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

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

AcuCort is granted SME status by the European Medicines Agency, EMA

AcuCort AB (publ) (Spotlight Stock Market: ACUC) announces that the European Medicines Agency, EMA, has decided that the company meets the requirements for SME status in accordance with current EU regulations. The positive decision entails certain administrative and financial benefits for AcuCort in future applications for market approval for the company's pharmaceutical product ISICORT® within the EU.During the spring, AcuCort applied to EMA aiming to qualify the company in the category micro, small or medium-sized enterprise (SME) laid down in Regulation (EC) No 2049/2005. EMA's positive

AcuCort confirms response from the Swedish MPA regarding ISICORT® market application

AcuCort AB (Spotlight Stock Market: ACUC) has received the Primary Round Assessment Report from the Swedish Medical Products Agency (MPA), in response to the national Market Authorization Application (MAA) for ISICORT® in September 2019. The company is currently reviewing the report and preparing answers. No significant obstacles have been identified. No major objections towards an approval have been raised by the MPA.As reported on September 30[th] 2019, AcuCort AB has submitted a national hybrid application for approval of the company’s drug candidate ISICORT® to the Swedish Medical

AcuCort obtains regulatory approval to start bioequivalence study for the US

AcuCort AB (Spotlight Stock Market: ACUC) today announces that the Czech State Institute for Drug Control, SUKL has approved the company’s application to conduct the first of two bioequivalence studies that are planned to be the basis for a registration application for the company’s innovative allergy drug Dexa ODF in the United States.In order to conduct clinical studies, AcuCort must gain approval from both the ethical committee and the regulatory authority in the country where the study will be performed. Together with the obtained approval from the ethical committee, today’s news means

AcuCort obtains regulatory approval to start bioequivalence study for the EU

AcuCort AB (Spotlight Stock Market: ACUC) today announces that the Czech State Institute for Drug Control, SUKL has approved the company’s application to conduct the bioequivalence study that is planned to be the basis for a registration application for the company’s innovative allergy drug Dexa ODF in the EU.In order to conduct clinical studies, AcuCort must gain approval from both the ethical committee and the regulatory authority in the country where the study will be performed. Together with the previously obtained approval from the ethical committee, today’s news means that the study

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