ARS has also filed and cleared validation of a Marketing Authorization Application (MAA) in Europe, which is currently under review by the European Medicines Agency (EMA). Food and Drug Administration (FDA) with an anticipated Prescription Drug User Fee Act (PDUFA) date in mid-2023. The Company’s New Drug Application (NDA) submission for neffy ® is currently under review by the U.S. With its needle-free administration, neffy ® may help eliminate the anxiety and hesitation associated with using an epinephrine injection device. Effective as of the closing of the merger, ARS has over $280 million in cash and marketable securities.ĪRS has designed and developed neffy ® to provide injection-like absorption of epinephrine, in a small, easy-to-carry, easy-to-use, rapidly administered, and reliable nasal spray device for the treatment of Type I severe allergic reactions, including anaphylaxis. The combined company will operate as ARS Pharmaceuticals, Inc., and shares of its common stock will commence trading under the trading symbol “SPRY” on November 9, 2022, on the Nasdaq Global Select Market. This follows the satisfaction of all customary closing conditions, including approval of the merger by the stockholders of Silverback. (Nasdaq: SPRY) (ARS or the Company), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today announced the closing of its merger with Silverback Therapeutics, Inc. SAN DIEGO – Novem– ARS Pharmaceuticals, Inc. MAA validated in the European Union Under Review NDA Currently Under FDA Review PDUFA Anticipated Mid-2023 Over $280 Million in Combined Cash and Securities and at least Three Years Operating Runway to Support Launch and Commercialization of neffy ® in the U.S., if Approved
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