ARS Pharmaceuticals Strengthens Leadership Team with Appointment of Industry Veteran Donn Casale as President

ARS Pharmaceuticals (Nasdaq: SPRY) appointed industry veteran Donn Casale as President, effective June 1, 2026, while Richard Lowenthal remains CEO.

Rhea-AI Summary

ARS Pharmaceuticals (Nasdaq: SPRY) appointed industry veteran Donn Casale as President, effective June 1, 2026, while Richard Lowenthal remains CEO.

Casale will lead global commercial operations for neffy (epinephrine nasal spray) and support expansion into chronic spontaneous urticaria, drawing on prior experience scaling HEPLISAV-B to over $300 million annualized revenue.

Positive

• Appoints 25-year biopharmaceutical commercial leader as President effective June 1, 2026
• New President to oversee global commercial operations and growth infrastructure for neffy
• Leadership hire aligned with planned expansion into chronic spontaneous urticaria (CSU)

Negative

• None.

Argus May 13 session

-7.18% close to close Open Argus

Details

News Market Reaction – SPRY

On May 13, the day this news came out, SPRY closed 7.18% below the previous close.

Data tracked by StockTitan Argus for the May 13 session.

Market Context

On May 13, the day this news came out, the stock closed 7.2% below the previous close. A negative re...

Analysis

On May 13, the day this news came out, the stock closed 7.2% below the previous close. A negative reaction despite the appointment of a seasoned commercial leader would fit a recent pattern where constructive operational or regulatory updates were followed by soft trading, including multiple events with -1% to -6% next-day moves. Such a decline could reflect skepticism toward leadership changes until concrete metrics like neffy prescription growth, international ramp, or progress in chronic spontaneous urticaria are demonstrated in subsequent disclosures.

Key Figures

Industry experience: 25-year biopharmaceutical commercial leader HEPLISAV-B revenue: More than $300 million annualized revenue HEPLISAV-B U.S. share: Over 50 percent U.S. market share +2 more

Industry experience

25-year biopharmaceutical commercial leader

Background of newly appointed President Donn Casale

HEPLISAV-B revenue

More than $300 million annualized revenue

Performance of HEPLISAV-B under Casale at Dynavax

HEPLISAV-B U.S. share

Over 50 percent U.S. market share

HEPLISAV-B market position during Casale’s tenure

Dynavax acquisition

$2.2 billion

Value of Sanofi’s acquisition of Dynavax mentioned in Casale’s track record

Effective date

June 1, 2026

Start date for Donn Casale as President of ARS Pharmaceuticals

Historical Context

5 past events · Latest: 2026-05-07

5 events

1. 2026-05-07

   Earnings call notice

   24h Move

   -3.0%

   Announced date and time for Q1 2026 earnings call and webcast.

2. 2026-04-15

   Canada approval

   24h Move

   -1.5%

   Health Canada approved neffy 2 mg for anaphylaxis with partnership economics.

3. 2026-03-27

   FDA label change

   24h Move

   -5.7%

   FDA removed age requirement from neffy 1 mg label, broadening eligible patients.

4. 2026-03-09

   Earnings and update

   24h Move

   -0.1%

   Reported 2025 results and detailed neffy commercialization and cash position.

5. 2026-02-23

   Earnings call notice

   24h Move

   +2.3%

   Announced timing for Q4 and full-year 2025 earnings call and conferences.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

anaphylaxis, chronic spontaneous urticaria, hepatitis b vaccine, epinephrine nasal spray, +1 more

5 terms

anaphylaxis medical

"protect against severe allergic reactions that can lead to anaphylaxis"

Anaphylaxis is a sudden, severe allergic reaction in which the body's defense system overreacts to a trigger (like a drug, food, or insect sting), causing widespread symptoms such as difficulty breathing, low blood pressure, and shock; it can be life‑threatening without prompt treatment. Investors care because anaphylaxis risks can affect a drug or product's safety profile, regulatory approval, liability exposure and market acceptance—similar to a sprinkler system going off and damaging the whole house rather than just one room.

chronic spontaneous urticaria medical

"including advancement into chronic spontaneous urticaria (CSU)."

