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ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) is a pioneering biopharmaceutical company dedicated to developing innovative solutions for patients at risk of severe allergic reactions, potentially leading to anaphylaxis. The company is primarily focused on its flagship product candidate, neffy, a nasal spray formulation of epinephrine designed for emergency treatment of Type I allergic reactions.
ARS Pharma is committed to addressing the limitations of traditional epinephrine autoinjectors, such as needle phobia, portability issues, and complexity of use. neffy aims to provide a needle-free, easy-to-use, and reliable alternative, enhancing patient compliance and timely administration in emergency situations. Leveraging a proprietary absorption enhancer, Intravail, neffy ensures rapid and effective epinephrine absorption comparable to injections.
As of November 2023, ARS Pharma announced that despite initial regulatory hurdles, the company is on track to resubmit its New Drug Application (NDA) for neffy to the FDA by mid-2024, with potential U.S. market launch in the latter half of the year. This follows the FDA's additional requirement for a pre-approval repeat-dose rhinitis study, which ARS Pharma has proactively addressed. The company recently published positive results from clinical studies in the Journal of Allergy and Clinical Immunology, further validating neffy's safety and efficacy.
Financially, ARS Pharma is solidly positioned, with an expected $195 million in cash and equivalents by the anticipated neffy launch date. This ensures the company's capability to sustain operations and support the product's market introduction and growth. Additionally, ARS Pharma has expanded its reach by entering into an exclusive distribution agreement with CSL Seqirus for the Australian and New Zealand markets, exemplifying its strategic approach to global commercialization.
The company's latest achievements include the successful completion of a Phase 2 trial for neffy in treating chronic spontaneous urticaria, showing promising results in alleviating symptoms such as itch and hives. ARS Pharma plans to initiate further outpatient studies in 2024, potentially leading to a pivotal efficacy study in 2025.
Overall, ARS Pharmaceuticals stands out for its innovative approach to addressing unmet needs in allergy treatment, demonstrating resilience and commitment to bringing a transformative, needle-free epinephrine solution to patients worldwide.
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.
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