ARS Pharmaceuticals Receives Positive Opinion for EURneffy 1mg Spray from EU
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 5d ago
0mins
Should l Buy SPRY?
ARS Pharmaceuticals announced 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 due to insect stings or bites, foods, medicinal products and other allergens, as well as idiopathic or exercise-induced anaphylaxis, in children who weigh greater than or equal to15 kg and less than 30 kg. The opinion supports an extension to EURneffy 2 mg approval granted by the European Commission in August 2024 for the emergency treatment of anaphylaxis in adults and children who weigh greater than or equal to3 0 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.
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Analyst Views on SPRY
Wall Street analysts forecast SPRY stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for SPRY is 32.50 USD with a low forecast of 30.00 USD and a high forecast of 35.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
4 Analyst Rating
4 Buy
0 Hold
0 Sell
Strong Buy
Current: 9.670
Low
30.00
Averages
32.50
High
35.00
Current: 9.670
Low
30.00
Averages
32.50
High
35.00
About SPRY
ARS Pharmaceuticals, Inc. is a biopharmaceutical company. The Company is focused on the commercialization and development of neffy for the needle-free intranasal delivery of epinephrine for the emergency treatment of Type I allergic reactions, including anaphylaxis. neffy is a proprietary composition of epinephrine with an innovative absorption enhancer called Intravail, which allows neffy to safely provide intranasal delivery of epinephrine at a low dose within the exposures of approved injectable products across a range of dosing conditions. Type I allergic reactions are potentially life-threatening hypersensitivity reactions that can occur within minutes of exposure to an allergen and need to be treated immediately to relieve symptoms and prevent further progression.
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.
Aquestive Therapeutics Receives Complete Response Letter from FDA
- FDA Response Letter: Aquestive Therapeutics received a Complete Response Letter from the FDA regarding the NDA for Anaphylm (dibutepinephrine) sublingual film, highlighting deficiencies in the human factors validation study that could impede the drug's market approval process.
- Human Factors Issues: The FDA identified problems in the human factors validation study for Anaphylm, including difficulties in opening the pouch and incorrect film placement, which, if unaddressed, could pose significant safety risks during anaphylaxis, affecting patient usability.
- Next Steps: To address the FDA's concerns, the company has modified the pouch opening, instructions, and labeling, and plans to rapidly conduct a new human factors validation study while also addressing potential tolerability issues to meet FDA requirements.
- Future Outlook: The company estimates resubmission in early Q3 2026 and plans to submit marketing authorization applications in Europe and New Drug Submissions in Canada in the second half of 2026, with analysts expecting Anaphylm's approval decision in the first half of 2027.
See More
ARS Pharmaceuticals Secures Expanded Authorization for EURneffy
- Positive Opinion Issued: The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion supporting the expanded marketing authorization for EURneffy 1 mg nasal adrenaline spray, aimed at emergency treatment of allergic reactions in children weighing between 15 kg and 30 kg, marking a significant expansion in the pediatric allergy treatment sector.
- Product Background: The approval of EURneffy 1 mg builds on the earlier approval of EURneffy 2 mg in August 2024, which was authorized for emergency treatment of anaphylaxis in adults and children weighing 30 kg or more, demonstrating the company's ongoing innovation in the allergy treatment market.
- Market Performance: Shares of ARS Pharmaceuticals rose over 2% in pre-market trading after closing at $9.99, down 2.25% on Friday, reflecting a positive market reaction to the new product approval, which could enhance the company's future market performance and investor confidence.
- International Expansion: EURneffy is already available in the U.S. and was launched in selected European countries and the U.K. in 2025, with recent approvals in Japan, China, and Australia, and Canadian approval expected in early 2026, indicating the company's potential for global market expansion.
See More
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- Optimistic Market Outlook: Analyst William Blair noted that ARS's neffy is currently the only option on the market, providing the company with additional time to solidify its market position, which is expected to enhance sales and market share in the future.
- Regulatory Dynamics Impact: ARS filed a petition with the FDA in September urging a delay in the approval of Aquestive's experimental treatment, emphasizing safety and efficacy concerns, which not only demonstrates ARS's proactive market response but may also influence the FDA's final decision.
- Sufficient Funding Support: Analysts believe ARS is well-funded to support the launch of neffy, showcasing strong market potential for the product and further boosting investor confidence in the company's future growth.