A long-term condition that causes recurring, itchy hives and sometimes swelling that appear without a clear trigger, like an alarm that goes off unpredictably on its own. It matters to investors because its chronic nature creates ongoing demand for treatments, diagnostics and follow-on care, influencing pharmaceutical research priorities, drug market size, regulatory review timelines and healthcare cost projections.

hepatitis b vaccine medical

"helped scale the hepatitis B vaccine HEPLISAV-B® from launch"

A hepatitis B vaccine is a medicine given as one or more shots that trains the immune system to prevent infection by the hepatitis B virus, which attacks the liver and can cause chronic illness or cancer. For investors it matters because vaccine development, approval, production capacity, pricing, and uptake determine potential sales, competitive positioning, and regulatory or public-health-driven demand—think of it as a product whose market size depends on both medical need and public policy.

epinephrine nasal spray medical

"neffy® (epinephrine nasal spray) and accelerating adoption and sales growth"

A nasal spray that delivers epinephrine, a fast-acting hormone that raises heart rate and opens airways, used to treat severe allergic reactions and other sudden medical emergencies. For investors, it matters because a spray form can be easier to use than injections, potentially widening the market, changing competitive dynamics, and creating regulatory and manufacturing considerations that affect approval timelines, pricing, and sales potential.

type i allergic reactions medical

"treatments for patients at risk of severe Type I allergic reactions."

Type I allergic reactions are immediate, often rapid immune overreactions in which the body’s defense system mistakes a harmless substance (like a drug, food, or insect sting) for a threat and releases chemicals that cause symptoms from hives and swelling to life‑threatening anaphylaxis. Like a smoke alarm that blares at burnt toast, these reactions can halt clinical trials, trigger safety warnings or product recalls, and influence regulatory decisions, liability exposure, and demand for treatments—making them important to investors evaluating health‑care and consumer product risks.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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SAN DIEGO, May 13, 2026 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering patients and their caregivers to better protect against severe allergic reactions that can lead to anaphylaxis, today announced the appointment of Donn Casale as President, effective June 1, 2026. Richard Lowenthal will continue to lead ARS Pharma as Chief Executive Officer.

Mr. Casale is a 25-year biopharmaceutical commercial leader with extensive experience scaling innovative products in large consumer-driven healthcare markets, including categories where patients seek therapies that help reduce the risk of future serious medical events. As President, Mr. Casale will oversee global commercial operations and growth infrastructure as ARS Pharma prepares for its next phase of expansion, including advancement into chronic spontaneous urticaria (CSU). He will partner closely with the executive leadership team to help drive the company’s next phase of commercial and organizational growth.

“We are very pleased to welcome Donn to the ARS team, where he will play a key role in leading our commercial strategy for neffy® (epinephrine nasal spray) and accelerating adoption and sales growth,” said Richard Lowenthal, Co-founder and CEO of ARS Pharma. “Donn has built and led commercial organizations that successfully scaled innovative products in large, patient-driven markets similar to our own. His expertise in retail channel execution and payor access strategy will help further expand patient access and accelerate adoption of neffy, while also preparing ARS Pharma for its next phase of growth, including expansion into CSU. We look forward to the strategic perspective and leadership he will bring as we continue expanding access to lifesaving treatments for patients at risk of severe Type I allergic reactions.”

Mr. Casale most recently served as Chief Commercial Officer at Dynavax Technologies, where he built the U.S. commercial infrastructure and helped scale the hepatitis B vaccine HEPLISAV-B® from launch to more than $300 million in annualized revenue and over 50 percent U.S. market share. He engineered a transformative commercial strategy and innovative retail pharmacy model that helped position HEPLISAV-B for significant commercial growth prior to Sanofi’s $2.2 billion acquisition of Dynavax.

Prior to Dynavax, Mr. Casale held marketing and commercial operations leadership roles at Depomed (now Assertio Therapeutics) and spent 14 years at Merck in progressive leadership roles across the U.S. vaccines business, spanning sales leadership and commercial strategy. Mr. Casale holds a B.A. in Political Science from California Polytechnic State University, San Luis Obispo.

