SPRY News & Events

ARS Pharmaceuticals announced that Health Canada has granted approval for neffy 2 mg for the emergency treatment of allergic reactions in adults and children who weigh 30 kg or more. ARS Pharma entered into an exclusive licensing agreement with ALK- Abello A/S in November 2024, providing ALK with exclusive rights to commercialize neffy in Europe, Canada, United Kingdom and certain other geographies outside of the U.S. Under the terms of the agreement, ARS Pharma has received upfront and milestone payments of $155M to date and is eligible to receive up to an additional $310M in regulatory and sales milestones, as well as tiered, double-digit royalties in the teens on net sales in licensed geographies. ARS Pharma will be responsible for manufacturing and supplying neffy to ALK in Canada and expects neffy to be available in the summer of 2026. ARS Pharma anticipates filing for approval of neffy 1 mg dose for children greater than 15 kg and less than 30 kg with Health Canada by this summer.

ARS Pharmaceuticals announced that the FDA has approved updating the neffy 1 mg prescribing information to remove the age criteria so all children and adults who weigh 33 pounds or more can utilize neffy for the emergency treatment of Type 1 allergic reactions, including anaphylaxis. Prior to the update, pediatric patients needed to meet a weight requirement and be at least four years of age. Additionally, the label update recommends patients carry neffy in the blister packaging or in the neffy carrying case.