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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’s CEO subscribes for an additional SEK 1 million in the ongoing rights issue, bringing total commitment to approximately SEK 2 million

AcuCort AB ("the Company" or "AcuCort") is currently conducting a rights issue of units totalling up to approximately SEK 47.7 million, as announced in a press release on 29 November 2024. The Company’s Board of Directors, CEO, and major shareholders had previously committed to subscriptions amounting to approximately SEK 14.8 million, corresponding to approximately 31 per cent of the rights issue. The Company’s CEO, Jonas Jönmark, has now pledged to subscribe for an additional SEK 1 million worth of units, increasing his total commitment to approximately SEK 2 million.In addition to the

AcuCort submits Initial Pediatric Study Plan (iPSP) to the FDA

AcuCort, a pharmaceutical company, has submitted its Initial Pediatric Study Plan (iPSP) to the U.S. Food and Drug Administration (FDA) as part of its regulatory pathway for obtaining FDA approval of Zeqmelit® in 2025.The submission of the iPSP represents a key milestone in the regulatory process to secure market authorization for Zeqmelit® in the United States. The FDA mandates that all companies seeking approval for new drug applications (NDAs) submit an iPSP as part of the approval process. “This submission marks an important step forward in our efforts to make Zeqmelit® accessible to

AcuCort Presented at ISPOR in Barcelona

AcuCort recently participated in the ISPOR Europe scientific conference in Barcelona, where the company presented 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."AcuCort has conducted the study "Swedish Allergists' View on the Role of Cortisone and the Formulation (Tablets or Self-Dissolving Film) for the Treatment of Acute Allergic Reactions" through interviews with clinically experienced allergists. The primary objective of the study was to clarify

All patients have completed AcuCort's phase IV study ZEQ001

AcuCort's Phase IV study, ZEQ001, began in late January 2024. This study enrolled 50 patients, and the last participant has now completed it. The study findings are intended to be published in scientific journals, providing key support for AcuCort's upcoming launch initiatives.“Our Phase IV study, ZEQ001, marks a significant milestone for AcuCort and the scientific foundation for Zeqmelit®. The study offers valuable insights into patients’ experiences and confidence with the medication. We look forward to sharing the scientific findings and are confident that they will provide a vital

AcuCort reschedules publication date for third quarter interim report

AcuCort has postponed the publication of its third-quarter interim report to November 29, 2024. The report was initially scheduled for release on November 22.AcuCort previously announced that the company would present the results of the study "Swedish Allergists' View on the Role of Cortisone and the Formulation (Tablets or Self-Dissolving Film) for the Treatment of Acute Allergic Reactions" at the ISPOR scientific conference in Barcelona.   Due to the high level of interest in the study’s results, AcuCort's CEO, Jonas Jönmark, will attend the conference in Barcelona from November 17–

AcuCort appoints nomination committee

AcuCort announces today that the nomination committee for the 2025 annual general meeting has been appointed and consists of the company’s three largest owners.After consultation with the company’s largest shareholders in terms of votes, as of September 30, 2024, the nomination committee consists of the following members, with Jan Poulsen newly appointed as a member of the nomination committee: •    Gustaf Albèrt, Aqilion AB, chair of the nomination committe.•    Thomas Nestenius, appointed by Zoya Invest AB•    Jan Poulsen, appointed by Life Science Investment Fund (LSIF) The

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

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