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SBTX News and Press, Silverback Therapeutics Inc. From 02/05/24

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Company Name: Silverback Therapeutics Inc.
Stock Symbol: SBTX
Market: NASDAQ

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SBTX - 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 patients 100% response rate with a single dose of neffy observed in pediatr...

SBTX - 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 (NDA) for neffy ® anticipated in H1 2024 Ended thi...

SBTX - 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 effective option across patient sub-populations based on data including the...

SBTX - 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 from severe allergic reactions that could lead to anaphylaxis, today announced that the United...

SBTX - 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, EpiPen Repeat doses of neffy resulted in statistically greater mean maximum responses o...

SBTX - ARS Pharmaceuticals, Inc. (SPRY) Investigation: Bronstein, Gewirtz & Grossman, LLC Encourages Investors to Seek Compensation for Alleged Wrongdoings

NEW YORK, NY / ACCESSWIRE / September 22, 2023 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of ARS Pharmaceuticals, Inc. ("ARS" or "the Company") (NASDAQ:SPRY). Investors who purchased ARS securities are encouraged to obtain additional inform...

SBTX - ARS Pharmaceuticals Investigated by Block & Leviton For Potential Securities Law Violations; Investors Who Have Lost Money Are Encouraged to Contact the Firm

BOSTON, MA / ACCESSWIRE / September 20, 2023 / Block & Leviton is investigating ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) for potential securities law violations. Investors who have lost money in their ARS Pharmaceuticals investment should contact the firm to learn more about how they might ...

SBTX - 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 Advisory Committee (PADAC), held in May 2023, recommended neffy ap...

SBTX - 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 with $252.2 million in cash, cash equivalents and short-term investments...

SBTX - 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 themselves from severe allergic reactions that could lead to anaphylaxis, today announced that the ...

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