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ARS Pharmaceuticals, Inc. develops and commercializes neffy, an epinephrine nasal spray for emergency treatment of Type I allergic reactions, including anaphylaxis. The company’s news commonly covers U.S. commercialization, product labeling, international approvals and licensing relationships for neffy, which is marketed as EURneffy in the European Union and the United Kingdom and under a separate trade name in China.
Recurring updates also include quarterly and annual financial results, clinical and scientific presentations on intranasal epinephrine, school-access programs, manufacturing and supply responsibilities for partners, and investor conference activity. The company’s allergy-treatment focus makes regulatory decisions, product access, clinical data and commercial launch progress central themes in its public announcements.
ARS Pharmaceuticals submitted the Day 180 response for neffy (epinephrine nasal spray) Marketing Authorization Application to EMA's CHMP and entered a license agreement with CSL Seqirus for commercialization in Australia and New Zealand. The CHMP opinion on neffy is expected in the second quarter of 2024, addressing all identified issues and including results from a repeat dose study and updated nitrosamine testing. CSL Seqirus will handle regulatory approval, reimbursement, and commercialization, while ARS Pharma will manage manufacturing and supply.
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