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.
Stock Titan’s news page for ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) aggregates company-specific updates for investors and followers of this commercial-stage biopharmaceutical company. ARS Pharma describes its focus as empowering at-risk patients and caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, primarily through its epinephrine nasal spray product, neffy®.
News coverage for SPRY commonly includes announcements about regulatory approvals and geographic expansion of neffy and EURneffy®. Recent press releases highlight approvals for neffy in markets such as Japan and China, as well as launches and approvals in Europe and the U.K. These items provide insight into how ARS Pharma is extending access to its needle-free epinephrine nasal spray through partnerships with companies including ALK, Alfresa Holdings, and Pediatrix Therapeutics.
Investors can also expect commercial and financial updates, such as quarterly financial results, commentary on U.S. commercialization progress, and details on direct-to-consumer campaigns and programs like “Get neffy on Us” and neffyInSchools. These disclosures often describe prescriber adoption, marketing initiatives, and real-world evidence efforts related to neffy’s use in community and clinical settings.
Another key category of SPRY news involves scientific and medical conference activity. ARS Pharma regularly reports on late-breaking oral presentations, poster sessions, and case reports at meetings such as the American College of Allergy, Asthma and Immunology Annual Scientific Meeting, focusing on real-world data, patient experience, dosing rationale, safety, and product stability for intranasal epinephrine.
Additional items may include intellectual property developments, such as decisions from the European Patent Office or the U.S. Patent and Trademark Office, as well as legal and competitive updates like Paragraph IV certification notices regarding potential generic versions of neffy. By following this news feed, readers can monitor how ARS Pharma communicates its regulatory, commercial, scientific, and legal milestones related to neffy and its intranasal epinephrine program.
Summary not available.
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.