Business
ARS Reports Second Quarter 2023 Financial Results and Provides Business Updates
ARS continues engagement with U.S. FDA on final labeling and post-marketing commitments for the neffy® new drug application; PDUFA target action date set for
About this update from Ars Pharmaceuticals, Inc.
[{"type":"text","content":"ARS continues engagement with U.S. FDA on final labeling and post-marketing commitments for the neffy® new drug application; PDUFA target action date set for September 19, 2023 Ended second quarter with $252.2 million in cash, cash equivalents and short-term investments; well-capitalized to support anticipated launch of neffy in the U.S. and an expected operating runway of at least three years SAN DIEGO, Aug. 10, 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 reported business updates and financial results for the second quarter of 2023. “Our primary focus is on making neffy, an investigational new drug, available to people as quickly as possible and we believe that our interactions with FDA are nearly complete,” said Richard Lowenthal, president and chief executive officer of ARS. “With a PDUFA date next month, we continue to advance our preparations to ensure we are well-positioned for a successful launch of neffy in the U.S., if approved. We are in the final stages of labeling and post-marketing commitment discussions with FDA and are putting the right structures in place to enable patient access to neffy quickly, within about eight weeks from the final label. We are excited to not only transition the company to a commercial organization, but to potentially bring to the allergy community the first medical treatment advancement in more than 35 years: an easy-to-carry, simple-to-administer, needle-free nasal spray to address the anxiety and hesitation associated with today’s injectable devices.” Preparing for U.S. launch of neffy® In May, the U.S. Food and Drug Administration (FDA) convened an Advisory Committee meeting, which concluded a favorable benefit-risk profile of neffy, with a 16:6 vote in favor for adults and 17:5 vote in favor for children (≥30 kg) for the treatment of patients with allergic reactions (Type 1), including anaphylaxis. The Advisory Committee vote, while not binding, will be considered by FDA when making its decision regarding the potential approval of neffy. In June, FDA extended the Prescription Drug User Fee Act (PDUFA) target action date to September 19, 2023, for the New Drug Application (NDA) for ne...