EURneffy® 1 mg (adrenaline nasal spray) Recommended for Approval in the EU for Emergency Treatment of Type 1 Allergic Reactions, including Anaphylaxis in Children Weighing ≥15 kg to <30 kg

Rhea-AI Summary

ARS Pharmaceuticals (Nasdaq: SPRY) announced that the EMA CHMP has adopted a positive opinion recommending expansion of EURneffy marketing authorization to include a 1 mg nasal adrenaline spray for emergency treatment of anaphylaxis in children weighing ≥15 kg to <30 kg.

Following European Commission approval, ALK-Abelló will distribute EURneffy across EU member states, Iceland, Liechtenstein and Norway; this complements the August 2024 EC approval of EURneffy 2 mg for patients ≥30 kg and recent regulatory activity in the U.S., Canada (anticipated), Japan, China and Australia.

Positive

• CHMP adopted a positive opinion for EURneffy 1 mg for children ≥15 kg to <30 kg
• Expected EU-wide marketing authorization will include EU plus Iceland, Liechtenstein and Norway
• ALK-Abelló named as distributor in the EU following expected European Commission approval
• Builds on existing EURneffy 2 mg EC approval (August 2024) and prior global regulatory progress

Negative

• EURneffy 1 mg remains pending final European Commission authorization, timing uncertain

Key Figures

EURneffy dose: 1 mg Pediatric weight range: ≥15 kg to <30 kg Existing EURneffy dose: 2 mg +5 more

8 metrics

EURneffy dose 1 mg Nasal adrenaline spray for younger children in EU recommendation

Pediatric weight range ≥15 kg to <30 kg Indicated weight range for EURneffy 1 mg in EU

Existing EURneffy dose 2 mg Previously approved EU dose for adults and children ≥30 kg

Temperature excursion limit 50°C (122°F) Maximum temperature excursions neffy device can tolerate

US minimum weight 33 pounds Minimum weight for neffy use in adults and children in the U.S.

EU 2 mg approval date August 2024 European Commission approval for EURneffy 2 mg

EU 2 mg launch timing 2025 ALK launch of EURneffy 2 mg in selected European countries and U.K.

Canada approval timing Early 2026 Expected timing for neffy regulatory approvals in Canada

Market Reality Check

Price: $9.99 Vol: Volume 1,760,305 is sligh...

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$9.99 Last Close

Volume Volume 1,760,305 is slightly below the 20-day average of 1,809,400 (relative volume 0.97). normal

Technical Shares at $9.99 are trading below the 200-day MA of $12.61 and about 47.14% below the 52-week high of $18.90.

Peers on Argus

SPRY showed a -2.25% move while key biotech peers were mixed: ATAI -1.83%, CRMD ...

SPRY showed a -2.25% move while key biotech peers were mixed: ATAI -1.83%, CRMD -4.08%, MRVI -0.59%, RAPP +0.26%, XERS +0.82%, indicating stock-specific trading rather than a clear sector trend.

Historical Context

5 past events · Latest: Jan 21 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 21	Access program expansion	Positive	-0.1%	Expanded neffyinSchools to California, increasing free needle-free epinephrine access.
Dec 29	Regulatory approval	Positive	+3.0%	China approval for neffy 2 mg as first community-use epinephrine product.
Nov 26	Conference participation	Neutral	+3.1%	Management participation in Piper Sandler healthcare conference and investor meetings.
Nov 10	Earnings update	Neutral	+0.3%	Q3 2025 results showing strong neffy revenue growth with ongoing net losses.
Nov 04	Access program launch	Positive	+1.0%	Launch of Get neffy on Us to improve patient access via virtual visits and co-pay support.

Pattern Detected

Recent commercial and regulatory news for neffy has usually led to modestly positive price moves, with only one slight divergence on otherwise constructive news.

Recent Company History

Over the last few months, ARS Pharmaceuticals has focused on expanding neffy’s reach and awareness. A China approval with community-use positioning and up to $84M in potential milestones on Dec 29, 2025 coincided with a +2.99% move. Access programs such as Get neffy on Us and neffyInSchools, plus participation in the Piper Sandler healthcare conference, saw small positive reactions. Q3 2025 earnings on Nov 10, 2025 highlighted rapid revenue growth but continued losses, with only a slight uptick in the share price.

Market Pulse Summary

This announcement extends EURneffy’s European footprint, with CHMP recommending approval of a 1 mg n...

Analysis

This announcement extends EURneffy’s European footprint, with CHMP recommending approval of a 1 mg nasal adrenaline spray for children weighing 15–<30 kg, complementing the existing 2 mg indication approved in August 2024. It reinforces ARS Pharma’s strategy of global expansion for needle-free anaphylaxis treatment, following launches in Europe, the U.S., and approvals in Asia-Pacific markets. Investors may watch execution with partner ALK, uptake in younger children, and how added indications translate into revenue growth relative to recent Q3 2025 results.

