공시 • Apr 13
AcuCort and the FDA Agree on iPSP - Important Step Towards US Market Approval AcuCort announced 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 agreement with the FDA on the iPSP. The next step is for AcuCort to apply for a renewed Small Business Waiver from the FDA, which would exempt the company from the application fee of approximately SEK 16 million. AcuCort was granted such a waiver in 2022. Following approval, the company can proceed with the submission of the NDA in the United States. 공시 • Mar 30
AcuCort AB (publ) to Report Q1, 2026 Results on Apr 28, 2026 AcuCort AB (publ) announced that they will report Q1, 2026 results on Apr 28, 2026 공시 • Jan 22
AcuCort AB (publ) to Report Fiscal Year 2025 Results on Feb 20, 2026 AcuCort AB (publ) announced that they will report fiscal year 2025 results at 12:00 PM, Central European Standard Time on Feb 20, 2026 공시 • Oct 16
AcuCort AB (publ) to Report Q3, 2025 Results on Nov 14, 2025 AcuCort AB (publ) announced that they will report Q3, 2025 results on Nov 14, 2025 공시 • Oct 15
AcuCort Appoints 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 business development and commercialisation strategy, establishing a global network of licensees and distributors, and negotiating international agreements. At Camurus, she was instrumental in the launch of the company's first commercial product in supportive cancer care across several international markets. 공시 • Jul 21
AcuCort AB (publ) to Report Q2, 2025 Results on Aug 19, 2025 AcuCort AB (publ) announced that they will report Q2, 2025 results on Aug 19, 2025 Reported Earnings • Apr 20
Full year 2024 earnings released Full year 2024 results: Revenue: kr7.72m (up 17% from FY 2023). Net loss: kr17.4m (loss widened 27% from FY 2023). 공시 • Apr 09
AcuCort AB (publ) to Report Q1, 2025 Results on May 08, 2025 AcuCort AB (publ) announced that they will report Q1, 2025 results on May 08, 2025 공시 • Mar 20
AcuCort Receives Renewed Marketing Authorisation for Zeqmelit® in Norway 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 authorisation for the Norwegian market, this time without a time restriction. 공시 • Mar 19
AcuCort Receives Renewed Marketing Authorisation for Zeqmelit® in Denmark AcuCort has received a renewed marketing authorisation for its medicinal product Zeqmelit from the Danish Medicines Agency (Laegemiddelstyrelsen), 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 time without a time limitation. 공시 • Mar 05
AcuCort AB (publ) Receives Renewed Marketing Authorisation from the Swedish Medical Products Agency AcuCort AB (publ) 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 authorization for its medicinal product in 2020. That authorization 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 without time limitation. 공시 • Jan 23
AcuCort AB (publ) to Report Fiscal Year 2024 Results on Feb 21, 2025 AcuCort AB (publ) announced that they will report fiscal year 2024 results on Feb 21, 2025 New Risk • Jan 22
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Swedish stocks, typically moving 12% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr26m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings have declined by 14% per year over the past 5 years. Shareholders have been substantially diluted in the past year (42% increase in shares outstanding). Revenue is less than US$1m (kr7.0m revenue, or US$637k). Market cap is less than US$10m (kr95.3m market cap, or US$8.67m). New Risk • Jan 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 42% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr26m free cash flow). Earnings have declined by 14% per year over the past 5 years. Shareholders have been substantially diluted in the past year (42% increase in shares outstanding). Revenue is less than US$1m (kr7.0m revenue, or US$628k). Market cap is less than US$10m (kr79.6m market cap, or US$7.13m). Minor Risk Share price has been volatile over the past 3 months (11% average weekly change). Reported Earnings • Dec 04
Third quarter 2024 earnings released Third quarter 2024 results: Revenue: kr1.74m (up 1.2% from 3Q 2023). Net loss: kr2.48m (loss narrowed 21% from 3Q 2023). Over the last 3 years on average, earnings per share has increased by 22% per year but the company’s share price has fallen by 37% per year, which means it is significantly lagging earnings. 공시 • Nov 14
All Patients 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. A key objective of the study, an open, non-randomised, low-intervention study, is to obtain scientific data from patients who previously used tablets but, in the study, are using Zeqmelit® instead. The study will answer essential questions, such as whether patients feel confident with Zeqmelit®, what the experience of using the medication is like, and whether they carry it with them. The study results will be published in scientific journals, thereby providing crucial support for the launch of Zeqmelit® in selected markets. New Risk • Oct 29
