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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 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 announcement from the EMA ensures that registration fees are kept as low as possible, and we can take advantage of the advisory services and other benefits available to small companies within the EU,” says Jonas Jönmark, CEO of AcuCort. For further information: Jonas Jönmark, vd, AcuCort ABTel: +46 70 365 5400Email: jonas.jonmark@acucort.se About AcuCort AB (publ)AcuCort has developed and is commercializing Zeqmelit®, a new rapidly dissolving oral film

Zeqmelit® Launched in Norway and Finland

AcuCort's launch of Zeqmelit® is proceeding according to the previously communicated plan. At the beginning of September, the medication became available in Swedish pharmacies, and as of September 15, Zeqmelit® is also available in pharmacies in Norway and Finland.AcuCort had previously communicated that the launch of Zeqmelit® in Norway and Finland would occur shortly after the product's launch in Sweden. Zeqmelit® was launched in Sweden on September 2, and as of September 15, the medication is available in pharmacies in Norway and Finland. – The launch of Zeqmelit® is progressing as

AcuCort Presents Study Results at the ISPOR Scientific Conference in Barcelona

AcuCort will participate in the ISPOR scientific conference in Barcelona on November 19, 2024. The company will present the results of the study titled "Swedish Allergists' View on the Role of Cortisone and the Formulation (Tablets or Self-Dissolving Film) for the Treatment of Acute Allergic Reactions."The study titled "Swedish Allergists' View on the Role of Cortisone and the Formulation (Tablets or Self-Dissolving Film) for the Treatment of Acute Allergic Reactions" was conducted in 2023. The study was carried out through interviews with clinically experienced allergists. The primary

Launch of Zeqmelit® Initiated – Now Available at Pharmacies

AcuCort has previously announced that the market launch of Zeqmelit® would begin in early September. In line with this plan, Zeqmelit® is available at Swedish pharmacies starting today, Monday, September 2nd. The product will soon also be available at pharmacies in Norway and Finland.– The launch is proceeding exactly as planned, and we have thus achieved yet another important milestone. Physicians can prescribe Zeqmelit®, and the product is now available at Swedish pharmacies. It will soon also be available at pharmacies in Norway and Finland, says AcuCort's CEO, Jonas Jönmark.  For

AcuCort’s drug Zeqmelit® registered as a trademark in the USA

AcuCort AB announces that the company’s drug Zeqmelit® has been registered as a trademark in the USA.The trademark protection is strategically important for the company’s commercialization phase. The USA is both the world's largest individual pharmaceutical market and AcuCort’s most important market.  – It is very positive that we have now received trademark protection for our oral film Zeqmelit® with associated applications in the USA. The trademark protection is an important step towards our upcoming commercialization phase in the USA. Furthermore, we look forward to launching

Zeqmelit® Planned to be Available in Pharmacies Starting September 1

The medication Zeqmelit® is planned to be available in pharmacies in Sweden from September 1, 2024. Launches in Norway and Finland are expected to follow shortly thereafter. In parallel, pre-launch activities are underway to prepare the market for an effective launch.AcuCort’s medication Zeqmelit® – a fast-dissolving oral film placed on the tongue for the treatment of severe to acute allergy –is currently in an intensive commercialization phase. Based on extensive pre-launch activities, the planned launch will take place on September 1, 2024, making the product available to patients. The

Very High Willingness to Pay for Zeqmelit® According to Publication in International Scientific Journal

The esteemed scientific journal, Journal of Health Economics and Outcomes Research, has published an article on the willingness to pay among Swedish patients with acute allergic reactions for a medication like Zeqmelit®. This means that two independent international journals have now published results showing both a significant patient need for Zeqmelit® and a strong willingness to pay for the medication among patients.In collaboration with IHE, the Institute for Health Economics, AcuCort conducted a survey study among over 400 patients in Sweden who have experienced acute allergic

Study on Patients' Willingness to Pay Published in an International Scientific Journal

