Commercial launch of neffy ® (epinephrine nasal spray) underway in the United States Supplemental NDA for neffy ® 1mg dose granted priority review by FDA; PDUFA target date set for March 6, 2025 Exclusive license agreement with ALK-Abelló to commercialize neffy ® in Europe, Canada and certain other geographies; ARS Pharma to receive $145 million in upfront payment with total deal consideration of up to $465 million plus... Read More

Agreement leverages ALK’s global footprint in developing and commercializing innovative allergy products ARS Pharma to receive an upfront cash payment of $145 million, with total deal consideration of up to $465 million plus double-digit royalties on net sales ARS Pharma retains all U.S. rights, and existing partnerships in Japan, China, Australia and New Zealand with Alfresa, Pediatrix and CSL, respectively SAN DIEGO, Nov.... Read More

SAN DIEGO, Nov. 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 the company will host a conference call and webcast on Wednesday, November 13, 2024, at 8:00 a.m. ET to discuss its third quarter 2024 financial... Read More

SAN DIEGO, Oct. 24, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, announced today that seven abstracts will be featured tomorrow, Friday, October 25 at the 2024 ACAAI Annual Scientific Meeting taking place in Boston,... Read More

SAN DIEGO, Sept. 23, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, announced today that neffy ® (epinephrine nasal spray) is... Read More

SAN DIEGO, Sept. 10, 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 2024 Cantor Global Healthcare Conference being held September 17-19, 2024 in New York City. Richard Lowenthal, Co-Founder,... Read More

If approved, neffy 1 mg will be the first and only needle-free epinephrine treatment available for younger school-aged children The submission of neffy 1 mg sNDA follows FDA approval on August 9, 2024, of neffy (2 mg) for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh 30 kg (66 lbs.) or greater SAN DIEGO, Sept. 09, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc.... Read More

Patients can request a prescription from their existing healthcare provider, or meet with a physician virtually, to request a prescription for neffy ahead of product availability expected by late September Visit neffy.com to pre-order and access comprehensive patient assistance programs available to patients and caregivers Patients who already have a prescription can work with their healthcare provider to request neffy... Read More

EURneffy offers adults and children (≥30 kg) in Europe living with severe allergic reactions the first new delivery method for adrenaline in more than 30 years in the EU European Commission decision follows FDA approval in the United States on August 9, 2024 SAN DIEGO, Aug. 26, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to the development of products to better... Read More

neffy Offers Adults and Children (≥30 kg) Living with Severe Allergic Reactions the First New Delivery Method for Epinephrine in more than 35 Years Well-capitalized to Support Launch and Commercialization of neffy in the U.S., and an Expected Operating Runway of at Least Three Years ARS Pharma to Host Investor Conference Call... Read More

SAN DIEGO, Aug. 07, 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 2024 Wedbush PacGrow Healthcare Conference being held August 13-14, 2024 in New York City. Company management will... Read More

neffy ® (epinephrine nasal spray) New Drug Application (NDA) under review by FDA; discussions are ongoing to finalize labeling with FDA; PDUFA date in early October 2024 EURneffy ® (adrenaline nasal spray) recommended for approval by EMA’s CHMP; formal marketing authorization anticipated in the third quarter of 2024 Outpatient study of neffy for urticaria (hives) on track to initiate in the fourth quarter of 2024 $218.7... Read More

EURneffy positioned to be the first and only needle-free adrenaline option authorized for emergency treatment of allergic reactions (anaphylaxis) in Europe Positive CHMP opinion and recommendation for approval of a mixed application for marketing authorization based on comprehensive data package comparing EURneffy to approved injectable products across a range of dosing scenarios as well as supportive historical data from... Read More

neffy ® (epinephrine nasal spray) New Drug Application (NDA) and CRL response under review by FDA with anticipated review completion by early October 2024 Response submitted for neffy Marketing Authorization Application (MAA) to EMA’s CHMP; CHMP opinion expected in the second quarter of 2024 Preparing to initiate outpatient study of neffy for urticaria (hives) in second half of 2024 $223.6 million in cash and securities as... Read More

CHMP opinion on neffy Marketing Authorization Application anticipated in the second quarter of 2024 Response addresses all issues previously identified by CHMP, and includes results from a repeat dose PK/PD study of neffy under NAC conditions and updated testing concerning nitrosamine levels Exclusive licensing deal for Australia and New Zealand with CSL Seqirus; CSL Seqirus will be responsible for applying for regulatory... Read More

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