Tillkännagivande • Apr 17

ARS Pharmaceuticals, Inc. Announces Approval of Neffy Epinephrine Nasal Spray in Canada

ARS Pharmaceuticals, Inc. announced that Health Canada has granted approval for neffy 2 mg (epinephrine nasal spray) for the emergency treatment of allergic reactions (anaphylaxis) in adults and children who weigh 30 kg or more. neffy offers a new delivery method for epinephrine in Canada for adults and children (>30 kg) living with severe allergic reactions. ALK- Abelló A/S, which licenses the rights to market neffy in Canada, expects availability in the summer of 2026. 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 a 30-month shelf life, temperature excursions up to 122oF (50oC), and, if accidentally frozen, can be used once thawed. ARS Pharma entered into an exclusive licensing agreement with ALK- Abelló A/S (ALK) in November 2024, providing ALK with exclusive rights to commercialize neffy in Europe, Canada, United Kingdom and certain other geographies outside of the U.S. Under the terms of the agreement, ARS Pharma has received upfront and milestone payments of $155 million to date and is eligible to receive up to an additional $310 million in regulatory and sales milestones, as well as tiered, double-digit royalties in the teens on net sales in licensed geographies. ARS Pharma will be responsible for manufacturing and supplying neffy to ALK in Canada and expects neffy to be available in the summer of 2026. ARS Pharma anticipates filing for approval of neffy 1 mg dose for children greater than 15 kg and less than 30 kg with Health Canada by this summer. The regulatory clearance in Canada follows the latest granted approval in China for neffy in partnership with Pediatrix Therapeutics. The National Medical Products Administration (NMPA) in China is responsible for evaluating medicines and medical devices, previously granted approval for neffy 2 mg (epinephrine nasal spray) for the emergency treatment of allergic reactions (anaphylaxis) in adults and children who weigh 30 kg or more in December 2025. ARS Pharma and Pediatrix Therapeutics anticipate filing for approval of neffy 1 mg dose for children greater than 15 kg and less than 30 kg in the coming months. 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 (15 kg). neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children who weigh 33 lbs. or greater. neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 33 lbs. or greater. 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 because may not know when anaphylaxis may happen and because 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 it is noticed 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 the healthcare provider if there is underlying structural or anatomical nasal conditions, about all the medicines take, and about all medical conditions, especially if there is the heart problems, kidney problems, low potassium in the blood, Parkinson's disease, thyroid problems, high blood pressure, diabetes, are pregnant or plan to become pregnant, or plan to breastfeed. Tell the healthcare provider if take or use other nasal sprays or water pills (diuretics) or if 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 there is certain medical conditions or take certain medicines, the condition may get worse, or may have more or longer lasting side effects when there is a use of 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 the healthcare provider if there is any side effects that bother or that do not go away after using neffy. These are not all of the possible side effects of neffy. Call the healthcare provider for medical advice about side effects.

Tillkännagivande • Feb 20

ARS Pharmaceuticals, Inc. Announces Favorable Topline Results from Repeat Dosing Study of neffy (Epinephrine Nasal Spray) Under Nasal Allergen Challenge Conditions, Readies Data for Response to FDA’s Complete Response Letter

