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Response addresses all additional requests in FDA CRL, including positive data from a repeat dose PK/PD study of neffy under nasal allergen challenge (NAC) conditions, and updated testing that detected no measurable nitrosamine levels, conducted per August 2023 FDA Guidance Submission...
Preparing to submit response to the FDA’s CRL for neffy ® (epinephrine nasal spray) in Type I allergic reactions in early Q2 2024, following successful completion of neffy repeat dose nasal allergen challenge study and nitrosamine assessments, with ...
Significant unmet need with 80-90% of patients with current epinephrine Rx not using as directed, and only ~15% of diagnosed severe Type I allergy population with a current epinephrine prescription Multiple favorable attributes and potential best-in-class profile of neffy highlighted ...
SAN DIEGO, March 06, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today announced its participa...
neffy demonstrated statistically significant and clinically meaningful improvement in pruritus, hives, body surface area and erythema in treatment-resistant chronic spontaneous urticaria patients, a skin disorder that causes itchy hives and/or angioedema Data supports continued ...
Repeat doses of neffy under nasal allergen challenge demonstrate a pharmacokinetic profile greater than or similar to injection, and a pharmacodynamic profile greater than injection Company believes completion of repeat dosing study and nitrosamine assessments address the de...
Six posters and oral presentations to be presented, including efficacy data for neffy from two distinct clinical studies in oral food challenge induced anaphylaxis and chronic urticaria patients 100% response rate with a single dose of neffy observed in pediatr...
Company is on track with ongoing repeat-dose study under allergen-induced allergic rhinitis conditions requested by U.S. FDA with topline data expected in Q1 2024 Resubmission of New Drug Application (NDA) for neffy ® anticipated in H1 2024 Ended thi...
Data to be Presented in Four Oral Presentations and Posters at the 2023 American College of Allergy, Asthma and Immunology Annual Scientific Meeting Supports neffy’s potential to be a safe and effective option across patient sub-populations based on data including the...
SAN DIEGO, Oct. 06, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc . (NASDAQ: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today announced that the United...
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Response addresses all additional requests in FDA CRL, including positive data from a repeat dose PK/PD study of neffy under nasal allergen challenge (NAC) conditions, and updated testing that detected no measurable nitrosamine levels, conducted per August 2023 FDA Guidance Submission...
Preparing to submit response to the FDA’s CRL for neffy ® (epinephrine nasal spray) in Type I allergic reactions in early Q2 2024, following successful completion of neffy repeat dose nasal allergen challenge study and nitrosamine assessments, with ...
Significant unmet need with 80-90% of patients with current epinephrine Rx not using as directed, and only ~15% of diagnosed severe Type I allergy population with a current epinephrine prescription Multiple favorable attributes and potential best-in-class profile of neffy highlighted ...