Core Viewpoint - ALK has received a positive opinion from the CHMP recommending the marketing authorisation for EURneffy, a 1 mg nasal adrenaline spray for emergency treatment of anaphylaxis in children aged 4 years and older [1][2][3] Group 1: Product Development and Authorisation - The positive CHMP opinion supports an extension to the existing marketing authorisation for EURneffy 2 mg, which was granted in August 2024 for adults and children weighing ≥30 kg [2] - The marketing authorisation for EURneffy 1 mg, if approved, will be valid across all EU member states, as well as Iceland, Liechtenstein, and Norway [3] Group 2: Market Context and Impact - Anaphylaxis is a severe allergic reaction requiring immediate medical intervention, with an incidence rate of approximately 1 in 761 children in Europe each year [4] - Foods are the most common trigger for anaphylaxis in children, accounting for over two-thirds of cases, with increasing hospitalisations due to food allergies [4] Group 3: Strategic Partnerships - ALK entered into a strategic license agreement with ARS Pharmaceuticals in November 2024, granting exclusive global rights to commercialise neffy, excluding the USA, Australia, New Zealand, Japan, and China [5] - The partnership was extended in May 2025 to include a co-promotion agreement in the USA [5] Group 4: Company Overview - ALK is a global specialty pharmaceutical company focused on allergy, covering the entire value chain from development to marketing of products for diagnosing and treating respiratory allergies and severe allergic reactions [8] - The company is headquartered in Denmark and employs around 2,700 people worldwide, listed on Nasdaq Copenhagen [8]