Business
ARS Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Business Updates
Commercial launch of neffy® (epinephrine nasal spray) underway in the United StatesSupplemental NDA for neffy®1mg dose granted priority review by FDA; PDUFA
About this update from Ars Pharmaceuticals, Inc.
[{"type":"text","content":"Commercial launch of neffy® (epinephrine nasal spray) underway in the United StatesSupplemental NDA for neffy®1mg dose granted priority review by FDA; PDUFA target date set for March 6, 2025Exclusive license agreement with ALK-Abelló to commercialize neffy® in Europe, Canada and certain other geographies; ARS Pharma to receive $145 million in upfront payment with total deal consideration of up to $465 million plus double-digit royaltiesWell-capitalized with $349.6 million in cash, cash equivalents and short-term investments on a pro forma basis, supporting an operating runway of at least three yearsCompany to host conference call and webcast today at 8:00 a.m. ET SAN DIEGO, Nov. 13, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, today reported early progress on the U.S. commercial launch of neffy® (epinephrine nasal spray) 2 mg for the treatment of Type I allergic reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.), as well as business highlights and financial results for the third quarter of 2024. “The third quarter marked a transformative period for ARS Pharma, driven by the FDA approval of neffy in the U.S. and the European Commission approval of EURneffy® in the European Union,” stated Richard Lowenthal, President and CEO of ARS Pharmaceuticals. “With strong demand among healthcare providers and patients for neffy as the first and only needle-free epinephrine treatment, robust patient support systems in place, and favorable early payer discussions ongoing, we feel very good about the early momentum in our U.S. launch. We’re also proud to have further expanded the reach of neffy outside the U.S. by partnering with ALK-Abelló, a global leader in allergy product commercialization. Operationally, we stand very well positioned with a balance sheet that is further strengthened by the $145 million upfront payment from ALK, positioning us to execute our U.S. commercial plans and business goals to enable patients around the world to have access to this vital epinephrine treatment.” U.S. commercial launch ongoing for neffy, the first and only needle-free epinephrine treatment for Type 1 allergic reactions, including a...