Offers no-hassle, free virtual visit with healthcare provider for patients to receive neffy for $0 co-pay if eligible with commercial insurance Program is available to eligible patients who may already have an auto-injector, but are looking for a smaller, easier to administer option SAN DIEGO, Nov. 04, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a commercial-stage biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect themselves from ...

Core Insights - ARS Pharmaceuticals will present significant real-world data on the effectiveness of neffy® (epinephrine nasal spray) at the 2025 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology, showcasing its impact on treating anaphylaxis [1][2] Group 1: Presentation Details - One late-breaking oral presentation titled "Real World Data on the Effectiveness of Epinephrine Nasal Spray in Clinical Practice – Update" will be delivered on November 8, 2025 [3] - Six poster presentations will cover various aspects of neffy, including its effectiveness compared to autoinjectors, patient surveys, and case reports from clinical settings [5][6] Group 2: Expert Opinions - Dr. Jonathan Spergel emphasized that the real-world data supports intranasal epinephrine as a reliable alternative to injections, providing confidence to clinicians and patients [2] - Sarina Tanimoto, Co-founder and Chief Medical Officer of ARS Pharma, highlighted the breadth of research reinforcing the value of neffy in allergic emergencies [2] Group 3: Product Information - Neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in patients aged 4 years and older who weigh at least 33 lbs [8] - The product aims to address limitations associated with traditional epinephrine auto-injectors, such as needle fear and portability issues [17]

SAN DIEGO, Nov. 03, 2025 (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 could lead to anaphylaxis, today announced the company will host a conference call and webcast on Monday, November 10, 2025, at 5:30 a.m. PT / 8:30 a.m. ET to discuss its third quarter 2025 financial results and business highlights. Dial-in information for conference participant ...

Core Insights - ARS Pharmaceuticals is presenting real-world data on the effectiveness of neffy® (epinephrine nasal spray) at the 2025 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology, highlighting that approximately 90% of patients experiencing anaphylaxis were effectively treated with a single dose of neffy [1][2] - The presentations include one late-breaking oral presentation and six poster presentations, showcasing the treatment's value and effectiveness in various clinical settings [1][2] Company Overview - ARS Pharmaceuticals is focused on empowering at-risk patients and their caregivers to manage severe allergic reactions that could lead to anaphylaxis [1][18] - The company is commercializing neffy®, an epinephrine nasal spray indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in patients aged 4 years and older [1][18] Presentation Details - The oral presentation titled "Real World Data on the Effectiveness of Epinephrine Nasal Spray in Clinical Practice – Update" will take place on November 8, 2025 [3] - Six poster presentations will cover various topics, including the effectiveness of neffy in clinical settings and patient experiences with the nasal spray compared to autoinjectors [5][6][7] Clinical Evidence - Dr. Jonathan Spergel emphasized that the consistency of outcomes across diverse patient populations supports the reliability of intranasal epinephrine, asserting that it is as effective as injections [2] - Case reports presented during the meeting demonstrate the successful use of neffy in patients undergoing oral food challenges and allergy immunotherapy [2][7] Market Context - There are approximately 40 million people in the U.S. experiencing Type I allergic reactions, with a significant number diagnosed with severe reactions that may lead to anaphylaxis [17] - Despite the availability of epinephrine auto-injectors, many patients delay or do not administer treatment during emergencies due to various limitations, highlighting the need for alternatives like neffy [17]

Core Insights - ARS Pharmaceuticals, Inc. announced that the European Patent Office upheld the validity of its patent EP 3678649, which covers nasal spray epinephrine formulations, including alkyl-glycoside [1] - The company's global intellectual property portfolio related to its product neffy provides coverage until at least 2039 [2] - The successful defense of two patents in different jurisdictions strengthens the company's position against future patent challenges [3] Patent Validity and Legal Outcomes - The EPO's unanimous decision supports the strength and validity of ARS Pharma's extensive patent portfolio [4] - Earlier this year, the United States Patent and Trademark Office upheld key claims for U.S. Patent No. 10,682,414, which pertains to treating type-1 hypersensitivity reactions with an epinephrine nasal spray [2][4] Product Information - Neffy is 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 [5] - The product is designed to address limitations associated with epinephrine auto-injectors, such as needle fear and portability issues [13] Market Context - Approximately 40 million people in the U.S. experience type I allergic reactions, with 20 million diagnosed and treated for severe reactions in the last three years [13] - Despite the prevalence, only 3.2 million filled their active epinephrine auto-injector prescriptions in 2023, highlighting a significant market opportunity for neffy [13]

Company Overview - Adverum Biotechnologies (ADVM) is a clinical-stage biotechnology company focused on developing gene therapies for serious ocular diseases, particularly wet age-related macular degeneration (AMD), which is a leading cause of blindness in older adults [3] - The company has a market capitalization of $94.6 million and aims to help patients retain vision while minimizing the need for frequent treatments [3] Product Development - The lead candidate, ixoberogene soroparvovec (ixo-vec), is a gene therapy administered as a single intravitreal injection, designed to provide long-term treatment for wet AMD by enabling the eye to produce a therapeutic protein [2][6] - Adverum is conducting the ARTEMIS Phase 3 trial for ixo-vec, with enrollment expected to conclude in Q1 2026 and top-line data anticipated in the first half of 2027 [2] - The company plans to present two-year follow-up results from the LUNA Phase 2 trial in Q4 2025, which are expected to support the long-term safety and efficacy of ixo-vec [1] Financial Performance - In Q2, Adverum reported a net loss of $49.2 million, with cash, cash equivalents, and short-term investments totaling $44.4 million, expected to sustain operations until Q4 2025 [6] - Management noted a growing enthusiasm for gene therapy among retina specialists, with nearly half of surveyed specialists identifying it as the most promising innovation in the pipeline [6] Market Potential and Analyst Sentiment - Ixo-vec has received FDA Fast Track and RMAT designations, as well as EMA PRIME and the U.K. Innovation Passport, indicating significant market potential upon approval [6] - Wall Street analysts are optimistic about Adverum stock, with five out of seven analysts rating it as a "Strong Buy" and an average target price of $19.50, suggesting a potential increase of 332.4% from current levels [7]

