Eton Pharmaceuticals, Inc.

Eton Pharmaceuticals announced the submission of a Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration (FDA) for KHINDIVI® (hydrocortisone) oral solution. This submission seeks to expand the product's label to include younger pediatric patients, as the new formulation successfully demonstrated bioequivalence to ALKINDI SPRINKLE®. The company anticipates a potential approval for the expanded indication in the first half of 2027, aiming to address the largest need for an FDA-approved oral liquid hydrocortisone in children under five.

Eton Pharmaceuticals announced the submission of a Prior Approval Supplement (PAS) to the U.S. FDA for KHINDIVI (hydrocortisone) oral solution. The submission aims to expand the product's label to include younger pediatric patients, specifically those under five years of age, for adrenocortical insufficiency. A new formulation of KHINDIVI successfully demonstrated bioequivalence to ALKINDI SPRINKLE®, and the company anticipates potential FDA approval for this expanded indication in the first half of 2027.

Eton Pharmaceuticals, Inc. announced it has entered into a supply and distribution agreement for the exclusive U.S. commercialization rights to IMPAVIDO® (miltefosine) from an affiliate of Knight Therapeutics, Inc. IMPAVIDO® is the first and only FDA-approved oral therapy for visceral, cutaneous, and mucosal leishmaniasis, a rare and potentially life-threatening parasitic disease. The agreement, which takes effect on September 26, 2026, expands Eton's growing portfolio of orphan therapies and reinforces its focus on rare disease commercialization.

Eton Pharmaceuticals reported a net income of $1.55 million for Q1 2026, a significant improvement from a net loss of $1.57 million in Q1 2025. Total net revenues increased by 40.4% to $24.27 million, driven by strong product sales. The company also completed the acquisition of U.S. rights to HEMANGEOL® for $14 million during the quarter, contributing to a decrease in cash and cash equivalents despite strong operating cash flow.

Eton Pharmaceuticals reported strong financial results for the first quarter ended March 31, 2026, with product sales increasing 73% year-over-year to $24.3 million. Based on this performance, the company raised its full-year 2026 revenue guidance to exceed $120 million. Key business achievements include the FDA approval and launch of DESMODA, the acquisition and relaunch of HEMANGEOL, and significant progress in its R&D pipeline with the initiation of the ET-700 clinical study and FDA clearance for the INCRELEX label harmonization study.

Eton Pharmaceuticals announced that its executive management will participate in three upcoming investor conferences in May and June 2026. These include the 26th Annual B. Riley Securities Investor Conference on May 20, the 23rd Annual Craig-Hallum Institutional Investor Conference on May 28, and the Jefferies Global Healthcare Conference on June 4. While there will be no presentations for the B. Riley and Craig-Hallum events, a webcast will be available for the Jefferies conference.

Eton Pharmaceuticals, Inc. announced the relaunch of HEMANGEOL®, the only FDA-approved treatment for proliferating infantile hemangioma. The product is now exclusively available through Anovo Specialty Pharmacy to streamline access and therapy initiation. Eton has also integrated its full Eton Cares patient support, including $0 co-pay for eligible commercially insured patients and expanded patient assistance programs, aiming to ensure timely treatment for the estimated 5,000-10,000 infants annually affected by this time-sensitive rare disease.

Eton Pharmaceuticals, Inc. announced the commencement of a pilot study for its product candidate ET-700. This extended-release formulation of zinc acetate is being developed for the treatment of Wilson disease. The study is designed to compare the efficacy of ET-700 against both Galzin and a placebo.

Eton Pharmaceuticals, Inc. announced the dosing of the first patient in a pilot clinical study for ET-700, its proprietary extended-release zinc acetate formulation for Wilson disease. This study aims to assess the efficacy of a simpler dosing regimen using 64Cu PET imaging to reduce intestinal copper absorption. Topline results are anticipated in the second half of 2026, with a pivotal study planned for early 2027 if the pilot is successful. The company believes ET-700 could achieve over $100 million in peak annual sales in the U.S.

Eton Pharmaceuticals, Inc. announced its 2026 Annual Meeting of Stockholders will be held virtually on June 9, 2026, at 10:00 a.m. CDT. Key proposals include the election of Jenn Adams and Charles J. Casamento as Class II directors and the ratification of Grant Thornton LLP as the independent registered public accounting firm for fiscal year 2026. The record date for stockholders entitled to vote is April 10, 2026, with 27,359,791 shares outstanding.