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Investing.com -- ARS Pharmaceuticals Inc. (NASDAQ:SPRY) stock rose 7% Friday after Japanese regulators approved the company’s needle-free epinephrine nasal spray, neffy, for emergency treatment of allergic reactions.
The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan granted approval for neffy 1 mg and 2 mg doses for adults and children weighing more than 15 kilograms. This approval marks the first needle-free epinephrine treatment available in Japan for patients with severe allergies.
Alfresa Holdings, which owns the commercialization rights for neffy in Japan through a 2020 exclusive licensing agreement with ARS Pharmaceuticals, expects the product to be available in the fourth quarter of 2025. Following the listing of neffy on the Japanese National Health Institute Drug Price List, ARS Pharma will receive a $2 million regulatory milestone payment and will sell the product to Alfresa at a transfer price.
According to ARS Pharmaceuticals, approximately 900,000 Japanese individuals are affected by food allergies, with prevalence in children doubling from 2010 to 2019. A 2025 survey revealed that only 14% of Japanese patients who experienced anaphylaxis had an epinephrine auto-injector prescription, and just half of those used their device during their most recent anaphylactic episode.
The product is already commercially available in the U.S. and has launched in Germany through ARS Pharma’s European partner ALK. Regulatory approvals in Canada, Australia, New Zealand, and the UK have been secured, with approvals in China expected in the first half of 2026.
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