# EDGAR Filing Document

**Accession Number:** 0001710340
**File Stem:** 0001437749-25-022298
**Filing Date:** 2025-7
**Character Count:** 9619
**Document Hash:** 0e141f0623178e52d153c5e575c0bfeb
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-25-022298.hdr.sgml**: 20250708

**ACCESSION NUMBER**: 0001437749-25-022298

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250708

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250708

**DATE AS OF CHANGE**: 20250708

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Eton Pharmaceuticals, Inc.
- **CENTRAL INDEX KEY:** 0001710340
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 371858472
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38738
- **FILM NUMBER:** 251109518

**BUSINESS ADDRESS:**
- **STREET 1:** 21925 W. FIELD PARKWAY
- **STREET 2:** SUITE 235
- **CITY:** DEER PARK
- **STATE:** IL
- **ZIP:** 60010-7278
- **BUSINESS PHONE:** (847) 787-7361

**MAIL ADDRESS:**
- **STREET 1:** 21925 W. FIELD PARKWAY
- **STREET 2:** SUITE 235
- **CITY:** DEER PARK
- **STATE:** IL
- **ZIP:** 60010-7278

?xml version='1.0' encoding='ASCII'? eton20250702_8k.htm

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**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

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**FORM**8-K**

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**CURRENT REPORT**

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

**July 08, 2025**

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**Date of Report (Date of earliest event reported)**

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**ETON PHARMACEUTICALS, INC.**

**(Exact name of registrant as specified in its charter)**

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

---

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| |
|:---|
| **21925 W. Field Parkway, Suite 235** |
| **Deer Park**,**Illinois60010**-7278** |
| **(Address of principal executive offices) (Zip code)** |
| **(**847**)**787-7361** |
| **(Registrant**'**s telephone number, including area code)** |

---

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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:**

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| | | |
|:---|:---|:---|
| **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** |

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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. ☐

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**Item 8.01: Other Events**

On July 8, 2025, Eton Pharmaceuticals, Inc. (the "Company") issued a press release announcing that the Company's New Drug Application for ET-600, a proprietary patented formulation of desmopressin oral solution, was accepted for review by the Food and Drug Administration (FDA) and assigned a Prescription Drug User Fee Administration target action date of February 25, 2026.

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**

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| **Exhibit 99.1** | [Press Release dated July 08, 2025](ex_836124.htm) |
| 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.

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| | | |
|:---|:---|:---|
| Date: July 8, 2025 | By: | */s/ James R. Gruber* |
|  |  | James R. Gruber |
|  |  | Chief Financial Officer and Secretary |
|  |  | (Principal Financial Officer) |

---

## Exhibit 99.1

**Exhibit 99.1**

**Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-600 (Desmopressin Oral Solution)**

- NDA assigned a Target Action Date of February 25, 2026 -

- Product has patent protection through 2044 -

DEER PARK, Ill., July 08, 2025 (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 Company's New Drug Application (NDA) for ET-600, a proprietary patented formulation of desmopressin oral solution, has been accepted for review by the U.S. Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 25, 2026.

"We are thrilled to be one step closer to bringing ET-600 to patients and addressing another significant unmet need within the pediatric endocrinology community. Currently, caregivers are often forced to cut fractional tablets or use unapproved liquid suspensions from compounding pharmacies to accommodate the precise, titratable doses required to treat pediatric patients. If approved, ET-600 is expected to be the only oral liquid option on the market, providing a much-needed avenue for delivering accurate doses for children," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. "ET-600 represents yet another high-value near term product launch opportunity for Eton and our team has already initiated commercial preparation activities in anticipation of a potential launch in the first quarter of 2026."

**About ET-600**

ET-600 is a proprietary formulation of desmopressin oral solution developed for the treatment of central diabetes insipidius, also known as arginine vasopressin deficiency (AVP-D). The company has been issued a patent for ET-600's formulation that extends to 2044 and has an additional patent application under review by the United States Patent and Trademark Office. AVP-D is estimated to impact approximately 3,000 pediatric patients in the United States.

**About Eton Pharmaceuticals**

Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has eight commercial rare disease products: KHINDIVI™, INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has five additional product candidates in late-stage development: ET-600, 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:**<br> Lisa M. Wilson, In-Site Communications, Inc.<br> T: 212-452-2793<br> E: lwilson@insitecony.com

Source: Eton Pharmaceuticals.