HEMANGEOL relaunch with Eton Cares support at Eton (NASDAQ: ETON)

Filing Impact

(High)

Filing Sentiment

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

Eton Pharmaceuticals filed a report describing the relaunch of HEMANGEOL (propranolol) Oral Solution, the only FDA‑approved treatment for infantile hemangioma, a rare pediatric vascular tumor that can be time‑sensitive.

The relaunch integrates the full Eton Cares patient support program, including $0 co‑pay for eligible commercially insured patients and expanded patient assistance. HEMANGEOL is an orphan drug typically started between five weeks and five months of age and used for about six months to help prevent complications. The company estimates approximately 5,000–10,000 infants in the United States are treated with HEMANGEOL each year and is using an exclusive rare disease specialty pharmacy distribution model to support timely access.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Key Figures

Estimated HEMANGEOL patients: 5,000–10,000 infants annually Treatment initiation age: 5 weeks to 5 months Typical treatment duration: Approximately 6 months +3 more

6 metrics

Estimated HEMANGEOL patients 5,000–10,000 infants annually Estimated number of infants treated each year in the United States

Treatment initiation age 5 weeks to 5 months Typical age window when HEMANGEOL therapy is started

Typical treatment duration Approximately 6 months Length of HEMANGEOL therapy for infantile hemangioma

Commercial rare disease products 10 products Number of commercial rare disease products currently at Eton

Late-stage product candidates 4 candidates Amglidia, ET-700, ET-800 and ZENEO hydrocortisone autoinjector

HEMANGEOL helpline 833-486-5950 Dedicated HEMANGEOL line at Anovo specialty pharmacy

Key Terms

infantile hemangioma, orphan drug, rare disease specialty pharmacy, Eton Cares, +2 more

6 terms

infantile hemangioma medical

"HEMANGEOL is the only FDA-approved treatment for infantile hemangioma, a pediatric rare disease"

A benign vascular tumor that appears as a raised red or purple birthmark on newborns, caused by an unusually dense cluster of blood vessels that often grows for a few months and then typically shrinks over years. It matters to investors because some cases need medical treatment or surgery—creating demand for drugs, devices and specialized care—so advances, approvals, or changes in treatment patterns can affect the revenue and risk profiles of healthcare and pharmaceutical companies.

orphan drug regulatory

"HEMANGEOL is an orphan drug indicated for the treatment of proliferating infantile hemangioma"

A drug designated for an orphan disease is a medicine developed to treat a rare condition that affects only a small number of people. Regulators often give these drugs special incentives—such as reduced costs, faster review, and temporary exclusive selling rights—to encourage development, which matters to investors because those incentives can make a small market financially viable and reduce competition, much like a temporary patent on a niche product.

rare disease specialty pharmacy medical

"with Eton Cares and a dedicated rare disease specialty pharmacy model"

Eton Cares other

"Eton has integrated full Eton Cares patient support, including $0 co-pay"

hypoglycemia medical

"Low blood sugar (hypoglycemia), which can be serious and may lead to seizures"

Hypoglycemia is a condition where blood sugar falls too low to fuel the body and brain, causing symptoms like shakiness, confusion, sweating or fainting. Think of it as a car running low on gas: systems slow or fail until fuel is restored. Investors care because treatments, devices or drugs that cause or prevent hypoglycemia affect patient safety, regulatory approval, product labeling and market acceptance, which influence a company’s commercial prospects.

PHACE syndrome medical

"HEMANGEOL may increase the risk of stroke in children with certain blood vessel conditions (such as PHACE syndrome)"

Understanding 8-K Material Events →

05/01/2026 - 07:05 AM

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

May 1, 2026

Date of Report (Date of earliest event reported)

ETON PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-38738	37-1858472
(State of	(Commission	(I.R.S. Employer
incorporation)	File Number)	Identification Number)

21925 W. Field Parkway, Suite 235

Deer Park, Illinois 60010-7278

(Address of principal executive offices) (Zip code)

(847) 787-7361

(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		ETON		NASDAQ Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01: Other Events

On May 1, 2026, Eton Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that it has launched HEMANGEOL® (propranolol) Oral Solution. HEMANGEOL is the only FDA-approved treatment for infantile hemangioma, a pediatric rare disease that can be time-sensitive. Eton has integrated full Eton Cares patient support, including $0 co-pay for eligible commercially insured patients and expanded patient assistance programs.

