SPRY News & Events

ARS Pharmaceuticals announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, has adopted a positive opinion, recommending expanding the marketing authorization for EURneffy to include a 1 mg nasal adrenaline spray. EURneffy 1 mg is for the emergency treatment of allergic reactions due to insect stings or bites, foods, medicinal products and other allergens, as well as idiopathic or exercise-induced anaphylaxis, in children who weigh greater than or equal to15 kg and less than 30 kg. The opinion supports an extension to EURneffy 2 mg approval granted by the European Commission in August 2024 for the emergency treatment of anaphylaxis in adults and children who weigh greater than or equal to3 0 kg. Following grant of 1 mg dose, the marketing authorization will be valid in all EU member states, as well as Iceland, Liechtenstein and Norway.

ARS Pharmaceuticals announced that California is now eligible for its neffyinSchools program. "One year ago, we envisioned a nationwide program that would give school nurses and staff the confidence to respond quickly to a severe allergic emergency, and we're thrilled that California schools are now eligible to participate in this program," said Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma. "With neffy's needle-free design, long shelf life and stability at temperature excursions of up to 122 degrees F, schools have an option that is compact, easy to use, easily disposable and is ready when needed. We look forward to adding more school communities in the future."

ARS Pharmaceuticals' (SPRY) competitor Aquestive Therapeutics (AQST) received an FDA letter citing NDA deficiencies for Anaphylm, preventing discussion of labeling and post-marketing commitments, though the review remains ongoing and no final decision has been made, Raymond James tells investors in a research note. Given past safety concerns highlighted by ARS Pharmaceuticals, a complete response letter is considered likely, potentially delaying Anaphylm's market entry by about a year or more, the firm says. The firm has a Strong Buy rating on ARS Pharmaceuticals.

ARS Pharmaceuticals announced that the National Medical Products Administration in China has granted approval for neffy 2 mg for the emergency treatment of Type 1 allergic reactions in adults and children who weigh 30 kg or more. ARS Pharma and Pediatrix Therapeutics anticipate filing for approval of neffy 1 mg dose for children greater than 15 kg and less than 30 kg in the coming months. ARS Pharma entered into an exclusive licensing agreement with Pediatrix Therapeutics in 2021, providing them with exclusive rights to commercialize neffy in China for severe allergic reactions as well as certain other diseases such as chronic spontaneous urticaria. ARS Pharma will receive a final regulatory milestone of $4M and is eligible to receive up to $80M in sales milestones, as well as tiered royalties in the low double digits on annual net sales. ARS Pharma will be responsible for manufacturing and supplying neffy to Pediatrix Therapeutics in China at cost of goods and expects neffy to be available in the spring of 2026.