Core Insights - ARS Pharmaceuticals has secured a senior secured term loan facility of up to $250 million to enhance its market share in the U.S. for its product neffy, a needle-free epinephrine nasal spray [1][3] Funding and Use of Proceeds - The company has initially borrowed $100 million from the loan facility, primarily aimed at accelerating neffy's commercial growth and supporting marketing initiatives to generate real-world evidence of its effectiveness [2][3] - The loan facility includes provisions for additional funding, with $25 million available as a delayed draw term loan contingent on achieving specific revenue milestones [4] Market Potential and Strategy - Neffy is expanding its prescriber base across various medical fields, nearly doubling its prescribing breadth in the last four months, indicating strong market traction [3] - A consumer survey revealed that over 93% of patients would consider neffy if recommended by healthcare providers, with 68% being extremely likely to consider it [3] - The company aims to convert the current ~$2 billion annual U.S. epinephrine market by improving adherence and refill rates among patients [4] Product Overview - Neffy is indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in patients aged 4 years and older who weigh at least 33 lbs [9][19] - The product addresses limitations of traditional epinephrine auto-injectors, such as fear of needles and complexity, which have led to delays in treatment during emergencies [18] Company Background - ARS Pharmaceuticals is focused on empowering at-risk patients and their caregivers to manage allergic reactions effectively, with neffy being a key product in their portfolio [19]

Core Viewpoint - ARS Pharmaceuticals (NASDAQ: SPRY) is highlighted for its stock performance and potential value, with a current price around $13.8 and an estimated fair value of $24.85 driven by its product neffy [1] Group 1: Investment Strategy - The investment approach combines fundamental analysis with options strategies, focusing on various investment styles including income-oriented investments, growth at a reasonable price, deep value, and dividend aristocrats [1] - The analyst employs 20-25 options strategies for purposes such as hedging, bullish substitutes, neutral trades, trading volatility, and earnings-related trades [1] Group 2: Analyst Position - The analyst holds a beneficial long position in SPRY through stock ownership, options, or other derivatives, indicating a personal investment in the company [2] - A covered call position in SPRY is also mentioned, suggesting a strategy to generate income from the stock [2]

Core Viewpoint - ARS Pharmaceuticals has received approval from Japanese regulators for neffy, a needle-free epinephrine nasal spray, which addresses a significant need for emergency treatment of anaphylaxis in both adults and children in Japan [1][2] Group 1: Product Approval and Market Entry - The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has approved neffy in 1 mg and 2 mg doses for emergency treatment of allergic reactions in individuals weighing over 15 kg [1] - Alfresa Holdings, which holds the marketing rights for neffy in Japan, anticipates that the product will be available in the fourth quarter of 2025 [1][3] Group 2: Market Need and Patient Statistics - Approximately 900,000 individuals in Japan are estimated to be affected by food allergies, with the prevalence in children doubling from 2010 to 2019 [2] - A survey conducted in 2025 revealed that only 14% of Japanese patients who experienced anaphylaxis had an epinephrine auto-injector prescription, and only half used it during their most recent episode [2] Group 3: Product Features and Advantages - Neffy offers a compact design with an extended shelf life of 24 months, making it easier for patients and caregivers to carry and administer during emergencies [2] - The product is already commercially available in the U.S. and has received regulatory approvals in Germany and the U.K., with further approvals expected in Canada, Australia, New Zealand, and China by 2026 [4]

Core Thesis - ARS Pharmaceuticals, Inc. is positioned favorably in the epinephrine delivery market with its nasal spray Neffy, supported by a robust patent portfolio and strong management, despite facing legal challenges and competition [2][4][5] Patent and Legal Landscape - ARS Pharmaceuticals holds a portfolio of patents covering various aspects of Neffy, with protections extending to 2039, but is currently facing a lawsuit from Lupin, a major generic manufacturer, which could lead to generic competition [2] - The litigation against Lupin triggers a 30-month delay on generic entry, providing a temporary shield for Neffy [2] - Historical data indicates that generics succeed in patent infringement cases about 45% of the time, but ARS's strong patent position and cash reserves enhance its defensive capabilities [2] Market Dynamics and Competition - Insurance coverage for Neffy is expanding, currently at 60% and projected to reach 80% by the end of 2025, which is expected to support market adoption [3] - The competitive landscape includes Aquestive Therapeutics' Anaphylm, which has an 80% probability of FDA approval and may enter the market in early 2026, presenting a faster-acting alternative to Neffy [3] - Neffy benefits from a first responder-friendly nasal delivery method, while mouth films like Anaphylm face challenges in certain emergency scenarios [3] Management and Market Position - The management of ARS Pharmaceuticals has a proven track record, having previously captured 95% of the Narcan market, although current adoption of Neffy is slower at around 5% [4] - Brand awareness for Neffy stands at 49%, and the company has established international licensing agreements, providing a competitive edge [4] - Despite the market advantages and growth potential, the uncertain outcome of patent litigation and competition from AQST suggest a cautious approach to investment [4][5]