Is ARS Pharmaceuticals a buy?

Roth Capital Markets analyst Kyle Bauser reiterated a Buy rating and a 12-month price target of $30.00 on ARS Pharmaceuticals (ARS Pharmaceuticals Stock Quote, Chart, News, Analysts, Financials NASDAQ:SPRY) after the company secured earlier-than-expected regulatory approval for neffy in China.

Bauser said ARS announced Dec. 29 that China’s National Medical Products Association approved neffy 2 mg for the emergency treatment of Type 1 allergic reactions (anaphylaxis) in adults and children weighing 30 kilograms or more. Pediatrix Therapeutics will market the product in China under the trade name 优敏速, translated as “Excellent Allergy (treatment) Fast,” with commercial availability expected in spring 2026.

“Today’s news is ahead of expectations, as we had anticipated China approval in 1H26,” Bauser said.

He said the opportunity in China is significant, with an estimated 4.0% to 8.2% of the population, roughly 50 to 100 million people, affected by food allergies and at risk for severe reactions. Bauser added that neffy is now the first and only epinephrine product approved for community use outside hospital settings in China, including auto-injectors.

Bauser also pointed to longer-term upside from chronic spontaneous urticaria, which affects an estimated 6.5 million people in China. ARS is currently developing an intranasal CSU treatment in a Phase 2b study.

Under a 2021 exclusive licensing agreement, Pediatrix holds commercialization rights to neffy in China for anaphylaxis and certain other allergic indications. ARS is eligible to receive a final regulatory milestone of $4-million, up to $80-million in sales milestones, and tiered royalties in the low double digits, while supplying product at cost of goods.

The China approval follows recent global momentum for neffy, including approvals in Australia, Japan, and Europe, with New Zealand approval expected by year-end 2025.

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