Welcome to our dedicated page for ARS Pharms news (Ticker: SPRY), a resource for investors and traders seeking the latest updates and insights on ARS Pharms stock.
ARS Pharmaceuticals, Inc. (SPRY) is a biopharmaceutical innovator developing neffy®, a needle-free epinephrine nasal spray for emergency treatment of severe allergic reactions. This page provides investors and healthcare stakeholders with timely, verified updates on the company’s progress in redefining allergy care through intranasal technology.
Discover comprehensive coverage of SPRY’s regulatory milestones, clinical trial results, and strategic partnerships. Our news collection focuses on developments impacting neffy’s market adoption, manufacturing updates, and scientific validation of its needle-free delivery system. Key updates include FDA communications, international expansion efforts, and patient access initiatives.
This resource serves as your central hub for understanding SPRY’s role in addressing critical gaps in anaphylaxis treatment. Bookmark this page for ongoing insights into how ARS Pharmaceuticals combines biopharmaceutical innovation with patient-centric solutions in emergency care.
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.
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