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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
March 3, 2025
Date of Report (Date of earliest event reported)
ETON PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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001-38738
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37-1858472
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(State of
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(Commission
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(I.R.S. Employer
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incorporation)
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File Number)
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Identification Number)
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21925 W. Field Parkway, Suite 235
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Deer Park, Illinois 60010-7208
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(Address of principal executive offices) (Zip code)
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(847) 787-7361
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(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:
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☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading symbol(s)
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Name of each exchange on which registered
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Common Stock, par value $0.001 per share
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ETON
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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. ☐
Item 8.01: Other Events
On March 3, 2025, Eton Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that it has launched Galzin® (zinc acetate) capsules. Galzin is FDA-approved for the maintenance treatment of patients with Wilson disease who have been initially treated with a chelating agent. It is the only FDA-approved zinc therapy for Wilson disease. Galzin is now available exclusively through Optime Care, a specialty pharmacy dedicated to helping patients with rare diseases manage their conditions. Optime Care will administer the Eton Cares Program in partnership with Eton Pharmaceuticals.
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
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: March 3, 2025
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By:
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/s/ James R. Gruber
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James R. Gruber
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Chief Financial Officer and Secretary
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(Principal Financial Officer)
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Exhibit 99.1
Eton Pharmaceuticals Announces Commercial Launch of Galzin® (zinc acetate) Capsules
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Eton expects to significantly expand patient access to this critical treatment for Wilson disease patients |
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$0 co-pay for all eligible patients and best-in-class patient support services |
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Now available exclusively through Optime Care |
DEER PARK, Ill., Mar. 03, 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 that it has launched Galzin® (zinc acetate) capsules. Galzin is FDA-approved for the maintenance treatment of patients with Wilson disease who have been initially treated with a chelating agent. It is the only FDA-approved zinc therapy for Wilson disease.
“We are excited to launch Galzin with our dedicated sales force and robust Eton Cares patient support services. Due to historic availability and affordability challenges, many patients have turned to unapproved compounded products or over-the-counter supplements to manage their Wilson disease. We are dedicated to increasing both access to and awareness of this critical medication. Through Eton Cares, we intend to ensure that every patient that needs Galzin will have access to it,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “As part of our commitment to the Wilson disease community, Eton is also actively investing in further research and development in an effort to drive meaningful advancements in treatment.”
“Galzin is an important medication for Wilson disease patients, and we look forward to partnering with Eton to ensure patients have continued access to this drug,” said Rhonda Rowland, President, Wilson Disease Association.
Galzin is now available exclusively through Optime Care, a specialty pharmacy dedicated to helping patients with rare diseases manage their conditions. Optime Care will administer the Eton Cares Program in partnership with Eton Pharmaceuticals. The program will provide prescription fulfillment, insurance benefits investigation, educational support, and qualified patient financial assistance, along with other services designed to help eligible patients access treatment. Eton Cares will offer $0 co-pay for all eligible patients.
Clinicians seeking to prescribe Galzin can e-prescribe by selecting Optime Care as the pharmacy or fax in a patient referral form to 866-318-2990. Additional product details can be found on the product website, www.galzin.com.
IMPORTANT SAFETY INFORMATION
Warning and Precautions
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Copper Deficiency: Several postmarketing cases reported that zinc acetate taken over extended periods of time (i.e., months to years) may result in decreased enteral copper absorption and copper deficiency. The cases reported the following complications of copper deficiency: anemia, granulocytopenia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and myeloneuropathy.
If a patient develops signs and/or symptoms of copper deficiency during treatment with zinc acetate, interrupt zinc treatment and measure zinc, 24-hr urinary copper, and non-ceruloplasmin bound copper (NCC) levels. Consider restarting zinc acetate treatment based on periodic monitoring of 24-hr urinary copper and NCC levels.
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Gastric Ulcer: There have been postmarketing reports of gastric ulcers with long-term use of zinc acetate. The cases reported the complications of anemia and gastric ulcer perforation with peritonitis. In some cases, ulcers persisted after treatment until zinc acetate was discontinued.
If a patient develops signs and/or symptoms of gastric ulcer during treatment with zinc acetate, discontinue zinc treatment. Most patients showed improvement after cessation of zinc treatment.
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General: Zinc acetate is not recommended for the initial therapy of symptomatic patients because of the delay required for zinc-induced increase in enterocytic metallothionein and blockade of copper uptake. Symptomatic patients should be treated initially, using chelating agents. During initial therapy, neurological deterioration may occur as stores of copper are mobilized. Once initial therapy has been completed, and the patient is clinically stable, maintenance treatment with zinc acetate can be considered, but patients may be continued on initial therapy as clinically indicated.
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Information for Patients: Patients should take GALZIN® on an empty stomach, at least one hour before or two to three hours after meals. Capsules should be swallowed whole, not opened or chewed. In the rare event of gastric intolerance of zinc, generally occurring with the morning dose, this dose may be taken between breakfast and lunch. Patients must be clinically monitored to determine the adequacy of zinc acetate therapy. Since strict adherence to the zinc regimen is essential for optimal control of copper distribution and metabolism, the physician must reinforce the need for compliance at each contact with the patient.
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Monitoring Patients: Patients should be monitored primarily by assessment of existing signs and symptoms of Wilson’s disease and 24-hour urine copper. Neuropsychiatric evaluations including speech as well as liver function tests including bilirubin and aminotransferases, should be done as appropriate.
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Adverse Reactions
The following adverse reactions associated with the use of zinc acetate were identified from postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal disorders: gastric irritation
Investigations: elevations of serum alkaline phosphatase, amylase, and lipase lasting from weeks to months suggesting pancreatitis; the levels usually return to high normal within the first one or two years of zinc therapy.
INDICATION
Zinc acetate therapy is indicated for maintenance treatment of patients with Wilson's disease who have been initially treated with a chelating agent
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 seven commercial rare disease products: INCRELEX® (mecasermin) injection, ALKINDI SPRINKLE® (hydrocortisone) oral granules, GALZIN® (zinc acetate) capsules, PKU GOLIKE®, Carglumic Acid tablets, Betaine Anhydrous oral solution, and Nitisinone capsules. The Company has four additional product candidates in late-stage development: ET-400, ET-600, Amglidia® (glyburide oral suspension), 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
Source: Eton Pharmaceuticals, Inc.
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