EURneffy
1 mg will be the first and only needle-free adrenaline available to younger children in the European Union
ARS Pharma’s partner, ALK-Abelló A/S, who owns the rights to market
EURneffy
in the EU, will distribute following expected authorization by the European Commission
SAN DIEGO, Feb. 02, 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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending expanding the marketing authorization for
EUR
neffy
®
to include a 1 mg nasal adrenaline spray.
EUR
neffy
1 mg is for the 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 children who weigh ≥15 kg and <30 kg.
The opinion supports an extension to
EUR
neffy
2 mg approval granted by the European Commission (EC) in August 2024 for the emergency treatment of anaphylaxis in adults and children who weigh ≥30 kg. Following grant of 1 mg dose, the marketing authorization will be valid in all EU member states, as well as Iceland, Liechtenstein and Norway.
“The availability of a needle-free adrenaline option for younger children directly addresses one of the most significant barriers to timely treatment in this age group,” said Richard Lowenthal, Co-founder, President and CEO of ARS Pharma. “CHMP’s positive opinion marks an important milestone for families, particularly given that approximately one-quarter of epinephrine auto-injector use in Europe is for younger children weighing less than 30 kg.
1
Following the expected authorization of
EUR
neffy
1 mg, parents and caregivers with younger children will have a convenient, needle-free 1 mg option that they can administer quickly and confidently. As
neffy
(marketed as
EUR
neffy
in the EU) continues to receive regulatory approvals and expands globally, we are focused on ensuring more families have access to a treatment option designed for practicality and ease of use when seconds matter.”
neffy
’s needle-free design reduces barriers to timely treatment while fitting more naturally into everyday life. It is easy to carry, simple to use, has temperature excursions up to 50
o
C (122
o
F), and, if accidentally frozen, can be used once thawed without damage to the device or product within.
neffy
is commercially available in the U.S. for the emergency treatment of allergic reactions, including anaphylaxis, in adults and children who weigh at least 33 pounds. In 2025, ALK successfully launched
EUR
neffy
2 mg in selected countries throughout Europe and in the U.K. Regulatory approvals for
neffy
in Canada are expected in early 2026. Additionally, recent regulatory approvals for
neffy
occurred in Japan (with Alfresa), China (with Pediatrix Therapeutics) and in Australia (with CSL Seqirus).
About
neffy
®
(marketed as
EUR
neffy
in the EU)
neffy
is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs. or greater.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR
neffy
(epinephrine nasal spray)
INDICATION
neffy
is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients aged 4 years and older who weigh 33 lbs. or greater.
IMPORTANT SAFETY INFORMATION
neffy
contains 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 two
neffy
nasal sprays with you because you may not know when anaphylaxis may happen and because you may need a second dose of
neffy
if symptoms continue or come back. Each
neffy
contains a single dose of epinephrine.
neffy
is for use in the nose only.
Use
neffy
right away, as soon as you notice symptoms of an allergic reaction. If symptoms continue or get worse after the first dose of
neffy
, a second dose is needed. If needed, administer a second dose using a new
neffy
in 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 using
neffy
.
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.
neffy
and other medications may affect each other, causing side effects.
neffy
may affect the way other medicines work, and other medicines may affect how
neffy
works.
neffy
may 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 use
neffy
.
Common side effects of
neffy
include: 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.
Tell your healthcare provider if you have any side effects that bother you or that do not go away after using
neffy
.
These are not all of the possible side effects of
neffy
. Call your healthcare provider for medical advice about side effects. To report side effects, contact ARS Pharmaceuticals Operations, Inc. at
1-877-MY-NEFFY (877-696-3339)
or the FDA at
1-800-FDA-1088
or
.
Please see the full
Prescribing Information
and
Patient Information
for
neffy
.
About Type I Allergic Reactions Including Anaphylaxis
Type 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 commercializing
neffy
® (trade name
EU
Rneffy
® 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 4 years of age and older 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, visit
.
Forward-Looking Statements
Statements 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 of
neffy
, including its needle-free, compact, portable and easy to use design, temperature stability, and extended shelf life; evaluations, judgments and expectations regarding regulatory processes for
EUR
neffy
1 mg in the EU, including the expected authorization of
EUR
neffy
1 mg by the European Commission, and ARS’ commercialization strategies; the anticipated timing of regulatory decisions for
neffy
in Canada; 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 from
neffy
; the ability to obtain and maintain regulatory approval for
neffy
in its currently approved indications; the scope, progress and expansion of developing and commercializing
neffy
; 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 for
neffy
; the size and growth of the market for
neffy
and 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on November 10, 2025. This document can also be accessed on ARS Pharma’s website at
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, visit
, and follow us on
LinkedIn
and
X
.
ARS Investor Contact:
Justin Chakma
ARS Pharmaceuticals
justinc@ars-pharma.com
ARS Media Contact:
Christy Curran
Sam Brown Inc.
615.414.8668
christycurran@sambrown.com
Reference:
IQVIA MIDAS Database