ARS Pharma's neffy allergy spray wins broader FDA approval amid $60M loss

ARS Pharma's neffy allergy spray wins broader FDA approval amid $60M loss

Poster stating that in 2022, Big Pharma charged Americans two to three times more than other countries for the same drugs, with images of medication bottles and a syringe.

ARS Pharma's neffy allergy spray wins broader FDA approval amid $60M loss

ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) has released its financial results for the first quarter of 2026. The company reported a net loss of $60.6 million while maintaining a strong cash reserve of $201.0 million.

During the same period, the US Food and Drug Administration (FDA) expanded approval for neffy, the company’s emergency allergy treatment, removing previous age restrictions. The FDA’s updated approval now allows neffy to be used by all children and adults weighing 33 lbs. or more for treating Type I allergic reactions, including anaphylaxis. This change broadens access to the nasal spray treatment, which previously had stricter age-based limitations.

Florida also added neffy to its Medicaid formulary without prior authorisation requirements. With this addition, nine US states now cover the treatment under Medicaid without restrictions. ARS Pharma further submitted a proposal to CVS Caremark, seeking inclusion of neffy in its commercial formulary on similar terms.

Financially, the company recorded total revenue of $22.7 million for the quarter. However, expenses remained high, with Selling, General and Administrative (SG&A) costs reaching $72.2 million. Research and Development (R&D) spending was $4.3 million. Despite the net loss of $60.6 million, or ($0.61) per share, ARS Pharma stated that its current cash position of $201.0 million should support operations until the company reaches cash-flow break-even. The FDA’s expanded approval and Florida’s Medicaid decision increase neffy’s availability for emergency allergy treatment. ARS Pharma’s cash reserves are expected to sustain operations as it works toward financial stability. The company continues to push for broader formulary inclusion to improve patient access.

Neueste Nachrichten