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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.