ARS Pharma Gets Positive CHMP Opinion For 1 Mg EURneffy Nasal Spray

(RTTNews) - ARS Pharmaceuticals, Inc. (SPRY) said Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion supporting expanded marketing authorization for EURneffy to include a 1 mg nasal adrenaline spray.

EURneffy 1 mg is proposed for the emergency treatment of allergic reactions due to insect stings or bites, foods, medicinal products and other allergens, as well as idiopathic or exercise-induced anaphylaxis, in children weighing between 15 kg and less than 30 kg.

The opinion builds on the approval of EURneffy 2 mg, which was granted by the European Commission in August 2024 for the emergency treatment of anaphylaxis in adults and children weighing 30 kg or more.

neffy, marketed as EURneffy in Europe and the UK, is commercially available in the U.S. for the emergency treatment of allergic reactions, including anaphylaxis, in adults and children weighing at least 33 pounds. In 2025, ALK launched EURneffy 2 mg in selected European countries and the U.K. It has also recently been approved in Japan, China, and Australia, with approvals in Canada expected in early 2026.

Shares of ARS Pharma were up more than 2% in pre-market trading, after closing at $9.99, down 2.25% on Friday.