AcuCort AB has announced that an article on a study regarding Swedish patients' willingness to pay for Zeqmelit® will be published in the scientific journal Journal of Health Economics and Outcomes Research.The scientific study presented in the article is titled Treatment preferences for acute allergic reactions – a discrete choice experiment in Sweden. The study investigates the willingness to pay for a corticosteroid oral film among Swedish individuals with acute allergic reactions. The premise is that corticosteroids are a common treatment for acute allergic reactions, and the oral film

The patient study on Zeqmelit® is fully recruited

All 50 patients in AcuCort's phase IV study ZEQ001 for Zeqmelit® have been enrolled.The phase IV study ZEQ001 on the oral film Zeqmelit®, an innovative oral film for the treatment of severe and acute allergies, commenced at the end of January. Now, 50 patients have been allocated the oral film for use when needed for acute allergic reactions. "The patient recruitment has exceeded our already high expectations, indicating the significant patient need for our pharmaceutical product," says Jonas Jönmark, CEO of AcuCort. "Furthermore, the study results can be used in an application to be

Update on Phase IV Study: 40 of 50 Patients Recruited

AcuCort's Phase IV study ZEQ001 for Zeqmelit® is ongoing. 40 patients have been assigned the oral film for use when needed for acute allergic reactions.As previously communicated, the Phase IV study ZEQ001 concerning the oral film Zeqmelit® commenced at the end of January. The purpose of the study is to collect scientific data on patient usage of Zeqmelit®. The results will be published in scientific journals to enhance the product's marketing. The recruitment of patients for the study meets AcuCort's high expectations, with 40 patients, out of 50 in total, currently enrolled. "It's

AcuCort's study to be published in an international scientific journal

AcuCort AB has been informed that an article regarding the company's survey study on treatment preferences among Swedish patients with acute allergic reactions will be published in the scientific journal World Allergy Organization Journal.AcuCort is working to increase awareness of the oral film Zeqmelit®, with a planned launch at pharmacies in the Nordic countries during the summer. The scientific journal World Allergy Organization Journal, targeting allergists, allergy patient associations, and other relevant groups, has announced that an article on AcuCort's survey study will be

Update on Phase 4 Study: 25 Patients Recruited

AcuCort's Phase IV study ZEQ001 for Zeqmelit® is ongoing. 25 patients have been assigned the oral film for use when treatment for acute allergic reactions is needed.As previously communicated, the Phase IV study ZEQ001 concerning the oral film Zeqmelit® commenced at the end of January. The purpose of the study is to gather scientific data on patient usage of Zeqmelit®. The results will be published in scientific journals and enhance the product's marketing. The recruitment of patients for the study meets AcuCort's high expectations. Already, approximately 1.5 months in, 25 allergy patients

Insider trading in subscription option TO1 - CEO Jonas Jönmark increases his stake in AcuCort AB

During the ongoing exercise period for subscription option TO1, AcuCort's CEO Jonas Jönmark has purchased 250,000 subscription options with the intention to convert them into shares during the TO period.AcuCort announces that CEO Jonas Jönmark has purchased 250,000 subscription options on Spotlight Stock Market for a total amount of 3,750 SEK, corresponding to an average price of 0.015 SEK per subscription option TO1. "Through the acquisition of subscription options, I have the opportunity to strengthen my ownership position in AcuCort ahead of the company's launch of the oral film

Update on AcuCort's FDA Application ahead of Launch in the USA

The process for AcuCort's application for market approval in the USA for Zeqmelit® is in an intensive phase. The company assesses that the dialogue with the FDA is constructive and that there are conditions to submit the application during the second half of 2024.AcuCort received the company's first commercial order for the oral film Zeqmelit® at the end of February and plans to start sales in the Nordic region during the summer of 2024. As a result, the company is enhancing preparations for the prioritized potential market in the USA. The FDA, Food and Drug Administration, process has

Newsletter focusing on the sales launch of Zeqmelit®

The sales launch of Zeqmelit® is the theme of AcuCort's newsletter #3, which is being published today.The first commercial order of Zeqmelit® is the featured topic of the newsletter. Jonas Jönmark, CEO of AcuCort, discusses how the company is working to support sales efforts and prepare for the launch. The newsletter can be read via the following link: https://mailchi.mp/acucort/acucort-newsletter-february2024 To subscribe, register here: https://www.acucort.se/en/#mailchimp-module

