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ARS Pharmaceuticals, Inc. develops and commercializes neffy, an epinephrine nasal spray for emergency treatment of Type I allergic reactions, including anaphylaxis. The company’s news commonly covers U.S. commercialization, product labeling, international approvals and licensing relationships for neffy, which is marketed as EURneffy in the European Union and the United Kingdom and under a separate trade name in China.
Recurring updates also include quarterly and annual financial results, clinical and scientific presentations on intranasal epinephrine, school-access programs, manufacturing and supply responsibilities for partners, and investor conference activity. The company’s allergy-treatment focus makes regulatory decisions, product access, clinical data and commercial launch progress central themes in its public announcements.
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.
ARS Pharmaceuticals (Nasdaq: SPRY), a biopharmaceutical company focused on protecting patients from severe allergic reactions, has announced its participation in the 2024 Cantor Global Healthcare Conference in New York City from September 17-19, 2024. The company's leadership, including Richard Lowenthal (Co-Founder, President, and CEO) and Eric Karas (Chief Commercial Officer), will engage in a fireside chat on September 17 at 9:10 a.m. ET.
Additionally, management will conduct one-on-one meetings with investors during the conference. The fireside chat will be accessible via live webcast on the company's website, with a replay available for 90 days in the Investors & Media section.
ARS Pharmaceuticals (Nasdaq: SPRY) has submitted a supplemental New Drug Application (sNDA) for neffy® 1 mg, a needle-free epinephrine treatment for Type I Allergic Reactions, including anaphylaxis, in children weighing 15 to 30 kg (33-66 lbs.). This follows the FDA approval of neffy (2 mg) on August 9, 2024, for adults and children weighing 30 kg or more. Key highlights include:
- No risk of needle-related adverse events
- Simple insert and press mechanism for instant delivery
- Easy to use by untrained adults and children as young as 10
- Temperature resistant up to 122°F (50°C)
If approved, neffy 1 mg will be the first needle-free epinephrine option for younger children in over 35 years, addressing the needs of approximately six million children with food allergies in the U.S.