공고 • Aug 06
Alk-Abelló's Subsidiary Alk-Abelló Pharmaceuticals Inc. Canada Announces Neffy Now Available Across Canada ALK-Abelló Pharmaceuticals Inc. Canada announced that neffy is now available across Canada, following its approval by Health Canada in April 2026. neffy is approved for use in adults and children with a body weight of 30 kg (66 pounds) or more for the emergency treatment of allergic reactions, including anaphylaxis to insect stings or bites, foods, medicines and other allergens, as well as anaphylaxis where the cause is not known or anaphylaxis caused by exercise. neffy 2 mg is a nasal spray designed to provide fast absorption of epinephrine. neffy delivers a full, single dose of epinephrine in a user-friendly format, without the need for priming. It has a 30-month shelf life and no special storage requirements, with the ability to withstand temperature excursions of up to 50°C. Freezing does not affect its shelf life, however if it is accidentally frozen the nasal spray should be allowed to thaw for at least one hour before use, because it will not activate if frozen. The most frequently occurring adverse reactions (very common events = 10%) observed in clinical studies of neffy were reported only after a second 2 mg dose (4 mg total) and include throat irritation (18.8%), headache (17.6%), nasal discomfort (12.9%) and feeling jittery (10.6%). Buy Or Sell Opportunity • Jul 06
Now 20% undervalued Over the last 90 days, the stock has risen 19% to €32.36. The fair value is estimated to be €40.68, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 12% over the last 3 years. Earnings per share has grown by 43%. For the next 3 years, revenue is forecast to grow by 12% per annum. Earnings are also forecast to grow by 14% per annum over the same time period. 공고 • Jun 18
ALK Receives UK Approval For EURneffy 1 Mg As The First And Only Needle-Free Adrenaline Treatment For Young Children At Risk Of Anaphylaxis ALK announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for EURneffy 1 mg, the first and only needle-free adrenaline treatment for anaphylaxis for children aged 4 and older living with severe allergies in the UK – extending a class of treatment previously available only by injection. EURneffy 1 mg is now indicated in the UK for the emergency treatment of severe allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products and other allergens, as well as idiopathic or exercise-induced anaphylaxis in children aged 4 years and over weighing 15 kg to less than 30 kg. This approval follows the existing UK marketing authorisation for EURneffy 2 mg, previously approved by the MHRA for the emergency treatment of anaphylaxis in adults and children weighing =30 kg. This approval means more people with severe allergies, including children aged 4 years and older who weigh 15 kg to less than 30 kg, will be eligible for treatment with EURneffy, the only needle-free adrenaline-based product currently approved in the UK. EURneffy provides rapid absorption of adrenaline within minutes of administration. EURneffy has an established safety profile, based on clinical data from the EURneffy development programme involving over 700 participants. The most common adverse reactions in subjects weighing 15 kg to less than 30 kg treated with EURneffy 1 mg included: nasal congestion (19.0%), upper respiratory tract congestion (14.3%), dry throat, nasal dryness, and paraesthesia (each 9.5%). There were no clinically relevant differences in the safety between the paediatric and adult populations treated with EURneffy. EURneffy 2 mg performed as well as traditional adrenaline auto-injectors or intramuscular adrenaline across a range of real-world scenarios examining the clinical pharmacological effect including single and repeat doses, self-administration, and situations with nasal congestion from allergies. EURneffy 1 mg dose demonstrated a comparable absorption and pharmacodynamic effect in children (15-30 kg) as the 2 mg dose in children and adults above 30 kg. EURneffy is the first and only needle-free adrenaline-based product approved for the emergency treatment of anaphylaxis in adults and children. EURneffy is well absorbed through the nose and distributed quickly into body tissues, offering a portable, pocket-sized alternative to injectable forms of adrenaline