ARS Pharmaceuticals Inc

ARS Pharmaceuticals, Inc. engages in developing neffy™, an intranasal epinephrine product in clinical development for patients and their caregivers with Type I allergic reactions including food, medications, and insect bites that could lead to life-threatening anaphylaxis. The company is headquartered in San Diego, CA.

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ARS Pharmaceuticals advances neffy launch amidst financial challenges

ARS Pharmaceuticals made notable progress with neffy's approval and launch, though facing financial challenges in Q3.
Strengths lie in positive feedback, strategic partnerships, and opportunities for expansion and market penetration.
Challenges include financial losses, revenue recognition complexities, and meeting commercial coverage targets.
Opportunities abound in global expansion, diverse market interest, and potential for accelerated launch plans.

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ARS Pharmaceuticals, Inc. is a biopharmaceutical company, which focuses on the development of a novel, potentially first-in-class product candidate, neffy, for the emergency treatment of Type I allergic reactions including anaphylaxis. Its product includes Epinephrine Nasal Spray. The company was founded by Richard Lowenthal, Robert Bell, and Sarina Tanimoto on August 5, 2015 and is headquartered in San Diego, CA.

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 (CRL) previously issued regarding its new drug application (NDA) for neffy ® (epinephrine nasal spray) for the treatment of allergic reactions (Type I), including anaphylaxis.

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

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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.

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

Aquestive Therapeutics Inc

Both ARS Pharmaceuticals and Aquestive Therapeutics are developing non-injectable epinephrine products for anaphylaxis, with potential to capture significant market share from current standard (auto-injectors). At current prices I expect that upside of either stock if successful will significantly outweight downside risk for the other stock, while upside potential from both stocks is not unlikely. Risks include regulatory delays (unlikely for SPRY but possible for AQST), several competing nasal epinephrine devices under clinical development (a major risk to SPRY) and precarious financial situation of AQST.

ARS Pharmaceuticals Vs. Aquestive Therapeutics; Neffy CRL Creates An Opportunity For Investing In Both

ARS Pharmaceuticals, Inc. (SPRY) plunges on a surprise CRL by the FDA for its nasal spray curated for allergic reactions.

ARS Pharmaceuticals (SPRY) Down on CRL for Nasal Spray

ARS Pharmaceutical is seeking the approval of Neffy, a nasal spray version of epinephrine. The FDA is seeking additional dosing studies before approving Neffy.

Why Shares of ARS Pharmaceuticals Are Plummeting on Wednesday

Shares of ARS Pharmaceuticals Inc plummeted 51% in premarket trading after the US Food and Drug Administration (FDA) unexpectedly declined to approve its needle-free nasal spray, Neffy, designed for emergency treatment of allergic reactions. The decision came as a shock, especially since the FDA's independent experts had endorsed the spray in May.

ARS Pharma shares bomb on surprise FDA rebuff

Sharesof ARS Pharmaceuticals Inc. SPRY plunged 46.9% toward a 15-month low in premarket trading Wednesday, after the biopharmaceutical company said the U.S. Food and Drug Administration issued a Complete Response Letter regarding the New Drug Application for its epinephrine nasal spray Neffy. In the CRL, the FDA requested completion of a study assessing repeat doses of Neffy.

ARS Pharmaceuticals stock falls toward record selloff after FDA issues surprise CRL, requesting additional studies

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

ARS Pharmaceuticals develops neffy, a nasal spray for severe allergies, with promising clinical trials and potential FDA approval. Financially, ARS has robust liquidity, minimal debt, and manageable operational losses, but might need further financing long-term. Given neffy's potential and ARS' solid financial position, I recommend a "Buy" but with awareness of regulatory and market risks.

ARS Pharmaceuticals Prepares For Neffy's Anticipated Launch

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

ARS Reports Second Quarter 2023 Financial Results and Provides Business Updates

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

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

NEW YORK , May 30, 2023 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of  ARS Pharmaceuticals, Inc. ("ARS" or the "Company") (NASDAQ: SPRY).  Such investors are advised to contact Robert S.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of ARS Pharmaceuticals, Inc. - SPRY

ARS Pharmaceuticals (SPRY) gains as it gets favorable votes from the FDA advisory committee for epinephrine spray to treat severe allergic reactions.

ARS Pharma (SPRY) Gets FDA Panel Vote for Epinephrine Nasal Spray

ARS Pharmaceuticals' Neffy, a nasal spray for emergency Type I allergic reactions, received a favorable FDA committee vote, increasing approval chances and boosting ARS stock by 75%. Neffy offers a potential breakthrough in allergy treatment, as it would be the first non-injectable option, addressing issues like needle fear and device complexity that come with current epinephrine autoinjectors.

ARS Pharmaceuticals: Potential Revolution In Allergy Treatment With Neffy

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

ARS Pharmaceuticals Highlights Progress and Reports First Quarter 2023 Financial Results

LOS ANGELES--(BUSINESS WIRE)---- $SPRY #SPRY--The Schall Law Firm Announces it is Investigating Claims Against ARS Pharmaceuticals, Inc. and Encourages Investors with Losses to Contact the Firm.

INVESTIGATION REMINDER: The Schall Law Firm Announces it is Investigating Claims Against ARS Pharmaceuticals, Inc. and Encourages Investors with Losses to Contact the Firm

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 (

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

NEW YORK--(BUSINESS WIRE)---- $SPRY #classaction--Attorney Advertising--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 information and assist the investigation by visiting the firm's site: www.bgandg.com/spry. The investigation concerns whether ARS has violated federal securities laws. On May 9, 2023, ARS issued a press relea.

Bronstein, Gewirtz & Grossman, LLC Notifies Shareholders of ARS Pharmaceuticals, Inc. (SPRY) Investigation

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 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.

ARS Pharmaceuticals Announces Availability of Briefing Documents for FDA Advisory Committee Meeting on neffy® for the Treatment of Type I Allergic Reactions 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.

ARS Pharmaceuticals Announces FDA Advisory Committee for neffy® for the Treatment of 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

ARS Pharmaceuticals Highlights Progress and Reports Fourth Quarter and Full Year 2022 Financial Results

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

News for ARS Pharmaceuticals Inc Stock (SPRY)