Anuncio • Feb 20

ARS Pharmaceuticals, Inc. Announces Favorable Topline Results from Repeat Dosing Study of neffy (Epinephrine Nasal Spray) Under Nasal Allergen Challenge Conditions, Readies Data for Response to FDA’s Complete Response Letter

ARS Pharmaceuticals, Inc. announced topline results from its clinical study comparing repeat doses of neffy (epinephrine nasal spray) to repeat doses of epinephrine intramuscular (IM) injection, as requested by the FDA with and without nasal allergen challenge (NAC) conditions. Based on the company’s analysis of the data, the company believed these results should support filing its response to the FDA’s CRL. The repeat dose study under NAC conditions was designed with the FDA to address the Agency’s outstanding questions regarding neffy as described in the Complete Response Letter (CRL) from September 2023. FDA did not provide guidance on a prespecified set of endpoints, but the data are anticipated to be informative to labeling if a second dose of neffy is needed. ARS Pharma also completed the nitrosamine testing requested in the CRL per FDA’s draft guidance issued in August 2023, with no measurable levels of nitrosamines detected. Previously reported data with a single dose of neffy under NAC conditions showed accelerated absorption of neffy with exposures higher than IM injection during the early time period when clinical response to epinephrine is expected. ARS Pharma intends to submit this repeat dose NAC study data to the FDA as part of its response to the CRL early in the second quarter of 2024. neffy Repeat Dosing Study Design: The randomized, crossover pharmacokinetic (PK) and pharmacodynamic (PD) study enrolled 43 patients with seasonal allergic rhinitis who tested positive with a Total Nasal Symptom Score (TNSS) of =5 out of 12 and a congestion score of =2 out of 3 during the screening NAC. NAC involves spraying purified antigen directly onto the nasal mucosa – a worst-case experimental condition in contrast to real-world nasal conditions such as upper respiratory tract infections or acute allergic rhinitis from natural causes. All patients were dosed with epinephrine within 15 minutes of induction of the NAC during the peak effect, without allowing time for nasal symptoms to subside. A second dose of epinephrine was given to patients 10 minutes after the first dose per FDA labeling of epinephrine products. FDA explicitly requested that ARS Pharma include intramuscular (IM) epinephrine given via manual syringe as the comparator in this study, as IM is the reference-listed drug and historical basis for efficacy of all other epinephrine products. Meta-analyses (Patel et al, JACI 2021) analyzing over 30,000 anaphylaxis events demonstrate that about 90% of events respond to a single dose of epinephrine injection irrespective of the delivery device, despite significant differences in PK. PK/PD Study Results: Data from the company’s primary analysis of the completed study showed that responses on pharmacodynamic (PD) surrogate markers for efficacy in anaphylaxis, such as systolic blood pressure and heart rate, correlated well with pharmacokinetic (PK) exposures and were consistently higher for repeat doses of neffy, irrespective of dosing in the same nostril (R/R) or opposite nostrils (R/L), compared to repeat doses of IM injection. Dosing in the same nostril (R/R) resulted in higher PD than injection at all time points measured, while dosing in the opposite nostril (R/L) was higher than injection until the 40 to 60 minute time points, after which PD was indistinguishable from injection. Consistent with prior studies, significant responses on these PD surrogate markers of efficacy with neffy were observed even at one minute after dosing. The PD responses demonstrate that the epinephrine exposures achieved with repeat doses of neffy (R/R or R/L) fully activate the receptors involved in reversing anaphylaxis symptoms. The clinical data also demonstrated that mean epinephrine concentrations following repeat doses of 2 mg neffy in the same nostril (R/R) were numerically higher than repeat doses of 0.3 mg injection at all time points through at least 240 minutes under NAC conditions. Mean epinephrine concentrations of 2 mg neffy in the opposite nostril (R/L) were also numerically higher than repeat doses of 0.3 mg injection for approximately 30 minutes, which is longer than the time period when clinical response would be expected to be observed after dosing epinephrine (i.e., within 10 minutes). The PK profile of repeat doses of neffy during normal nasal conditions was shown in prior studies to be highly similar to repeat doses of EpiPen, which serves as the upper bracket for exposures established to be safe. In this study, the PK profile of repeat doses of neffy in the same nostril (R/R) during nasal allergen challenge was highly similar to repeat doses of neffy during normal nasal conditions, and therefore also in the range of exposures established to be safe. Other ARS Pharma clinical studies have evaluated neffy PK/PD in people with the same TNSS and congestion severity scores as the experimental NAC studies, but with nasal symptoms due to real-world conditions such as upper respiratory tract infections or acute allergic rhinitis from natural causes. These other studies showed no meaningful difference on PK/PD compared to dosing neffy under normal nasal conditions. Repeat doses of neffy were considered safe and well-tolerated. All adverse events were mild and continue to be consistent with those observed in prior studies of neffy across more than 700 subjects. There were no serious adverse events. Regulatory Status of neffy: Additional discussions with FDA subsequent to its issuance of the CRL confirmed that the new data are anticipated to be informative to labeling of administering a second dose of neffy. In May 2023, the FDA Advisory Committee (PADAC), determined a favorable benefit-risk profile of neffy (16:6 for adults and 17:5 for children). No PADAC member requested a repeat dose study during allergen-induced allergic rhinitis. In addition, multiple PADAC members highlighted the favorable profile of neffy in the company's single dose NAC study. ARS Pharma intends to file its response to the FDA’s CRL for neffy early in the second quarter of 2024, with an expected PDUFA action date six months from filing, followed by potential U.S. launch of neffy in the second half of 2024. ARS Pharma also intends to submit this repeat dose study data to the European Medicines Agency (EMA) to inform its Committee for Medicinal Products for Human Use (CHMP) Opinion decision expected by mid-2024.