“As the first and only needle-free, easy-to-carry epinephrine nasal spray approved in the U.S., neffy has fundamentally changed what is possible in the treatment of severe allergic reactions,” said Mr. Casale. “I believe we have a profound responsibility to increase awareness of the critical need for epinephrine and to serve as a tireless advocate for patients and caregivers. neffy represents a compelling opportunity to redefine preparedness and access in severe allergic reactions, and I look forward to helping drive ARS Pharma’s next phase of growth.”

About ARS Pharmaceuticals, Inc.
ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients against allergic reactions that could lead to anaphylaxis. The Company is commercializing neffy^® (trade name EURneffy^® in the EU and UK and 优敏速^® in China), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult patients and pediatric patients who weigh 33 lbs. or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, and other allergens as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 15 kg or greater. For more information, visit www.ars-pharma.com.

Forward-Looking Statements
Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: the skillset and experience of ARS Pharma’s new president and expectations with respect to his future contributions to ARS Pharma and ARS Pharma’s ability to expand or grow its business; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “believe,” “can,” “could,” “expect,” “if,” “may,” “on track to/for,” “potential,” “plan,” “will,” “would,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharmaceuticals’ current expectations and involve assumptions that may never materialize or may prove to be incorrect.

Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: potential safety and other complications from neffy; the ability to obtain and maintain regulatory approval for neffy in its currently approved indications; the scope, progress and expansion of developing and commercializing neffy; the scope, progress and expansion of developing our intranasal epinephrine technology; clinical trial results; the potential for governments and payors to delay, limit or deny coverage for neffy; the size and growth of the market for neffy and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharma’s ability to protect its intellectual property position; and the impact of government laws, regulations and policies. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in ARS Pharma’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 9, 2026. This document can also be accessed on ARS Pharma’s website at www.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab.

The forward-looking statements included in this press release are made only as of the date hereof. ARS Pharma assumes no obligation and does not intend to update these forward-looking statements, except as required by law. For more information, visit www.ars-pharma.com, and follow us on LinkedIn and X.

ARS Investor Contacts:
Justin Chakma
ARS Pharmaceuticals
justinc@ars-pharma.com

ARS Media Contact:
Christy Curran
Sam Brown Inc.
615.414.8668
christycurran@sambrown.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What leadership change did ARS Pharmaceuticals (SPRY) announce on May 13, 2026?

ARS Pharmaceuticals announced that Donn Casale will become President effective June 1, 2026. According to ARS Pharma, Richard Lowenthal will continue as CEO while Casale oversees global commercial operations and supports the company’s next phase of commercial and organizational growth.

What will Donn Casale’s role be as President of ARS Pharmaceuticals (SPRY)?

Donn Casale will oversee global commercial operations and growth infrastructure at ARS Pharmaceuticals. According to ARS Pharma, he will focus on commercial strategy for neffy, accelerating adoption and sales, and preparing for expansion into chronic spontaneous urticaria (CSU).

How is ARS Pharmaceuticals (SPRY) positioning neffy epinephrine nasal spray for growth?

ARS Pharmaceuticals plans to accelerate adoption and sales growth of neffy, its epinephrine nasal spray. According to ARS Pharma, neffy is the first and only needle-free, easy-to-carry epinephrine nasal spray approved in the U.S., aimed at severe allergic reactions and anaphylaxis risk.

What experience does Donn Casale bring to ARS Pharmaceuticals (SPRY)?

Donn Casale brings 25 years of biopharmaceutical commercial leadership experience. According to ARS Pharma, he helped build Dynavax’s U.S. commercial infrastructure and scale HEPLISAV-B to more than $300 million in annualized revenue and over 50% U.S. market share before Dynavax’s acquisition.

How does the Donn Casale appointment support ARS Pharmaceuticals’ (SPRY) CSU plans?

The appointment supports ARS Pharma’s planned advancement into chronic spontaneous urticaria (CSU). According to ARS Pharma, Casale will help build the growth infrastructure and commercial capabilities needed for this next phase of expansion beyond severe Type I allergic reactions.

Who remains CEO of ARS Pharmaceuticals (SPRY) after the new President appointment?

Richard Lowenthal remains Chief Executive Officer of ARS Pharmaceuticals after Donn Casale’s appointment as President. According to ARS Pharma, Lowenthal will continue leading the company while partnering with Casale and the executive team on commercial strategy and organizational growth.