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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 signs its first commercial agreement for the company’s drug Zeqmelit™

AcuCort AB (publ) (Spotlight Stock Market: ACUC) today announces that the company has signed an exclusive commercial agreement with the global biopharmaceutical company Kamada Ltd., (NASDAQ: KMDA; TASE: KMDA.TA). The agreement gives Kamada the exclusive right to the marketing and sales as well as the distribution of AcuCort’s drug Zeqmelit™ for, among other things, the treatment of acute allergy on the Israeli market.Kamada Ltd., a leading global biopharmaceutical company, has a well-established infrastructure for marketing, sales, and distribution of commercial pharmaceutical products in

AcuCort reports positive results from the company’s questionnaire study about allergy treatments

AcuCort AB (publ) (Spotlight Stock Market: ACUC) reports today positive results from the company's questionnaire study on how allergy patients value their treatment. The results from the study will be included in the documentation in AcuCort's upcoming pricing and reimbursement application to the Swedish Dental and Pharmaceutical Benefits Agency, TLV.The questionnaire study includes a total of 426 patients who have answered questions about their allergy and how they value the available treatment options. From the beginning, just over 100 patients would have been included in the study, but

AcuCort receives marketing authorization for the drug Zeqmelit by the Norwegian Medicines Agency

AcuCort AB (publ) (Spotlight Stock Market: ACUC) today announces that the Norwegian Medicines Agency, Statens legemiddelsverk, has approved the company’s first drug under the name Zeqmelit in Norway.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 availability and relief in emergency situations such as severe and acute allergic reactions. The drug was recently approved in Denmark under the name Zeqmelit and has previously been approved in Sweden

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 applies for ethical review for a questionnaire study on allergy treatment

AcuCort AB (publ) (Spotlight Stock Market: ACUC) announces today that the company has submitted an ethical review application to the Swedish Ethical Review Authority regarding a questionnaire study. The purpose of the study is to document how allergy patients value their treatment. The questionnaire study is an important part of the future pricing and reimbursement application to the Swedish Dental and Pharmaceutical Benefits Agency, TLV.ISICORT® is a thin, small fast-dissolving oral film that is placed on the tongue where the active anti-inflammatory substance, dexamethasone, dissolves

AcuCort enters agreement with the pharmaceutical manufacturer Adhex Pharma regarding commercial and large-scale production of ISICORT®

AcuCort AB (publ) (Spotlight Stock Market: ACUC) announced today that the company has signed an agreement with the contract manufacturing company Adhex Pharma regarding commercial and large-scale production of ISICORT®. This product supply agreement is an important milestone for the upcoming commercialization of ISICORT®.Under the terms of this agreement with the contract manufacturer Adhex Pharma, AcuCort secures the commercial and large-scale production of its drug ISICORT®, and in line with GMP (Good Manufacturing Practice). Thus, by this agreement the product supply of ISICORT® is

AcuCort announces that the company signs an agreement with consulting company in pharmacovigilance before the upcoming commercialization of ISICORT®

AcuCort AB (publ) (Spotlight Stock Market: ACUC) announced today that the company has signed an agreement with the consulting company TFS (TFS Trial Form Support AB) regarding pharmacovigilance which includes follow-up of side effects and safety regarding ISICORT®. The agreement is a regulatory milestone prior to the upcoming commercialization of ISICORT®.Under the terms of this agreement, AcuCort ensures that resources and processes are in place, and that the company meets the regulatory requirements regarding pharmacovigilance prior to the upcoming commercialization of the company's

AcuCort announces that the registration process in the Nordic market is underway for the company’s drug ISICORT®

AcuCort AB (Spotlight Stock Market: ACUC) announced today that the registration process in Denmark, Finland, Iceland and Norway regarding the company’s drug ISICORT® is currently ongoing via a so-called reciprocal procedure, Mutual Recognition Process (MRP). ISICORT® has previously been approved in Sweden.In the development of ISICORT®, the advantages of the commonly prescribed and well-documented anti-inflammatory substance dexamethasone and the administration of a fast-dissolving oral film have been combined into a new drug. The innovative drug has a rapid uptake of the active

