ARS Pharmaceuticals, Inc. is a biopharmaceutical company that develops and commercializes treatments for severe allergic reactions in the United States and internationally. The company is developing neffy, a needle-free intranasal epinephrine delivery for emergency treatment of Type I allergic reactions, including anaphylaxis. Founded in 2015, ARS Pharmaceuticals is headquartered in San Diego, California.
ARS Pharma reports $26.2 million Q2 neffy revenue, shifts to provider-focused strategy
ARS Pharmaceuticals reported $26.2 million in U.S. neffy net product revenue for the second quarter of 2026, bringing year-to-date net product revenue to $43.7 million. The company said it is shifting from broad consumer advertising to targeted engagement with high-volume prescribers, a move expected to cut second-half 2026 cash-based SG&A and R&D expenses to between $100 million and $110 million, down more than 40% from the first half. ARS Pharma also announced the appointment of Meg Smith as Chief Commercial Officer effective August 17, 2026, and said its field sales expansion is complete, with efforts focused on prescribers representing 44% of the U.S. market opportunity. The company expects a path to cash flow breakeven by the end of 2027 and plans to report interim Phase 2b data for its chronic spontaneous urticaria program in the first quarter of 2027. Total second-quarter revenue was $33.7 million, including $7.4 million in supply revenue from partners, while net loss was $62.3 million, or $0.63 per share, and cash, cash equivalents, and short-term investments stood at $143.8 million as of June 30, 2026.
Levi & Korsinsky Files Class Action Against ARS Pharmaceuticals Over neffy Insurance Coverage Claims
Levi & Korsinsky, LLP has filed a class action lawsuit against ARS Pharmaceuticals, Inc. on behalf of investors who purchased ARS securities between March 9, 2026 and June 24, 2026. The complaint alleges that the company made materially false and misleading statements about the expected timeline for expanded insurance coverage of its neffy product through CVS Caremark. On June 24, 2026, ARS disclosed that it did not receive expanded coverage by the guided July 1, 2026 deadline, and that CVS Caremark reserved its decision until January 2027. Following this news, ARS shares fell from $10.54 to $8.02, a decline of over 23.9% in a single day. Investors have until October 5, 2026 to seek appointment as lead plaintiff in the case, which is pending in the United States District Court for the Southern District of California.
ARS Pharmaceuticals Appoints Donn Casale as New CEO
ARS Pharmaceuticals has appointed Donn Casale as its new Chief Executive Officer, effective July 7. Casale, who previously served as the company's President, succeeds co-founder Richard Lowenthal, whose employment ended on July 6. Casale brings over 25 years of biopharma and commercial leadership experience, including a role as Chief Commercial Officer at Dynavax Technologies where he helped scale annual revenues of the hepatitis B vaccine HEPLISAV-B to more than $300 million and achieve over 50% U.S. market share before Sanofi acquired Dynavax for $2.2 billion. The leadership change comes as ARS Pharmaceuticals continues to work on payer access for neffy, its needle-free epinephrine nasal spray for anaphylaxis, with no new coverage decisions reported in the July 1 cycle.
Pomerantz Law Firm Investigates ARS Pharmaceuticals Over Securities Fraud Claims
Pomerantz LLP is investigating claims on behalf of investors of ARS Pharmaceuticals, Inc. regarding potential securities fraud or unlawful business practices. The investigation follows a June 24, 2026 press release in which ARS disclosed that its neffy epinephrine nasal spray had failed to secure commercial insurance coverage. On this news, ARS’s stock price fell $2.52 per share, or 23.91%, to close at $8.02 per share on June 25, 2026. Investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, extension 7980.
ARS Pharmaceuticals Names Donn Casale CEO as Co-Founder Richard Lowenthal Departs
ARS Pharmaceuticals announced the immediate appointment of President Donn Casale as CEO, succeeding co-founder Richard Lowenthal, who is no longer an employee or officer effective June 6, 2026. Lowenthal co-founded the company in 2015 and led the development and commercialization of neffy, a treatment for Type 1 allergic reactions including anaphylaxis. No reason was given for his departure. Casale brings 25 years of biopharmaceutical experience, having previously served as Chief Commercial Officer at Dynavax Technologies where he oversaw the launch of the Hepatitis B vaccine HEPLISAV, and held roles at Depomed and Merck. ARS shares closed Tuesday at $8.19, down 1.68%, and slipped a further 0.73% to $8.13 in after-hours trading.
ARS Pharmaceuticals plunges 23% as neffy fails to secure insurance coverage
ARS Pharmaceuticals shares plunged 23% in after-hours trading on Wednesday after the company said its neffy nasal spray failed to secure commercial insurance coverage. No new commercial formulary additions or coverage decisions were issued for neffy, its epinephrine nasal spray for the emergency treatment of severe allergic reactions, in the July 1, 2026 cycle. The company said it will continue discussions with payers in pursuit of future coverage expansions. ARS Pharmaceuticals also lowered its fiscal 2026 cash-based operating expense guidance, excluding cost of goods sold, to approximately $248 million, citing lower spending in the second half of the year and continued investment discipline. The company reaffirmed that the neffy base business supports a path to cash-flow breakeven in 2027. At the end of the first quarter, neffy had approximately 120,000 U.S. patients and generated $72.2 million in U.S. net sales during 2025, accounting for 86% of the company's total revenue.
AI chip stocks surge on Micron, Qualcomm forecasts; Wendy's extends rally
U.S. stock futures edged higher Thursday as AI chip stocks surged following strong forecasts from Micron Technology and Qualcomm. Micron shares jumped 17% after its fiscal third-quarter results and guidance far exceeded Wall Street expectations, with fourth-quarter adjusted earnings seen between $30 and $32 per share on sales of $49 billion to $51 billion. Qualcomm rose 12% after unveiling a data center revenue target of more than $15 billion by fiscal 2029, part of a broader $40 billion non-handset revenue goal that also includes automotive and IoT. The Wendy's Company gained 15.4%, holding onto a retail-driven rally sparked by Reddit's WallStreetBets community. On the downside, ARS Pharmaceuticals tumbled 23% after reporting no new formulary additions for its neffy nasal spray, while Alibaba's U.S.-listed shares fell 3% to a 16-month low amid reports that Anthropic accused the company of illicitly accessing its AI models.
Chronic Spontaneous Urticaria Market Heats Up as Pharma Companies Race to Address Unmet Needs
The chronic spontaneous urticaria market across the seven major markets reached approximately 2 billion dollars in 2025, with the United States holding the largest share. Total diagnosed prevalent cases of chronic urticaria in those markets were about 4.8 million in 2025 and are expected to rise by 2036. Key companies advancing new therapies include Celldex Therapeutics, Sanofi, Jasper Therapeutics, Evommune, Blueprint Medicines, ARS Pharmaceuticals, Nurix Therapeutics, InflaRx, and Otsuka Holdings through Taiho Pharmaceutical. Promising pipeline candidates such as barzolvolimab, rilzabrutinib, briquilimab, EVO756, BLU-808, ARS-1, bexobrutideg, INF904, and TAS5315 are in clinical development, while recent approvals of DUPIXENT and RHAPSIDO have already broadened treatment options beyond traditional anti-IgE biologics.
United States