New adrenaline nasal spray gets EU approval

SAN DIEGO - ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company, announced the European Commission's approval of EURneffy® for emergency treatment of severe allergic reactions in adults and children weighing at least 30 kilograms. This approval, dated August 22, 2024, introduces the first needle-free adrenaline delivery method in the European Union (EU) in over 30 years.

EURneffy®, known as neffy® in the United States, is a nasal spray formulation of adrenaline, which is the primary treatment for anaphylaxis, a severe and potentially life-threatening allergic reaction. The product's design aims to address the underutilization of adrenaline due to the limitations of current injectable therapies.

Professor Antonella Muraro, lead author of the European Academy of Allergology and Clinical Immunology (EAACI) treatment guidelines for anaphylaxis, highlighted the significance of a needle-free option that may encourage more patients to carry and use adrenaline promptly during emergencies.

The nasal spray's approval followed a comprehensive review of data from a development program that involved over 700 participants and more than 1,200 administrations. The program assessed the pharmacodynamics and pharmacokinetics of EURneffy under various conditions, including different nasal states that can affect drug delivery.

EURneffy is set to benefit from an eight-year data protection period in the EU, during which other applicants cannot rely on the data submitted for its marketing authorization application. Additionally, a ten-year market exclusivity period prevents the sale of generic, hybrid, or biosimilar versions within the EU. The product's patents in Europe are valid until 2039.

ARS Pharma anticipates the availability of EURneffy in certain EU Member States in the fourth quarter of 2024 through a partner with an established commercial presence in Europe.

This news is based on a press release statement from ARS Pharmaceuticals, Inc. The company focuses on developing products to protect patients from severe allergic reactions leading to anaphylaxis. For more information, visit their website at www.ars-pharma.com.

In other recent news, ARS Pharmaceuticals has garnered attention with the FDA's approval of Neffy, an intra-nasal epinephrine product for treating Type I allergic reactions. This approval has been a significant factor in the company's recent momentum, highlighted by Cantor Fitzgerald initiating coverage with an Overweight rating. The proprietary Intravail absorption technology used in Neffy not only bolsters the product's market potential but also contributes to a robust intellectual property portfolio.

ARS Pharmaceuticals has also received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for marketing EURneffy, a needle-free adrenaline nasal spray. This 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 addition to these product developments, ARS Pharmaceuticals' shareholders elected three Class I directors and ratified Ernst & Young LLP as the independent auditor for the current fiscal year. These are the latest developments in the company's operations. As ARS Pharmaceuticals continues its pursuit of regulatory approvals for its products, it remains committed to developing products to protect patients from severe allergic reactions.

InvestingPro Insights

ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) has recently garnered significant attention following the European Commission's approval of EURneffy®. As investors assess the potential impact of this milestone on the company's financial health and stock performance, certain metrics and analyst insights from InvestingPro offer a glimpse into SPRY's current market position.

With a market capitalization of $1.26 billion, SPRY is navigating the biopharmaceutical landscape with a notable cash position that exceeds its debt, as per an InvestingPro Tip. This financial stability is crucial as the company prepares for the rollout of EURneffy across the EU. Moreover, analysts are optimistic about SPRY's sales growth in the current year, which could be buoyed by the recent product approval and expansion plans.

InvestingPro data highlights a remarkable revenue growth of 128.31% over the last twelve months as of Q2 2024, indicating a significant increase in the company's sales activities. However, it's worth noting that SPRY has a negative gross profit margin of -3913.2% for the same period, suggesting that the cost of goods sold exceeds the revenue generated, which is a point of concern reflected in the InvestingPro Tips that mention the company's weak gross profit margins.

Despite these challenges, SPRY has demonstrated strong returns for investors, with a one-year price total return of 86.74%. This performance is indicative of investor confidence and market enthusiasm, which may continue as the company expands EURneffy's reach. For those interested in deeper analysis and additional insights, InvestingPro offers a total of 15 InvestingPro Tips for SPRY, which can be accessed for further investment evaluation.

As ARS Pharmaceuticals, Inc. embarks on this new chapter, the InvestingPro platform remains a valuable resource for real-time data and expert analysis to help investors make informed decisions.

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