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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 (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.
ARS Pharmaceuticals (Nasdaq: SPRY) has launched pre-ordering services for neffy®, the first FDA-approved needle-free epinephrine nasal spray for Type I Allergic Reactions, including anaphylaxis. Patients can now pre-order neffy through neffy.com, with availability expected by late September. The company offers two options for obtaining prescriptions: through existing healthcare providers or virtual physician consultations.
ARS Pharmaceuticals is prioritizing patient access with comprehensive support programs, including:
- neffyConnect service for insurance navigation and prior authorization assistance
- Co-pay savings program limiting costs to $25 for eligible commercially insured patients
- Cash price of $199 for two doses for eligible patients without coverage
- Patient Assistance Program (PAP) providing neffy at no cost for eligible uninsured or underinsured patients
The company aims to address injection hesitancy and ensure timely treatment of anaphylaxis with this new delivery option.
ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) announced that the European Commission approved EURneffy (adrenaline nasal spray) on August 22, 2024, for emergency treatment of allergic reactions (anaphylaxis). This marks the first needle-free treatment option in the EU for adults and children (≥30 kg) with severe allergies in over 30 years. EURneffy's approval follows FDA approval in the US on August 9, 2024.
The approval was based on extensive clinical data from over 700 study participants and 1,200 administrations. EURneffy offers advantages such as a smaller form factor and longer, less temperature-sensitive shelf-life, potentially increasing the likelihood of patients carrying and administering adrenaline during allergic reactions. ARS Pharma anticipates EURneffy's availability in certain EU Member States by Q4 2024.
ARS Pharmaceuticals (Nasdaq: SPRY) has received FDA approval for neffy® (epinephrine nasal spray), the first needle-free treatment for Type I Allergic Reactions, including anaphylaxis. This breakthrough offers adults and children (≥30 kg) a new delivery method for epinephrine after 35 years. neffy is expected to be available within eight weeks of approval.
Key points:
- First needle-free, easy-to-carry epinephrine delivery method
- Potential to reduce administration time and improve clinical outcomes
- Robust patient access programs, including a $25 copay for most commercially insured patients
- 30-month shelf life with temperature tolerance up to 122°F (50°C)
- Expected EU launch in Q4 2024
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