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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) 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
ARS Pharmaceuticals (Nasdaq: SPRY), a company focused on protecting people from severe allergic reactions, announced its participation in the 2024 Wedbush PacGrow Healthcare Conference. The event will take place on August 13-14, 2024 in New York City. Company management will meet with investors on Wednesday, August 14, 2024, for one-on-one discussions.
This conference provides ARS Pharmaceuticals with an opportunity to showcase its work in empowering at-risk patients and caregivers against anaphylaxis. The company's presence at this healthcare-focused event could potentially attract investor interest and highlight its position in the biopharmaceutical sector.
ARS Pharmaceuticals (Nasdaq: SPRY) reported its Q2 2024 financial results and business highlights. Key points include:
1. neffy® (epinephrine nasal spray) NDA under FDA review with PDUFA date in early October 2024.
2. EURneffy® recommended for approval by EMA's CHMP, with formal marketing authorization expected in Q3 2024.
3. Outpatient study of neffy for urticaria set to begin in Q4 2024.
4. $218.7 million in cash and equivalents as of June 30, 2024, providing at least three years of operating runway.
5. Q2 2024 net loss of $12.5 million, compared to $17.4 million in Q2 2023.
6. R&D expenses decreased to $6.9 million, while G&A expenses reduced to $8.9 million in Q2 2024.
ARS Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) recommended the approval of EURneffy (adrenaline nasal spray) for emergency treatment of allergic reactions, including anaphylaxis, in the European Union. This decision marks EURneffy as potentially the first and only needle-free adrenaline option in Europe. The positive opinion is based on extensive data, including studies involving over 700 participants and 1,200 administrations, demonstrating its efficacy and safety. The European Commission is expected to grant formal marketing authorization in Q3 2024, with availability anticipated in Q4 2024. The U.S. FDA is reviewing the same data, with a decision expected by October 2, 2024.
ARS Pharmaceuticals reported progress in regulatory processes for neffy, an epinephrine nasal spray, with an anticipated FDA review completion by October 2024. The company submitted responses for NDA and MAA to FDA and EMA respectively. ARS is well-capitalized with $223.6 million in cash and securities as of March 31, 2024, supporting neffy's expected U.S. launch in the second half of 2024. Clinical expansion for urticaria is underway, along with partnerships for global commercialization. Financially, R&D expenses decreased, G&A expenses decreased, and the net loss reduced compared to the same quarter in 2023.
ARS Pharmaceuticals submitted the Day 180 response for neffy (epinephrine nasal spray) Marketing Authorization Application to EMA's CHMP and entered a license agreement with CSL Seqirus for commercialization in Australia and New Zealand. The CHMP opinion on neffy is expected in the second quarter of 2024, addressing all identified issues and including results from a repeat dose study and updated nitrosamine testing. CSL Seqirus will handle regulatory approval, reimbursement, and commercialization, while ARS Pharma will manage manufacturing and supply.
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