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) has filed for approval of neffy® (epinephrine nasal spray) 2 mg in Canada and the United Kingdom, where it will be marketed as EURneffy®, through its licensing partner ALK-Abelló A/S. This follows neffy's recent U.S. approval for Type I Allergic Reactions treatment in adults and children weighing ≥30 kg.
The November 2024 licensing agreement with ALK includes exclusive commercialization rights in Europe, Canada, UK, and other regions. ARS Pharma received a $145 million upfront payment and could earn up to $320 million in additional milestones, plus double-digit royalties on net sales. The company will manufacture and supply neffy to ALK.
ARS Pharma now has approval or pending applications in markets representing over 98% of the global epinephrine market. The company maintains U.S. rights and has existing partnerships in China, Japan, Australia, and New Zealand. A Phase 2b trial for chronic urticaria treatment is planned for early 2025.
ARS Pharmaceuticals (SPRY) announced that Express Scripts has added neffy® (epinephrine nasal spray) to its Commercial national formularies, effective November 22, 2024. This inclusion makes neffy accessible to millions of commercially insured patients nationwide. neffy 2 mg, the first FDA-approved epinephrine nasal spray, treats Type I Allergic Reactions in adults and children weighing ≥30 kg.
The product features a needle-free design, 30-month shelf-life, and temperature tolerance up to 122°F. This represents the first new epinephrine delivery method in over 35 years. The formulary inclusion occurred just nine weeks after product introduction, demonstrating strong market acceptance. ARS Pharma expects additional payers to provide neffy access in the coming weeks and offers support programs for coverage and affordability.
ARS Pharmaceuticals (SPRY), a biopharmaceutical company focused on protecting patients from severe allergic reactions and anaphylaxis, has announced its upcoming participation in the 43rd Annual J.P. Morgan Healthcare Conference. The conference will take place from January 13-16, 2025, in San Francisco.
Co-Founder, President and CEO Richard Lowenthal is scheduled to present on Wednesday, January 15, 2025, at 7:30 a.m. PT. The company's management team will also engage in one-on-one investor meetings during the event. A live webcast of the presentation will be accessible through the company's website's Investors & Media section, with the recording remaining available for 90 days afterward.
ARS Pharmaceuticals (SPRY) announced that its licensing partners have filed for approval of neffy® (epinephrine nasal spray) 2 mg in China, Japan, and Australia. This follows neffy's recent U.S. approval for Type I Allergic Reactions treatment in adults and children weighing ≥30 kg.
Clinical trials showed promising results, including a Phase 3 study in Japanese pediatric patients where 100% of participants responded to a single dose, with median symptom resolution time of 16 minutes. In China, an 81-person PK/PD study replicated U.S. trial results.
The company maintains U.S. rights while having partnerships with Pediatrix Therapeutics (China), Alfresa Pharma (Japan), CSL Seqirus (Australia/New Zealand), and ALK-Abelló (Europe/Canada).
ARS Pharmaceuticals (Nasdaq: SPRY) announced the launch of neffyinSchools Program in January 2025, providing eligible K-12 schools with free neffy® (epinephrine nasal spray) for emergency allergic reaction treatment. Schools will receive two cartons (four doses) of neffy® 2mg, with free replacements upon use or expiration.
The program addresses critical needs as studies show up to 18% of children with food allergies experience reactions at school, and 25% of severe reactions occur in children with no previous allergy diagnosis. neffy® offers a needle-free alternative with a 30-month shelf life, making it safer for school staff to administer.
Schools must verify state legislation compliance for epinephrine stocking and indemnification laws before participation. Currently, 49 states and Washington DC allow schools to stock epinephrine, though specific regulations may vary by state.
ARS Pharmaceuticals (SPRY) reported Q3 2024 financial results and business updates. The company launched neffy®, the first needle-free epinephrine nasal spray, in the US following FDA approval. Total revenue was $2.1M, with $0.6M from neffy sales. The company secured an exclusive license agreement with ALK-Abelló worth up to $465M plus royalties for European and Canadian markets. Net loss was $19.1M for Q3. The company has $349.6M in pro-forma cash position, providing a three-year runway. Over 5,700 healthcare providers were reached, with 1,700+ submitting neffy prescriptions. FDA granted priority review for neffy 1mg dose with PDUFA date set for March 6, 2025.
ARS Pharmaceuticals (SPRY) has entered into a licensing agreement with ALK-Abelló for the commercialization of neffy®, a needle-free epinephrine nasal spray for allergic reactions, in Europe, Canada, and other regions outside the U.S. The deal includes a $145 million upfront payment, with potential total consideration of up to $465 million plus double-digit royalties on net sales.
ARS Pharma retains all U.S. rights and maintains existing partnerships in Japan, China, Australia, and New Zealand. The agreement leverages ALK's presence across 46 countries. neffy® received FDA approval and European Commission marketing authorization in August 2024, with Canadian regulatory filing planned for late 2024.
ARS Pharmaceuticals (Nasdaq: SPRY) announced it will host a conference call and webcast on November 13, 2024, at 8:00 a.m. ET to discuss its third quarter 2024 financial results and business highlights. The company's management will also participate in several upcoming investor conferences, including Guggenheim's Inaugural Healthcare Innovation Conference, Stifel Healthcare Conference, and Jefferies London Healthcare Conference. Webcasts will be available on the company's website for 30 days following each event.
ARS Pharmaceuticals (Nasdaq: SPRY) announced the presentation of seven abstracts at the 2024 ACAAI Annual Scientific Meeting in Boston. The presentations focus on their product neffy®, the first needle-free intranasal epinephrine spray for Type I allergic reactions and anaphylaxis. The abstracts cover various aspects including cardiovascular safety, human factor studies, and real-world administration data in pediatric patients. The research demonstrates that nasal spray delivery of epinephrine is successfully administered in real-world situations and provides insights into epinephrine's mechanism of action. The presentations are scheduled for October 25, with topics ranging from pharmacokinetics to healthcare provider interest in the intranasal device.
ARS Pharmaceuticals (Nasdaq: SPRY) announced that neffy® (epinephrine nasal spray) is now available by prescription across the U.S. for treating Type I Allergic Reactions, including anaphylaxis, in adults and children weighing ≥30 kg. The FDA approved neffy 2 mg last month, marking it as the first and only needle-free treatment for severe allergic reactions.
Through neffyConnect and BlinkRx, eligible commercially insured patients can obtain two single-use neffy devices for a $25 co-pay. Uninsured patients or those without coverage can access neffy for $199 for two devices. The company is also offering free carrying cases and has implemented various patient assistance programs to ensure accessibility.
ARS Pharmaceuticals plans to expand access to EURneffy® in Europe and has submitted an sNDA for neffy 1 mg use in pediatric patients weighing 15 to 30 kg.
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