Eton Pharmaceuticals (Nasdaq: ETON) moves to widen KHINDIVI use

Rhea-AI Filing Summary

Eton Pharmaceuticals reported submitting a Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration to expand the indication of KHINDIVI (hydrocortisone) oral solution to younger pediatric patients. The new KHINDIVI formulation showed bioequivalence to ALKINDI SPRINKLE, an FDA-approved hydrocortisone granule formulation.

KHINDIVI is currently approved as replacement therapy for pediatric patients 5 years of age and older with adrenocortical insufficiency and is the only FDA‑approved oral hydrocortisone solution. Management comments that label expansion could potentially occur in the first half of 2027. Eton estimates approximately 10,000 pediatric adrenal insufficiency patients in the U.S. and highlights extensive safety warnings, including risks of adrenal crisis, hyperosmolarity, metabolic acidosis, growth retardation, Cushing’s syndrome, bone density loss, psychiatric effects, ophthalmic and gastrointestinal adverse reactions.

Filing Explained

The July 29 8-K records a submitted request to expand KHINDIVI’s indication, not an FDA approval: the product remains approved for pediatric patients aged five and older, so the filing does not yet change its authorized age range.

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

Current approved age range: 5 years of age and older Potential label expansion timing: first half of 2027 Estimated pediatric adrenal insufficiency patients: approximately 10,000 pediatric adrenal insufficiency patients in the U.S. +3 more

6 metrics

Current approved age range 5 years of age and older KHINDIVI indication for pediatric adrenocortical insufficiency at the time of the PAS submission

Potential label expansion timing first half of 2027 CEO expectation for potential KHINDIVI label expansion, subject to FDA review

Estimated pediatric adrenal insufficiency patients approximately 10,000 pediatric adrenal insufficiency patients in the U.S. Company estimate of target population for hydrocortisone replacement therapy

KHINDIVI approval date May 2025 Month and year KHINDIVI was approved as an oral hydrocortisone solution

Commercial rare disease products 11 commercial rare disease products Total number of marketed products reported by Eton

Late-stage product candidates 4 additional product candidates in late-stage development Amglidia, ET-700, ET-800 and ZENEO hydrocortisone autoinjector

Key Terms

Prior Approval Supplement (PAS), bioequivalence, adrenocortical insufficiency, hyperosmolarity, +1 more

5 terms

Prior Approval Supplement (PAS) regulatory

"the Company has submitted a Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration"

bioequivalence medical

"new formulation of KHINDIVI ... successfully showed bioequivalence to ALKINDI SPRINKLE"

When two medicines deliver the same amount of active ingredient into the bloodstream at about the same speed and level, they are considered bioequivalent. Investors care because bioequivalence is the regulatory test that allows generic or reformulated drugs to replace branded products without new safety trials, often opening large, lower‑cost market opportunities and changing a drug maker’s sales and competitive position—like two recipes that taste the same but sell at different prices.

adrenocortical insufficiency medical

"replacement therapy in pediatric patients five years of age and older with adrenocortical insufficiency"

A disorder in which the adrenal glands produce too little of the steroid hormones (mainly cortisol and sometimes aldosterone) that help control stress response, blood pressure, metabolism and electrolyte balance; imagine the body’s emergency engine running low on vital fuel. It matters to investors because cases, clinical trial outcomes, safety warnings, or new treatments can affect a drug’s development path, regulatory review, market demand, labeling requirements and potential healthcare costs.

hyperosmolarity medical

"resulting in increased plasma osmolarity in all pediatric patients, especially in pediatric patients less than 5 years of age"

Hyperosmolarity is a medical condition where the concentration of dissolved particles (like salts and sugars) in the blood or a fluid becomes abnormally high, pulling water out of cells and causing dehydration or organ stress. Investors should care because it affects drug safety, clinical trial outcomes, hospital treatments and product manufacturing quality; increases in incidence or regulatory warnings can influence approval, labeling, liability and market value.

Cushing’s syndrome medical

"Prolonged use with supraphysiologic doses may cause Cushing’s syndrome"

A hormonal disorder caused by chronic excess of the body’s main stress hormone (cortisol), Cushing’s syndrome arises when the body’s “cortisol faucet” is stuck open from various sources such as the adrenal glands or abnormal hormone signals. It matters to investors because it drives demand for diagnostics, drugs and surgeries, influences clinical trial outcomes and regulatory risk for therapies, and can affect healthcare costs and revenue forecasts in the endocrine and specialty-pharma markets.

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

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Available on EDGAR 07/29/2026 - 07:00 AM Accepted by SEC EDGAR 07/29/2026 - 07:00 AM Learn about SEC filing dates

FAQ

What did Eton Pharmaceuticals (ETON) announce regarding KHINDIVI?

Eton Pharmaceuticals submitted a Prior Approval Supplement to the FDA seeking to expand KHINDIVI (hydrocortisone) oral solution’s indication to younger pediatric patients. The new formulation showed bioequivalence to ALKINDI SPRINKLE, supporting the request for broader pediatric adrenal insufficiency use.

