercializing Zeqmelit®, a new rapidly dissolving oral film placed on the tongue, based on the well-known cortisone substance dexamethasone. The drug is a smart product in

AcuCort and the FDA agree on iPSP – important step towards US market approval

Pharmaceutical company AcuCort today announces that it has agreed an iPSP (Initial Pediatric Study Plan) with the U.S. Food and Drug Administration (FDA) for its product Zeqmelit®. This constitutes a prerequisite for AcuCort to submit a New Drug Application (NDA) in the United States, which is planned for later this year.The iPSP process is of central importance ahead of AcuCort’s forthcoming NDA submission to the FDA, the world’s single largest pharmaceutical market. At the end of March 2026, AcuCort submitted its responses to the FDA’s additional questions. The company has now reached

AcuCort publishes newsletter with CEO update

AcuCort has published its newsletter for March 2026. The newsletter features a CEO statement by Jonas Jönmark as well as two articles: one on the company now operating its pharmacovigilance system in-house, and one on Zeqmelits® being suitable for more indications than acute allergic reaction, where AcuCort sees opportunities primarily within two areas. The newsletter is available here: https://bit.ly/acucort-spring-2026  For further information: Jonas Jönmark, CEO, AcuCort ABPhone: 070 365 5400E-mail: jonas.jonmark@acucort.se About AcuCort AB (publ)AcuCort has developed

AcuCort to participate in Bio Europe Spring – focus on international partnerships

Swedish pharmaceutical company AcuCort will participate in the international partnering conference BIO Europe Spring, taking place from 23–25 March 2026 in Portugal. The participation forms part of the company’s broader strategy to advance its business development activities and establish new commercial partnerships.BIO Europe Spring is one of the leading global partnering conferences within the life sciences sector, offering structured one-to-one partnering meetings with prospective partners. The conference provides AcuCort with the opportunity to engage with international pharmaceutical

AcuCort signs commercial agreement with Glenmark Pharmaceuticals for Germany and five additional European countries

Pharmaceutical company AcuCort AB (publ) (AcuCort) has entered into a commercial agreement with the global pharmaceutical company, Glenmark Pharmaceuticals Limited (Glenmark) regarding the marketing and distribution of AcuCort’s product, Zeqmelit®, in six European countries: Germany, the Netherlands, the Czech Republic, Austria, Slovakia, and Ukraine.The commercial agreement replaces the Letter of Intent (LOI) announced on 17 June 2025 and means that the parties have now fully agreed on all commercial terms of the collaboration. Under the agreement, Glenmark will be responsible for the

AcuCort Secures New Order for Zeqmelit® – Continued Growth Across the Nordics

AcuCort has received a new order for Zeqmelit® from its Nordic distribution partner, Unimedic Pharma. The order covers the Nordic market.Zeqmelit® was launched in Sweden, Norway, and Finland in September 2024, followed by Denmark in the summer of 2025. The new order from Unimedic Pharma, AcuCort’s Nordic distribution partner, is for the Nordic market. “The launch of Zeqmelit® is developing in line with expectations for a newly introduced pharmaceutical, which is very encouraging,” says AcuCort’s CEO, Jonas Jönmark. The order is valued at EUR 112,000 and is expected to have a positive

AcuCort appoints nomination committee

AcuCort today announces that the nomination committee for the 2026 annual general meeting has been appointed and consists of representatives of the company’s three largest shareholders.After consultation with the company’s largest shareholders in terms of votes, as of September 30 2025, the nomination committee consists of the following members:•    Sarah Fredriksson, Aqilion AB, Chair of the nomination committee •    Anne-Charlotte Poulsen, Life Science Investment Fund (LSIF)•    Tomas Nilsson, representing Jonas Jönmark, CEO of AcuCortThe 2026 Annual General Meeting will be held

AcuCort strengthens its management team with the appointment of Anna Chérouvrier Hansson as Business Development Director

