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ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) is a pioneering biopharmaceutical company dedicated to developing innovative solutions for patients at risk of severe allergic reactions, potentially leading to anaphylaxis. The company is primarily focused on its flagship product candidate, neffy, a nasal spray formulation of epinephrine designed for emergency treatment of Type I allergic reactions.
ARS Pharma is committed to addressing the limitations of traditional epinephrine autoinjectors, such as needle phobia, portability issues, and complexity of use. neffy aims to provide a needle-free, easy-to-use, and reliable alternative, enhancing patient compliance and timely administration in emergency situations. Leveraging a proprietary absorption enhancer, Intravail, neffy ensures rapid and effective epinephrine absorption comparable to injections.
As of November 2023, ARS Pharma announced that despite initial regulatory hurdles, the company is on track to resubmit its New Drug Application (NDA) for neffy to the FDA by mid-2024, with potential U.S. market launch in the latter half of the year. This follows the FDA's additional requirement for a pre-approval repeat-dose rhinitis study, which ARS Pharma has proactively addressed. The company recently published positive results from clinical studies in the Journal of Allergy and Clinical Immunology, further validating neffy's safety and efficacy.
Financially, ARS Pharma is solidly positioned, with an expected $195 million in cash and equivalents by the anticipated neffy launch date. This ensures the company's capability to sustain operations and support the product's market introduction and growth. Additionally, ARS Pharma has expanded its reach by entering into an exclusive distribution agreement with CSL Seqirus for the Australian and New Zealand markets, exemplifying its strategic approach to global commercialization.
The company's latest achievements include the successful completion of a Phase 2 trial for neffy in treating chronic spontaneous urticaria, showing promising results in alleviating symptoms such as itch and hives. ARS Pharma plans to initiate further outpatient studies in 2024, potentially leading to a pivotal efficacy study in 2025.
Overall, ARS Pharmaceuticals stands out for its innovative approach to addressing unmet needs in allergy treatment, demonstrating resilience and commitment to bringing a transformative, needle-free epinephrine solution to patients worldwide.
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.
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.
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