Articles from ARS Pharmaceuticals, Inc.

Company to Host Conference Call on March 20 at 8:30 a.m. ET

Approximately five months after launch, the inclusion of neffy on these three additional formularies has expanded access to half of all patients and caregivers managing Type 1 allergic reactions, bringing the total number of formulary platforms covering neffy to 30

Oral presentation on an efficacy study conducted in Japanese patients comparing anaphylaxis symptoms during oral food challenge with neffy as the initial treatment compared to site historical data on intramuscular auto-injectors, antihistamines and inhalers; patients receiving neffy had lower symptom scores within 10 minutes, supporting neffy as a needle-free option for management of anaphylaxis

SAN DIEGO, Feb. 05, 2025 (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 Oppenheimer 35th Annual Healthcare Conference being held virtually.

School administrators and nurses are encouraged to review applicable state laws and regulations to ensure neffy® (epinephrine nasal spray) 2 mg for undesignated use meets applicable state law requirements

Preliminary fourth quarter neffy® net product revenue of approximately $6.5 million

Canada and United Kingdom represent two of the largest markets within the ALK portfolio with plans to expand filings of neffy (epinephrine nasal spray) 2 mg in other key global regions

Inclusion of neffy on Express Scripts commercial formularies was effective November 22, 2024 and expands access to patients and caregivers managing Type 1 Allergic Reactions

SAN DIEGO, Dec. 18, 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 43rd Annual J.P. Morgan Healthcare Conference, being held January 13-16, 2025 in San Francisco.

Licensing partners in key Asia Pacific countries have filed for approval of neffy (epinephrine nasal spray) 2 mg with regulatory agencies

Qualifying public and private K-12 Schools in the U.S. will be eligible to receive two free cartons (four single use doses) of neffy® (epinephrine nasal spray) 2mg for use in emergency treatment of allergic reactions including anaphylaxis

Commercial launch of neffy® (epinephrine nasal spray) underway in the United StatesSupplemental NDA for neffy®1mg dose granted priority review by FDA; PDUFA target date set for March 6, 2025Exclusive 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 double-digit royaltiesWell-capitalized with $349.6 million in cash, cash equivalents and short-term investments on a pro forma basis, supporting an operating runway of at least three yearsCompany to host conference call and webcast today at 8:00 a.m. ET

Agreement leverages ALK’s global footprint in developing and commercializing innovative allergy products

Third Quarter Earnings Conference Call to be Held on November 13 at 8:00 a.m. ET

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, Massachusetts. The posters highlight a wide range of studies focused on intranasal epinephrine administration, including cardiovascular safety, human factor study of carrying two devices at all times, and real-world administration data in pediatric patients.

Visit neffy.com to “Get neffy Now” and access the comprehensive patient assistance programs available through neffyConnect

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.

If approved, neffy 1 mg will be the first and only needle-free epinephrine treatment available for younger school-aged children

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

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

neffy Offers Adults and Children (≥30 kg) Living with Severe Allergic Reactions the First New Delivery Method for Epinephrine in more than 35 Years

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 participate in one-on-one meetings with investors on Wednesday, August 14, 2024.

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 positioned to be the first and only needle-free adrenaline option authorized for emergency treatment of allergic reactions (anaphylaxis) in Europe

neffy® (epinephrine nasal spray) New Drug Application (NDA) and CRL response under review by FDA with anticipated review completion by early October 2024

CHMP opinion on neffy Marketing Authorization Application anticipated in the second quarter of 2024

SAN DIEGO, April 03, 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, announced today that it has submitted its response to the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for neffy® (epinephrine nasal spray), for the treatment of Type I allergic reactions including anaphylaxis.

SAN DIEGO, March 07, 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 hosted an investor event highlighting neffy® (epinephrine nasal spray), an investigational new drug, for the treatment of Type I allergic reactions. The event included presentations by members of the ARS Pharma management team and by two distinguished allergists, Dr. Jonathan Spergel, M.D., Ph.D. and Dr. Thomas B. Casale, M.D.

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.

