ARS Pharmaceuticals Gets Health Canada Approval for Neffy 2 mg for Allergic Reactions
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 5 days ago
0mins
Should l Buy SPRY?
ARS Pharmaceuticals announced that Health Canada has granted approval for neffy 2 mg for the emergency treatment of allergic reactions in adults and children who weigh 30 kg or more. ARS Pharma entered into an exclusive licensing agreement with ALK- Abello A/S 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 $155M to date and is eligible to receive up to an additional $310M 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.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy SPRY?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on SPRY
Wall Street analysts forecast SPRY stock price to rise
4 Analyst Rating
4 Buy
0 Hold
0 Sell
Strong Buy
Current: 8.180
Low
30.00
Averages
32.50
High
35.00
Current: 8.180
Low
30.00
Averages
32.50
High
35.00
About SPRY
ARS Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to protect patients from allergic reactions that could lead to anaphylaxis. The Company is commercializing neffy, an epinephrine nasal spray indicated in the United States 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. neffy is an FDA and European Commission (EC)-approved needle-free epinephrine product, and also has approvals in the United Kingdom, Japan, Australia, and China. It is advancing its nasal spray development program across multiple Type I hypersensitivity reactions, including acute flares of urticaria.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
ARS Pharmaceuticals Launches New Allergy Treatment in Canada
- New Drug Approval: ARS Pharmaceuticals' neffy (2 mg epinephrine nasal spray) has received approval from Health Canada for use in adults and children over 30 kg, with availability expected in summer 2026, marking a significant advancement for over 2.5 million Canadians living with severe allergic reactions.
- Needle-Free Design Benefits: The needle-free design of neffy reduces barriers to timely treatment, making it easy to carry and use, with a 30-month shelf life and temperature stability up to 50°C, enhancing patient preparedness in allergic emergencies.
- Licensing Agreement Revenue: The exclusive licensing agreement with ALK-Abelló A/S has provided ARS Pharma with $155 million in upfront and milestone payments, with potential for an additional $310 million in regulatory and sales milestones, indicating strong market potential and profitability.
- Future Expansion Plans: ARS Pharma plans to launch neffy in Canada in summer 2026 and anticipates filing for approval of the 1 mg dose for children in the coming months, further expanding its market presence in allergy treatment and enhancing competitive positioning.
See More
Northland Capital Begins Coverage of ARS Pharmaceuticals Inc. with Outperform Rating and $25 Target Price
Company Overview: Northland Capital initiates coverage on a pharmaceutical company, ARSPHARMACEUTICALS, with a focus on its market potential.
Performance Rating: The coverage comes without a performance rating, indicating a neutral stance on the company's current market position.
Target Price: A target price of $25 has been set for the company's stock, suggesting potential growth opportunities.
Market Implications: The initiation of coverage may influence investor interest and market dynamics surrounding ARSPHARMACEUTICALS.
See More
FDA Allows ARS Pharmaceuticals to Remove Age Requirement for Neffy
- Age Requirement Removal: The FDA's approval for ARS Pharmaceuticals to eliminate the age requirement for neffy (epinephrine nasal spray) allows children and adults weighing at least 33 pounds (approximately 15 kg) to use the product, thereby expanding the potential user base and enhancing market acceptance.
- Labeling Update: The labeling change includes more flexible guidance regarding the administration of the medication, temperature excursions, and freezing conditions, aimed at improving usability and safety, thus enhancing the user experience.
- Sales Strategy Adjustment: ARS Pharmaceuticals is expanding its sales force and implementing a digital strategy to drive neffy sales growth while maintaining SG&A expenses in 2026, demonstrating the company's confidence in future market potential.
- Optimistic Market Outlook: With the gradual increase in neffy sales and global expansion, ARS Pharmaceuticals is positioned for a potential re-rating of its stock, attracting more investor attention and further driving company growth.
See More
ARS Pharmaceuticals Receives FDA Approval for neffy Label Update
- FDA Approval Update: ARS Pharmaceuticals announced that the U.S. FDA has approved an update to the prescribing information for neffy 1 mg epinephrine nasal spray, removing age restrictions and allowing all children and adults weighing 33 lbs. or more to use it, significantly broadening the drug's eligible user base.
