Business
ARS Pharmaceuticals Highlights Progress and Reports Fourth Quarter and Full Year 2022 Financial Results
New Drug Application and Marketing Authorization Application for neffy® Currently Under Review with the FDA and EMA; FDA PDUFA Target Action Date Anticipated
About this update from Ars Pharmaceuticals, Inc.
[{"type":"text","content":"New Drug Application and Marketing Authorization Application for neffy® Currently Under Review with the FDA and EMA; FDA PDUFA Target Action Date Anticipated in Mid-2023 Strong Financial Position with $274.4 Million in Cash, Cash Equivalents and Short-term Investments to Support Operating Runway for the Next Three Years SAN DIEGO, March 23, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), 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 highlighted recent progress and reported fourth quarter and full year 2022 financial results. “This is an incredibly exciting time for ARS, with potential regulatory approvals for neffy® around the corner and a resulting transition to a commercial-stage company. Our goal with neffy is to provide patients with the ability to deliver epinephrine with comparable pharmacokinetics to an intramuscular injection, but in an easy to use and rapidly administered needle-free nasal spray. We believe we are well on our way to achieving this goal,” said Richard Lowenthal, president and chief executive officer of ARS Pharmaceuticals. “Both our NDA and MAA for neffy are currently under review by the regulators in the U.S. and E.U. and we are on-track with our commercial preparedness activities for a potential U.S. launch later this year, if approved. We also recently reacquired European rights to neffy which enhance our optionality to evaluate potential partnerships or strategic transactions. The team has done a remarkable job executing the development of neffy, and we look forward to engaging with the regulatory agencies in an effort to impact the lives of millions of people with serious allergic reactions.” neffy Progress neffy NDA and MAA for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis, Under Review with FDA and EMA: The Company’s new drug application (NDA) and marketing authorization application (MAA) for neffy for the emergency treatment of allergic reactions (Type I), including anaphylaxis in adults and children ≥30 kg (66 lbs), were accepted for review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date t...