See More
Aquestive Therapeutics Faces 40% Stock Drop After FDA Identifies Deficiencies in Anaphylm NDA
- FDA Deficiency Notification: The FDA has identified deficiencies in Aquestive's New Drug Application for Anaphylm, preventing discussions on labeling and post-marketing commitments, which could delay the approval process and impact future revenues.
- Severe Market Reaction: Following the FDA's announcement, Aquestive's stock plummeted by 40.18% to $3.71 during Friday's trading session, with a volume of 5.68 million shares traded, significantly exceeding the average of 2.79 million shares, indicating investor concerns over the approval outlook.
- Strong Cash Position: As of the end of 2025, Aquestive reported approximately $120 million in cash and cash equivalents, which is expected to be sufficient to support the approval and launch processes for Anaphylm in the U.S., contingent upon FDA approval.
- International Expansion Plans: The company aims to submit regulatory applications for Anaphylm in Canada, Europe, and the U.K. in 2026, demonstrating its commitment to advancing the product in global markets despite the challenges posed by the FDA's feedback.
See More
ARS Pharma's Neffy Approved in China for Allergy Treatment
- Market Breakthrough: ARS Pharma's neffy has received approval from China's NMPA, becoming the first needle-free epinephrine nasal spray for emergency allergy treatment, with commercial availability expected in spring 2026, addressing the growing demand for allergy treatments and further expanding the company's global market presence.
- Market Potential: Neffy generated $31.3 million in U.S. sales in Q3 2025, demonstrating strong market adoption, and the upcoming launch in China is anticipated to significantly boost overall revenue and enhance brand influence.
- Strategic Positioning: This approval marks neffy's successful entry into multiple global markets, including the U.S., U.K., E.U., Japan, and Australia, underscoring the company's leadership in the global allergy treatment sector.
- Future Outlook: With the product's commercialization in China, ARS Pharma plans to strengthen its collaboration with Pediatrix Therapeutics, leveraging its marketing rights in China to drive sales growth and increase market share.
See More
ARS Pharma's neffy Approved as First Community Use Epinephrine Product in China
- Market Breakthrough: ARS Pharma's neffy (优敏速®) has been approved by China's National Medical Products Administration as the first community-use epinephrine product, expected to launch in spring 2026, addressing the needs of approximately 100 million people facing severe allergic reactions in China.
- Product Innovation: Featuring a needle-free design, neffy is easy to carry and use, maintaining stability at temperatures up to 50°C, significantly reducing barriers for patients in emergency situations and enhancing response efficiency for allergic reactions.
- Commercial Potential: The exclusive licensing agreement with Pediatrix Therapeutics will provide ARS Pharma with a $4 million regulatory milestone payment and the potential for up to $80 million in sales milestones along with low double-digit royalties, indicating substantial commercial potential for neffy in the Chinese market.
- Future Outlook: ARS Pharma plans to file for approval of the neffy 1 mg dose for children over 15 kg in the coming months, further expanding market coverage and strengthening the company's competitive position in the global allergy treatment sector.
See More
Aquestive Therapeutics Receives Complete Response Letter from FDA
- FDA Response Letter: Aquestive Therapeutics received a Complete Response Letter from the FDA regarding the NDA for Anaphylm (dibutepinephrine) sublingual film, highlighting deficiencies in the human factors validation study that could impede the drug's market approval process.
- Human Factors Issues: The FDA identified problems in the human factors validation study for Anaphylm, including difficulties in opening the pouch and incorrect film placement, which, if unaddressed, could pose significant safety risks during anaphylaxis, affecting patient usability.
- Next Steps: To address the FDA's concerns, the company has modified the pouch opening, instructions, and labeling, and plans to rapidly conduct a new human factors validation study while also addressing potential tolerability issues to meet FDA requirements.
- Future Outlook: The company estimates resubmission in early Q3 2026 and plans to submit marketing authorization applications in Europe and New Drug Submissions in Canada in the second half of 2026, with analysts expecting Anaphylm's approval decision in the first half of 2027.
See More
ARS Pharmaceuticals Secures Expanded Authorization for EURneffy
- Positive Opinion Issued: The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion supporting the expanded marketing authorization for EURneffy 1 mg nasal adrenaline spray, aimed at emergency treatment of allergic reactions in children weighing between 15 kg and 30 kg, marking a significant expansion in the pediatric allergy treatment sector.
- Product Background: The approval of EURneffy 1 mg builds on the earlier approval of EURneffy 2 mg in August 2024, which was authorized for emergency treatment of anaphylaxis in adults and children weighing 30 kg or more, demonstrating the company's ongoing innovation in the allergy treatment market.
