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 ...

Core Insights - California has joined 23 other states in the neffyinSchools program, allowing schools to receive free neffy® (epinephrine nasal spray) for emergency use [1][2][3] - The neffyinSchools program aims to provide schools with the necessary tools to respond quickly to severe allergic emergencies, particularly anaphylaxis, which can occur rapidly and without prior diagnosis [2][3] - Since its launch in January 2025, the program has expanded to over 8,000 schools across 24 states, with plans for further expansion as legislation evolves [2][4] Company Overview - ARS Pharmaceuticals, Inc. is a biopharmaceutical company focused on empowering at-risk patients and caregivers to manage allergic reactions that could lead to anaphylaxis [1][15] - The company is commercializing neffy®, a nasal spray indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in patients aged 4 years and older who weigh at least 33 lbs. [15][6] - neffy is recognized as the first significant innovation in epinephrine delivery for allergic reactions in over 35 years, addressing limitations of traditional auto-injectors [2][14] Program Details - The neffyinSchools program provides eligible public and private K-12 schools with two cartons (four single-use doses) of neffy at no cost for emergency situations [3][5] - Schools can apply online to receive the product, which includes both 1 mg and 2 mg doses of neffy, depending on the weight of the children [5][3] - To date, ARS Pharma has donated nearly 45,000 doses of neffy to participating schools, which can also receive replacements upon use or expiration [3][4] Market Context - Approximately 40 million people in the U.S. experience Type I allergic reactions, with a significant number diagnosed and treated for severe reactions that may lead to anaphylaxis [14] - Despite the availability of epinephrine auto-injectors, many patients and caregivers delay or do not administer treatment during emergencies due to various limitations [14] - The neffyinSchools program aims to mitigate these issues by providing a more accessible and user-friendly option for emergency treatment in schools [2][3]

Group 1 - ARS Pharmaceuticals Inc. stock increased by 18.86% to $13.01 following a negative update regarding its competitor, Aquestive Therapeutics Inc. [5] - The FDA identified deficiencies in Aquestive's Anaphylm's New Drug Application, which delays discussions on labeling and post-marketing commitments [1] - This situation allows ARS Pharmaceuticals to establish its needle-free epinephrine device, neffy, as the only option in the market for the time being [2] Group 2 - ARS Pharmaceuticals filed a petition urging the FDA to delay approval of Aquestive's AQST-109, citing safety and efficacy concerns [3] - The company argues that current data do not sufficiently demonstrate the drug's safety or efficacy for anaphylaxis patients and requests additional studies [4] - Analysts see significant potential for neffy and believe the company is well-funded to support its launch [4]

ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) is one of the 12 Stocks that Will Bounce Back According to Wall Street Analysts. On January 2, Roth MKM reiterated its Buy rating on ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) with a price target of $30 on the stock. In other news, on December 29, ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) reported that China’s National Medical Products Administration (NMPA) has approved neffy 2 mg, an epinephrine nasal spray, for the emergency treatment of Type 1 allergic reactions, anap ...

FDA Approvals & Rejections - ARS Pharma's neffy, a needle-free epinephrine nasal spray for emergency treatment of Type I allergic reactions, received approval in China, with commercial availability expected in spring 2026. The product generated $31.3 million in U.S. revenue in Q3 2025 [3][4]. - Vanda Pharmaceuticals' NEREUS, an oral NK-1 receptor antagonist for preventing motion-induced vomiting, received FDA approval, marking the first new treatment for motion sickness in over 40 years. The drug demonstrated a meaningful reduction in vomiting in clinical trials [5][6]. Clinical Trials - Breakthroughs & Setbacks - InflaRx's analyses from a halted Phase 3 trial of Vilobelimab in pyoderma gangrenosum indicated potential efficacy signals with longer treatment duration, prompting plans to discuss alternative endpoints with the FDA [15][17]. - SELLAS reported that survival in its Phase 3 REGAL trial for Galinpepimut-S (GPS) in acute myeloid leukaemia is extending longer than anticipated, potentially increasing the likelihood of a positive outcome [18][19]. - Ultragenyx announced that its Phase 3 studies for Setrusumab in Osteogenesis Imperfecta failed to meet primary endpoints, leading to a decline in investor confidence [20][21]. - Genmab decided to discontinue clinical development of Acasunlimab to focus on higher-priority programs, with no impact expected on its full-year 2025 financial guidance [22][23]. Corporate Actions - FONAR Corporation agreed to be taken private by a CEO-led acquisition group for $19.00 per share, valuing the transaction at a significant premium. The deal is expected to close in Q3 2026, subject to shareholder approval [12][13][14].