What is KHINDIVI currently approved for at ETON?

KHINDIVI is currently approved for pediatric patients 5 years and older as replacement therapy for adrenocortical insufficiency. It is the only FDA‑approved oral hydrocortisone solution, designed for precise, ready‑to‑use dosing without tablet manipulation or unapproved compounded liquid suspensions.

When could ETON potentially expand KHINDIVI’s label if approved?

Eton’s CEO stated that, based on the PAS submission and bioequivalence data, the company is one step closer to potentially expanding the label in the first half of 2027. This timing remains subject to FDA review and the regulatory decision process.

How large is ETON’s target pediatric adrenal insufficiency population?

Eton estimates there are approximately 10,000 pediatric adrenal insufficiency patients in the United States. Broader KHINDIVI labeling for younger children could address a substantial portion of this rare disease population that currently lacks an FDA‑approved oral liquid hydrocortisone option.

What key safety risks are highlighted for KHINDIVI in ETON’s disclosure?

Eton highlights serious risks including adrenal crisis, hyperosmolarity, metabolic acidosis, growth retardation, Cushing’s syndrome, decreased bone mineral density, psychiatric and ophthalmic effects, and gastrointestinal complications. Careful monitoring, dose management, and alternate products for stress dosing are emphasized in the safety information.

How many commercial and pipeline products does ETON report?

Eton reports having eleven commercial rare disease products, including KHINDIVI, and four additional product candidates in late-stage development, such as Amglidia, ET‑700, ET‑800 and the ZENEO hydrocortisone autoinjector, reflecting a focused rare disease portfolio.

false 0001710340 0001710340 2026-07-29 2026-07-29

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

July 29, 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 July 29, 2026, Eton Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the submission of a prior approval supplement to expand the indication of KHINDIVI® (hydrocortisone) oral solution.

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

2

Item 9.01: Financial Statements and Exhibits

Exhibit No.		Description
Exhibit 99.1		Press Release dated July 29, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

3

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: July 29, 2026	By:	/s/ Judith M. Matthews
		Judith M. Matthews
		Chief Financial Officer and Secretary
		(Principal Financial Officer)

4

Exhibit 99.1

Eton Pharmaceuticals Announces Submission of Prior Approval Supplement to Expand Indication of KHINDIVI® (hydrocortisone) Oral Solution

● FDA submission seeks to bring KHINDIVI to larger pediatric patient population within the adrenal insufficiency market

● New formulation successfully demonstrated bioequivalence to ALKINDI SPRINKLE®

● Submission allows for a potential first half 2027 approval of the expanded indication

DEER PARK, Ill., July 29, 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 that the Company’s new formulation of KHINDIVI (hydrocortisone) oral solution successfully showed bioequivalence to ALKINDI SPRINKLE (hydrocortisone) oral granules, the FDA-approved hydrocortisone granule formulation, and the Company has submitted a Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration (FDA) requesting an expansion of the product’s label to include younger pediatric patients. KHINDIVI is currently approved for patients ages five years and above.

“Today's submission represents an important milestone in our strategy to make KHINDIVI available to the broadest possible pediatric adrenal insufficiency population. We know the largest need for an FDA-approved oral liquid hydrocortisone remains with children under age five, so we are excited to fill this gap. Our new formulation was designed with young children in mind and now that we have submitted a PAS application demonstrating bioequivalence, we are one step closer to potentially expanding the label in the first half of 2027. We believe broadening the approved age range will drastically accelerate adoption of the product,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

KHINDIVI is the only FDA-approved oral solution of hydrocortisone and was approved in May 2025 as a replacement therapy in pediatric patients five years of age and older with adrenocortical insufficiency. The product was designed to offer precise, ready-to-use dosing without the need for tablet manipulation or relying on non-FDA approved compounded liquid suspensions, providing a therapy option for patients who have difficulty swallowing tablets or those with special administration needs, such as a gastric tube.

Adrenocortical insufficiency is a rare, but serious condition in which the adrenal glands do not produce sufficient cortisol. Eton estimates that there are approximately 10,000 pediatric adrenal insufficiency patients in the U.S.

INDICATION

KHINDIVI is a corticosteroid indicated as replacement therapy in pediatric patients 5 years of age and older with adrenocortical insufficiency.

Limitation of Use

KHINDIVI is not approved for increased dosing during periods of stress or acute events. Use a different hydrocortisone-containing drug product for stress dosing.

IMPORTANT SAFETY INFORMATION

Contraindication

Hypersensitivity to hydrocortisone or any of the other ingredients in KHINDIVI oral solution.

Warnings and Precautions

Adrenal Crisis: Undertreatment or sudden discontinuation of therapy with KHINDIVI may lead to symptoms of adrenal insufficiency, adrenal crisis, and death. Adrenal crisis may also be induced by stress events, such as infections or surgery when patients require higher doses of corticosteroids. During periods of stress (e.g., infections, surgery), switch to another oral hydrocortisone product and increase the dose if oral medications are tolerated. Monitor patients when switching to KHINDIVI to ensure KHINDIVI is providing the same level of hydrocortisone exposure as the previously used oral hydrocortisone formulation. If symptoms of adrenal insufficiency occur, increase the total daily dosage of KHINDIVI.