Anuncio • Nov 10

+ 5 more updates

ARS Pharmaceuticals, Inc. Announces Board Changes

On November 8, 2022, the Delaware corporation formerly known as “Silverback Therapeutics, Inc.” completed its previously announced merger transaction in accordance with the terms and conditions of the Agreement and Plan of Merger and Reorganization, dated as of July 21, 2022, as amended on August 11, 2022 and October 25, 2022 (the “Merger Agreement”), by and among Silverback Therapeutics, Inc. (“Silverback”), Sabre Merger Sub, Inc., a wholly owned subsidiary of Silverback (“Merger Sub”), and ARS Pharmaceuticals, Inc. (“ARS Pharma”), pursuant to which Merger Sub merged with and into ARS Pharma, with ARS Pharma surviving the merger as a wholly owned subsidiary of Silverback (the “Merger”). Additionally, on November 8, 2022, the Company changed its name from “Silverback Therapeutics, Inc.” to “ARS Pharmaceuticals, Inc.” (the “Company”). In accordance with the terms of the Merger Agreement, (i) each of Vicki L. Capps, Robert Hershberg, M.D., Ph.D., Maria Koehler, M.D., Ph.D., Andrew Powell, J.D. and Jonathan Root, M.D. resigned from the Company’s board of directors and any respective committee membership of the Company’s board of directors, effective as of the consummation of the Merger, and (ii) each of Jeffrey Pepe, Ph.D., J.D., the Company’s Interim Chief Executive Officer, General Counsel and Corporate Secretary, and Russ Hawkinson, the Company’s Interim Chief Financial Officer, were terminated in connection with the Company’s previously announced reduction in force. Appointment of Directors and Executive: At the effective time of the Merger, the Company’s board of directors (and its committees) and executive officers were reconstituted to include the following directors and executive officers: Richard Lowenthal, M.S., MSEL, age: 56, President, Chief Executive Officer and Class II Director. Sarina Tanimoto, M.D., M.B.A., age: 54, Chief Medical Officer; Eric Karas, age: 50, Chief Commercial Officer; Justin Chakma, age: 33, Chief Business Officer and Secretary. Non-Employee Directors: Pratik Shah, Ph.D., age: 52, Chair of the Board and Class I Director; Rajeev Dadoo, Ph.D., age: 52, Class I Director; Saqib Islam, J.D., age: 53, Class III Director; Michael Kelly, age: 57, Class I Director; Peter Kolchinsky, Ph.D., age: 46, Class II Director; Jonathan S. Leff, age: 53, Class III Director; Brenton L. Saunders, age: 52, Class II Director; Phillip Schneider, age: 66, Class III Director; Laura Shawver, Ph.D., age: 65, Class III Director; Peter A. Thompson, M.D., age: 63, Class II Director. Class III directors have a term expiring in 2023, Class I directors have a term expiring in 2024 and Class II directors have a term expiring in 2025. The members of the Audit Committee are Phillip Schneider (Chair), Michael Kelly and Rajeev Dadoo, Ph.D. The members of the Compensation Committee are Rajeev Dadoo, Ph.D. (Chair) and Saqib Islam, J.D. The members of the Nominating and Corporate Governance Committee are Peter Kolchinsky, Ph.D. (Chair) and Jonathan S. Leff. Pursuant to the terms of the Merger Agreement, each of (i) Mr. Lowenthal, Dr. Shah, Dr. Dadoo, Mr. Kelly, Dr. Kolchinsky, Mr. Leff, Mr. Saunders and Mr. Schneider were appointed to the board of directors of the Company as designees of ARS Pharma and (ii) Mr. Islam, Dr. Shawver and Dr. Thompson remained on the board of directors of the Company as designees