ARS Pharmaceuticals Receives FDA Approval to Remove Age Requirement From neffy® 1 mg (epinephrine nasal spray) Label

Children were previously required to weigh ≥33 lbs. and <66 lbs. and be at least four years of age to receiveneffy1 mg dose - approval enables families of younger children within the weight range to access a needle-free epinephrinewithout age restrictions

Updated labeling recommends storage in blister packaging or aneffycarrying case; ARS Pharma currently makes carrying cases available and will include one with each prescription beginning this summer

SAN DIEGO, March 27, 2026 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, announced today that the U.S. Food and Drug Administration (FDA) has approved updating theneffy®1 mg (epinephrine nasal spray) prescribing information to remove the age criteria so all children and adults who weigh 33 lbs. or more can utilizeneffyfor the emergency treatment of Type 1 allergic reactions, including anaphylaxis. Prior to the update, pediatric patients needed to meet a weight requirementandbe at least four years of age. Additionally, the label update recommends patients carryneffyin the blister packaging or in theneffycarrying case. The company currently offers patients a case designed specifically to hold twoneffydevices, free of charge, atwww.neffy.comand will begin including the carrying case in each prescription carton this summer.

“We are very pleased that based on clinical data presented to FDA forneffy, that the Agency removed the age requirement in the indication. This is a major advancement for the families with small children who live with the constant worry of severe allergic reactions in their youngest children,” said Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma. “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 but1now,neffycan be used safely in our most vulnerable young patients (≥33 lbs. and <66 lbs.), without age restrictions. This gives families access to a needle-free option that is simple to use, easy to carry and designed to help them act quickly with confidence during emergencies.”

"Severe allergic reactions are a major concern in early childhood and parents often delay treatment because they are afraid of hurting their child with a needle-injector or accidentally injecting themselves,” said Dr. Nicole Chase, MD, Allergy/Immunology and Pediatrics. “Having a needle-free epinephrine treatment available for anyone who meets the weight criteria is an important step forward, in broadening access, lowering treatment hurdles, and supporting caregivers who are doing everything they can to protect their children.”

Other label updates from the FDA included more flexible guidance around sniffing, temperature excursions and freezing. Specifically, language was updated to explain that even if a patient sniffs in after dosing withneffythat management of the event is the same as without sniffing, and if symptoms improve within 5 minutes, additional dosing ofneffyis not necessary.neffymay be used once thawed if accidentally frozen, and high temperature excursions (up to 122oF) are allowed.

neffyis available in two doses.neffy1 mg is for patients who weigh ≥33 lbs. and <66 lbs. (15 kg to <30 kg) andneffy2 mg is the recommended dosage for children and adults who weigh 66 lbs. (≥30 kg) or more.

INDICATION

neffyis indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 33 lbs. or greater.

IMPORTANT SAFETY INFORMATION

neffycontains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen in minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes.Always carry twoneffynasal sprays with you because you may not know when anaphylaxis may happen and because you may need a second dose ofneffyif symptoms continue or come back. Eachneffycontains a single dose of epinephrine.neffyis for use in the nose only.

Useneffyright away, as soon as you notice symptoms of an allergic reaction. If symptoms continue or get worse after the first dose ofneffy, a second dose is needed. If needed, administer a second dose using a newneffyin the same nostril starting 5 minutes after the first dose. Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed after usingneffy.

Tell your healthcare provider if you have underlying structural or anatomical nasal conditions, about all the medicines you take, and about all your medical conditions, especially if you have heart problems, kidney problems, low potassium in your blood, Parkinson's disease, thyroid problems, high blood pressure, diabetes, are pregnant or plan to become pregnant, or plan to breastfeed.

Tell your healthcare provider if you take or use other nasal sprays or water pills (diuretics) or if you take medicines to treat depression, abnormal heart beats, Parkinson's disease, heart disease, thyroid disease, medicines used in labor, and medicines to treat allergies.neffyand other medications may affect each other, causing side effects.neffymay affect the way other medicines work, and other medicines may affect howneffyworks.

neffymay cause serious side effects. If you have certain medical conditions or take certain medicines, your condition may get worse, or you may have more or longer lasting side effects when you useneffy.

Common side effects ofneffyinclude: nasal discomfort, headache, throat irritation, chest and nasal congestion, feeling overly excited, nervous or anxious, nose bleed, nose pain, sneezing, runny nose, dry nose or throat, tingling sensation, including in the nose, feeling tired, dizziness, nausea, and vomiting.

These are not all of the possible side effects ofneffy. Call your healthcare provider for medical advice about side effects. To report side effects, contact ARS Pharmaceuticals Operations, Inc. at1-877-MY-NEFFY (877-696-3339)or the FDA at1-800-FDA-1088orwww.fda.gov/medwatch.

About Type I Allergic Reactions Including AnaphylaxisType I allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine auto-injectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I allergic reactions. Of this group, over the last three years, approximately 20 million people have been diagnosed and treated for severe Type I allergic reactions that may lead to anaphylaxis, but (in 2023, for example) only 3.2 million filled their active epinephrine auto-injector prescription, and of those, only half consistently carry their prescribed auto-injector. Even if patients or caregivers carry an auto-injector, more than half either delay or do not administer the device when needed in an emergency.

About ARS Pharmaceuticals, Inc.ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis. The Company is commercializingneffy®(trade nameEURneffy®in the EU and 优敏速®in China), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult patients and pediatric patients who weigh 33 lbs. or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, and other allergens as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 30 kg or greater. For more information, visitwww.ars-pharma.com.

Forward-Looking StatementsStatements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: the patient benefits and effectiveness ofneffy, including its needle-free, compact, portable and easy to use design, temperature stability and temperature-handling flexibility, and extended shelf life; evaluations, expectations and judgments regarding the impact of the updatedneffy1 mg prescribing information on families and caregivers; ARS Pharma’s plan to including aneffycarrying case with each prescription carton this summer; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “believe,” “can,” “could,” “expect,” “if,” “may,” “on track to/for,” “potential,” “plan,” “will,” “would,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharmaceuticals’ current expectations and involve assumptions that may never materialize or may prove to be incorrect.

Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: potential safety and other complications fromneffy; the ability to obtain and maintain regulatory approval forneffyin its currently approved indications; the scope, progress and expansion of developing and commercializingneffy; the scope, progress and expansion of developing our intranasal epinephrine technology; clinical trial results; the potential for governments and payors to delay, limit or deny coverage forneffy; the size and growth of the market forneffyand the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharma’s ability to protect its intellectual property position; and the impact of government laws, regulations and policies. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in ARS Pharma’s Annual Report on Form 10-K for the year ended December 30, 2025, filed with the SEC on March 9, 2026. This document can also be accessed on ARS Pharma’s website at www.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab.

The forward-looking statements included in this press release are made only as of the date hereof. ARS Pharma assumes no obligation and does not intend to update these forward-looking statements, except as required by law. For more information, visitwww.ars-pharma.com, and follow us onLinkedInandX.

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