Highest-materiality recent filing
ARS Pharma reports Q1 revenue $22.7M, neffy net product revenue $17.5M
Net loss $60.6M ($0.61/share); cash $201M; expects to fund to cash-flow break-even.
ARS Pharma reports $72.2M neffy sales in first full year; net loss $171.3M
Full-year U.S. neffy net product revenue $72.2M; total revenue $84.3M including $9.7M partner revenue.
ARS Pharma reports Q3 net loss $51.2M; neffy net product revenue $31.3M
Q3 2025 total revenue $32.5M, including $31.3M neffy U.S. net product revenue; net loss $51.2M ($0.52/share).
ARS Pharmaceuticals enters $250M credit facility, draws $100M upfront
$100M Term A Loan drawn Sep 29 2025; up to $250M total available in four tranches.
ARS Pharma receives Paragraph IV notice from Lupin for generic neffy; intends to sue
Lupin filed ANDA for generic version of neffy (epinephrine nasal spray) before expiration of 8 Orange Book-listed patents.
ARS Pharma Q2 revenue $15.7M, neffy volume +180% QoQ, net loss $44.9M
Total revenue $15.7M, including $12.8M neffy U.S. net product revenue and $2.6M milestone from ALK.
ARS Pharma Q1 neffy revenue $7.8M, net loss $33.9M; commercial progress with 5,000+ prescribers
Net product revenue of $7.8M from neffy; total revenue $8.0M; net loss $33.9M ($0.35 per share).
ARS Pharma and ALK co-promote neffy nasal spray to up to 9,000 U.S. pediatricians
Co-promotion agreement with ALK-Abelló, Inc. for neffy (epinephrine nasal spray) targeting pediatricians and other prescribers.
ARS Pharma Q4 net income $49.9M, neffy sales $6.7M; pediatric approval expands market
neffy net product revenue $7.3M for FY2024 since Sep launch; Q4 net product revenue $6.7M.
FDA approves ARS Pharma's neffy 1 mg for pediatric allergic reactions
FDA approved neffy 1 mg (epinephrine nasal spray) on March 5, 2025 for children aged 4+ weighing 15-30 kg.
ARS Pharma reports preliminary Q4 2024 neffy revenue of $6.5M, cash $314M
Preliminary neffy net product revenue for Q4 2024 was approximately $6.5 million, total 2024 revenue $7.1 million since launch on Sept 23.
ARS Pharma Q3 net loss $19.1M; neffy launch progressing; ALK deal $145M
Net loss of $19.1M for Q3 2024; total revenue of $2.1M including $0.6M neffy product revenue from one week of sales.
ARS Pharma licenses neffy to ALK for $145M upfront; up to $320M milestones
Upfront $145M from ALK; regulatory/commercial milestones up to $20M and sales milestones up to $300M.
ARS Pharma enters long-term supply agreement for neffy glass microvials through 2035
Upfront payment of €3 million to Nuova Ompi for glass microvial supply.
FDA approves ARS Pharma's neffy epinephrine nasal spray for allergic reactions
FDA approved neffy on Aug 9, 2024 for emergency treatment of anaphylaxis in adults and children ≥30 kg.
ARS Pharma Q2 net loss $12.5M; neffy PDUFA Oct 2; cash $218.7M
Cash, equivalents and short-term investments $218.7M as of June 30, 2024, providing at least three years of operating runway.
CHMP recommends EU marketing authorization for ARS Pharma's epinephrine nasal spray EURneffy
CHMP adopted positive opinion for EURneffy (2 mg epinephrine nasal spray) for emergency anaphylaxis treatment.
ARS Pharma reports Q1 net loss $10.3M; neffy PDUFA date Oct 2, 2024; cash $223.6M
Cash and securities $223.6M as of March 31, 2024; expected operating runway at least three years.
ARS Pharma to submit CRL response in early Q2 2024; Q4 net loss $7.2M, cash $228.4M
CRL response for neffy (epinephrine nasal spray) to be submitted early Q2 2024; FDA action and potential launch expected H2 2024.
ARS Pharmaceuticals Q3 net loss $14.9M; neffy NDA resubmission anticipated H1 2024
Cash, equivalents and short-term investments $241.9M as of Sep 30, 2023; operating runway ≥3 years.
ARS Pharma receives FDA Complete Response Letter for neffy; plans appeal, resubmission H1 2024
FDA CRL requests a repeat-dose PK/PD study in allergen-induced allergic rhinitis conditions for approval.
ARS Pharma reports Q2 net loss $17.4M; neffy PDUFA date Sept 19, 2023
Cash, equivalents and short-term investments $252.2M as of June 30, 2023, funding at least three years.
ARS Pharma neffy FDA Panel Vote 'Favorable'; Q1 Net Loss $15.0M, Cash $264.5M
FDA advisory committee voted 16:6 (adults) and 17:5 (children) that neffy benefit-risk is favorable.
ARS Pharma faces FDA AdCom on May 11 for neffy (intranasal epinephrine); PK/PD sufficiency debated
FDA AdCom to discuss whether PK/PD data for ARS-1 (intranasal epinephrine) sufficiently establish efficacy for anaphylaxis; meeting scheduled May 11, 2023.
ARS Pharma reports FY2022 net loss $34.7M; neffy NDA under FDA review, PDUFA mid-2023
Net loss of $14.4M for Q4 2022 and $34.7M for full year 2022; cash & investments $274.4M as of Dec 31, 2022.
Terminated License and Supply Agreement with Recordati Ireland, effective immediately.
Merger completed Nov 8, 2022; ARS Pharma becomes wholly owned subsidiary of re-named ARS Pharmaceuticals, Inc.
FDA accepts ARS Pharma's NDA for neffy (epinephrine nasal spray) for allergic reactions
FDA accepted NDA for neffy (epinephrine nasal spray) for emergency treatment of allergic reactions including anaphylaxis in adults and children ≥30 kg.
Silverback terminates President/CSO and CFO; appoints interim CFO ahead of merger
Terminated Valerie Odegard (President/CSO) and Jonathan Piazza (CFO), effective Sept 2, 2022, to extend cash runway.
Silverback equity holders expected to own ~37%, ARS holders ~63% on fully-diluted basis.
appointed Donn Casale as the Company’s President effective as of the date he commences employment with the Company, which date is expected to be June 1, 2026.
Mr. Lowenthal previously served as President.
Effective as of December 6, 2022, ARS Pharmaceuticals, Inc. (the “Company”) appointed Brian T. Dorsey, MSc, as Chief Operations Officer of the Company.
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
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
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
Rajeev Dadoo, Ph.D. 52 Class I Director
Sarina Tanimoto, M.D., M.B.A. 54 Chief Medical Officer
Brenton L. Saunders 52 Class II Director
Peter Kolchinsky, Ph.D. 46 Class II Director
Pratik Shah, Ph.D. 52 Chair of the Board and Class I Director
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.
Max materiality 1.00 · Median 0.70 · Most common event other_material