Core Viewpoint - The approval of neffy, an epinephrine nasal spray, in China marks a significant advancement in the treatment of severe allergic reactions, providing a community-use option for patients and caregivers [3][4]. Group 1: Product Approval and Market Potential - Neffy is the first epinephrine product approved for use outside of a hospital setting in China for adults and children weighing over 30 kg, with availability expected in spring 2026 [1][4]. - Approximately 4.0% to 8.2% of the Chinese population, estimated at 50 to 100 million people, is affected by food allergies and at risk for severe allergic reactions [2]. - The approval in China follows recent approvals in Australia and the U.S., indicating a growing international market for neffy [5][6]. Group 2: Company Collaboration and Financial Aspects - ARS Pharmaceuticals has an exclusive licensing agreement with Pediatrix Therapeutics to commercialize neffy in China, which includes a final regulatory milestone payment of $4 million and potential sales milestones up to $80 million [4]. - ARS Pharma will manufacture and supply neffy to Pediatrix at cost, indicating a strategic partnership aimed at enhancing market penetration in China [4]. Group 3: Product Features and Benefits - Neffy's needle-free design is intended to reduce barriers to timely treatment, making it easier to carry and use in everyday life, with temperature stability up to 122°F (50°C) [3]. - The product aims to improve preparedness and outcomes for patients experiencing severe allergic reactions, addressing the limitations of traditional epinephrine auto-injectors [3][17].

Summary of ARS Pharmaceuticals FY Conference Call Company Overview - **Company**: ARS Pharmaceuticals (NasdaqGM:SPRY) - **Product**: Neffy, a needle-free epinephrine rescue product Key Industry Insights - **Epinephrine Market**: The company is focused on expanding the epinephrine market, particularly through the introduction of neffy, which is positioned as a safer and more user-friendly alternative to traditional auto-injectors [1][25]. Core Points and Arguments 1. **Early Adoption and Prescriber Engagement**: - Over 20,000 prescribers have prescribed neffy, with this number doubling in the last three months, indicating strong early adoption [2][4]. - The company has seen a two to threefold higher market share among physicians who have participated in their experience program [5]. 2. **Insurance Coverage and Access**: - The company has made significant progress in payer access, with major payers like UnitedHealth Group covering neffy quickly due to its medical necessity [6][8]. - Challenges remain with certain payers like CVS and some Blue Cross plans, which have delayed coverage [7][10]. 3. **Get Neffy on Us Program**: - This program lowers the copay for patients to zero, facilitating easier access to neffy through virtual prescribers [3][12]. - The program aims to reduce barriers for patients and caregivers, making it easier to obtain prescriptions without the need for in-person doctor visits [13][15]. 4. **Direct-to-Consumer (DTC) Marketing**: - Awareness of neffy has increased from under 20% to over 50% among patients and caregivers, which is crucial for driving adoption [20]. - The DTC campaign targets not only patients but also healthcare providers, particularly those who may not frequently prescribe epinephrine [21][28]. 5. **Market Expansion Metrics**: - Approximately 80% of neffy prescriptions are from switchers (patients who previously used auto-injectors), while 20% are from new market expansion [26]. - There are 3.2 million patients who have auto-injectors but did not fill their prescriptions, indicating a significant opportunity for neffy [27]. 6. **Real-World Outcomes Data**: - Data shows that neffy has a similar efficacy to traditional injections, with 90% of patients responding to a single dose [33][35]. - The company has published data supporting neffy's effectiveness, which is expected to enhance physician confidence in prescribing the product [36][37]. 7. **International Market Opportunities**: - The company is exploring international markets, with pricing in countries like Germany and Japan being more than double that of EpiPen, indicating strong market potential [41][42]. - Japan is expected to launch neffy by early January, with favorable pricing established [42]. 8. **Chronic Spontaneous Urticaria (CSU) Opportunity**: - The company is conducting a phase 2B study for CSU, targeting an unmet medical need for patients experiencing acute exacerbations [44][48]. - The product for CSU will have a lower dose than neffy, focusing on at-home use for rapid symptom relief [48]. Additional Important Insights - The company is addressing the challenges faced by healthcare providers in prescribing new medications, aiming to streamline the process and reduce the burden on doctors [16][18]. - There is a significant portion of the population at high risk for anaphylactic reactions who are not currently seeing doctors, highlighting a substantial market opportunity for neffy [29][30]. This summary encapsulates the key points discussed during the ARS Pharmaceuticals FY Conference Call, focusing on the company's strategies, market dynamics, and product positioning within the epinephrine rescue space.

