Business
ARS Pharmaceuticals Highlights neffy Regulatory Progress and Reports First Quarter 2024 Financial Results
neffy® (epinephrine nasal spray) New Drug Application (NDA) and CRL response under review by FDA with anticipated review completion by early October 2024
About this update from Ars Pharmaceuticals, Inc.
[{"type":"text","content":"neffy® (epinephrine nasal spray) New Drug Application (NDA) and CRL response under review by FDA with anticipated review completion by early October 2024 Response submitted for neffy Marketing Authorization Application (MAA) to EMA’s CHMP; CHMP opinion expected in the second quarter of 2024 Preparing to initiate outpatient study of neffy for urticaria (hives) in second half of 2024 $223.6 million in cash and securities as of March 31, 2024, providing an expected operating runway of at least three years; well-capitalized to support anticipated U.S. launch of neffy in the second half of 2024 SAN DIEGO, May 09, 2024 (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 reported business updates and financial results for the first quarter of 2024. “With the completion of all requested neffy® (epinephrine nasal spray) studies and submission of our response to FDA, we believe we are very close to delivering the first needle-free, safe, effective, and easy to carry epinephrine solution to the millions of people living with Type I allergies including anaphylaxis. Our primary focus is ensuring we are well-positioned for a successful launch of neffy in the U.S. upon approval, which is expected within the next six months. Importantly, we are well-capitalized with a multi-year operating runway that supports our neffy commercialization activities in the U.S.,” said Richard Lowenthal, Co-founder, President and CEO of ARS Pharma. “Our goal is to ensure that patients around the world have access to neffy in a timely manner. We’ve completed our submission to the EMA’s CHMP and expect an opinion on our MAA this quarter. We’re also delighted to partner with Australian pharmaceutical leader CSL Seqirus to support the approval and commercialization of neffy in Australia and New Zealand. These positive updates reflect our team’s strong execution and unwavering commitment to serving patients.” U.S. Regulatory Status of neffy for Type 1 Allergic Reactions In April, ARS Pharma submitted its response to the FDA’s Complete Response Letter (CRL) issued regarding its NDA for neffy for the treatment of Type I allergic reactions including anaphylaxis. The response addresse...