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: kr106.5m (US$9.99m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr25m free cash flow). Earnings have declined by 16% per year over the past 5 years. Shareholders have been substantially diluted in the past year (281% increase in shares outstanding). Revenue is less than US$1m (kr7.0m revenue, or US$655k). Market cap is less than US$10m (kr106.5m market cap, or US$9.99m). Minor Risk Share price has been volatile over the past 3 months (7.7% average weekly change). 공시 • Oct 24
AcuCort AB (publ) to Report Q3, 2024 Results on Nov 22, 2024 AcuCort AB (publ) announced that they will report Q3, 2024 results on Nov 22, 2024 공시 • Sep 03
Acucort AB (Publ) Announces 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 on September 2nd. The product will soon also be available at pharmacies in Norway and Finland. The launch is proceeding exactly as planned, and 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 hospitals in Norway and Finland. 공시 • Jul 25
AcuCort AB (publ) to Report First Half, 2024 Results on Aug 23, 2024 AcuCort AB (publ) announced that they will report first half, 2024 results on Aug 23, 2024 공시 • May 07
AcuCort AB (publ), Annual General Meeting, Jun 04, 2024 AcuCort AB (publ), Annual General Meeting, Jun 04, 2024. Reported Earnings • Apr 28
First quarter 2024 earnings released First quarter 2024 results: Revenue: kr1.19m (up 22% from 1Q 2023). Net loss: kr3.61m (loss widened 5.4% from 1Q 2023). 공시 • Apr 16
AcuCort AB (publ) Provides Update on Phase IV Study ZEQ001 AcuCort AB (publ) announced that its Phase IV study ZEQ001 for Zeqmelit® is ongoing. 40 patients have been assigned the oral film for use when needed for acute allergic reactions. 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. The study is running concurrently with the product's market launch in the Nordic region, where allergy patients are provided Zeqmelit® for use when needed for acute allergic reactions. The purpose of the study, an open-label non-randomized low-intervention trial, is to gather valuable scientific data on Zeqmelit® usage from patients previously prescribed corticosteroids in tablet form for self-treatment of acute allergic reactions. The study's results are expected by the end of 2024. 공시 • Mar 28
AcuCort AB (publ) to Report Q1, 2024 Results on Apr 26, 2024 AcuCort AB (publ) announced that they will report Q1, 2024 results on Apr 26, 2024 Recent Insider Transactions Derivative • Mar 28
Chief Executive Officer exercised options to buy kr161k worth of stock. On the 25th of March, Jonas Jonmark exercised options to buy 284k shares at a strike price of around kr0.40, costing a total of kr114k. This transaction amounted to 2,689% of their direct individual holding at the time of the trade. Since December 2023, Jonas' direct individual holding has increased from 10.56k shares to 294.60k. This was the only transaction from an insider over the last 12 months. New Risk • Mar 26
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swedish stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr18m free cash flow). Earnings have declined by 18% per year over the past 5 years. Shareholders have been substantially diluted in the past year (169% increase in shares outstanding). Revenue is less than US$1m (kr6.6m revenue, or US$622k). Market cap is less than US$10m (kr51.9m market cap, or US$4.90m). Minor Risk Share price has been volatile over the past 3 months (10% average weekly change). 공시 • Mar 07
AcuCort AB (publ) Announces Update on FDA Application Ahead of Launch in the USA The process for AcuCort AB (publ)'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 taken longer than previously estimated, which does not prompt any changes in AcuCort's strategy to launch Zeqmelit®? in the USA. Reported Earnings • Feb 18
Full year 2023 earnings released: kr0.44 loss per share (vs kr0.47 loss in FY 2022) Full year 2023 results: kr0.44 loss per share (improved from kr0.47 loss in FY 2022). Revenue: kr6.59m (up 31% from FY 2022). Net loss: kr13.7m (loss narrowed 7.4% from FY 2022). Over the last 3 years on average, earnings per share has increased by 1% per year but the company’s share price has fallen by 57% per year, which means it is significantly lagging earnings. Board Change • Feb 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. No highly experienced directors. Independent Director Monica Wallter was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. 공시 • Jan 31
AcuCort AB (publ) Announces First Patient Using Zeqmelit in Study Ahead of Market Launch AcuCort AB (publ) announced that 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 Zeqmelit®? from patients who have previously been prescribed corticosteroids in tablet form for self-treatment during acute allergic reactions. The study includes about 50 allergy patients who will be added continuously over the next six months. 공시 • Jan 24
AcuCort AB (publ) to Report Fiscal Year 2023 Results on Feb 16, 2024 AcuCort AB (publ) announced that they will report fiscal year 2023 results on Feb 16, 2024 New Risk • Jan 19