AcuCort’s drug ISICORT® demonstrates a three-year shelf life

AcuCort AB (Spotlight Stock Market: ACUC) today announced that the company’s drug ISICORT® has demonstrated a three-year shelf life.ISICORT® is a thin, fast-dissolving and user-friendly oral film for the treatment of acute and severe allergic reactions, croup in children, chemotherapy-induced nausea and vomiting (CINV) as well as for the treatment of COVID-19 patients who need supplemental oxygen treatment. The fast-dissolving oral film contains the glucocorticoid dexamethasone which is a well-known, often used and well-documented anti-inflammatory substance. “I am very pleased that

AcuCort receives a second US patent protection for its drug ISICORT®

AcuCort AB (Spotlight Stock Market: ACUC) today announces that the US Patent and Trademark Office, USPTO, has announced that the company’s patent application in the US for dexamethasone oral film is granted. This is the second patent protection in the US for AcuCort’s drug ISICORT®. This strengthened patent protection and extended exclusivity on the US market is in line with company’s strategy.ISICORT® is a thin, fast-dissolving and user-friendly oral film for the treatment of acute and severe allergic reactions, for croup in children and chemotherapy-induced nausea and vomiting (CINV). The

Press release 2021-08-23 AcuCort to present at events arranged by Aktiespararna

AcuCort AB (Spotlight Stock Market: ACUC) today announced that the company’s CEO Jonas Jönmark will participate and present at a number of events arranged by the Swedish Aktiespararna.The agenda and further details regarding the events, as well as details on accessing the digital events, will be made available on the Aktiespararna’s website . The presentations will be recorded and will be available following the conclusion of the events on AcuCort’s website, at the IR section . AcuCort to present at the

AcuCort announces that the Board of Directors and the CEO have subscribed for options to purchase shares in the company

AcuCort AB (Spotlight Stock Market: ACUC) announces that the Board of Directors and the CEO have subscribed for options to purchase shares in the company according to a resolution at the 2021 Annual General Meeting.The CEO has subscribed for options that provide the opportunity to subscribe for 133,336 shares, the Chairman of the Board 88,888 shares and all four Board members 44,444 shares each. Subscription of shares in AcuCort AB (publ) may take place during the period from April 1, 2023, to June 30, 2023, at a price of 9.62 SEK per share.

AcuCort progresses into a new phase and strengthens the commercialization team

AcuCort AB (Spotlight Stock Market: ACUC) has employed Louise Harting as Project Manager. The company has entered a new stage in the preparatory work for the upcoming commercialization and thus needs a dedicated and expanded resource. Louise has taken up the new position with a focus on market registration of the drug ISICORT®.Louise Harting holds a master degree (Msc) in International Business from Copenhagen Business School. She has experience of international product launches in the pharmaceutical industry from, among others, Novo Nordisk. In her role as Project Manager at AcuCort, her

AcuCort: Granted patent in Japan for the company’s drug ISICORT®

AcuCort AB (Spotlight Stock Market: ACUC) today announced that the Japan Patent Office (JPO) has granted a patent for the company’s drug ISICORT®. The positive decision means a patent protection for ISICORT® in Japan until the year 2035.ISICORT® is a thin, fast-dissolving and user-friendly oral film for the treatment of acute and severe allergic reactions, for croup in children, chemotherapy-induced nausea and vomiting (CINV) as well as for COVID-19 in patients who need supplemental oxygen treatment. The fast-dissolving oral film contains the glucocorticoid dexamethasone which is a well-

AcuCort is granted trademark protection in the US for its drug ISICORT®

AcuCort AB (Spotlight Stock Market: ACUC) today announced that the United States Patent and Trademark Office (USPTO) has granted the company’s drug ISICORT® trademark protection. AcuCort has an active strategy for the company’s trademarks that covers all major geographic markets, including the US.ISICORT® is a thin, fast-dissolving and user-friendly oral film for the treatment of acute and severe allergic reactions, for croup in children and chemotherapy-induced nausea and vomiting (CINV). The fast-dissolving oral film contains the glucocorticoid dexamethasone which is a well-known, often

AcuCort confirms good progress in ISICORT® national application process

AcuCort AB (Spotlight Stock Market: ACUC) received the Second Round Assessment Report from the Swedish MPA as planned in July. Thanks to the ambitious work answering the authority’s questions in the previous round, the Second Round Assessment Report is less extensive and no major issues can be foreseenAcuCort received the Second Round Assessment Report from the Swedish Medical Products Agency (MPA), for the ISICORT® national approval process, as per the application timeline. Now having made an assessment of the remaining questions, with regulatory support and further evaluation by the

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