Core Insights - ARS Pharmaceuticals, Inc. is participating in the Piper Sandler 37th Annual Healthcare Conference from December 2-4, 2025, in New York [1] - The company's management will engage in a fireside chat and one-on-one meetings with investors during the conference [2] Company Overview - ARS Pharmaceuticals is focused on empowering at-risk patients and their caregivers to manage allergic reactions that may lead to anaphylaxis [3] - The company is commercializing neffy® (EURneffy® in the EU), an epinephrine nasal spray for emergency treatment of Type I allergic reactions, including anaphylaxis, for patients aged 4 years and older in the U.S. and for various allergic reactions in the EU [3]

Core Insights - The article discusses ARS Pharmaceuticals, Inc. (SPRY), which markets Neffy, a needle-free intranasal delivery system for epinephrine aimed at treating Type I allergic reactions, including anaphylaxis [1] Company Overview - ARS Pharmaceuticals is focused on innovative delivery methods for emergency treatments in the biotech sector [1] - Neffy is positioned as a significant product for the company, targeting a critical need in emergency allergy treatment [1] Industry Context - The article emphasizes the importance of staying updated on stocks within the biotech, pharma, and healthcare industries, highlighting key trends and catalysts that influence market valuations [1] - The investing group Haggerston BioHealth provides insights and forecasts for major pharmaceutical companies, indicating a comprehensive approach to market analysis [1]

Financial Data and Key Metrics Changes - U.S. net product revenue for neffy reached $31.3 million in Q3 2025, a 2.5-fold increase from the prior quarter, exceeding consensus expectations of $28.3 million [3][20] - Total revenue for Q3 2025 was $32.5 million, with $1.1 million recognized in supply revenue and $0.1 million in royalties [20][21] - Net loss for Q3 2025 was $51.2 million or $0.52 per share [23] Business Line Data and Key Metrics Changes - The U.S. net product revenue from neffy was $31.3 million, reflecting strong growth in new patient starts and overall demand [3][20] - Gross-to-net retention improved, with cash prescriptions decreasing from about 20% to approximately 12% of total volume [13][21] - Approximately 19% of neffy patients were lapsed patients who had stopped filling prescriptions, indicating a new patient segment being reached [18] Market Data and Key Metrics Changes - Consumer awareness of neffy increased from 20% pre-campaign to 56% as of September 2025 [14] - The current U.S. epinephrine market is valued at $2 billion annually, growing at 6-8% organically prior to neffy's entry [18] - Market share among new prescribers reached 10.3%, indicating faster uptake compared to existing prescribers [17] Company Strategy and Development Direction - The company is focused on sustaining and accelerating neffy U.S. market share growth and enabling global expansion through multiple launches [25] - The "Get neffy on Us" program aims to simplify access to neffy and drive year-round sales growth [8][16] - The company plans to invest in direct-to-consumer initiatives and real-world evidence generation to support neffy's effectiveness [23][24] Management's Comments on Operating Environment and Future Outlook - Management acknowledged a temporary pause in market share growth due to back-to-school seasonality but expects growth to resume in Q4 2025 [6][7] - The company anticipates Q4 sales will decrease from Q3 due to typical seasonality in the epinephrine market [7][19] - Management expressed confidence in the long-term growth and profitability of neffy, supported by a strong balance sheet and cash position [11][24] Other Important Information - The company secured a term loan facility of up to $250 million, drawing down $100 million initially to accelerate commercial growth [11][23] - Neffy received approval in Japan in September 2025, with launches anticipated in Canada and China in 2026 [10] Q&A Session Summary Question: How did Q3 performance stack up against internal expectations? - Management indicated that Q3 performance exceeded analysts' expectations and met internal expectations, despite challenges faced during the summer [32] Question: What is the market share growth among new prescribers? - New prescribers are trialing neffy, and while their market share is increasing, existing prescribers are also expanding their use [37] Question: What percentage of covered lives require prior authorization? - Approximately 50% of prescriptions require prior authorization, with 57% of commercial prescriptions not requiring it [46] Question: What are the inventory levels for neffy? - Distributors maintain inventory levels between 15-20 days, which may fluctuate based on market demand [49] Question: How is the virtual prescriber program expected to impact growth? - The virtual prescriber program is anticipated to streamline the prescription process, making it easier for patients to access neffy and potentially increasing adoption [70]