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 168% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr19m free cash flow). Earnings have declined by 19% per year over the past 5 years. Shareholders have been substantially diluted in the past year (168% increase in shares outstanding). Revenue is less than US$1m (kr6.1m revenue, or US$579k). Market cap is less than US$10m (kr33.2m market cap, or US$3.18m). Reported Earnings • Dec 03
Third quarter 2023 earnings released Third quarter 2023 results: Revenue: kr1.72m (up 135% from 3Q 2022). Net loss: kr3.13m (loss narrowed 18% from 3Q 2022). Over the last 3 years on average, earnings per share has fallen by 9% per year but the company’s share price has fallen by 60% per year, which means it is performing significantly worse than earnings. 공시 • Nov 02
AcuCort AB (publ) has completed a Composite Units Offering. AcuCort AB (publ) has completed a Composite Units Offering.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 2,686,588
Price\Range: SEK 4.8
Transaction Features: Rights Offering 공시 • Nov 01
AcuCort AB (publ) to Report Q3, 2023 Results on Nov 30, 2023 AcuCort AB (publ) announced that they will report Q3, 2023 results on Nov 30, 2023 공시 • Oct 12
AcuCort AB (publ) to Report Q3, 2023 Results on Nov 10, 2023 AcuCort AB (publ) announced that they will report Q3, 2023 results on Nov 10, 2023 Reported Earnings • Sep 03
Second quarter 2023 earnings released Second quarter 2023 results: Revenue: kr1.09m (up 8.4% from 2Q 2022). Net loss: kr2.82m (loss narrowed 19% from 2Q 2022). Over the last 3 years on average, earnings per share has fallen by 13% per year but the company’s share price has fallen by 52% per year, which means it is performing significantly worse than earnings. 공시 • Aug 10
AcuCort AB (publ) to Report Q2, 2023 Results on Aug 31, 2023 AcuCort AB (publ) announced that they will report Q2, 2023 results on Aug 31, 2023 공시 • Jul 13
AcuCort AB (publ) to Report Q2, 2023 Results on Aug 11, 2023 AcuCort AB (publ) announced that they will report Q2, 2023 results on Aug 11, 2023 공시 • Jul 06
AcuCort Receives Ethics Approval for Study with Zeqmelit® AcuCort has received approval from the Swedish Medical Products Agency and the Swedish Ethical Review Authority to start the study ZEQ001. The purpose of the study is to evaluate Zeqmelit® in acute allergic reactions and is part of the upcoming commercialization of the product in the Nordics. The study, which is a phase IV, open non-randomized low-intervention study, has as its overall objective to obtain real-world experience with Zeqmelit® from patients previously prescribed corticosteroids in tablet form for self-treatment of acute allergic reactions. The study will provide information on availability, security with the treatment and perceived effect in the patients. The study is expected to start in the fourth quarter of 2023 and last until the second quarter of 2024. 공시 • Feb 20
Fda Requests Additional Information Prior to Acucort's Registration Application in the United States The American agency FDA (U.S. Food and Drug Administration) has announced that AcuCort AB (publ) needs to submit additional information prior to the company's registration application in the United States. This also extends the time for the exemption from registration fee that was previously communicated. AcuCort has been informed by the American authority FDA that additional documentation is required by the company for its registration application in the United States regarding the drug Zeqmelit®. The company does not see that it would change a positive outcome of the application. With the extended processing time that the supplement entails, AcuCort has also had the date for the last submission under the Small Business Waiver brought forward. This also extends the time for exemption from the registration fee of USD 1.6 million, approximately SEK 16.7 million. A new Small Business Waiver application deadline has not yet been provided to AcuCort. AcuCort will notify the market as soon as additional information is approved by the FDA and a new registration deadline has been communicated by the authority. 공시 • Jan 26
AcuCort AB (publ) to Report Fiscal Year 2022 Final Results on Feb 24, 2023 AcuCort AB (publ) announced that they will report fiscal year 2022 final results on Feb 24, 2023 공시 • Jan 25
AcuCort Submitted the Price and Subsidy Application to TLV Regarding Zeqmelit® AcuCort has submitted a price and subsidy application to the Swedish price authority Tandvårds- och läkemedelsförmånsverket (TLV) regarding the company's drug Zeqmelit®. The application is considered to be an important milestone ahead of the market introduction of Zeqmelit® in Sweden. The application aims to give AcuCort approval for a subsidized price of the oral film Zeqmelit® in Sweden, which means that the medicine can be sold to the end consumer for a lower price and at the same time be covered by the so-called high cost protection. As previously communicated, the application was preceded by a questionnaire study that included 426 allergy patients. The study yielded a positive outcome where, among other things, 72% of the patients answered that they would prefer an oral film to tablet treatment in the event of a severe allergic reaction. The survey study is considered by AcuCort to be an important basis for the application to TLV. 공시 • Jan 24
