ARS Pharmaceuticals (NASDAQ:SPRY) has received Health Canada approval for neffy 2 mg, marking the first time a needle-free epinephrine delivery system has been authorized for the emergency treatment of severe allergic reactions in Canada.
The approval covers adults and pediatric patients weighing 30 kilograms or more.
In conjunction with the regulatory milestone, ALK-Abelló A/S (ALK), the company’s exclusive commercial partner in Canada and Europe, indicated that the product is expected to be commercially available to Canadian patients by the summer of 2026.
The financial framework of the partnership continues to yield significant liquidity for ARS Pharmaceuticals.
To date, the company has received $155 million in upfront and milestone payments from ALK.
Under the terms of their exclusive licensing agreement, ARS remains eligible for up to an additional $310 million in regulatory and sales-based milestones, alongside tiered, double-digit royalties on net sales within licensed territories.
ARS will maintain responsibility for the global manufacturing and supply of neffy to ensure consistency across international markets.
Looking ahead, ARS Pharmaceuticals is working to expand the indicated patient population.
The company plans to file a supplemental submission with Health Canada by the summer of 2026 for a 1 mg pediatric dose, intended for children weighing between 15 kg and 30 kg.
This expansion follows the product's established regulatory momentum in other global jurisdictions, including the United States and China, as the firm seeks to replace traditional auto-injectors with its proprietary intranasal technology.