TEL AVIV, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Nasus Pharma Ltd. (NYSE: NSRX) (“Nasus Pharma” or the “Company”), a clinical-stage pharmaceutical company focused on the development of innovative intranasal products to treat emergency medical conditions, today announced that it recently received a No-Objection Letter from Health Canada, the country’s primary regulatory authority for drugs and medical products, for the Company’s planned Phase 2 clinical study of NS002, its investigational intranasal epinephrine p ...

Core Insights - The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved EURneffy 2 mg in the UK for the treatment of anaphylaxis in adults and children weighing 30 kg or more, with market launch expected soon after access negotiations [1][2][4] - EURneffy is the first approved adrenaline nasal spray for emergency treatment of anaphylaxis, potentially transforming the lives of patients with severe allergies in the UK, which is the largest anaphylaxis market in Europe [2][4] - The product features a needle-free design, longer shelf life of 30 months, and superior temperature stability compared to existing adrenaline auto-injectors, enhancing usability in emergency situations [3][4] Company Overview - ALK is a global specialty pharmaceutical company focused on allergy and allergic asthma, headquartered in Hørsholm, Denmark, employing around 2,800 people and listed on Nasdaq Copenhagen [9] - The approval of EURneffy does not impact ALK's financial guidance for 2025, indicating stable financial expectations despite the new product introduction [6] Market Context - Anaphylaxis affects up to eight out of every 100,000 people annually in Europe, with one in 300 experiencing it at some point in their lives, highlighting the significant market need for effective treatment options [5] - The strategic license agreement with ARS Pharmaceuticals grants ALK exclusive global rights to commercialize neffy, excluding certain regions, and includes a co-promotion agreement in the USA [6]

Summary of ARS Pharmaceuticals (SPRY) FY Conference Call - June 03, 2025 Company Overview - **Company**: ARS Pharmaceuticals - **Product**: Nefi, an epinephrine nasal spray designed to treat emergency type one allergic reactions, including anaphylaxis [2][3] Market Opportunity - **Market Size**: The existing prescription market consists of approximately 6.5 million patients, representing a market value of about $3 billion [4][18] - **Potential Expansion**: There is a significant population that has not received prescriptions, estimated to be around 13.5 million, which presents a substantial opportunity for market growth [19][20] - **Institutional Use**: Nefi's needle-free design allows for broader institutional use, which is currently limited by the need for training associated with auto-injectors [5][21] Product Features and Advantages - **Administration Method**: Nefi is a needle-free solution, making it less intimidating and easier to use compared to traditional auto-injectors [10][12] - **Patient Compliance**: Only 10-20% of patients use auto-injectors correctly, and about 50% do not carry them at all. Nefi's design aims to improve patient compliance and reduce delays in treatment [10][12][14] - **Device Reliability**: The device used for Nefi is the same as that for Narcan, known for its reliability and ease of use [14][15] Sales and Marketing Strategy - **Sales Performance**: Nefi reported net sales of $7.8 million in the first quarter, just two quarters post-launch [3] - **Insurance Coverage**: Currently, 92% of commercial insurance plans cover Nefi, with 57% not requiring prior authorization [26][38] - **Direct-to-Consumer Campaign**: A significant investment of $45 million is planned for the DTC campaign to raise awareness and drive demand [28][42] Regulatory and Approval Status - **Global Approvals**: Nefi has received approval in Europe and is pending approval in the UK, Japan, and China [22][24] - **Patent Protection**: Strong patent protection is in place, with recent challenges to patents being upheld, providing confidence in market exclusivity [5][66] Future Outlook - **Market Growth Potential**: The company anticipates a potential market size exceeding $3 billion, with additional opportunities in chronic therapy markets [56][57] - **Expansion of Sales Force**: A partnership with ALK will enhance the sales force's reach, particularly among pediatricians [52][54] - **Clinical Studies**: Ongoing studies for urticaria treatment are expected to yield results in the second quarter of next year, potentially expanding the product's indications [55] Key Challenges - **Awareness and Education**: Only 16% of patients were aware of Nefi prior to the DTC campaign, indicating a need for increased education and outreach [43][44] - **Cost and Coverage Concerns**: Some doctors cite cost and coverage as barriers to prescribing Nefi, although these issues are improving [36][38] Conclusion - **Strategic Focus**: The company is focused on expanding awareness, improving insurance coverage, and enhancing the comfort of doctors in prescribing Nefi, with expectations for accelerated growth in the coming years [56][57]