- Increased Accessibility: The label update not only lowers treatment hurdles but also encourages patients to carry neffy in its blister packaging or carrying case, ensuring rapid access during emergencies, thereby enhancing the response capability to Type 1 allergic reactions and anaphylaxis.
- Expert Commentary: Allergy/Immunology and Pediatrics expert Nicole Chase stated that having a needle-free epinephrine treatment available is an important step forward, helping more patients and caregivers alleviate treatment barriers while protecting children.
- Stock Price Reaction: ARS Pharmaceuticals shares were trading at $8.56 at the last close, up 8.35%, reflecting a positive market response to the FDA approval news, which may further drive the company's market share in the allergy treatment sector.
See More
ARS Pharma Updates neffy Dosage Guidelines for All Weights
- Removal of Age Restrictions: The FDA has approved an update to the prescribing information for neffy® 1 mg, eliminating age restrictions for children, allowing all individuals weighing ≥33 lbs to access this needle-free epinephrine, significantly enhancing emergency treatment options for allergic reactions, particularly for children under four.
- Increased Portability: The updated labeling recommends that patients store neffy in blister packaging or a dedicated carrying case, with ARS Pharma set to include a carrying case with each prescription starting this summer, aimed at improving convenience and confidence for patients during emergencies.
- Market Demand Response: Approximately 25% of patients requiring epinephrine are children weighing ≥33 lbs and <66 lbs, with about 25% being under four years old; the updated guidelines will effectively reduce barriers for parents in emergency situations, enhancing the product's market competitiveness.
- Enhanced Safety: The FDA also updated flexible guidance on using neffy, allowing for use after accidental freezing and at high temperatures (up to 122°F), further improving the product's applicability and safety, meeting patient needs across various environments.
See More
ARS Pharmaceuticals Q4 2025 Earnings Call Insights
- Significant Revenue Growth: ARS Pharmaceuticals reported total revenue of $84.3 million for 2025, with U.S. net product revenue at $72.2 million, indicating strong performance in new markets and potential for future market share expansion.
- Sales Team Expansion Plan: The company plans to increase its sales force from 106 to 150 in Q2 2026, funded through the reallocation of existing resources, ensuring no increase in SG&A expenses for 2026 while enhancing engagement with priority accounts.
- Improved Market Coverage: By the end of 2025, ARS achieved approximately 93% overall commercial coverage, with 57% of covered lives having access without prior authorization, which is expected to drive sales growth and improve customer satisfaction.
- International Market Expansion: ARS Pharmaceuticals has secured regulatory approvals in Europe, China, Japan, and Australia, with plans for further product launches in 2026, demonstrating its strategic commitment to global expansion.
See More
ARS Pharmaceuticals Launches New Allergy Treatment in Canada
- New Drug Approval: ARS Pharmaceuticals' neffy (2 mg epinephrine nasal spray) has received approval from Health Canada for use in adults and children over 30 kg, with availability expected in summer 2026, marking a significant advancement for over 2.5 million Canadians living with severe allergic reactions.
- Needle-Free Design Benefits: The needle-free design of neffy reduces barriers to timely treatment, making it easy to carry and use, with a 30-month shelf life and temperature stability up to 50°C, enhancing patient preparedness in allergic emergencies.
- Licensing Agreement Revenue: The exclusive licensing agreement with ALK-Abelló A/S has provided ARS Pharma with $155 million in upfront and milestone payments, with potential for an additional $310 million in regulatory and sales milestones, indicating strong market potential and profitability.
- Future Expansion Plans: ARS Pharma plans to launch neffy in Canada in summer 2026 and anticipates filing for approval of the 1 mg dose for children in the coming months, further expanding its market presence in allergy treatment and enhancing competitive positioning.
See More
Northland Capital Begins Coverage of ARS Pharmaceuticals Inc. with Outperform Rating and $25 Target Price
Company Overview: Northland Capital initiates coverage on a pharmaceutical company, ARSPHARMACEUTICALS, with a focus on its market potential.
Performance Rating: The coverage comes without a performance rating, indicating a neutral stance on the company's current market position.
Target Price: A target price of $25 has been set for the company's stock, suggesting potential growth opportunities.
