"The approval of neffy by Health Canada marks a meaningful advancement for the more than 2.5 million people living with allergic reactions that could lead to anaphylaxis¹ in Canada, delivering the first needle-free epinephrine for use at the first signs of an allergic reaction," said Richard Lowenthal, Co-founder, President and CEO of ARS Pharma. "neffy's needle-free design reduces barriers to timely treatment while fitting more naturally into everyday life. It is easy to carry, simple to use, has a 30-month shelf life, temperature excursions up to 122oF (50oC), and, if accidentally frozen, can be used once thawed. In partnership with ALK Canada, we are focused on moving quickly to make neffy accessible across the country and helping people feel prepared in an allergic emergency."

ARS Pharma entered into an exclusive licensing agreement with ALK- Abelló A/S (ALK) 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 $155 million to date and is eligible to receive up to an additional $310 million 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.

The regulatory clearance in Canada follows the latest granted approval in China for neffy in partnership with Pediatrix Therapeutics. The National Medical Products Administration (NMPA) in China is responsible for evaluating medicines and medical devices, previously granted approval for neffy 2 mg (epinephrine nasal spray) for the emergency treatment of allergic reactions (anaphylaxis) in adults and children who weigh 30 kg or more in December 2025. ARS Pharma and Pediatrix Therapeutics anticipate filing for approval of neffy 1 mg dose for children greater than 15 kg and less than 30 kg in the coming months.

neffy is commercially available in the U.S. for the emergency treatment of allergic reactions, including anaphylaxis, in adults and children who weigh at least 33 pounds (15 kg).