Key Terms

anaphylaxis, Committee for Medicinal Products for Human Use, CHMP, European Medicines Agency, +2 more

6 terms

anaphylaxis medical

"emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites"

Anaphylaxis is a sudden, severe allergic reaction in which the body's defense system overreacts to a trigger (like a drug, food, or insect sting), causing widespread symptoms such as difficulty breathing, low blood pressure, and shock; it can be life‑threatening without prompt treatment. Investors care because anaphylaxis risks can affect a drug or product's safety profile, regulatory approval, liability exposure and market acceptance—similar to a sprinkler system going off and damaging the whole house rather than just one room.

Committee for Medicinal Products for Human Use regulatory

"the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency"

The Committee for Medicinal Products for Human Use is the expert scientific panel within the European medicines regulator that assesses whether medicines for people are safe, effective and of acceptable quality, and issues formal opinions used in the drug-approval process. Its assessments act like a gatekeeper or safety inspector for entering the European market, so the committee’s opinion can materially affect a drug’s commercial prospects, regulatory risk and a company’s stock valuation.

CHMP regulatory

"CHMP’s positive opinion marks an important milestone for families"

The CHMP is the European Medicines Agency’s expert panel that evaluates whether a medicine for people should be recommended for approval across the EU. Think of it as a technical review board whose positive or negative opinion strongly affects a drug maker’s ability to sell a product in the European market, shaping potential revenues, regulatory risk and investment timelines for companies developing or marketing therapies.

European Medicines Agency regulatory

"Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)"

The European Medicines Agency is the central drug regulator that evaluates and authorizes medicines for use across the European Union and related countries, similar to a referee or safety inspector who checks that a medicine is safe and effective before it can be sold. Its decisions matter to investors because approvals, rejections, or safety warnings directly affect a drug maker’s ability to sell products, generate revenue, and face legal or reputational risks, which in turn influence stock value.

EMA regulatory

"Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)"

Exponential moving average (EMA) is a type of trend line that smooths a stream of recent price data while giving more weight to the newest prices, similar to how a spotlight focuses more on what's happening now than what happened long ago. Investors use EMAs to see whether a stock’s short-term direction is changing, to compare fast and slow averages for momentum signals, and to help time entries, exits, and risk controls without overreacting to random day-to-day noise.

marketing authorization regulatory

"recommending expanding the marketing authorization for EURneffy to include a 1 mg"

An official government approval that allows a drug, vaccine, or medical device to be sold and promoted in a specific country or region. Think of it as a safety and effectiveness passport issued after regulators review the product’s tests and manufacturing; for investors, receiving this authorization typically unlocks sales, revenue potential, and lower regulatory risk, while delays or denials can substantially affect a company’s value and timeline.

AI-generated analysis. Not financial advice.

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 EURneffy® to include a 1 mg nasal adrenaline spray. EURneffy 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 EURneffy 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 EURneffy 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 EURneffy 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^oC (122^oF), 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 EURneffy 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 EURneffy 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 www.fda.gov/medwatch.
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 EURneffy® 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 www.ars-pharma.com.

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 EURneffy 1 mg in the EU, including the expected authorization of EURneffy 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 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, visit www.ars-pharma.com, 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:

1. IQVIA MIDAS Database
   
   

FAQ

What did the EMA CHMP recommend for EURneffy 1 mg for children and how does it affect SPRY (EURneffy)?

The CHMP recommended approval of EURneffy 1 mg for children weighing ≥15 kg to <30 kg, enabling a needle-free option. According to ARS Pharmaceuticals, this expands the product label beyond the 2 mg dose and could enable EU-wide distribution after European Commission authorization.

When will EURneffy 1 mg be available across EU countries for patients (SPRY)?

EURneffy 1 mg will be available after European Commission approval and national implementation. According to ARS Pharmaceuticals, the CHMP positive opinion is a key step but final availability depends on the Commission decision and subsequent distribution setup by ALK-Abelló.

Which children are eligible for EURneffy 1 mg under the recommended EU labeling (SPRY)?

The recommended label covers emergency treatment of anaphylaxis in children who weigh ≥15 kg and <30 kg. According to ARS Pharmaceuticals, this fills an unmet need for a needle-free adrenaline option specifically targeted to younger children in that weight band.

Who will distribute EURneffy 1 mg in the European Union if authorized (SPRY)?

ALK-Abelló will distribute EURneffy in the EU following expected authorization. According to ARS Pharmaceuticals, ALK-Abelló holds the EU marketing rights and led the EURneffy 2 mg launches across selected European countries and the U.K.

How does EURneffy 1 mg compare on storage and ease-of-use for caregivers (SPRY)?

EURneffy is needle-free, easy to carry and use, with temperature excursions up to 50°C and no damage if accidentally frozen and thawed. According to ARS Pharmaceuticals, these features are intended to lower barriers to timely administration by parents and caregivers.