Business
ARS Pharmaceuticals Provides Business Highlights and Reports Second Quarter 2024 Financial Results
neffy® (epinephrine nasal spray) New Drug Application (NDA) under review by FDA; discussions are ongoing to finalize labeling with FDA; PDUFA date in early
About this update from Ars Pharmaceuticals, Inc.
[{"type":"text","content":"neffy® (epinephrine nasal spray) New Drug Application (NDA) under review by FDA; discussions are ongoing to finalize labeling with FDA; PDUFA date in early October 2024 EURneffy® (adrenaline nasal spray) recommended for approval by EMA’s CHMP; formal marketing authorization anticipated in the third quarter of 2024 Outpatient study of neffy for urticaria (hives) on track to initiate in the fourth quarter of 2024 $218.7 million in cash, cash equivalents and short-term investments as of June 30, 2024, providing an expected operating runway of at least three years; well-capitalized to support anticipated U.S. launch of neffy, if approved SAN DIEGO, Aug. 06, 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 highlights and financial results for the second quarter of 2024. “Thanks to the diligent work by the entire ARS team, we believe we are in the final steps with FDA, with draft physician labeling in hand and commercial readiness efforts well underway to support the successful launch of neffy upon FDA approval,” stated Richard Lowenthal, Co-founder, President, and CEO of ARS Pharma. “We are also greatly encouraged by the EMA’s CHMP positive opinion adopted for EURneffy and are in advanced discussions to select a pharmaceutical partner with a strong commercial infrastructure who will launch EURneffy in Europe. Importantly, our robust balance sheet provides us with a multi-year operating runway that supports our planned neffy commercialization activities in the U.S. We are well positioned to bring this treatment to the millions of patients living with Type I allergies, including anaphylaxis, and their dedicated caregivers, who we believe are in dire need of a needle-free, safe, effective, and easy-to-carry epinephrine treatment solution.” Second Quarter 2024 Financial Results Cash Position: Cash, cash equivalents and short-term investments were $218.7 million as of June 30, 2024, which ARS Pharma believes is sufficient to fund its current operating plan for at least three years.Research and Development (R&D) Expenses: R&D expenses were $6.9 million for the quarter ended June 30, 2024, compared to $7.3 million for the quar...