A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01: Financial Statements and Exhibits

Exhibit No.		Description

Exhibit 99.1		Press Release dated May 1, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: May 1, 2026	By:	/s/ James R. Gruber
		James R. Gruber
		Chief Financial Officer and Secretary
		(Principal Financial Officer)

Exhibit 99.1

Eton Pharmaceuticals relaunches HEMANGEOL® (propranolol) Oral Solution with Eton Cares and Exclusive Specialty Pharmacy Distribution

●

HEMANGEOL is now available exclusively through Anovo Specialty Pharmacy to streamline access and therapy initiation

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Eton has integrated full Eton Cares patient support, including $0 co-pay for eligible commercially insured patients and expanded patient assistance programs

●

HEMANGEOL is the only FDA-approved treatment for infantile hemangioma, a pediatric rare disease that can be time-sensitive

DEER PARK, Ill., May 1, 2026 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the relaunch of HEMANGEOL®.

“We are excited to deliver another major product launch for the company. HEMANGEOL is a critical and time-sensitive therapy where early treatment can meaningfully impact outcomes, and the only FDA-approved treatment for infantile hemangiomas. With the integration of Eton Cares and a dedicated rare disease specialty pharmacy model, we are focused on helping patients start therapy quickly and ensuring families are supported from prescription through treatment. Our HEMANGEOL commercial team has been actively working with caregivers, healthcare professionals, and pharmacies to ensure a seamless transition for patients,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

“Infantile hemangiomas can evolve rapidly, and timely intervention is critical. In practice, the challenge is often not recognizing when to treat but ensuring that infants can start therapy without delays. Streamlined access to an FDA-approved treatment designed specifically for this population can meaningfully improve both outcomes and the care experience for families,” said Dr. Maria Gnarra Buethe, MD, PhD, Division Chief of Dermatology, Rady Children’s Hospital of Orange County and Director of Pediatric Dermatology, University of California, Irvine.

Dr. Kristi Derrick, MD, ScM, Clinical Assistant Professor, SUNY Downstate Health Sciences University (NY) and Paragon Skin Dermatology (NJ) added, “Infantile hemangiomas are common, but in some cases these skin lesions need to be treated urgently to prevent complications and provide the best cosmetic outcome. When a baby has an infantile hemangioma on the face, scalp, diaper area, skin folds or large or multiple lesions, it is important that the baby can get into a specialist quickly to discuss treatment options.”

“For families, an infantile hemangioma diagnosis is overwhelming and the window of opportunity to potentially prevent negative consequences is narrow. In order to prevent these adverse complications, prompt and early treatment is critical. At the Vascular Birthmarks Foundation, we advocate starting treatment as soon as the lesion is diagnosed. We strongly lobby for all primary care doctors to initiate HEMANGEOL treatment as soon as medically feasible,” said Dr. Linda Rozell- Shannon, Founder & President of The Vascular Birthmarks Foundation, a global non-profit that has networked over 150,000 patients with vascular malformations into treatment for over 30 years.

HEMANGEOL is an orphan drug indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy. Infantile hemangiomas are non-cancerous vascular tumors which typically appear in the first days or weeks of a newborn’s life. In severe cases, infantile hemangiomas can lead to more serious complications, and require intervention with systemic therapy. Treatment with HEMANGEOL is typically initiated between five weeks to five months of age, and continues for approximately six months, representing a critical window where timely intervention can prevent complications and improve outcomes. It is estimated that approximately 5,000-10,000 infants are treated with HEMANGEOL annually in the United States.

Clinicians seeking to prescribe HEMANGEOL can e-prescribe by selecting Anovo #5 (Memphis) or fax a patient referral form to 855-813-2039. Patients with questions regarding their prescription or healthcare providers can call Anovo at the dedicated HEMANGEOL line 833-486-5950. Additional product details can be found on the product website, https://www.hemangeol.com.

Ref: American Academy of Pediatrics. Clinical Practice Guideline for the Management of Infantile Hemangiomas. Pediatrics. January 2019.

USE

HEMANGEOL (propranolol hydrochloride) oral solution is a prescription medicine used to treat proliferating infantile hemangioma (a type of birthmark) requiring treatment throughout the body.

Who should NOT take HEMANGEOL?

