SAN DIEGO - ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) announced today that the U.S. Food and Drug Administration (FDA) has approved neffy®, the first new delivery method for epinephrine in over three decades, designed to treat severe allergic reactions in adults and children weighing at least 30 kg (66 lbs.). This needle-free nasal spray offers a new option for those at risk of anaphylaxis, a potentially life-threatening condition triggered by allergies to foods, medications, or insect bites.
The approval of neffy comes as a significant advancement in allergy treatment, providing a less intimidating alternative to the traditional epinephrine auto-injector. According to Professor Thomas B. Casale from the University of South Florida, the ease of use and needle-free administration may lead to quicker treatment during allergic reactions, improving clinical outcomes and quality of life for patients and their caregivers.
Clinical trials have demonstrated neffy's efficacy, with pharmacokinetic and pharmacodynamic data aligning with those of approved injectable epinephrine products. The trials, which included various patient groups such as children and individuals with allergic rhinitis, reported no serious adverse events and only mild side effects.
ARS Pharma is committed to making neffy accessible, with patient support programs designed to limit out-of-pocket expenses for commercially insured patients to $25 for two doses. Uninsured patients and those without coverage for neffy can purchase two doses for $199 through digital pharmacy services like BlinkRx and GoodRx.
The company also offers a Patient Assistance Program (PAP) for eligible individuals who are uninsured or underinsured, providing neffy at no cost. ARS Pharma anticipates that most payors will establish coverage policies within the next six months, during which time the neffyconnect program will aid healthcare professionals and patients in accessing financial support and medication fulfillment services.
Neffy is expected to be available in the U.S. within eight weeks following FDA approval, with ARS Pharma planning to submit a supplemental NDA for children between 15 to
In other recent news, ARS Pharmaceuticals has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for the marketing of EURneffy®, a needle-free adrenaline nasal spray for emergency treatment of severe allergic reactions. The final marketing authorization process by the European Commission is expected in the third quarter of 2024. The product, which demonstrated efficacy in a data package involving over 700 participants and more than 1,200 administrations, is anticipated to be available in Europe in the fourth quarter of 2024.
In other company news, ARS Pharmaceuticals' shareholders elected three Class I directors and ratified Ernst & Young LLP as the independent auditor for the current fiscal year. The company has also responded to regulatory concerns from both the European Medicines Agency and the U.S. Food and Drug Administration regarding its epinephrine nasal spray, neffy®. These are the latest developments in the company's operations.
InvestingPro Insights
As ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) heralds the FDA's nod for its innovative needle-free epinephrine nasal spray, neffy®, the company's financial health and market performance provide additional context for investors. SPRY holds a notable position with more cash than debt on its balance sheet, indicating a solid liquidity position that could support the upcoming commercialization efforts for neffy. Moreover, analysts have a positive outlook on the company's sales growth in the current year, aligning with the expected product launches and expanded market access.
InvestingPro data shows a substantial revenue growth of 128.31% over the last twelve months as of Q2 2024, which may reflect investor optimism about the company's growth trajectory. Despite not being profitable over the last twelve months, with a reported gross profit margin of -3913.2%, the company's liquid assets exceed its short-term obligations, suggesting it has the financial resilience to navigate through its growth phase. Additionally, the stock has been trading near its 52-week high, with a price 92.52% of this peak, which could indicate market confidence in the company's prospects.
InvestingPro Tips highlight that while SPRY is not expected to be profitable this year, its trajectory is marked by a large price uptick over the last six months, demonstrating significant investor interest. These insights, along with numerous additional tips available on InvestingPro, provide a more comprehensive view of ARS Pharma's potential in the wake of neffy's approval.
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