for treating severe allergic reactions. EURneffy has a total shelf life of 30 months (2 mg) and 24 months (1 mg), no special storage requirements and freezing does not affect its shelf life. Upon activation, EURneffy nasal spray delivers a full, single dose of adrenaline, without the need for priming. It is recommended that two EURneffy devices are carried to treat a potentially life-threatening emergency in case a second dose is required. In the UK and European Union, EURneffy 2 mg is approved for the emergency treatment of anaphylaxis in adults and children who weigh = 30kg, and EURneffy 1 mg is approved for the emergency treatment of anaphylaxis in children aged 4 and older who weigh from 15 kg to less than 30 kg. In the United States, Japan, China, Australia and Canada EURneffy 2 mg is approved under the brand name neffy 2 mg. In the US and Australia, neffy 1 mg has also been approved for children who weigh 15–30 kg (with an age restriction of 4 years and older in Australia) and in Japan, neffy 1 mg and 2 mg are approved for the emergency treatment of severe allergic reactions (anaphylaxis) in adults and children who weigh =15 kg. 공고 • May 06
Alk-Abelló A/S Upgrades Earnings Guidance for the Full-Year 2026 ALK-Abelló A/S upgraded earnings guidance for the full-year 2026. For the year, the company revenue is now expected to grow by 13-16% in local currencies (previously 11-15% growth) based on growth across all sales regions and product lines. The EBIT margin is now expected at around 26% (previously 25%). Reported Earnings • May 05
First quarter 2026 earnings released: EPS: kr.2.00 (vs kr.1.60 in 1Q 2025) First quarter 2026 results: EPS: kr.2.00 (up from kr.1.60 in 1Q 2025). Revenue: kr.1.77b (up 16% from 1Q 2025). Net income: kr.437.0m (up 23% from 1Q 2025). Profit margin: 25% (up from 23% in 1Q 2025). The increase in margin was driven by higher revenue. Revenue is forecast to grow 12% p.a. on average during the next 3 years, compared to a 5.0% growth forecast for the Pharmaceuticals industry in Europe. 공고 • Apr 21
ALK Announces Successful Outcome of Phase 2 Trial with Its Tablet for Treatment of Peanut Allergy Demonstrating Early Onset of Efficacy ALK announced positive topline results from the phase 2 clinical trial (named ‘ALLIANCE’) with its once-daily investigational sublingual immunotherapy (‘SLIT’) tablet for the treatment of peanut allergy in patients aged 4-65 years. The trial included 150 patients and was a randomised, double-blinded placebo-controlled dose-finding phase 2 clinical trial evaluating safety and efficacy of two different doses of the peanut tablet compared to placebo. Patients were up-dosed followed by maintenance dosing for 24 weeks. After only 24 weeks of maintenance treatment, clear dose-dependent and statistically significant efficacy was demonstrated across multiple efficacy endpoints based either on the Tolerated Dose (TD) or Eliciting Dose (ED) as measured by a double-blind, placebo-controlled exit food challenge with peanut protein: TD300 efficacy endpoint: 49% of patients treated with the highest dose of the peanut tablet tolerated a dose of 300 mg peanut protein vs. 18% in placebo (p<0.001). TD600 efficacy endpoint:31% of patients treated with the highest dose of the peanut tablet tolerated a dose of 600 mg peanut protein vs. 8% of the placebo treated patients (p<0.01). TD1000 efficacy endpoint: 22% of patients treated with the highest dose of the peanut tablet tolerated a dose of 1.000 mg peanut protein vs. 2% in placebo (p<0.01). ED based efficacy endpointiii:65% of patients treated with the highest dose of the tablet responded to treatment when defining responders as patients with a baseline ED = 30 mg who achieved an ED = 300 mg or a patient with a baseline of ED = 100 mg who achieved an ED = 600 mg of peanut protein during the oral food challenge (24% in placebo, p<0.001). Efficacy was observed across all age groups. Treatment with the tablet was safe and well-tolerated across all treatment groups, and the level of treatment-related discontinuations was low. No treatment-related anaphylaxis or treatment-related serious adverse events were reported. The peanut tablet spearheads ALK’s future portfolio in food allergy, which also spans novel concepts in pre-clinical development targeting other pathways and indications. 