of Silverback. Richard Lowenthal, M.S., MSEL is a co-founder of ARS Pharma and has served as its President and a member of the board of directors of ARS Pharma since ARS Pharma’s inception in August 2015 and as ARS Pharma’s Chief Executive Officer since September 2018. From August 2015 to November 2007, Mr. Lowenthal served as President of Pacific-Link Regulatory Consulting and Research, Inc., a medicinal product development consultancy founded by Mr. Lowenthal, where he provided leadership and mentoring on clinical development, regulatory affairs, quality assurance, licensing and investment opportunities, including supporting the clinical and regulatory development of Valtoco (diazepam nasal spray). Prior to Pacific-Link Regulatory Consulting and Research, Inc., Mr. Lowenthal held many leadership roles at several biopharmaceutical and pharmaceutical companies that included Chief Executive Officer and President of MTG Biotherapeutics Inc.; Vice President of Regulatory Affairs and quality assurance for Cadence Pharmaceuticals, Inc.; Head of Worldwide Regulatory Affairs, Quality Assurance and Drug Safety for Maxim Pharmaceuticals, Inc.; Vice President of Regulatory Affairs and Quality Assurance for AnGes, MG, Inc.; Global Project Leader and Global Director of Regulatory Affairs for Janssen Research Foundation; Director of Regulatory Affairs and Quality Assurance for Somerset Pharmaceuticals Inc.; and New Drug Review Chemist for the U.S. Food and Drug Administration in the Division of Neuropharmacologic Drug Products and the Division of Oncology and Pulmonary Drug Products. Mr. Lowenthal holds an M.Sc. in organic chemistry from Florida State University and a Master’s in Business Science for Executive Leadership from the University of San Diego. He has served as past chair of the American Association of Pharmaceutical Scientists (San Diego region), as well as member of the USP Biotechnology Expert Committee, chair of the Virology Working group, member of the National Organization of Rare Disease Corporate Council and has worked with various PhRMA and ICH Working Groups. The Company believes Mr. Lowenthal is qualified to serve on its board of directors due to his over 28 years of biotechnology and pharmaceutical development experience, his experience as a founder, director and executive officer of biopharmaceutical companies and his educational background.

Ratio de cobertura de intereses	n/a
Efectivo	US$200.97m
Patrimonio	US$61.31m
Total pasivo	US$226.26m
Activos totales	US$287.57m

Datos	Última actualización (huso horario UTC)
Análisis de la empresa	2026/06/11 08:06
Precio de las acciones al final del día	2026/06/11 00:00
Beneficios	2026/03/31
Ingresos anuales	2025/12/31

Paquete	Datos	Marco temporal	Ejemplo Fuente EE.UU. ^*
Finanzas de la empresa	10 años	Cuenta de resultados Estado de tesorería Balance	Formulario SEC 10-K Formulario SEC 10-Q
Estimaciones del consenso de analistas	+3 años	Previsiones financieras Objetivos de precios de los analistas	Informes de análisis Blue Matrix
Precios de mercado	30 años	Precios de las acciones Dividendos, escisiones y acciones	Datos de mercado ICE Formulario S-1 de la SEC
Propiedad	10 años	Accionistas principales Información privilegiada	Formulario SEC 4 Formulario SEC 13D
Gestión	10 años	Equipo directivo Consejo de Administración	Formulario SEC 10-K Formulario SEC DEF 14A
Principales avances	10 años	Anuncios de empresas	Formulario SEC 8-K