AcuCort presents at three events for investors

AcuCort will participate in three investor presentations during March. CEO Jonas Jönmark will summarize the latest news and discuss the launch of the oral film Zeqmelit®.What does the process look like regarding the launch of the oral film Zeqmelit® and how will the company evolve with the transition from a research company to a pharmaceutical company? These are the key areas that will be addressed when AcuCort's CEO Jonas Jönmark participates in Stora Aktiedagen, Invest Live, and Stockholm Corporate Finance Capital Markets Days Life Science in the near future. Information about the

AcuCort receives its first order of Zeqmelit®

AcuCort has received its first order of the oral film Zeqmelit®. The order value will have a significant positive impact on the company's financial results.– This order signifies a crucial milestone in AcuCort's history, says Jonas Jönmark, CEO of AcuCort.Zeqmelit®, a rapidly dissolving oral film administered on the tongue for the treatment of severe to acute allergies, is in an intensive commercialization phase. Now, the first order has been received. The purchaser is Unimedic Pharma, also responsible for Zeqmelit® sales in the Nordic region. The order includes Zeqmelit® in its three

AcuCort Update on Phase 4 Study: 10 Patients Recruited

AcuCort's Phase IV study ZEQ001 for Zeqmelit® is progressing as expected. The tenth patient has been allocated the oral film for use when needed for the treatment of acute allergic reactions.As previously communicated, the Phase IV study ZEQ001 regarding the oral film Zeqmelit® commenced at the end of January. The purpose of the study is to collect scientific data related to the launch in the Nordic region from practical experience of patients. The recruitment of patients for the study meets AcuCort's high expectations. Already after one week, ten allergy patients are included in the study,

AcuCort presents at Invest Live: Update on the process leading up to the launch of Zeqmelit®

AcuCort will participate in Invest Live on Tuesday, February 6th, at 12:20 PM. Jonas Jönmark, CEO, will summarize the latest news and discuss the process leading to the commercialization of Zeqmelit®.What milestones have been achieved, and what does the process look like going forward in terms of the commercialization of the oral film Zeqmelit®? These are the key areas that will be addressed during the presentation on Tuesday. Additionally, Jonas Jönmark will provide an in-depth overview of how the company will evolve with the transition from a research company to a pharmaceutical company.

First patient using Zeqmelit® in study ahead of market launch

The first patient in the AcuCort Phase IV study ZEQ001 has been assigned the oral film Zeqmelit®. The purpose of the study is to enhance marketing with practical experience from doctors and patients in connection with the launch in the Nordic region.The study will run concurrently with the Nordic market launch. In the study, allergy patients are assigned the company’s oral film Zeqmelit® for use when the need for treatment for acute allergic reactions arises. The goal of the study, which is an open-label non-randomized low-intervention study, is to obtain valuable data on the use of

AcuCort receives trademark protection for Zeqmelit® in Switzerland

AcuCort AB announces that the trademark for the company's medication Zeqmelit® has been registered for trademark protection in Switzerland.The trademark protection is strategically important as the company enters its commercialization phase. "It is very gratifying that we have now obtained trademark protection in Switzerland for our oral film Zeqmelit® with its associated areas of use. It is an important step towards commercialization in Switzerland," says AcuCort's CEO Jonas Jönmark. The trademark protection for Zeqmelit® in Switzerland is valid for the next 10 years, after which the

AcuCort obtains trademark protection for Zeqmelit® in India

AcuCort AB announces that the trademark for the company's drug Zeqmelit® has been registered for trademark protection in India.The trademark protection is of strategic importance as the company enters the commercialization phase. "It is very gratifying that we have now obtained trademark protection in India for our oral film Zeqmelit® and its associated applications. This is an important step towards commercialization in India," says Jonas Jönmark”, CEO of AcuCort. The trademark protection for Zeqmelit® in India is valid for the next 10 years, after which the company must apply for an

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