Shares of ARS Pharmaceuticals Inc. (NASDAQ:SPRY) climbed 7% on Friday following regulatory approval in Japan for the company’s needle-free epinephrine nasal spray, neffy, intended for emergency treatment of severe allergic reactions.
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) authorized neffy in 1 mg and 2 mg doses for adults and children over 15 kilograms, making it the first needle-free epinephrine option available in the country.
Alfresa Holdings, which holds exclusive commercialization rights in Japan under a 2020 licensing agreement with ARS Pharmaceuticals, plans to launch neffy in the fourth quarter of 2025. Upon listing on the Japanese National Health Institute Drug Price List, ARS will receive a $2 million milestone payment and sell the product to Alfresa at an agreed transfer price.
According to ARS Pharmaceuticals, roughly 900,000 people in Japan suffer from food allergies, with pediatric cases having doubled between 2010 and 2019. A 2025 survey found that only 14% of patients who experienced anaphylaxis had an epinephrine auto-injector prescription, and only half of them used it during their most recent severe reaction.
Neffy is already commercially available in the U.S. and has launched in Germany through ARS Pharma’s European partner ALK. The product has also gained regulatory clearance in Canada, Australia, New Zealand, and the U.K., with approval in China expected in the first half of 2026.
ARS Pharmaceuticals stock price
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