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SAN DIEGO - ARS Pharmaceuticals, Inc. (NASDAQ:SPRY), a nearly $1 billion market cap pharmaceutical company, announced Friday that Japanese regulators have approved neffy, an epinephrine nasal spray, for emergency treatment of allergic reactions in adults and children weighing more than 15 kilograms. According to InvestingPro data, the company maintains a strong financial position with a current ratio of 6.17, indicating robust short-term liquidity.
The Pharmaceuticals and Medical Devices Agency (PMDA) granted approval for both 1 mg and 2 mg doses of neffy, according to a company press release. The product represents the first needle-free epinephrine treatment available in Japan.
Alfresa Holdings, which secured exclusive licensing rights to commercialize neffy in Japan through a 2020 agreement with ARS Pharmaceuticals, expects to make the product available in the fourth quarter of 2025 following its listing on the Japanese National Health Institute Drug Price List.
"This represents a significant breakthrough as neffy meets a vital need for patients who may not carry, or hesitate to use, an injectable option for use during emergencies," said Richard Lowenthal, Co-founder, President and CEO of ARS Pharma.
The approval comes as food allergies affect approximately 900,000 Japanese individuals, with prevalence in children doubling from 2010 to 2019. A 2025 survey revealed only 14% of Japanese patients who experienced anaphylaxis had an epinephrine auto-injector prescription, and only half of those patients used their device during their most recent anaphylactic episode.
Under the licensing agreement terms, ARS Pharma will receive a $2 million regulatory milestone payment following the product’s listing on Japan’s drug price list.
Neffy is already commercially available in the United States for similar indications and has launched in Germany. Regulatory approvals are expected in Canada, Australia, New Zealand by the end of 2025, with China expected in the first half of 2026. For investors interested in deeper analysis of ARS Pharmaceuticals’ global expansion potential, InvestingPro offers comprehensive research reports with detailed financial metrics and growth projections, along with 10+ additional ProTips that could help inform investment decisions.
In other recent news, ARS Pharmaceuticals reported a revenue of $15.7 million for the second quarter of 2025, exceeding the forecast of $13.77 million by 14.16%. The earnings per share (EPS) matched the forecast at -$0.46. Raymond James reiterated a Strong Buy rating for ARS Pharmaceuticals, citing strong sales of their neffy product, with a $32.00 price target. The company achieved net sales of $12.8 million for neffy, selling approximately 35,000 two-packs during the quarter. Additionally, neffy has secured 93% commercial coverage, with 57% requiring no prior authorization. ARS Pharmaceuticals also received a Buy rating from Roth/MKM, with a $40.00 price target, due to the potential of their needle-free epinephrine product, neffy. Furthermore, the company received a Paragraph IV certification notice from Lupin Inc., which is seeking FDA approval to produce a generic version of neffy. Lupin claims that ARS Pharmaceuticals’ patents are invalid or unenforceable.
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