ARS Pharma Unlocks Key Pediatric Market with FDA Label Change for neffy

Edgen Stock

·Mar 27 2026, 12:24

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Key Takeaways

ARS Pharmaceuticals has secured a significant regulatory win from the U.S. Food and Drug Administration for its needle-free epinephrine spray, neffy®. The approval removes a key age restriction, expanding the product's addressable market to include younger children and bolstering its competitive position against traditional auto-injectors. This development builds on a strong commercial launch that saw the product generate over $72 million in U.S. sales in its first full year.

Regulatory Win: The FDA on March 27, 2026, approved the removal of the minimum age requirement for the neffy 1 mg dose, making it available to all patients weighing 33 lbs. or more.
Market Expansion: The change grants access to a critical demographic, as approximately 25% of children in the 33-66 lbs. weight category who need epinephrine are under the age of four.
Financial Momentum: This approval follows neffy's successful first year, which generated $72.2 million in U.S. net revenue in 2025, supported by a strong $245 million cash position for further commercial expansion.

FDA Approval Unlocks Market for Patients Weighing Over 33 lbs.

ARS Pharmaceuticals (NASDAQ: SPRY) announced on March 27, 2026, that it received U.S. Food and Drug Administration (FDA) approval to update the prescribing information for its neffy 1 mg epinephrine nasal spray. The revision removes the previous minimum four-year-old age requirement, expanding access to all patients who weigh at least 33 lbs. This change directly addresses a significant gap in the market for treating severe Type I allergic reactions, including anaphylaxis, in very young children.

Previously, caregivers of children under four who met the weight criteria could not use the needle-free device. This label expansion is a crucial milestone for families seeking alternatives to needle-based auto-injectors, which can cause fear and hesitation during emergencies. According to the company, approximately 25% of the pediatric patient population weighing between 33 and 66 lbs. is under the age of four.

Approximately one-quarter of patients requiring epinephrine are children weighing ≥33 lbs. and <66 lbs., including approximately 25% under the age of four. Caregivers often face tremendous fear administering needle-based treatment options but now, neffy can be used safely in our most vulnerable young patients (≥33 lbs. and <66 lbs.), without age restrictions.

— Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma.

Label Update Builds on $72.2M First-Year Revenue

The regulatory approval strengthens the commercial foundation neffy established in its first full year on the market. In 2025, the product generated $72.2 million in U.S. net product revenue, contributing to a total company revenue of $84.3 million. ARS Pharma is well-positioned to capitalize on the expanded label, ending 2025 with a robust balance sheet of $245.0 million in cash and short-term investments.

To drive adoption, the company is increasing its commercial footprint. ARS plans to expand its sales force from 106 to 150 representatives starting in the second quarter of 2026. This investment aims to increase call frequency with high-prescribing allergists and accelerate market share growth. The strategy builds on existing momentum, with more than 22,500 healthcare providers having prescribed neffy to date.