Analista	Institución
Joshua Schimmer	Cantor Fitzgerald & Co.
Roanna Clarissa Ruiz	Leerink Partners LLC
Carl Byrnes	Northland Capital Markets

Salud financiera de hoja de balance de ARS Pharmaceuticals

Salud financiera controles de criterios 5/6

Información clave

Actualizaciones recientes sobre salud financiera

ARS Pharmaceuticals (NASDAQ:SPRY) May Not Be Profitable But It Seems To Be Managing Its Debt Just Fine, Anyway

We're Interested To See How ARS Pharmaceuticals (NASDAQ:SPRY) Uses Its Cash Hoard To Grow

We're Not Very Worried About ARS Pharmaceuticals' (NASDAQ:SPRY) Cash Burn Rate

ARS Pharmaceuticals (NASDAQ:SPRY) Is In A Good Position To Deliver On Growth Plans

Here's Why We're Not Too Worried About ARS Pharmaceuticals' (NASDAQ:SPRY) Cash Burn Situation

Recent updates

SPRY: Future Allergy And Urticaria Franchise Will Support Substantial Upside Potential

Price target increased by 14% to US$28.80

SPRY: Bullish Outperform Views Will Support Future Allergy Treatment Upside

Consensus EPS estimates fall by 12%

First quarter 2026 earnings: Revenues exceed analysts expectations while EPS lags behind

Insufficient new directors

ARS Pharmaceuticals: Still A Buy As Neffy Access Improves

ARS Pharmaceuticals, Inc. Announces Appointment of Donn Casale as President, Effective June 1, 2026

ARS Pharmaceuticals, Inc., Annual General Meeting, Jun 24, 2026

SPRY: Disruptor Positioning And Recent Approvals Will Support Future Upside Potential

ARS Pharmaceuticals, Inc. Announces Approval of Neffy Epinephrine Nasal Spray in Canada

SPRY: Bullish Coverage Sees Future Upside From Execution On Commercial Rollout

SPRY: Rival FDA Setback Will Support Future Anaphylaxis Market Upside

ARS Pharmaceuticals Inc Receives FDA Approval To Remove Age Requirement From Neffy 1 Mg Epinephrine Nasal Spray Label

SPRY: Competitor FDA Setback Will Support Future Upside Potential

SPRY: Rival FDA Setback And Global Approvals Will Support Future Upside

SPRY: Competitor FDA Setback And Global Approvals Will Support Future Upside

Ars Pharmaceuticals to Showcase Scientific Innovation and Robust Clinical Data on Neffy®? (Epinephrine Nasal Spray) At 2026 American Academy of Allergy, Asthma and Immunology (Aaai) Annual Scientific Meeting

SPRY: Competitor Delay And Global Allergy Access Will Drive Future Upside

ARS Pharmaceuticals Announces EURneffy 1 Mg (Adrenaline Nasal Spray) Recommended For Approval In The EU For Emergency Treatment Of Type 1 Allergic Reactions In Children Weighing 15 Kg To Less Than 30 Kg

SPRY: Virtual Access And China Approval Will Drive Needle Free Allergy Share

ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) Stock Catapults 25% Though Its Price And Business Still Lag The Industry

SPRY: Needle Free Allergy Rescue Will Gain Share On Virtual Access Programs

ARS Pharmaceuticals, Inc. Announces Approval in China as the First and Only Community Use Epinephrine Product for the Treatment of Allergic Reactions (Anaphylaxis)

SPRY: Neffy Launch Momentum And DTC Campaigns Will Drive Future Upside

SPRY: Needle-Free Delivery Will Capture Market Share From Auto-Injectors

SPRY: Needle-Free Allergy Treatment Will Drive Market Share Expansion

ARS Pharmaceuticals, Inc. announced that it expects to receive $250 million in funding

ARS Pharmaceuticals, Inc. Announces Approval for Neffy®? (epinephrine Nasal Spray) for the Emergency Treatment of Allergic Reactions

ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) May Have Run Too Fast Too Soon With Recent 27% Price Plummet

ARS Pharmaceuticals (NASDAQ:SPRY) May Not Be Profitable But It Seems To Be Managing Its Debt Just Fine, Anyway

AARS Pharmaceuticals, Inc. Announces Approval of EURneffy®? (Adrenaline Nasal Spray) for the Emergency Treatment of Allergic Reactions

ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) Stock Rockets 26% As Investors Are Less Pessimistic Than Expected

ARS Pharmaceuticals, Inc.(NasdaqGM:SPRY) dropped from Russell 3000E Growth Index

Analysts Have Just Cut Their ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) Revenue Estimates By 15%

ARS Pharmaceuticals, Inc.'s Neffy (epinephrine Nasal Spray) 1 mg Is Now Available in the United States for Type I Allergic Reactions, Including Anaphylaxis, in Pediatric Patients Weighing 15 to < 30 Kilograms

80% Coverage And Pediatric Launch Will Expand Global Markets

ARS Pharmaceuticals, Inc., Annual General Meeting, Jun 25, 2025

Revenues Not Telling The Story For ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) After Shares Rise 28%

Downgrade: Here's How Analysts See ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) Performing In The Near Term

ARS Pharmaceuticals Announces FDA Approval of neffy 1 mg (epinephrine nasal spray) for Type I Allergic Reactions, Including Anaphylaxis, in Pediatric Patients Weighing 15 to < 30 Kilograms

ARS Pharmaceuticals, Inc. Add neffy® (Epinephrine Nasal Spray) to National Formularies, Further Expanding Coverage for Patients

ARS Pharmaceuticals' Neffy Launch Could Be A Hit For Severe Allergic Reactions

ARS Pharmaceuticals Files for Approval of neffy® in Canada and the United Kingdom on Behalf of Licensing Partner ALK-Abelló A/S

ARS Pharmaceuticals, Inc. Announces neffy® (Epinephrine Nasal Spray) is available on Express Scripts Commercial National Formularies

ARS Pharmaceuticals Announces Filings for Approval of Neffy in China, Japan and Australia

ARS Pharmaceuticals: Demand Curve Is Key Unknown

We're Interested To See How ARS Pharmaceuticals (NASDAQ:SPRY) Uses Its Cash Hoard To Grow

ARS Pharmaceuticals: A Decent Bet For Upside After Neffy Approval

ARS Pharmaceuticals, Inc. Launches Pre-Ordering Services for neffy to Help Patients Access the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis

ARS Pharmaceuticals, Inc. Announces Approval of EURneffy (adrenaline nasal spray) in the EU as the First and Only Needle-Free Emergency Treatment of Allergic Reactions (anaphylaxis)

ARS Pharmaceuticals, Inc. Receives FDA Approval of Neffy® (Epinephrine Nasal Spray), the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis

ARS Pharmaceuticals, Inc.(NasdaqGM:SPRY) dropped from Russell Small Cap Comp Value Index

ARS Pharmaceuticals, Inc. Announces EURneffy (Adrenaline Nasal Spray) Recommended for Approval by CHMP for Emergency Treatment of Allergic Reactions (Anaphylaxis)

ARS Pharmaceuticals On Track With Neffy Despite Regulatory Hurdles

First quarter 2024 earnings released: US$0.11 loss per share (vs US$0.16 loss in 1Q 2023)

ARS Pharmaceuticals, Inc. Submits Response for Neffy (Epinephrine Nasal Spray) Marketing Authorization Application to EMA's Chmp

ARS Pharmaceuticals, Inc., Annual General Meeting, Jun 20, 2024

Founder exercised options to buy US$1.6m worth of stock.

ARS Pharmaceuticals, Inc. Submits Response to FDA Complete Response Letter for Neffy® (Epinephrine Nasal Spray)

Consensus revenue estimates decrease by 19%, EPS upgraded

Full year 2023 earnings: EPS and revenues exceed analyst expectations

We're Not Very Worried About ARS Pharmaceuticals' (NASDAQ:SPRY) Cash Burn Rate

ARS Pharmaceuticals Announces neffy Meets Primary Endpoints and Shows Rapid Symptom Control in Phase 2 Urticaria Clinical Study

New minor risk - Profitability

Consensus revenue estimates decrease by 25%

Forecast to breakeven in 2026

ARS Pharmaceuticals, Inc. Announces Favorable Topline Results from Repeat Dosing Study of neffy (Epinephrine Nasal Spray) Under Nasal Allergen Challenge Conditions, Readies Data for Response to FDA’s Complete Response Letter

Consensus EPS estimates upgraded to US$0.64 loss

ARS Pharmaceuticals (NASDAQ:SPRY) Is In A Good Position To Deliver On Growth Plans