ARS Pharmaceuticals, Inc. announced topline results from its clinical study comparing repeat doses of neffy (epinephrine nasal spray) to repeat doses of epinephrine intramuscular (IM) injection, as requested by the FDA with and without nasal allergen challenge (NAC) conditions. Based on the company’s analysis of the data, the company believed these results should support filing its response to the FDA’s CRL. The repeat dose study under NAC conditions was designed with the FDA to address the Agency’s outstanding questions regarding neffy as described in the Complete Response Letter (CRL) from September 2023. FDA did not provide guidance on a prespecified set of endpoints, but the data are anticipated to be informative to labeling if a second dose of neffy is needed. ARS Pharma also completed the nitrosamine testing requested in the CRL per FDA’s draft guidance issued in August 2023, with no measurable levels of nitrosamines detected. Previously reported data with a single dose of neffy under NAC conditions showed accelerated absorption of neffy with exposures higher than IM injection during the early time period when clinical response to epinephrine is expected. ARS Pharma intends to submit this repeat dose NAC study data to the FDA as part of its response to the CRL early in the second quarter of 2024. neffy Repeat Dosing Study Design: The randomized, crossover pharmacokinetic (PK) and pharmacodynamic (PD) study enrolled 43 patients with seasonal allergic rhinitis who tested positive with a Total Nasal Symptom Score (TNSS) of =5 out of 12 and a congestion score of =2 out of 3 during the screening NAC. NAC involves spraying purified antigen directly onto the nasal mucosa – a worst-case experimental condition in contrast to real-world nasal conditions such as upper respiratory tract infections or acute allergic rhinitis from natural causes. All patients were dosed with epinephrine within 15 minutes of induction of the NAC during the peak effect, without allowing time for nasal symptoms to subside. A second dose of epinephrine was given to patients 10 minutes after the first dose per FDA labeling of epinephrine products. FDA explicitly requested that ARS Pharma include intramuscular (IM) epinephrine given via manual syringe as the comparator in this study, as IM is the reference-listed drug and historical basis for efficacy of all other epinephrine products. Meta-analyses (Patel et al, JACI 2021) analyzing over 30,000 anaphylaxis events demonstrate that about 90% of events respond to a single dose of epinephrine injection irrespective of the delivery device, despite significant differences in PK. PK/PD Study Results: Data from the company’s primary analysis of the completed study showed that responses on pharmacodynamic (PD) surrogate markers for efficacy in anaphylaxis, such as systolic blood pressure and heart rate, correlated well with pharmacokinetic (PK) exposures and were consistently higher for repeat doses of neffy, irrespective of dosing in the same nostril (R/R) or opposite nostrils (R/L), compared to repeat doses of IM injection. Dosing in the same nostril (R/R) resulted in higher PD than injection at all time points measured, while dosing in the opposite nostril (R/L) was higher than injection until the 40 to 60 minute time points, after which PD was indistinguishable from injection. Consistent with prior studies, significant responses on these PD surrogate markers of efficacy with neffy were observed even at one minute after dosing. The PD responses demonstrate that the epinephrine exposures achieved with repeat doses of neffy (R/R or R/L) fully activate the receptors involved in reversing anaphylaxis symptoms. The clinical data also demonstrated that mean epinephrine concentrations following repeat doses of 2 mg neffy in the same nostril (R/R) were numerically higher than repeat doses of 0.3 mg injection at all time points through at least 240 minutes under NAC conditions. Mean epinephrine concentrations of 2 mg neffy in the opposite nostril (R/L) were also numerically higher than repeat doses of 0.3 mg injection for approximately 30 minutes, which is longer than the time period when clinical response would be expected to be observed after dosing epinephrine (i.e., within 10 minutes). The PK profile of repeat doses of neffy during normal nasal conditions was shown in prior studies to be highly similar to repeat doses of EpiPen, which serves as the upper bracket for exposures established to be safe. In this study, the PK profile of repeat doses of neffy in the same nostril (R/R) during nasal allergen challenge was highly similar to repeat doses of neffy during normal nasal conditions, and therefore also in the range of exposures established to be safe. Other ARS Pharma clinical studies have evaluated neffy PK/PD in people with the same TNSS and congestion severity scores as the experimental NAC studies, but with nasal symptoms due to real-world conditions such as upper respiratory tract infections or acute allergic rhinitis from natural causes. These other studies showed no meaningful difference on PK/PD compared to dosing neffy under normal nasal conditions. Repeat doses of neffy were considered safe and well-tolerated. All adverse events were mild and continue to be consistent with those observed in prior studies of neffy across more than 700 subjects. There were no serious adverse events. Regulatory Status of neffy: Additional discussions with FDA subsequent to its issuance of the CRL confirmed that the new data are anticipated to be informative to labeling of administering a second dose of neffy. In May 2023, the FDA Advisory Committee (PADAC), determined a favorable benefit-risk profile of neffy (16:6 for adults and 17:5 for children). No PADAC member requested a repeat dose study during allergen-induced allergic rhinitis. In addition, multiple PADAC members highlighted the favorable profile of neffy in the company's single dose NAC study. ARS Pharma intends to file its response to the FDA’s CRL for neffy early in the second quarter of 2024, with an expected PDUFA action date six months from filing, followed by potential U.S. launch of neffy in the second half of 2024. ARS Pharma also intends to submit this repeat dose study data to the European Medicines Agency (EMA) to inform its Committee for Medicinal Products for Human Use (CHMP) Opinion decision expected by mid-2024.

