ARS Pharmaceuticals Stock Rises 18.86% Following FDA Update on Rival
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 09 2026
0mins
Should l Buy SPRY?
Source: Benzinga
ARS Pharmaceuticals Inc's stock surged by 15.71% during regular trading, crossing above the 5-day SMA, as the broader market showed strength with the Nasdaq-100 up 1.07% and the S&P 500 up 0.73%.
The increase in ARS Pharmaceuticals' stock price is primarily due to the FDA's negative update on rival Aquestive Therapeutics, which identified deficiencies in its New Drug Application for Anaphylm. This development delays potential competition, thereby strengthening ARS's position in the needle-free epinephrine market. Analysts have noted that ARS's neffy is currently the only option available, providing the company with additional time to solidify its market share and enhance future sales.
This positive momentum reflects investor confidence in ARS Pharmaceuticals' growth potential, especially as the company is well-funded to support the launch of neffy. The market's reaction indicates a favorable outlook for ARS as it navigates the competitive landscape.
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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: 9.280
Low
30.00
Averages
32.50
High
35.00
Current: 9.280
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.
Breakthroughs in Gene Therapy and Needle-Free Treatment
- Pioneering Gene Therapy: Krystal Biotech's Vyjuvek, the first FDA-approved topical gene therapy, is projected to generate sales of $388 million to $389 million in 2023, reflecting a 34% increase year-over-year, indicating strong demand and potential profitability in the rare skin disease market.
- Needle-Free Treatment Innovation: ARS Pharmaceuticals' Neffy has received FDA approval as the first needle-free epinephrine nasal spray, and despite facing advertising controversies, it holds significant market potential, with the global epinephrine market expected to reach $2.48 billion by 2025.
- Strong Financial Performance: Krystal Biotech anticipates earnings per share between $6.46 and $8.92, representing a 156% increase from the previous year, which will support the development of its other gene therapies and further solidify its market position.
- Risks and Opportunities: Although ARS Pharma's stock has declined over 24% year-to-date, its revenue reached $51.8 million in the first nine months of 2025, demonstrating strong market demand and potential for future profitability.
See More
Biotech Companies' Growth Prospects
- Krystal Biotech Growth: Krystal Biotech anticipates annual sales of $388 million for its skin disorder treatment Vyjuvek, representing a 34% increase from last year, which will fund further gene therapy developments.
- FDA Approval Acceleration: Krystal's KB707 recently received FDA's Regenerative Medicine Advanced Therapy designation, potentially speeding up its development for non-small cell lung cancer, thereby enhancing its market competitiveness.
- ARS Pharma Market Potential: The global epinephrine market is projected to reach $2.48 billion by 2025, and despite not being profitable yet, ARS Pharma's Neffy shows strong demand with rapid order uptake.
- Financial Comparison: ARS Pharma reported $51.8 million in revenue for the first nine months of 2025, a significant increase from $568,000 in the same period last year, although it posted a loss of $1.32 per share, its cash reserves are sufficient to sustain operations until profitability.
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
Breakthroughs in Gene Therapy and Needle-Free Treatment
- Pioneering Gene Therapy: Krystal Biotech's Vyjuvek, the first FDA-approved topical gene therapy, is projected to generate sales of $388 million to $389 million in 2023, reflecting a 34% increase year-over-year, indicating strong demand and potential profitability in the rare skin disease market.
- Needle-Free Treatment Innovation: ARS Pharmaceuticals' Neffy has received FDA approval as the first needle-free epinephrine nasal spray, and despite facing advertising controversies, it holds significant market potential, with the global epinephrine market expected to reach $2.48 billion by 2025.
- Strong Financial Performance: Krystal Biotech anticipates earnings per share between $6.46 and $8.92, representing a 156% increase from the previous year, which will support the development of its other gene therapies and further solidify its market position.
- Risks and Opportunities: Although ARS Pharma's stock has declined over 24% year-to-date, its revenue reached $51.8 million in the first nine months of 2025, demonstrating strong market demand and potential for future profitability.
See More
Biotech Companies' Growth Prospects
- Krystal Biotech Growth: Krystal Biotech anticipates annual sales of $388 million for its skin disorder treatment Vyjuvek, representing a 34% increase from last year, which will fund further gene therapy developments.
- FDA Approval Acceleration: Krystal's KB707 recently received FDA's Regenerative Medicine Advanced Therapy designation, potentially speeding up its development for non-small cell lung cancer, thereby enhancing its market competitiveness.
- ARS Pharma Market Potential: The global epinephrine market is projected to reach $2.48 billion by 2025, and despite not being profitable yet, ARS Pharma's Neffy shows strong demand with rapid order uptake.
- Financial Comparison: ARS Pharma reported $51.8 million in revenue for the first nine months of 2025, a significant increase from $568,000 in the same period last year, although it posted a loss of $1.32 per share, its cash reserves are sufficient to sustain operations until profitability.
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
