Welcome to our dedicated page for ARS Pharms news (Ticker: SPRY), a resource for investors and traders seeking the latest updates and insights on ARS Pharms stock.
Stock Titan’s news page for ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) aggregates company-specific updates for investors and followers of this commercial-stage biopharmaceutical company. ARS Pharma describes its focus as empowering at-risk patients and caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, primarily through its epinephrine nasal spray product, neffy®.
News coverage for SPRY commonly includes announcements about regulatory approvals and geographic expansion of neffy and EURneffy®. Recent press releases highlight approvals for neffy in markets such as Japan and China, as well as launches and approvals in Europe and the U.K. These items provide insight into how ARS Pharma is extending access to its needle-free epinephrine nasal spray through partnerships with companies including ALK, Alfresa Holdings, and Pediatrix Therapeutics.
Investors can also expect commercial and financial updates, such as quarterly financial results, commentary on U.S. commercialization progress, and details on direct-to-consumer campaigns and programs like “Get neffy on Us” and neffyInSchools. These disclosures often describe prescriber adoption, marketing initiatives, and real-world evidence efforts related to neffy’s use in community and clinical settings.
Another key category of SPRY news involves scientific and medical conference activity. ARS Pharma regularly reports on late-breaking oral presentations, poster sessions, and case reports at meetings such as the American College of Allergy, Asthma and Immunology Annual Scientific Meeting, focusing on real-world data, patient experience, dosing rationale, safety, and product stability for intranasal epinephrine.
Additional items may include intellectual property developments, such as decisions from the European Patent Office or the U.S. Patent and Trademark Office, as well as legal and competitive updates like Paragraph IV certification notices regarding potential generic versions of neffy. By following this news feed, readers can monitor how ARS Pharma communicates its regulatory, commercial, scientific, and legal milestones related to neffy and its intranasal epinephrine program.
ARS Pharmaceuticals (NASDAQ: SPRY), a biopharmaceutical company focused on developing solutions for anaphylaxis protection, has scheduled a conference call and webcast for Wednesday, May 14, 2025, at 5:30 a.m. PT / 8:30 a.m. ET. The event will cover the company's first quarter 2025 financial results and business highlights.
Participants can obtain dial-in information by registering for the event. The webcast and presentation slides will be accessible through the Events & Presentations page in the Investors & Media section of the company's website. A replay will remain available for 30 days after the event.
ARS Pharmaceuticals (SPRY) reported strong financial results for Q4 and full year 2024, with total revenue of $89.1 million, including $7.3 million from neffy® sales since its September 2024 launch. The company achieved net income of $49.9 million in Q4 and $8.0 million for the full year.
Key highlights include FDA approval of neffy 1 mg for children aged four and older weighing 15-30 kg, expanding market reach to ~2 million younger children. The company secured favorable coverage decisions from major insurers and is on track for >60% commercial lives coverage by Q1 2025.
With $314.0 million in cash and investments as of December 31, 2024, ARS maintains a three-year operating runway. The company received a $145 million upfront payment from ALK-Abelló partnership, with $73.5 million recognized as Q4 revenue.
ARS Pharmaceuticals (NASDAQ: SPRY) has received FDA approval for neffy® 1 mg, the first needle-free epinephrine nasal spray for Type I Allergic Reactions, including anaphylaxis, in children aged 4+ years weighing 15-30 kg. The approval marks the first major innovation in epinephrine delivery for this patient population in over 35 years.
The approval is supported by extensive clinical trials showing pharmacokinetic and pharmacodynamic responses comparable to injectable epinephrine. Human factor studies demonstrated effective use by children as young as 10 and untrained caregivers. The device maintains stability at room temperature for 24 months.
neffy 1 mg will be available in the US by May 2025, with most commercially insured patients paying $25 or less for two devices. A cash price of $199 for two doses is available through BlinkRx, with additional support through the neffyConnect program and Patient Assistance Program for eligible individuals.
ARS Pharmaceuticals (SPRY), a biopharmaceutical company focused on anaphylaxis prevention, has scheduled its fourth quarter and full year 2024 financial results conference call for March 20, 2025, at 8:30 a.m. ET.
The company will also participate in upcoming investor events including:
- Leerink Partners Global Healthcare Conference with a fireside chat on March 10, 2025
- 37th Annual Roth Conference with investor meetings on March 16-18, 2025
A webcast replay will be available for 30 days following the earnings call on the company's website under the Events & Presentations page.
