SAN DIEGO - ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) has submitted a supplemental New Drug Application (sNDA) for neffy® 1 mg, a needle-free epinephrine treatment for children weighing 15 to 30 kg (33-66 lbs.) for Type I Allergic Reactions, including anaphylaxis. This submission follows the FDA's approval on August 9, 2024, of neffy 2 mg for patients 30 kg or greater.
The company reports that neffy 1 mg has pharmacokinetic data slightly higher than that of adults receiving the same dose and a similar pharmacodynamic response. The submission aims to address the fear of needles that over two-thirds of children and more than half of parents have, which often leads to the refusal of treatment with auto-injectors.
Neffy 1 mg, if approved, would be the first needle-free option for younger children and represents the first new delivery method for this demographic in over three decades. It features a simple insert and press mechanism that delivers epinephrine without hold time in the nose. Human factor studies indicate that even untrained individuals, including children as young as 10 years old, can successfully use the device by following the instructions.
ARS Pharmaceuticals emphasizes the safety of neffy, highlighting the absence of needle-related adverse events, which currently occur approximately 3,500 times annually in the U.S. with existing epinephrine injection devices. The company also notes that neffy can withstand temperatures up to 122°F (50°C) and remains effective even after being accidentally frozen and thawed.
The Food Allergy & Anaphylaxis Connection Team (FAACT), a national patient advocacy group, supports the urgency of making neffy 1 mg available, citing the lack of advancements in emergency treatments for children with food allergies.
Type I severe allergic reactions are life-threatening and can occur within minutes of exposure to an allergen. Despite the effectiveness of epinephrine auto-injectors, limitations such as needle fear, lack of portability, and device complexity result in delayed or non-administration in emergencies.
ARS Pharmaceuticals is focused on developing products to protect patients from severe allergic reactions leading to anaphylaxis. The company's information is based on a press release statement.
In other recent news, ARS Pharmaceuticals has made significant strides with its product, EURneffy, a needle-free adrenaline nasal spray for emergency treatment of severe allergic reactions. The European Commission approved the product, marking the first such approval for this kind of delivery method in the European Union in over 30 years. Cantor Fitzgerald initiated coverage of ARS Pharmaceuticals with an Overweight rating, highlighting the impact of the FDA's approval of Neffy, an intra-nasal epinephrine product. The company also received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for marketing EURneffy.
In other developments, ARS Pharmaceuticals' shareholders elected three Class I directors and ratified Ernst & Young LLP as the independent auditor for the current fiscal year. The company 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. The product's patents in Europe are valid until 2039, and the product 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.
InvestingPro Insights
ARS Pharmaceuticals, Inc. (NASDAQ: SPRY), the innovator behind the needle-free epinephrine treatment neffy®, is making strides in the pharmaceutical industry with its recent sNDA submission. As the company positions itself to potentially revolutionize the way we treat severe allergic reactions in children, investors and stakeholders are closely monitoring its financial health and market potential.
InvestingPro data reveals that ARS Pharmaceuticals has a market capitalization of $1.13 billion, indicating a solid presence in the market. Despite the company's significant revenue growth of 128.31% over the last twelve months as of Q2 2024, it is important to note that the company has a negative P/E ratio of -24.94, suggesting that it is not currently profitable. This aligns with the InvestingPro Tip that analysts do not anticipate the company will be profitable this year.
However, the company's stock has experienced a strong return over the last year, with a 54.14% price total return, reflecting investor optimism. This may be partially attributed to the anticipation of sales growth in the current year, as highlighted by another InvestingPro Tip. Additionally, the company's liquid assets surpass its short-term obligations, which may provide some financial stability as it seeks FDA approval for neffy 1 mg.
For those interested in diving deeper into ARS Pharmaceuticals' financials and future prospects, InvestingPro offers additional tips that can provide valuable insights. In fact, there are 11 more InvestingPro Tips available for SPRY, which can be accessed at InvestingPro to help investors make more informed decisions.
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