ARS Pharms Stock Price, News & Analysis

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.

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.