Company Overview - ARS Pharmaceuticals, Inc. is a biopharmaceutical company focused on empowering at-risk patients and their caregivers to protect against allergic reactions that could lead to anaphylaxis [3] Upcoming Events - The company will host a conference call and webcast on March 9, 2026, at 5:30 a.m. PT / 8:30 a.m. ET to discuss its fourth quarter and full year 2025 financial results and business highlights [1] - ARS Pharma Management will participate in several upcoming investor conferences, including the 10th Annual Oppenheimer Emerging Growth Conference on February 25, 2026, and the Leerink Conference on March 11, 2026 [4] Product Information - ARS Pharmaceuticals is commercializing neffy® (trade name EURneffy® in the EU and 优敏速® in China), an epinephrine nasal spray for emergency treatment of Type I allergic reactions, including anaphylaxis, in adults and pediatric patients aged 4 years and older who weigh 33 lbs. or greater in the U.S. [3] - In the EU, neffy® is indicated 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 [3]

Core Insights - Krystal Biotech and ARS Pharmaceuticals are gaining attention due to their unique therapies with blockbuster potential [1][2] Krystal Biotech - Krystal Biotech has developed Vyjuvek, the first topical genetic therapy approved by the FDA for dystrophic epidermolysis bullosa, a rare skin disorder [2] - The company is working on expanding the labels for Vyjuvek while using its growing revenues to fund its pipeline [3] - Krystal's KB707 candidate is aimed at treating advanced or metastatic non-small cell lung cancer and has received a Regenerative Medicine Advanced Therapy designation from the FDA [6] - Preliminary sales for Vyjuvek are expected to reach $388 million to $389 million, indicating a 34% increase at the midpoint [7] - Analysts predict annual EPS for Krystal will be between $6.46 and $8.92, a 156% increase over the prior year at the midpoint [8] - The stock has increased over 10% year to date and nearly 80% over the past year, currently trading around $270 per share [8] ARS Pharmaceuticals - ARS Pharma focuses on preventing allergic reactions that can lead to anaphylaxis, with its product Neffy being the first non-injection epinephrine treatment approved by the FDA [2][9] - The company has faced challenges with the FDA regarding its advertising for Neffy, which was deemed misleading [11] - ARS Pharma's stock has decreased over 24% year to date and over the past 12 months, indicating a riskier investment compared to Krystal Biotech [12] - Revenue for ARS Pharma reached $51.8 million in the first nine months of 2025, a significant increase from $568,000 in the same period in 2024 [13] - The global market size for epinephrine is projected to be $2.48 billion in 2025, highlighting ARS Pharma's growth potential [13] - ARS Pharma is also looking to expand indications for Neffy and has a pipeline candidate, ARS-2, for treating chronic urticaria [14]

Core Insights - ARS Pharmaceuticals is showcasing the clinical advancements and real-world usability of neffy, a needle-free epinephrine delivery system, at the 2026 AAAAI Annual Scientific Meeting [1][2] - The nasal epinephrine has a longer shelf life compared to auto-injectors, leading to a more affordable price point [1] - Patient preference for the nasal option increased by over 25% due to the aversion to needle-based administration [1] Group 1: Clinical Presentations - Five poster presentations and one healthcare professional case report will focus on neffy, highlighting health-economic analyses, patient preference research, and pharmacokinetic comparisons with injectable epinephrine [1][2] - The presentations will demonstrate that neffy 2 mg exposure is comparable to 0.5 mg intramuscular injection, indicating potential cost-effectiveness and patient preference [2] Group 2: Poster Presentation Details - The first poster will discuss the societal value of nasal epinephrine due to needle aversion [3] - The second poster will compare the pharmacokinetics and pharmacodynamics of nasal spray and intramuscular injection [3] - The third poster will focus on treatment preferences between nasal epinephrine and autoinjectors among food-allergic patients [3][4] - Additional posters will address the importance of characteristics of epinephrine treatments and treatment adherence related to nasal versus autoinjector options [4] Group 3: HCP Case Report and Partner Presentations - A healthcare professional case report will evaluate the effectiveness of intranasal epinephrine in routine allergy practice [5] - Late-breaking partner presentations will explore device portability and user preferences between epinephrine autoinjectors and nasal delivery systems [6]

Core Viewpoint - ARS Pharmaceuticals has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing authorization of EURneffy 1 mg, a needle-free adrenaline nasal spray for emergency treatment of anaphylaxis in children weighing between 15 kg and 30 kg in the European Union [1][2][3] Group 1: Product Information - EURneffy 1 mg will be the first and only needle-free adrenaline option available for younger children in the EU, addressing significant barriers to timely treatment [1][3] - The product is designed for emergency treatment of allergic reactions, including anaphylaxis due to insect stings, foods, and other allergens [1][5] - The 1 mg dose follows the previously approved EURneffy 2 mg for adults and children weighing 30 kg or more, which was authorized in August 2024 [2] Group 2: Market and Distribution - ALK-Abelló A/S, the partner of ARS Pharma, will distribute EURneffy in the EU following the expected authorization by the European Commission [1] - The marketing authorization will be valid across all EU member states, as well as Iceland, Liechtenstein, and Norway [2] Group 3: Company Background - ARS Pharmaceuticals is focused on empowering at-risk patients and their caregivers to protect against allergic reactions that could lead to anaphylaxis [15] - The company is also commercializing neffy in the U.S. for emergency treatment of allergic reactions in adults and children weighing at least 33 pounds [4][5] - Recent regulatory approvals for neffy have occurred in Japan, China, and Australia, indicating a global expansion strategy [4]

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]

Core Insights - ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) is recognized by Wall Street analysts as one of the stocks expected to rebound, with Roth MKM maintaining a Buy rating and a price target of $30 for the stock [1] Group 1: Regulatory Approvals and Product Launch - The National Medical Products Administration (NMPA) in China has approved neffy 2 mg, an epinephrine nasal spray, for emergency treatment of Type 1 allergic reactions and anaphylaxis, applicable to adults and children weighing at least 30 kilograms [2] - ARS Pharmaceuticals has an exclusive licensing agreement with Pediatrix Therapeutics for the commercialization of neffy in China, which includes a final regulatory milestone payment of $4 million and potential additional sales-based milestone payments of up to $80 million [3] - The company will manufacture and supply neffy to Pediatrix in China at cost and expects the product to be available in the spring of 2026 [4] Group 2: Future Plans and Market Strategy - ARS Pharmaceuticals and Pediatrix plan to file for approval of a neffy 1 mg dose for children weighing more than 15 kilograms and less than 30 kilograms in the upcoming months [4] - The company is focused on developing treatments for allergies that could lead to anaphylaxis, indicating a strategic emphasis on addressing severe allergic reactions [5]

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.