Acucort Receives Market Approval from the Finnish Medicines Agency for the Drug Zeqmelit AcuCort has received approval for the company's first drug Zeqmelit® in Finland from the Finnish drug monitoring agency, Fimea. Thus, Zeqmelit® has been approved in all Nordic countries. In the development of the drug Zeqmelit®, AcuCort has succeeded in combining the advantages of the well-proven substance dexamethasone and a patented user-friendly oral film for quick availability and relief in emergency situations such as severe and acute allergic reactions. Zeqmelit® has previously been approved by pharmaceutical authorities in Sweden, Norway and Denmark. AcuCort's objective is to commercialize Zeqmelit® globally, i.e. in the EU, USA and in selected key markets. 공시 • Oct 19
Acucort AB (Publ) Receives Granted Patent in Canada for the Company's Drug Zeqmelit™ AcuCort AB (publ) announced that the Canadian Intellectual Property Office, CIPO, has granted a patent for AcuCort's drug Zeqmelit™. The patent protection covers the oral film technology with steroids that enables a user-friendly form of administration for the patient. The positive decision from the Canadian Intellectual Property Office means that the oral film technology with steroids used in AcuCort's approved drug Zeqmelit™ has patent protection. The drug's name was formerly ISICORT. The Canadian patent is co-owned with AcuCort's former manufacturing partner LTS Lohmann. Intellectual property rights such as patent and trademark protection play a crucial role in AcuCort's future commercial opportunities. The company has an active IP strategy covering the important pharmaceutical markets. Zeqmelit™ currently has patent protection in more than 30 countries, including Europe, the U.S., Japan, China and Canada. In the development of Zeqmelit™, 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. Zeqmelit™ is approved in Sweden, Denmark and Norway. The registration process for other countries within the EU is ongoing. AcuCort's overarching goal is to commercialize Zeqmelit™ globally, i.e. in the EU, the U.S. and in other priority markets. 공시 • Oct 13
AcuCort AB (publ) to Report Q3, 2022 Results on Nov 11, 2022 AcuCort AB (publ) announced that they will report Q3, 2022 results on Nov 11, 2022 공시 • Sep 29
AcuCort Reports Positive Results from the Company's Questionnaire Study About Allergy Treatments AcuCort AB (publ) reported 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 the great interest in participating and the commitment among the allergy patients led to the study being expanded and finally 426 respondents were included. The results from the now completed questionnaire study are an important component of AcuCort's pricing and reimbursement application for ISICORT® to the Swedish pricing and reimbursement agency, TLV. The other two components are partly a literature study and partly a panel of leading experts. Facts about health economics and the benefits ("the added value") that ISICORT® can contribute are important in the company's upcoming application. The study results in brief 72% of the patients answered that they would prefer an oral film to tablet treatment at a severe allergic reaction. 24% of the patients answered that they had experienced difficulties swallowing their allergy medication when they had a severe allergic reaction. 68% of the patients answered that they at some point had to seek emergency medical care because they could not be treated with their allergy tablets at a severe allergic reaction; partly because they had not had the tablets with them, partly because they could not swallow the tablets. 41% of the patients answered that they had at some point feared for their lives at a severe allergic reaction. 공시 • Sep 28
AcuCort AB (publ) Receives Marketing Authorization for the Drug Zeqmelit by the Norwegian Medicines Agency AcuCort AB (publ) announced 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 under the brand name ISICORT®. The registration process for Finland is ongoing and intensive work is underway on registration applications for other priority markets. AcuCort's goal is to commercialize Zeqmelit/ISICORT® globally, i.e. in the EU, the US and in selected key markets. 공시 • Aug 17
AcuCort AB (publ) Receives Marketing Authorization for the Drug Zeqmelit by the Danish Medicines Agency AcuCort AB (publ) announced 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 Nordic market is ongoing and the drug is now approved in Denmark and Sweden. Intensive work is underway on registration applications for other priority markets. AcuCort's goal is to commercialize Zeqmelit/ISICORT® globally, i.e. in the EU, the US and in selected key markets. Reported Earnings • Aug 16
