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SAN DIEGO, CA – ARS Pharmaceuticals, Inc. (SPRY), a pharmaceutical company with a market capitalization of $1.06 billion that according to InvestingPro analysis trades near its Fair Value, has announced that the U.S. Food and Drug Administration (FDA) has approved neffy 1 mg (epinephrine nasal spray) for emergency treatment of severe allergic reactions, including anaphylaxis, in children four years and older who weigh between 15 and 30 kilograms. The approval, announced Today, is based on clinical trial data demonstrating the nasal spray’s pharmacokinetic and pharmacodynamic responses are consistent with those of injectable epinephrine products.
The company’s clinical trials indicated that the adverse events were generally mild and temporary. Human factor studies also suggest that children as young as ten and untrained individuals can effectively administer neffy 1 mg by following the provided instructions.
Neffy 1 mg is expected to be available in the U.S. market by the end of May 2025. This follows the FDA’s previous approval of neffy 2 mg for individuals weighing 30 kilograms or more, which was granted on August 9, 2024, and the approval of EURneffy, the European Union’s equivalent, on August 22, 2024.
The company’s forward-looking statements indicate optimism for neffy 1 mg’s commercial availability but caution that results may vary due to risks and uncertainties. These include maintaining regulatory approval and potential supply and distribution challenges. While the company maintains a strong financial position with a current ratio of 12.56 and negligible debt, analysts project significant revenue growth of over 300% for the current fiscal year. The company’s latest quarterly report filed on November 13, 2024, contains further details on the associated risks. InvestingPro subscribers can access additional insights and 8 more key tips about SPRY’s financial health and growth prospects.
This news is based on a press release statement and the information provided is intended solely for informational purposes. The approval marks a significant step for ARS Pharmaceuticals, expanding its portfolio of emergency treatment options for allergic reactions. Investors should note that the company’s next earnings report is scheduled for March 20, 2025, where management is expected to provide further details on the commercialization timeline and strategy.
In other recent news, ARS Pharmaceuticals announced its preliminary fourth-quarter net revenue for its allergy spray, Neffy, which reached approximately $6.5 million, significantly surpassing the analyst estimate of $3.11 million. The total net product sales for 2024 amounted to around $7.1 million, following the product’s availability to wholesalers and pharmacies starting September 23. Additionally, ARS Pharmaceuticals is actively seeking regulatory approvals for Neffy in the Asia Pacific region, with filings submitted in China, Japan, and Australia. This follows the recent U.S. approval for adults and children weighing at least 30 kg. Clinical trials in Japan and China have shown promising results, supporting these regulatory filings. ARS Pharmaceuticals has partnered with several companies, including Pediatrix Therapeutics and Alfresa Pharma, to expand Neffy’s reach in these regions. The company also has an agreement with ALK-Abelló for commercialization in Europe and Canada, where EU approval was granted in August 2024. These developments are part of ARS Pharmaceuticals’ strategy to make Neffy globally available.
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