Market Implications: The initiation of coverage may influence investor interest and market dynamics surrounding ARSPHARMACEUTICALS.
See More
FDA Allows ARS Pharmaceuticals to Remove Age Requirement for Neffy
- Age Requirement Removal: The FDA's approval for ARS Pharmaceuticals to eliminate the age requirement for neffy (epinephrine nasal spray) allows children and adults weighing at least 33 pounds (approximately 15 kg) to use the product, thereby expanding the potential user base and enhancing market acceptance.
- Labeling Update: The labeling change includes more flexible guidance regarding the administration of the medication, temperature excursions, and freezing conditions, aimed at improving usability and safety, thus enhancing the user experience.
- Sales Strategy Adjustment: ARS Pharmaceuticals is expanding its sales force and implementing a digital strategy to drive neffy sales growth while maintaining SG&A expenses in 2026, demonstrating the company's confidence in future market potential.
- Optimistic Market Outlook: With the gradual increase in neffy sales and global expansion, ARS Pharmaceuticals is positioned for a potential re-rating of its stock, attracting more investor attention and further driving company growth.
See More
ARS Pharmaceuticals Receives FDA Approval for neffy Label Update
- FDA Approval Update: ARS Pharmaceuticals announced that the U.S. FDA has approved an update to the prescribing information for neffy 1 mg epinephrine nasal spray, removing age restrictions and allowing all children and adults weighing 33 lbs. or more to use it, significantly broadening the drug's eligible user base.
- Increased Accessibility: The label update not only lowers treatment hurdles but also encourages patients to carry neffy in its blister packaging or carrying case, ensuring rapid access during emergencies, thereby enhancing the response capability to Type 1 allergic reactions and anaphylaxis.
- Expert Commentary: Allergy/Immunology and Pediatrics expert Nicole Chase stated that having a needle-free epinephrine treatment available is an important step forward, helping more patients and caregivers alleviate treatment barriers while protecting children.
- Stock Price Reaction: ARS Pharmaceuticals shares were trading at $8.56 at the last close, up 8.35%, reflecting a positive market response to the FDA approval news, which may further drive the company's market share in the allergy treatment sector.
See More
ARS Pharma Updates neffy Dosage Guidelines for All Weights
- Removal of Age Restrictions: The FDA has approved an update to the prescribing information for neffy® 1 mg, eliminating age restrictions for children, allowing all individuals weighing ≥33 lbs to access this needle-free epinephrine, significantly enhancing emergency treatment options for allergic reactions, particularly for children under four.
- Increased Portability: The updated labeling recommends that patients store neffy in blister packaging or a dedicated carrying case, with ARS Pharma set to include a carrying case with each prescription starting this summer, aimed at improving convenience and confidence for patients during emergencies.
- Market Demand Response: Approximately 25% of patients requiring epinephrine are children weighing ≥33 lbs and <66 lbs, with about 25% being under four years old; the updated guidelines will effectively reduce barriers for parents in emergency situations, enhancing the product's market competitiveness.
- Enhanced Safety: The FDA also updated flexible guidance on using neffy, allowing for use after accidental freezing and at high temperatures (up to 122°F), further improving the product's applicability and safety, meeting patient needs across various environments.
See More
ARS Pharmaceuticals Q4 2025 Earnings Call Insights
- Significant Revenue Growth: ARS Pharmaceuticals reported total revenue of $84.3 million for 2025, with U.S. net product revenue at $72.2 million, indicating strong performance in new markets and potential for future market share expansion.
- Sales Team Expansion Plan: The company plans to increase its sales force from 106 to 150 in Q2 2026, funded through the reallocation of existing resources, ensuring no increase in SG&A expenses for 2026 while enhancing engagement with priority accounts.
- Improved Market Coverage: By the end of 2025, ARS achieved approximately 93% overall commercial coverage, with 57% of covered lives having access without prior authorization, which is expected to drive sales growth and improve customer satisfaction.
- International Market Expansion: ARS Pharmaceuticals has secured regulatory approvals in Europe, China, Japan, and Australia, with plans for further product launches in 2026, demonstrating its strategic commitment to global expansion.
See More