Second quarter 2022 earnings released Second quarter 2022 results: Revenue: kr1.01m (up 118% from 2Q 2021). Net loss: kr3.48m (loss widened 5.9% from 2Q 2021). 공시 • Jul 14
AcuCort AB (publ) to Report Q2, 2022 Results on Aug 12, 2022 AcuCort AB (publ) announced that they will report Q2, 2022 results on Aug 12, 2022 Board Change • Apr 27
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 5 non-independent directors. Director Monica Wallter was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Reported Earnings • Apr 16
Full year 2021 earnings released: kr0.58 loss per share (vs kr0.40 loss in FY 2020) Full year 2021 results: kr0.58 loss per share (down from kr0.40 loss in FY 2020). Net loss: kr11.3m (loss widened 46% from FY 2020). Over the last 3 years on average, earnings per share has increased by 9% per year but the company’s share price has fallen by 30% per year, which means it is significantly lagging earnings. 공시 • Mar 31
AcuCort AB (publ) to Report Q1, 2022 Results on Apr 28, 2022 AcuCort AB (publ) announced that they will report Q1, 2022 results on Apr 28, 2022 공시 • Mar 03
AcuCort AB (publ) is Exempted from the Application Fee by the U.S. Food and Drug Administration AcuCort AB (publ) announced that the U.S. Food and Drug Administration, FDA, grants the company's waiver request under the small business waiver provision regarding the application fee for the new drug application of ISICORT®. The positive decision means that AcuCort is exempted from paying an application fee of USD 1.6 million provided that the application is submitted no later than the last day of February 2023. AcuCort identifies, develops, and commercializes smart drugs that meet the patient's medical needs for a quick and effective treatment as well as simplicity of administration. ISICORT® is approved in Sweden for the treatment of mainly acute and severe allergic reactions. The United States is the world's largest pharmaceutical market and the application to the FDA is strategically important for the company's global commercialization and expansion. AcuCort has previously made the assessment that the company would meet the criteria set by the FDA to qualify for exemption from the application fee. In the fall of 2021, AcuCort filed an application for a fee waiver, which the FDA has now granted. A dialogue with the FDA is ongoing to maximize the probability of a quick and positive processing of the registration application once it has been submitted. Is New 90 Day High Low • Jan 13
New 90-day low: kr4.61 The company is down 29% from its price of kr6.50 on 15 October 2020. The Swedish market is up 7.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is flat over the same period. Is New 90 Day High Low • Dec 29
New 90-day low: kr5.12 The company is down 25% from its price of kr6.86 on 30 September 2020. The Swedish market is up 5.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 2.0% over the same period. Is New 90 Day High Low • Dec 09
New 90-day low: kr5.16 The company is down 13% from its price of kr5.90 on 10 September 2020. The Swedish market is up 7.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 2.0% over the same period. 공시 • Nov 05
AcuCort AB (publ) Announces That the China National Intellectual Property Administration Has Granted the Company's Patent Application for Its Drug ISICORT® AcuCort AB announced that the China National Intellectual Property Administration has granted the company's patent application for its drug ISICORT®. The company has an active patent strategy covering all major geographic markets, including China. 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 used and well-documented anti-inflammatory substance. 공시 • Oct 17
AcuCort AB (publ) to Report Q3, 2020 Results on Nov 13, 2020 AcuCort AB (publ) announced that they will report Q3, 2020 results on Nov 13, 2020 공시 • Sep 12
AcuCort AB (publ) to Report Q2, 2020 Results on Aug 28, 2020 AcuCort AB (publ) announced that they will report Q2, 2020 results on Aug 28, 2020 공시 • Jul 18
AcuCort AB (publ) Appoints Jonas Jönmark as New CEO, Effective August 9, 2020 AcuCort AB announced that the company has finalized the process to recruit a permanent CEO and that Jonas Jönmark will assume the CEO position on August 9, 2020. Jonas Jönmark has an MBA degree from Lund University, Sweden. He has more than 20 years' experience from leading positions as well as the CEO role in the pharmaceutical industry and the life science sector. His career has included big international pharma companies such as Pfizer AB, Astellas Pharma A/S and Astra Zeneca Sweden, but also smaller start-up companies such as Life Science Support AB and Alteco Medical AB. Jonas has a broad experience from international product launches, establishment of sales- and distribution channels, commercial partnerships, pricing and reimbursement negotiations with authorities as well as international business development in life science. 