Räntetäckningsgrad	n/a
Kontanter	US$200.97m
Eget kapital	US$61.31m
Summa skulder	US$226.26m
Totala tillgångar	US$287.57m

Uppgifter	Senast uppdaterad (UTC-tid)
Analys av företag	2026/07/09 14:40
Aktiekurs vid dagens slut	2026/07/09 00:00
Intäkter	2026/03/31
Årlig intjäning	2025/12/31

Paket	Uppgifter	Tidsram	Exempel US-källa
Företagets finansiella ställning	10 år	Resultaträkning Kassaflödesanalys Balansräkning	SEC Form 10-K SEC Form 10-Q
Analytikernas konsensusuppskattningar	+3 år	Prognos för finansiella poster Analytikernas prismål	Rapporter från analytiker Blue Matrix
Marknadspriser	30 år	Aktiekurser Utdelningar, splittar och åtgärder	ICE Marknadsdata SEC Form S-1
Ägarskap	10 år	Största aktieägare Insiderhandel	SEC Formulär 4 SEC Formulär 13D
Förvaltning	10 år	Ledningsgrupp Styrelse och verkställande direktörer	SEC Form 10-K SEC Form DEF 14A
Viktiga utvecklingstendenser	10 år	Företagsmeddelanden	SEC Formulär 8-K

Analytiker	Institution
Joshua Schimmer	Cantor Fitzgerald & Co.
Roanna Clarissa Ruiz	Leerink Partners LLC
Ryan Deschner	Raymond James & Associates

ARS Pharmaceuticals Balansräkning Hälsa

Finansiell hälsa kriterier kontrolleras 4/6

Viktig information

Nya uppdateringar om finansiell hälsa

ARS Pharmaceuticals (NASDAQ:SPRY) May Not Be Profitable But It Seems To Be Managing Its Debt Just Fine, Anyway

We're Interested To See How ARS Pharmaceuticals (NASDAQ:SPRY) Uses Its Cash Hoard To Grow

We're Not Very Worried About ARS Pharmaceuticals' (NASDAQ:SPRY) Cash Burn Rate

ARS Pharmaceuticals (NASDAQ:SPRY) Is In A Good Position To Deliver On Growth Plans

Here's Why We're Not Too Worried About ARS Pharmaceuticals' (NASDAQ:SPRY) Cash Burn Situation

Recent updates

Price target decreased by 7.1% to US$26.75

ARS Pharmaceuticals, Inc. Announces CEO Changes

SPRY: Future Allergy And Urticaria Franchise Seen Driving Upside Potential

ARS Pharmaceuticals, Inc.(NasdaqGM:SPRY) dropped from Russell 2000 Growth-Defensive Index

New minor risk - Profitability

ARS Pharmaceuticals, Inc.(NasdaqGM:SPRY) dropped from Russell 2000 Defensive Index

ARS Pharma: Strong Growth Meets A Coverage Wall

Neffy Fails to Secure Major Insurance Coverage as ARS Pharmaceuticals Eyes 2027 Break-Even

SPRY: Future Upside Seen From Allergy Launch And ARS-2 Urticaria Program

Why the Market is Wrong About the ARS Pharma vs. Aquestive "DUOPOLY"

Chief Commercial Officer notifies of intention to sell stock

SPRY: Future Allergy And Urticaria Franchise Will Support Substantial Upside Potential

Price target increased by 14% to US$28.80

SPRY: Bullish Outperform Views Will Support Future Allergy Treatment Upside

Consensus EPS estimates fall by 12%

First quarter 2026 earnings: Revenues exceed analysts expectations while EPS lags behind

Insufficient new directors

ARS Pharmaceuticals, Inc. Announces Appointment of Donn Casale as President, Effective June 1, 2026

ARS Pharmaceuticals, Inc., Annual General Meeting, Jun 24, 2026

SPRY: Disruptor Positioning And Recent Approvals Will Support Future Upside Potential

ARS Pharmaceuticals, Inc. Announces Approval of Neffy Epinephrine Nasal Spray in Canada

SPRY: Bullish Coverage Sees Future Upside From Execution On Commercial Rollout

SPRY: Rival FDA Setback Will Support Future Anaphylaxis Market Upside

ARS Pharmaceuticals Inc Receives FDA Approval To Remove Age Requirement From Neffy 1 Mg Epinephrine Nasal Spray Label

SPRY: Competitor FDA Setback Will Support Future Upside Potential

SPRY: Rival FDA Setback And Global Approvals Will Support Future Upside

SPRY: Competitor FDA Setback And Global Approvals Will Support Future Upside

Ars Pharmaceuticals to Showcase Scientific Innovation and Robust Clinical Data on Neffy®? (Epinephrine Nasal Spray) At 2026 American Academy of Allergy, Asthma and Immunology (Aaai) Annual Scientific Meeting