Do not give HEMANGEOL to your child if they:

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Were born early and are less than 5 weeks corrected age

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Weigh less than 4.5 lbs

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Have asthma or a history of breathing problems (bronchospasm)

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Have certain heart conditions (such as slow heart rate, heart block, or heart failure)

●

Have very low blood pressure

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Have high blood pressure caused by a tumor on the adrenal gland, called “pheochromocytoma”

●

Are allergic to propranolol or any of the ingredients in HEMANGEOL

IMPORTANT SAFETY INFORMATION

HEMANGEOL may cause serious side effects, including:

Low blood sugar (hypoglycemia), which can be serious and may lead to seizures, loss of consciousness, or even death. This is more likely if your child is not eating well, is vomiting, or is sick. Always give HEMANGEOL during or right after feeding. Do not give a dose if your child is not eating. Signs of low blood sugar may include pale skin, sweating, irritability, unusual sleepiness, or seizures.

Bradycardia and hypotension. HEMANGEOL may slow your child’s heart rate or lower their blood pressure. Call your healthcare provider if your child seems unusually tired, dizzy, faints, or has pale or cold skin.

Bronchospasm. HEMANGEOL can cause breathing problems or make them worse. Get medical help right away if your child has wheezing or trouble breathing.

Cardiac failure. In certain patients with preexisting heart conditions, HEMANGEOL can worsen the heart’s ability to pump blood.

Increased risk of stroke. HEMANGEOL may increase the risk of stroke in children with certain blood vessel conditions (such as PHACE syndrome). Your healthcare provider may check for these conditions, especially in infants with large facial hemangiomas, before starting treatment.

Hypersensitivity. HEMANGEOL may make severe allergic reactions worse and may make it harder to treat these reactions with epinephrine (a medicine used in emergencies).

What are the most common side effects of HEMANGEOL?

The most common side effects include trouble sleeping, respiratory infections (such as colds or bronchitis), diarrhea, and vomiting.

Drug interactions

Tell your healthcare provider about all medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect how HEMANGEOL works or increase the risk of side effects, including medicines that affect how the body processes propranolol or increase the risk of low blood sugar (such as corticosteroids).

You are encouraged to report negative side effects of prescription drugs by contacting Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at https://www.fda.gov/safety/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information for more information.

About Eton Pharmaceuticals

Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has ten commercial rare disease products: KHINDIVI^TM, INCRELEX®, ALKINDI SPRINKLE®, DESMODA™, GALZIN®, HEMANGEOL®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has four additional product candidates in late-stage development: Amglidia®, ET-700, ET-800 and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com.

Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793

E: lwilson@insitecony.com

Source: View Original Filing on SEC EDGAR

FAQ

What did Eton Pharmaceuticals (ETON) announce about HEMANGEOL?

Eton Pharmaceuticals announced the relaunch of HEMANGEOL (propranolol) Oral Solution, the only FDA‑approved treatment for infantile hemangioma. The relaunch includes integrated Eton Cares patient support and distribution through an exclusive rare disease specialty pharmacy model to help infants start therapy quickly.

What condition does HEMANGEOL from Eton Pharmaceuticals (ETON) treat?

HEMANGEOL treats proliferating infantile hemangioma, a non‑cancerous vascular tumor in infants requiring systemic therapy. These lesions typically appear in the first days or weeks of life and, in severe cases, can cause serious complications that require timely intervention to improve outcomes and cosmetic results.

How many infants are treated with HEMANGEOL annually in the United States?

The company estimates that approximately 5,000–10,000 infants are treated with HEMANGEOL each year in the United States. Treatment is usually started between five weeks and five months of age and continues for around six months, covering a critical window when early therapy can prevent complications.

What support does the Eton Cares program offer HEMANGEOL patients?

Eton Cares provides patient support for HEMANGEOL, including a $0 co‑pay for eligible commercially insured patients and expanded patient assistance programs. The program aims to streamline access, help families start therapy without delays, and support them from prescription through treatment in this time‑sensitive condition.

How can clinicians prescribe HEMANGEOL according to Eton Pharmaceuticals?

Clinicians can e‑prescribe HEMANGEOL by selecting Anovo #5 (Memphis) or fax a patient referral form to 855‑813‑2039. Patients or healthcare providers with questions about prescriptions can call Anovo’s dedicated HEMANGEOL line at 833‑486‑5950, supporting coordinated access through an exclusive specialty pharmacy.

What are key safety concerns highlighted for HEMANGEOL therapy?

Key safety concerns include low blood sugar, bradycardia, hypotension, bronchospasm, cardiac failure, increased stroke risk in certain vascular conditions, and worsened hypersensitivity reactions. Caregivers are advised to give doses with feeding, watch for symptoms like unusual sleepiness or breathing problems, and contact healthcare providers promptly.

Filing Exhibits & Attachments

5 documents

Press Releases

EX-99.1 EXHIBIT 99.1 PRESS RELEASE HEMANGEOL LAUNCH 21.4 KB