Eton Pharmaceuticals (NASDAQ: ETON) licenses ultra-rare generic therapy rights

Rhea-AI Filing Summary

Eton Pharmaceuticals reported that it has licensed U.S. marketing rights to an ultra-rare disease product candidate. The product, once approved, is expected to be the first and only generic alternative to an existing treatment for an ultra-rare condition affecting fewer than 100 patients in the United States.

The licensing arrangement was disclosed through a press release dated February 2, 2026, which is attached as an exhibit to the report.

Insights

Biopharma strategy analyst

Eton adds an ultra-rare generic candidate via U.S. marketing license.

Eton Pharmaceuticals has licensed U.S. marketing rights to a product candidate aimed at an ultra-rare condition with fewer than 100 U.S. patients. The product is expected to be the first and only generic alternative to an existing treatment once approved.

This move expands Eton’s rare-disease portfolio into a niche market where competition appears limited by definition. However, the affected population is very small, and the report does not describe any financial terms, development responsibilities, or expected timelines.

The disclosed information centers on strategic positioning rather than near-term financial impact. Future company communications may clarify regulatory progress, commercial strategy, and how any potential approvals could contribute to revenue once the product is on the market.

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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

February 02, 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 February 2, 2026, Eton Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the licensing of U.S. marketing rights to an ultra-rare disease product candidate. Once approved, the product is expected to be the first and only generic alternative to a product used to treat an ultra-rare condition that impacts fewer than 100 patients in the United States.

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

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Item 9.01: Financial Statements and Exhibits

Exhibit No.		Description
Exhibit 99.1		Press Release dated February 02, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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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: February 2, 2026	By:	/s/ James R. Gruber
		James R. Gruber
		Chief Financial Officer and Secretary
		(Principal Financial Officer)

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FAQ

What did Eton Pharmaceuticals (ETON) disclose in this 8-K filing?

Eton Pharmaceuticals disclosed that it licensed U.S. marketing rights to an ultra-rare disease product candidate. The product is expected to become the first and only generic alternative to an existing treatment, targeting a condition affecting fewer than 100 patients in the United States.

What type of product did Eton Pharmaceuticals (ETON) license marketing rights for?

Eton Pharmaceuticals licensed U.S. marketing rights for an ultra-rare disease product candidate. Once approved, it is expected to be the first and only generic alternative to a product treating an ultra-rare condition with fewer than 100 patients in the United States.

How rare is the condition targeted by Eton Pharmaceuticals’ new product candidate?

The product candidate targets an ultra-rare condition that impacts fewer than 100 patients in the United States. This extremely small patient population underscores the niche nature of the therapy and highlights the specialized focus of Eton’s licensed product opportunity.

Will Eton’s new ultra-rare disease product be a generic alternative?

Yes. Eton Pharmaceuticals states the product is expected to be the first and only generic alternative to an existing product. It would serve patients with an ultra-rare condition affecting fewer than 100 individuals in the United States, assuming the product receives approval.

How did Eton Pharmaceuticals (ETON) announce the ultra-rare product licensing?

Eton Pharmaceuticals announced the licensing of U.S. marketing rights through a press release dated February 2, 2026. That press release is attached as Exhibit 99.1 to the report, providing additional detail beyond the brief description included in the main disclosure section.