AcuCort has appointed Anna Chérouvrier Hansson as its Business Development Director. The appointment is part of AcuCort’s continued commercial development and focus on strengthening strategic partnerships to support the launch of Zeqmelit® in additional markets.Anna Chérouvrier Hansson brings more than 15 years of experience in business development, sales and marketing within the life science sector. She has held senior positions in both listed companies and fast-growing SMEs, including SenzaGen and Camurus. At SenzaGen, she played a key role in building and driving the company’s

AcuCort granted extended SME status by the European Medicines Agency (EMA)

AcuCort AB has been granted extended SME (Small or Medium-sized Enterprise) status by the European Medicines Agency (EMA).The extension means that AcuCort will be treated as an SME by the Agency until 31 December 2026. As a result, the company will be exempt, either fully or partially, from fees associated with regulatory applications related to the sale and marketing of pharmaceuticals within the EU and EEA.– The extension of our SME status is highly valuable. It helps us keep our regulatory costs down and provides access to qualified support in key processes. Maintaining SME status is

AcuCort’s CEO to present at Life Science Conference in Copenhagen

AcuCort’s CEO, Jonas Jönmark, will present the company at Økonomisk Ugebrev’s Life Science Conference on 24 September 2025 in Copenhagen.The conference brings together investors, analysts and industry experts to highlight the most exciting trends within the life science sector. In addition to a market update, three listed companies developing innovative solutions will also present. Jonas Jönmark’s presentation is scheduled for 16:55–17:25. “We look forward to introducing AcuCort to Danish investors and industry colleagues, as well as providing an update on our business and future

Sales of Zeqmelit® commenced in Denmark

Pharmaceutical company AcuCort, through its Nordic distribution partner Unimedic Pharma, began sales of the drug Zeqmelit® to Danish pharmacies during the summer months. This development reflects a positive market reception and strengthens the company’s commercial momentum in its Nordic expansion.In April 2025, AcuCort received its first order for Zeqmelit® from Unimedic Pharma for the Danish market, marking the start of the launch. Over the summer, distribution to Danish pharmacies commenced, and initial feedback from the market points to demand in line with the company’s expectations. “

LSIF invests SEK 1 million in AcuCort through exercise of warrants – strong support ahead of final day for exercising TO 2

AcuCort AB (publ) ("AcuCort" or the "Company") announces today that one of its principal shareholders, the life science investor LSIF, has decided to exercise series TO 2 warrants ("TO 2") amounting to at least SEK 1 million, regardless of the current share price. The decision is being made public two days before the final exercise date, June 20, 2025, and highlights the confidence in AcuCort’s continued commercial development.“At LSIF, we have decided to support the subscription by subscribing for SEK 1 million regardless of the share price. Our motivation is that, in our view, the two

AcuCort signs Letter of Intent (LOI) with Glenmark Pharmaceuticals for Germany and five additional European countries

The pharmaceutical company AcuCort has signed a Letter of Intent (LOI) with the global pharmaceutical company Glenmark Pharmaceuticals. The LOI covers the distribution and marketing of AcuCort’s product Zeqmelit® in six European countries: Germany, the Netherlands, the Czech Republic, Austria, Slovakia, and Ukraine.Glenmark Pharmaceuticals is a well-established player in the pharmaceutical industry with a strong presence in several key markets. With operations in over 80 countries, the company represents a strategically important partner for AcuCort.According to the LOI, Glenmark

AcuCort signs Letter of Intent (LOI) with Lunatus for the Middle East and Gulf States

The pharmaceutical company AcuCort AB (publ) has signed a Letter of Intent (LOI) with Dubai-based Lunatus, regarding the distribution and marketing of its drug Zeqmelit® in the Middle East and Gulf States.Lunatus is a well-established company with over 20 years of experience representing international healthcare companies in the region, including Abbott Diagnostics and Boston Scientific. The company has a proven track record of successfully introducing and developing profitable pharmaceutical and medical technology brands. Lunatus collaborates with more than 40 global companies and offers a

AcuCort’s drug Zeqmelit® registered as a trademark in Canada

The pharmaceutical company AcuCort announces that its trademark Zeqmelit® has been granted trademark protection in Canada. The decision was made by the Canadian Intellectual Property Office.Trademark protection is strategically important in AcuCort’s ongoing commercialisation phase. – The fact that Zeqmelit® is now also protected as a trademark in Canada is an important step in our international expansion. It strengthens our ability to establish the product in new markets and is part of our strategic work to build a strong and protected global brand, says AcuCort’s CEO Jonas Jönmark.

