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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.
ARS Pharmaceuticals has successfully merged with Silverback Therapeutics, creating a new entity called ARS Pharmaceuticals, Inc. The merger, effective November 9, 2022, has provided ARS with over $280 million in cash and securities to support the potential launch of neffy®, a nasal spray for treating severe allergic reactions. The New Drug Application for neffy® is currently under FDA review with a PDUFA date anticipated in mid-2023. This product aims to provide a needle-free solution for patients hesitant to use traditional epinephrine injection devices.
Silverback Therapeutics announced the FDA's acceptance of ARS Pharmaceuticals' NDA for neffy, a potential first non-injectable treatment for allergic reactions including anaphylaxis. This nasal spray aims to simplify epinephrine delivery, targeting 25-40 million Americans facing severe allergies. The FDA set a PDUFA date for mid-2023. Initial studies show neffy met clinical endpoints, with over 500 individuals reporting mostly mild side effects. The company is poised to merge with ARS Pharma to focus on neffy commercialization.
Silverback Therapeutics and ARS Pharmaceuticals have announced a merger in an all-stock transaction. The combined entity will prioritize the commercialization of neffy™, a needle-free epinephrine nasal spray aimed at treating Type I allergic reactions. The merger is projected to close in Q4 2022, with approximately $265M in cash and equivalents expected post-merger. If approved, neffy™ aims to launch in the U.S. in 2023, addressing a significant market need, given that only a fraction of severe allergy sufferers currently use epinephrine autoinjectors.
Silverback Therapeutics, Inc. (Nasdaq: SBTX) will participate in the H.C. Wainwright 24th Global Investment Conference from May 23-25, 2022. CEO Laura Shawver, Ph.D., will provide a corporate overview on May 24 at 7:00 AM ET. The presentation will be available for 30 days on their Investor Relations website. Silverback develops therapeutics for chronic viral infections, cancer, and other diseases using its ImmunoTAC technology platform, which targets specific disease sites with monoclonal antibodies.
Silverback Therapeutics, Inc. (SBTX) reported significant advancements in its lead program SBT8230 for chronic hepatitis B during Q1 2022, expecting a regulatory submission by Q4 2022 and Phase 1 study initiation in Q1 2023. Financially, the company posted a net loss of $24.6 million, up from $18.9 million year-over-year. Research and development expenses rose to $16.9 million from $12.2 million due to escalating preclinical costs. As of March 31, 2022, cash reserves stood at $298.1 million, anticipated to cover operational costs until mid-2026.
Silverback Therapeutics (SBTX) announced a strategic shift focusing on SBT8230 for chronic hepatitis B virus, discontinuing SBT6050 and SBT6290 oncology programs. The company plans to submit a Phase 1 regulatory filing for SBT8230 by Q4 2022. A workforce reduction of 27% aims to streamline operations and extend the cash runway into H2 2026. Financial results revealed a net loss of $23.5 million for Q4 2021, up from $13.1 million in Q4 2020, with total 2021 losses reaching $89.5 million, increasing R&D costs significantly.