SPRY: Competitor Delay And Global Allergy Access Will Drive Future Upside

ARS Pharmaceuticals Announces EURneffy 1 Mg (Adrenaline Nasal Spray) Recommended For Approval In The EU For Emergency Treatment Of Type 1 Allergic Reactions In Children Weighing 15 Kg To Less Than 30 Kg

SPRY: Virtual Access And China Approval Will Drive Needle Free Allergy Share

ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) Stock Catapults 25% Though Its Price And Business Still Lag The Industry

SPRY: Needle Free Allergy Rescue Will Gain Share On Virtual Access Programs

ARS Pharmaceuticals, Inc. Announces Approval in China as the First and Only Community Use Epinephrine Product for the Treatment of Allergic Reactions (Anaphylaxis)

SPRY: Neffy Launch Momentum And DTC Campaigns Will Drive Future Upside

SPRY: Needle-Free Delivery Will Capture Market Share From Auto-Injectors

SPRY: Needle-Free Allergy Treatment Will Drive Market Share Expansion

ARS Pharmaceuticals, Inc. announced that it expects to receive $250 million in funding

ARS Pharmaceuticals, Inc. Announces Approval for Neffy®? (epinephrine Nasal Spray) for the Emergency Treatment of Allergic Reactions

ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) May Have Run Too Fast Too Soon With Recent 27% Price Plummet

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AARS Pharmaceuticals, Inc. Announces Approval of EURneffy®? (Adrenaline Nasal Spray) for the Emergency Treatment of Allergic Reactions

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Analysts Have Just Cut Their ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) Revenue Estimates By 15%

ARS Pharmaceuticals, Inc.'s Neffy (epinephrine Nasal Spray) 1 mg Is Now Available in the United States for Type I Allergic Reactions, Including Anaphylaxis, in Pediatric Patients Weighing 15 to < 30 Kilograms

80% Coverage And Pediatric Launch Will Expand Global Markets

ARS Pharmaceuticals, Inc., Annual General Meeting, Jun 25, 2025

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Downgrade: Here's How Analysts See ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) Performing In The Near Term

ARS Pharmaceuticals Announces FDA Approval of neffy 1 mg (epinephrine nasal spray) for Type I Allergic Reactions, Including Anaphylaxis, in Pediatric Patients Weighing 15 to < 30 Kilograms

ARS Pharmaceuticals, Inc. Add neffy® (Epinephrine Nasal Spray) to National Formularies, Further Expanding Coverage for Patients

ARS Pharmaceuticals' Neffy Launch Could Be A Hit For Severe Allergic Reactions

ARS Pharmaceuticals Files for Approval of neffy® in Canada and the United Kingdom on Behalf of Licensing Partner ALK-Abelló A/S

ARS Pharmaceuticals, Inc. Announces neffy® (Epinephrine Nasal Spray) is available on Express Scripts Commercial National Formularies

ARS Pharmaceuticals Announces Filings for Approval of Neffy in China, Japan and Australia

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ARS Pharmaceuticals, Inc. Launches Pre-Ordering Services for neffy to Help Patients Access the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis

ARS Pharmaceuticals, Inc. Announces Approval of EURneffy (adrenaline nasal spray) in the EU as the First and Only Needle-Free Emergency Treatment of Allergic Reactions (anaphylaxis)

ARS Pharmaceuticals, Inc. Receives FDA Approval of Neffy® (Epinephrine Nasal Spray), the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis

ARS Pharmaceuticals, Inc.(NasdaqGM:SPRY) dropped from Russell Small Cap Comp Value Index

ARS Pharmaceuticals, Inc. Announces EURneffy (Adrenaline Nasal Spray) Recommended for Approval by CHMP for Emergency Treatment of Allergic Reactions (Anaphylaxis)

ARS Pharmaceuticals On Track With Neffy Despite Regulatory Hurdles

First quarter 2024 earnings released: US$0.11 loss per share (vs US$0.16 loss in 1Q 2023)

ARS Pharmaceuticals, Inc. Submits Response for Neffy (Epinephrine Nasal Spray) Marketing Authorization Application to EMA's Chmp

ARS Pharmaceuticals, Inc., Annual General Meeting, Jun 20, 2024

Founder exercised options to buy US$1.6m worth of stock.

ARS Pharmaceuticals, Inc. Submits Response to FDA Complete Response Letter for Neffy® (Epinephrine Nasal Spray)