ARS Pharmaceuticals (NASDAQ: SPRY) announced that OptumRx, Cigna Healthcare, and Navitus Health Systems have added neffy® (epinephrine nasal spray) to their National Formularies. This expansion, occurring approximately five months after launch, provides access to half of all patients managing Type 1 allergic reactions, with coverage now available through 30 formulary platforms.
Patients insured by these providers will have access to neffy at the lowest branded copay without prior authorizations or step therapies. With ARS Pharma copay assistance, qualified patients can obtain neffy for $25. The company is currently working with UnitedHealthcare to add neffy to their formulary.
neffy 2 mg, the first FDA-approved epinephrine nasal spray, is designed for adults and children weighing ≥30 kg. A supplemental NDA for neffy 1 mg, intended for children over four years weighing 15-30 kg, has a PDUFA date of March 6, 2025, with expected availability by May 2025.
ARS Pharmaceuticals (NASDAQ: SPRY) announced nine presentations featuring data on neffy® (epinephrine nasal spray) at the 2025 AAAAI Annual Scientific Meeting. Key highlights include an oral presentation showing neffy's superior efficacy in Japanese patients during food challenges, with lower symptom scores within 10 minutes compared to traditional treatments.
The presentations will showcase comprehensive clinical research data, including pharmacokinetics and pharmacodynamics studies in Chinese subjects, demonstrating neffy's comparable efficacy and safety to intramuscular injection under various conditions. The studies confirm neffy's effectiveness in children four years or older weighing more than 15 kilograms.
neffy is the first and only FDA-approved needle-free treatment for Type I allergic reactions, including anaphylaxis, in adults and children weighing ≥30 kg (66 lbs). The event will be held from February 28 to March 3, 2025, in San Diego, California.
ARS Pharmaceuticals (SPRY), a biopharmaceutical company focused on protecting patients from severe allergic reactions and anaphylaxis, has announced its upcoming participation in the Oppenheimer 35th Annual Healthcare Conference.
The company's leadership, including Co-Founder, President and CEO Richard Lowenthal and Chief Commercial Officer Eric Karas, will engage in a fireside chat on February 12, 2025, at 2:40 p.m. ET. The conference will be held virtually, and management will also conduct one-on-one meetings with investors.
A live webcast of the fireside chat will be accessible online and through the company's website's Investors & Media section. The webcast recording will remain available for 90 days on the company's website.
ARS Pharmaceuticals (Nasdaq: SPRY) has launched the neffyinSchools program, offering free neffy® (epinephrine nasal spray) to eligible K-12 schools across the U.S. This initiative aims to provide emergency treatment for severe allergic reactions, such as anaphylaxis, which can occur due to various triggers including foods, insects, and medication.
The program supplies two cartons (four single-use doses) of neffy 2 mg, approved for treating Type I Allergic Reactions in adults and children weighing ≥30 kg (66 lbs.), at no cost to schools. Replacement doses will be provided when the product is used or expires. Schools are encouraged to review state laws to ensure compliance with local regulations regarding undesignated use of epinephrine.
ARS Pharma emphasizes the importance of readily available epinephrine in schools, noting that anaphylaxis can occur suddenly and that one-quarter of anaphylactic reactions in schools are among students with previously undiagnosed allergies. The company also highlights the need for states to update legislation to include nasal delivery of epinephrine.
Interested schools can apply for the program via the School Health Corp. SHConnect platform. A webinar for school nurses and administrators about the program will be held on January 22, 2025. More information is available at www.neffy.com/community-programs.
ARS Pharmaceuticals has announced its preliminary fourth quarter 2024 financial results and 2025 objectives for neffy® (epinephrine nasal spray). The preliminary net product revenue for neffy in Q4 2024 is approximately $6.5 million, with total net product sales for 2024 reaching $7.1 million since its launch on September 23, 2024. More than 14,500 neffy two-pack units were delivered in Q4, including over 1,500 units in the last week of 2024.
The company reported cash, cash equivalents, and short-term investments of approximately $314.0 million as of December 31, 2024, sufficient to fund its operations for at least three years. In 2025, ARS aims to drive neffy’s growth through targeted commercial initiatives, aiming for over 80% commercial insurance coverage and launching direct-to-consumer marketing campaigns.
ARS plans to expand neffy’s commercial access, with Express Scripts adding it to its commercial national formularies in November 2024, targeting over 60% coverage by Q1 2025, and over 80% by Q3 2025. The company also aims to obtain FDA approval for neffy 1 mg for children who weigh 15 to 30 kg by March 6, 2025, with product availability expected in Q2 2025.
Richard Lowenthal, President and CEO of ARS Pharma, will present a company overview at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025.