SAN DIEGO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQSPRY), 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 positive efficacy results in its phase 2 inpatient chronic spontaneous urticaria study with neffy (epinephrine nasal spray), an investigational new drug. The trial met its primary endpoints with both 1 mg and 2 mg neffy demonstrating statistically significant and clinically meaningful changes from baseline in itch, hives, urticaria and erythema scores as early as 5 minutes after dosing. Urticaria is a skin disorder that causes itchy hives and/or angioedema; 50% of chronic urticaria cases1 are non-responsive to first-line antihistamine therapy.

SAN DIEGO, Feb. 22, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQSPRY), 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 the event, please register here.

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

SAN DIEGO, Feb. 05, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQSPRY), 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 new clinical data, including efficacy outcomes supporting neffy (epinephrine nasal spray), will be presented during the 2024 American Academy of Allergy, Asthma and Immunology (AAAAI). The meeting will be held February 23-26, 2024, in Washington, DC.

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

Data to be Presented in Four Oral Presentations and Posters at the 2023 American College of Allergy, Asthma and Immunology Annual Scientific Meeting

SAN DIEGO, Oct. 06, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQSPRY), 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 (CRL) previously issued regarding its new drug application (NDA) for neffy® (epinephrine nasal spray) for the treatment of allergic reactions (Type I), including anaphylaxis.

SAN DIEGO, Oct. 03, 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, announced today the publication of its full pharmacokinetic and pharmacodynamic results from one of its four primary registration studies of neffy (epinephrine nasal spray) in the Journal of Allergy and Clinical Immunology (JACI). JACI is the official scientific publication of the American Academy of Allergy, Asthma and Immunology and the most cited journal in the field of allergy and clinical immunology. The clinical study evaluated single and repeat doses of neffy compared to single and repeat doses of approved injection products in healthy subjects.

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

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

Additional Time Needed for Labeling and Post-Marketing Requirements Discussions; PDUFA Date Set for September 19, 2023

FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for neffy® for the Treatment of Allergic Reactions (Type I), Including Anaphylaxis

SAN DIEGO, May 11, 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’s (FDA) Pulmonary-Allergy Drug Advisory Committee (PADAC) voted 16:6 in favor for adults, and 17:5 in favor for children (<18 years of age and ≥30 kg), that available data support a favorable benefit-risk assessment for neffy in the treatment of severe allergic reaction (Type 1), including anaphylaxis,for adults and children who weigh more than 30kg.

SAN DIEGO, May 09, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQSPRY), 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 review the new drug application (NDA) for neffy®. neffy has the potential to be the first, non-injectable epinephrine nasal spray medicine for the treatment of patients with allergic reactions (type 1), including anaphylaxis.

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 May 11, 2023 to review the new drug application (NDA) for neffy®. neffy has the potential to be the first, non-injectable epinephrine nasal spray medicine for the treatment of patients with allergic reactions (type 1), including anaphylaxis.

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

Data to be Presented in Five Poster Presentations at the 2023 American Academy of Allergy, Asthma and Immunology Annual Meeting

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 agreement followed a portfolio review conducted by Recordati aimed at focusing commercial efforts on core strategic therapeutic areas. In 2020, the original license and supply agreement between ARS and Recordati provided ARS with non-dilutive funding for the early clinical development of neffy, while providing Recordati marketing rights to neffy in the European Union, Iceland, Liechtenstein, Norway, Switzerland, United Kingdom, Russia/CIS, Turkey, Middle East and French-speaking African countries. Today, ARS is in a strong position, with approximately $275 million in cash as of year-end 2022, and an anticipated 2023 US launch of neffy, if approved. ARS’ cash is projected to be at least three years of operating runway based on the company’s current operating plan.

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 chat during the SVB Securities Virtual Global Biopharma Conference 2023 on Thursday, February 16, 2023 at 2:20 p.m. ET.

Data from Pivotal Clinical Trials to be Presented in Five Poster Presentations at the 2022 American College of Allergy, Asthma and Immunology Annual Scientific Meeting

ARS Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review ARS’ New Drug Application (NDA) for neffy for the emergency treatment of allergic reactions (type I) including anaphylaxis in adults and children ≥30 kg (66 lbs). If approved by the FDA, neffy would be the first non-injectable treatment available to patients with allergic reactions (type I) including anaphylaxis.

ARS Pharmaceuticals, Inc., 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 expansion of its executive leadership team with the appointments of industry veterans, Eric Karas as chief commercial officer and Kathleen (Kathy) Scott as chief financial officer.