AcuCort receives new order for Zeqmelit® – strong development in the Nordic market

The pharmaceutical company AcuCort has received a new order for Zeqmelit® from Unimedic Pharma, the company’s Nordic distribution partner. The order pertains to the Nordic market.Zeqmelit® was launched in the Nordics in September 2024 and has since received a positive response from the medical community. The new order from Unimedic Pharma, AcuCort’s Nordic distribution partner, relates to the Nordic market. “The Nordic market is developing strongly, particularly now as allergy season leads to an increased number of healthcare visits. We are seeing strong support from physicians for our

AcuCort receives new order for Zeqmelit® and begin Danish expansion

The pharmaceutical company AcuCort has received a new order for Zeqmelit® from Unimedic Pharma, the company’s Nordic distribution partner. The order marks an important step in AcuCort’s expansion and means that Zeqmelit® will soon be available on the Danish market.Zeqmelit® was launched in pharmacies in Sweden, Norway, and Finland in September 2024. The new order from Unimedic Pharma is part of AcuCort’s planned growth strategy and strengthens the company’s Nordic presence. “The market launch in the Nordic region is progressing according to plan, and this order covers the initial phase

AcuCort receives renewed marketing authorisation for Zeqmelit® in Norway

The pharmaceutical company AcuCort has received a renewed marketing authorisation for its medicinal product Zeqmelit® from the Norwegian Medical Products Agency (Direktoratet for medisinske produkter), Norway’s equivalent of the Swedish Medical Products Agency. The decision grants approval without a time limitation.AcuCort was first granted a marketing authorisation for Zeqmelit® in Norway in 2022. That approval was time-limited, which is standard for new medicines. Following an application for renewal, the Norwegian Medical Products Agency has now granted an extended marketing

AcuCort receives renewed marketing authorisation for Zeqmelit® in Denmark

The pharmaceutical company AcuCort has received a renewed marketing authorisation for its medicinal product Zeqmelit® from the Danish Medicines Agency (Lægemiddelstyrelsen), Denmark’s equivalent of the Swedish Medical Products Agency. The decision grants approval without a time limitation.AcuCort was first granted a marketing authorisation for Zeqmelit® in Denmark in 2022. That approval was time-limited, which is standard for new medicines. Now, following an inspection by the Swedish Medical Products Agency, the Danish Medicines Agency has granted an extended marketing authorisation, this

AcuCort’s medicinal product receives renewed marketing authorisation from the Swedish Medical Products Agency

The pharmaceutical company AcuCort has received renewed marketing authorisation for its medicinal product Zeqmelit® from the Swedish Medical Products Agency. The decision is valid indefinitely.AcuCort applied for and was granted marketing authorisation for its medicinal product in 2020. That authorisation was valid for a period of five years, which is standard practice for new medicines. As a result, AcuCort applied for an extension, and the Swedish Medical Products Agency has now granted renewed marketing authorisation, effective from 6 October 2025. This time, the authorisation is valid

Promising results from AcuCort’s Phase IV study – scientific articles under preparation for international publication

In mid-November 2024, the final patient completed AcuCort’s Phase IV clinical trial. Subsequently, all data were compiled and analyzed, resulting in a clinical study report showcasing highly encouraging outcomes for Zeqmelit®. The company is now preparing manuscripts for submission to leading peer-reviewed international scientific journals. These publications represent a strategic milestone in AcuCort’s strategy to expand its presence in European and U.S. markets.AcuCort’s Phase IV trial ZEQ001 commenced in late January 2024 with the objective of generating real-world evidence from patients

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