Systemic Adverse Reactions Due to Inactive Ingredients:

Hyperosmolarity

KHINDIVI is not approved in pediatric patients less than 5 years of age. The inactive ingredients polyethylene glycol 400, propylene glycol, and glycerin undergo substantial systemic absorption, individually or in combination, resulting in increased plasma osmolarity in all pediatric patients, especially in pediatric patients less than 5 years of age. Monitor pediatric patients using KHINDIVI for signs and symptoms consistent with hyperosmolarity.

Metabolic Acidosis and Other Adverse Reactions

The inactive ingredient polyethylene glycol 400 and propylene glycol that may result in metabolic acidosis, hypoglycemia, hepato-renal injury, and central nervous system toxicity (e.g., seizure and coma), may increase the risk of adrenal crisis. Monitor laboratory values and for physical signs and symptoms of these adverse reactions.

Laxative Effects Due to Inactive Ingredients

The inactive ingredients polyethylene glycol 400 and glycerin, whether alone or in combination, may cause gastrointestinal irritation resulting in vomiting and/or diarrhea. These gastrointestinal reactions may increase the risk of adrenal crisis. Monitor for signs or symptoms of gastrointestinal irritation and associated fluid and electrolyte abnormalities.

Immunosuppression and Increased Risk of infection with Use of a Dosage Greater Than Replacement: The use of a greater than replacement dosage can suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Monitor for the development of infection and consider dosage reduction as needed.

Growth Retardation: Long-term use in excessive doses may cause growth retardation. Use the minimum dosage of KHINDIVI to achieve desired clinical response and monitor the patient’s growth.

Cushing’s Syndrome Due to Use of Excessive Doses of Corticosteroids: Prolonged use with supraphysiologic doses may cause Cushing’s syndrome. Monitor patients for signs and symptoms of Cushing’s syndrome every 6 months.

Decrease in Bone Mineral Density: Corticosteroids decrease bone formation and increase bone resorption which may lead to the development of osteoporosis. Use the minimum dosage of KHINDIVI to achieve desired clinical response.

Psychiatric Adverse Reactions: Use may be associated with severe psychiatric adverse reactions, such as euphoria, mania, psychosis with hallucinations and delirium, or depression. Symptoms typically emerge within a few days or weeks of starting the treatment. Most reactions resolve after either dose reduction or withdrawal, although specific treatment may be necessary. Monitor patients for behavioral and mood disturbances during treatment. Instruct caregivers and/or patients to seek medical advice if psychiatric symptoms develop.

Ophthalmic Adverse Reactions: Cataracts, glaucoma, and central serous chorioretinopathy have been reported with prolonged use of high doses. Monitor patients for blurred vision or other visual disturbances, and if they occur, refer them to an ophthalmologist.

Gastrointestinal Adverse Reactions: There is an increased risk of gastrointestinal perforation in patients with certain gastrointestinal disorders. Signs of gastrointestinal perforation, such as peritoneal irritation, may be masked in patients receiving corticosteroids. Corticosteroids should be used with caution if there is a probability of impending perforation, abscess, or other pyogenic infections; diverticulitis, fresh intestinal anastomoses, and active or latent peptic ulcer.

Concurrent administration of corticosteroids with nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of gastrointestinal adverse reactions. Monitor patients receiving corticosteroids and concomitant NSAIDs for gastrointestinal adverse reactions.

Risk of Kaposi’s Sarcoma with Use of a Dosage Greater Than Replacement: Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions at a dosage greater than replacement (supraphysiologic dosage). If patients take a supraphysiologic chronic dosage of KHINDIVI, they are at increased risk of developing Kaposi’s sarcoma.

Vaccination: Administration of live vaccines may be acceptable in KHINDIVI-treated pediatric patients with adrenocortical insufficiency who receive replacement corticosteroids.

Adverse Reactions

The serious adverse reactions associated with KHINDIVI are adrenal crisis, systemic adverse reactions due to inactive ingredients, immunosuppression and increased risk of infection with dosage greater than replacement, Cushing’s Syndrome, growth retardation, Kaposi’s Sarcoma risk, psychiatric, ophthalmic and gastrointestinal adverse reactions.

To report a suspected adverse event related to KHINDIVI, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at http://www.fda.gov/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 eleven commercial rare disease products: KHINDIVI®, INCRELEX®, ALKINDI SPRINKLE®, DESMODA™, GALZIN®, HEMANGEOL®, PKU GOLIKE®, IMPAVIDO®, 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.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. 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 “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s 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, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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

E: lwilson@insitecony.com

Filing Exhibits & Attachments

5 documents

Press Releases

• EX-99.1 EXHIBIT 99.1 PRESS RELEASE RELATING TO KHINDIVI 23.9 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.5 KB
• EX-101 XBRL TAXONOMY EXTENSION DEFINITION LINKBASE 11.2 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 15.0 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.3 KB