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February 05, 2024 09:01 ET | Source: ARS Pharmaceuticals, Inc.

ARS Pharmaceuticals to Present Positive Clinical Efficacy Data for neffy® (epinephrine nasal spray) at 2024 AAAAI Annual Meeting

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 patients100%...
November 09, 2023 16:00 ET | Source: ARS Pharmaceuticals, Inc.

ARS Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Business Updates

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...
November 09, 2023 11:02 ET | Source: ARS Pharmaceuticals, Inc.

ARS Pharmaceuticals Announces Presentation of Clinical Data Supporting neffy® (epinephrine nasal spray) for the Treatment of Allergic Reactions (Type I) including Anaphylaxis

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...
October 06, 2023 09:03 ET | Source: ARS Pharmaceuticals, Inc.

ARS Pharmaceuticals Announces Scheduling of a Type A Meeting with the U.S. FDA for neffy® (epinephrine nasal spray)

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...
October 03, 2023 09:03 ET | Source: ARS Pharmaceuticals, Inc.

Single and Repeat Dose Clinical Study of neffy (epinephrine nasal spray) Published in the Journal of Allergy and Clinical Immunology

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, EpiPenRepeat doses...
September 19, 2023 22:49 ET | Source: ARS Pharmaceuticals, Inc.

FDA Issues Complete Response Letter for neffy® (epinephrine nasal spray) New Drug Application with Request for Additional Study

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...
August 10, 2023 16:00 ET | Source: ARS Pharmaceuticals, Inc.

ARS Reports Second Quarter 2023 Financial Results and Provides Business Updates

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...
June 20, 2023 08:00 ET | Source: ARS Pharmaceuticals, Inc.

ARS Pharmaceuticals Announces PDUFA Date Extension for neffy® (Intranasal (IN) Epinephrine) for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis

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...
May 15, 2023 09:00 ET | Source: ARS Pharmaceuticals, Inc.

ARS Pharmaceuticals Highlights Progress and Reports First Quarter 2023 Financial Results

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...
May 11, 2023 19:01 ET | Source: ARS Pharmaceuticals, Inc.

FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for neffy® (Intranasal (IN) Epinephrine) for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis

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...