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 of CRL response triggers up to six-month review period by the FDA SAN DIEGO, April 03, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc.... Read More

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 expected up to six-month review period In Phase 2 urticaria clinical trial, neffy met primary endpoints and showed rapid symptom control; planning to initiate outpatient study... Read More

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 at the event Potential for epinephrine market to significantly expand from today due to availability of neffy SAN DIEGO, March 07, 2024 (GLOBE... Read More

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 participation in the Leerink Partners Global Biopharma Conference 2024 being held March 11-13, 2024 in Miami, Florida. Richard Lowenthal,... Read More

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 development of neffy in urticaria with planned... Read More

SAN DIEGO, Feb. 22, 2024 (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 it will host a virtual investor day highlighting neffy ® (epinephrine nasal spray) on Thursday, March 7, 2024, at 1:00 p.m. ET. To participate in... Read More

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 deficiencies identified in the U.S. Food and Drug... Read More

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 pediatric subjects experiencing anaphylaxis symptoms following oral food challenge; efficacy data intended to support post-marketing promotion of neffy, if approved On track... Read More

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 third quarter with $241.9 million in cash, cash equivalents and short-term investments with an expected operating runway of at least three years; well-capitalized to support... Read More

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 relationship between BMI/body weight and epinephrine exposure, congestion/rhinitis during upper respiratory tract infection, and pediatrics SAN DIEGO, Nov. 09,... Read More

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 States (U.S.) Food and Drug Administration (FDA) has scheduled a Type A meeting to discuss the contents of a Complete Response Letter... Read More

neffy resulted in robust responses on pharmacodynamic (PD) surrogates of efficacy observed even at 1 minute after dosing, and which were comparable to, or greater in magnitude than, EpiPen Repeat doses of neffy resulted in statistically greater mean maximum responses on PD surrogates for efficacy compared to EpiPen Repeat... Read More

Company aligned with FDA in August 2023 on both physician labeling and post-market requirements, which included a repeat-dose study of neffy under allergen-induced allergic rhinitis conditions FDA Advisory Committee (PADAC), held in May 2023, recommended neffy approval based on current data set and without recommending additional trials FDA now requests repeat-dose study be completed prior to neffy approval as opposed to... Read More

ARS continues engagement with U.S. FDA on final labeling and post-marketing commitments for the neffy® new drug application; PDUFA target action date set for September 19, 2023 Ended second quarter with $252.2 million in cash, cash equivalents and short-term investments; well-capitalized to support anticipated launch of neffy in the U.S. and an expected operating runway of at least three years SAN DIEGO, Aug. 10, 2023 (GLOBE... Read More

SAN DIEGO, June 20, 2023 (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 that the U.S. Food and Drug Administration (FDA) extended the Prescription Drug User Fee Act (PDUFA) target action date by three months for the New... Read More

FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for neffy® for the Treatment of Allergic Reactions (Type I), Including Anaphylaxis New Drug and Marketing Authorization Applications for neffy Under Review with FDA and EMA, Respectively; FDA PDUFA Target Action Date Anticipated mid-2023 $264.5 Million in Cash, Cash Equivalents and Short-term Investments to Support Operating Runway for the Next Three... Read More

FDA Advisory Committee Votes: neffy Data Support a Favorable Benefit-Risk Assessment in Adults (16:6 in Favor) and in Children <18 years of age and ≥30 kg (17:5 in Favor) If Approved, neffy Will Become the First Needle-Free Epinephrine Product for the Treatment of Severe Allergic Reactions FDA Approval Decision Anticipated Mid-2023 SAN DIEGO, May 11, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc . (Nasdaq: SPRY), a... Read More

SAN DIEGO, May 09, 2023 (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 that the U.S. Food and Drug Administration (FDA) posted briefing documents for the Pulmonology, Allergy-Drugs Advisory Committee (PADAC) meeting to... Read More

SAN DIEGO, March 28, 2023 (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 that the U.S. Food and Drug Administration (FDA) has scheduled a Division of Pulmonology, Allergy and Critical Care Advisory Committee meeting on... Read More

New Drug Application and Marketing Authorization Application for neffy ® Currently Under Review with the FDA and EMA; FDA PDUFA Target Action Date Anticipated in Mid-2023 Strong Financial Position with $274.4 Million in Cash, Cash Equivalents and Short-term Investments to Support Operating Runway for the Next Three Years SAN DIEGO, March 23, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a... Read More

Data to be Presented in Five Poster Presentations at the 2023 American Academy of Allergy, Asthma and Immunology Annual Meeting Data Support New Drug Application for neffy ® , Currently Under Review with the FDA SAN DIEGO, Feb. 23, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe... Read More

SAN DIEGO, Feb. 22, 2023 (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 that the company reached agreement to reacquire commercial rights to neffy , known as ARS-1 in the European region, from Recordati S.p.A. The... Read More

SAN DIEGO, Feb. 09, 2023 (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 reported that Richard Lowenthal, M.Sc., MSEL, co-founder and chief executive officer, and Eric Karas, chief commercial officer, will participate in a fireside... Read More

Over $280 Million in Combined Cash and Securities and at least Three Years Operating Runway to Support Launch and Commercialization of neffy ® in the U.S., if Approved NDA Currently Under FDA Review; PDUFA Anticipated Mid-2023 MAA validated in the European Union Under Review SAN DIEGO – November 8, 2022 – ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) (ARS or the Company), a biopharmaceutical company dedicated to empowering... Read More