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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.
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ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) announced that the FDA has scheduled an Advisory Committee meeting on May 11, 2023, to review the NDA for neffy, a potential first non-injectable epinephrine nasal spray for allergic reactions, including anaphylaxis. The FDA deemed the Advisory Committee meeting important due to the new delivery method and the complexities of clinical efficacy trials. CEO Richard Lowenthal expressed optimism about the meeting as a positive step towards neffy's potential approval. The PDUFA target action date for neffy is set for mid-2023.
ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) provided an update on its progress regarding neffy®, a needle-free nasal spray for treating severe allergic reactions. The FDA and EMA are currently reviewing their New Drug Application and Marketing Authorization Application, with a PDUFA target action date expected in mid-2023. Financially, ARS reported a robust cash position of $274.4 million, sufficient to support operations for the next three years. R&D expenses for Q4 2022 were $4.7 million, leading to a net loss of $14.4 million for the quarter and $34.7 million for the year. The company is well-prepared for a potential U.S. launch if approved.
ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) announced the presentation of positive data supporting neffy® at the 2023 AAAAI meeting, which is currently under FDA review. This potential first non-injectable treatment for Type I allergic reactions, including anaphylaxis, will be highlighted in five poster presentations. The data indicates that neffy delivers consistent epinephrine levels comparable to intramuscular injection products. Surveys reveal that needle-phobia is a major barrier to using epinephrine prescriptions, underscoring the need for neffy as a needle-free alternative. The total market for Type I allergic reactions includes 25-40 million individuals in the U.S.
ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) has reacquired commercial rights to neffy (ARS-1) from Recordati S.p.A., facilitating a strategic move to enhance the product's market potential. This decision follows Recordati's portfolio review aimed at prioritizing core therapeutic areas. As of year-end 2022, ARS holds approximately $275 million in cash, projected for at least three years of operations. The marketing authorization application for neffy is under review by the EMA, with an anticipated U.S. launch in 2023, contingent on approval. The agreement also includes upfront payments and milestone fees based on commercial sales.
SAN DIEGO, Feb. 09, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, a biopharmaceutical company focused on severe allergic reactions, announced that CEO Richard Lowenthal and CCO Eric Karas will speak at the SVB Securities Virtual Global Biopharma Conference on February 16, 2023, at 2:20 p.m. ET. A live webcast will be accessible on the company's investor website and will be archived for 30 days post-event. The company is known for developing neffy®, an intranasal epinephrine product for patients at risk of anaphylaxis from allergies to foods, medications, and insect bites.
ARS Pharmaceuticals, Inc. announced significant clinical data supporting neffy® (previously ARS-1), a non-injectable treatment for severe allergic reactions, to be presented at the 2022 American College of Allergy, Asthma and Immunology Annual Scientific Meeting. The data from trials EPI-15 and EPI-16 confirm that neffy effectively delivers epinephrine levels comparable to existing injectable products. The U.S. FDA is currently reviewing the New Drug Application for neffy with a decision expected mid-2023, highlighting its potential for improved patient adherence and faster response in emergencies.