- Market Performance: Shares of ARS Pharmaceuticals rose over 2% in pre-market trading after closing at $9.99, down 2.25% on Friday, reflecting a positive market reaction to the new product approval, which could enhance the company's future market performance and investor confidence.
- International Expansion: EURneffy is already available in the U.S. and was launched in selected European countries and the U.K. in 2025, with recent approvals in Japan, China, and Australia, and Canadian approval expected in early 2026, indicating the company's potential for global market expansion.
See More
ARS Pharmaceuticals Stock Rises 18.86% Following FDA Update on Rival Aquestive
- Competitive Advantage Boost: ARS Pharmaceuticals' stock surged 18.86% to $13.01, primarily driven by the FDA's negative update on rival Aquestive, indicating deficiencies in its new drug application, which delays potential competition and strengthens ARS's position in the needle-free epinephrine market.
- Optimistic Market Outlook: Analyst William Blair noted that ARS's neffy is currently the only option on the market, providing the company with additional time to solidify its market position, which is expected to enhance sales and market share in the future.
- Regulatory Dynamics Impact: ARS filed a petition with the FDA in September urging a delay in the approval of Aquestive's experimental treatment, emphasizing safety and efficacy concerns, which not only demonstrates ARS's proactive market response but may also influence the FDA's final decision.
- Sufficient Funding Support: Analysts believe ARS is well-funded to support the launch of neffy, showcasing strong market potential for the product and further boosting investor confidence in the company's future growth.
See More
Aquestive Therapeutics Faces 40% Stock Drop After FDA Identifies Deficiencies in Anaphylm NDA
- FDA Deficiency Notification: The FDA has identified deficiencies in Aquestive's New Drug Application for Anaphylm, preventing discussions on labeling and post-marketing commitments, which could delay the approval process and impact future revenues.
- Severe Market Reaction: Following the FDA's announcement, Aquestive's stock plummeted by 40.18% to $3.71 during Friday's trading session, with a volume of 5.68 million shares traded, significantly exceeding the average of 2.79 million shares, indicating investor concerns over the approval outlook.
- Strong Cash Position: As of the end of 2025, Aquestive reported approximately $120 million in cash and cash equivalents, which is expected to be sufficient to support the approval and launch processes for Anaphylm in the U.S., contingent upon FDA approval.
- International Expansion Plans: The company aims to submit regulatory applications for Anaphylm in Canada, Europe, and the U.K. in 2026, demonstrating its commitment to advancing the product in global markets despite the challenges posed by the FDA's feedback.
See More
ARS Pharma's Neffy Approved in China for Allergy Treatment
- Market Breakthrough: ARS Pharma's neffy has received approval from China's NMPA, becoming the first needle-free epinephrine nasal spray for emergency allergy treatment, with commercial availability expected in spring 2026, addressing the growing demand for allergy treatments and further expanding the company's global market presence.
- Market Potential: Neffy generated $31.3 million in U.S. sales in Q3 2025, demonstrating strong market adoption, and the upcoming launch in China is anticipated to significantly boost overall revenue and enhance brand influence.
- Strategic Positioning: This approval marks neffy's successful entry into multiple global markets, including the U.S., U.K., E.U., Japan, and Australia, underscoring the company's leadership in the global allergy treatment sector.
- Future Outlook: With the product's commercialization in China, ARS Pharma plans to strengthen its collaboration with Pediatrix Therapeutics, leveraging its marketing rights in China to drive sales growth and increase market share.
See More
ARS Pharma's neffy Approved as First Community Use Epinephrine Product in China
- Market Breakthrough: ARS Pharma's neffy (优敏速®) has been approved by China's National Medical Products Administration as the first community-use epinephrine product, expected to launch in spring 2026, addressing the needs of approximately 100 million people facing severe allergic reactions in China.
- Product Innovation: Featuring a needle-free design, neffy is easy to carry and use, maintaining stability at temperatures up to 50°C, significantly reducing barriers for patients in emergency situations and enhancing response efficiency for allergic reactions.
- Commercial Potential: The exclusive licensing agreement with Pediatrix Therapeutics will provide ARS Pharma with a $4 million regulatory milestone payment and the potential for up to $80 million in sales milestones along with low double-digit royalties, indicating substantial commercial potential for neffy in the Chinese market.
- Future Outlook: ARS Pharma plans to file for approval of the neffy 1 mg dose for children over 15 kg in the coming months, further expanding market coverage and strengthening the company's competitive position in the global allergy treatment sector.
See More
