Welcome to our dedicated page for Eton Pharmaceuticals news (Ticker: ETON), a resource for investors and traders seeking the latest updates and insights on Eton Pharmaceuticals stock.
Eton Pharmaceuticals develops and commercializes treatments for rare diseases, with commercial products that include KHINDIVI, INCRELEX, ALKINDI SPRINKLE, DESMODA, GALZIN, HEMANGEOL, PKU GOLIKE, Carglumic Acid, Betaine Anhydrous and Nitisinone. Company news commonly covers FDA approvals, product launches, licensing of U.S. commercialization rights, specialty pharmacy distribution and Eton Cares patient-support programs.
Updates also address financial results, product-sales trends, late-stage product candidates and clinical work for rare-disease therapies. Pipeline references include Amglidia, ET-700, ET-800 and ZENEO hydrocortisone autoinjector, with ET-700 described as an extended-release zinc acetate formulation for Wilson disease.
Eton Pharmaceuticals (Nasdaq:ETON) signed a supply and distribution agreement for exclusive U.S. commercialization rights to IMPAVIDO (miltefosine), effective September 26, 2026. IMPAVIDO is the first and only FDA-approved oral therapy for visceral, cutaneous, and mucosal leishmaniasis caused by specific Leishmania species in eligible patients.
The deal expands Eton’s rare disease portfolio and supports its orphan-focused commercial model.
Eton Pharmaceuticals (Nasdaq: ETON) reported Q1 2026 net revenue and product sales of $24.3 million, with product sales up 73% year-over-year. GAAP diluted EPS was $0.05, non-GAAP EPS $0.14, and Adjusted EBITDA $5.7 million (24% margin).
The company raised 2026 revenue guidance to more than $120 million and targets at least a 30% Adjusted EBITDA margin. Eton launched FDA-approved DESMODA, acquired and relaunched HEMANGEOL, initiated the ET-700 trial, advanced KHINDIVI label expansion, and received FDA clearance for an INCRELEX label harmonization study.
Eton Pharmaceuticals (Nasdaq: ETON), a rare disease-focused pharmaceutical company, announced executive participation in three investor conferences in May and June 2026.
Events include the B. Riley Securities and Craig-Hallum conferences without presentations, and a Jefferies Global Healthcare Conference appearance with a webcast on June 4, 2026.
Eton Pharmaceuticals (NASDAQ: ETON) will report first quarter 2026 financial results on Thursday, May 14, 2026, and will host a conference call and live audio webcast at 4:30 p.m. ET (3:30 p.m. CT).
Management will take live questions on the call and answer emailed investor questions sent to investorrelations@etonpharma.com. The live webcast is available on the company's Investors website, with an archived webcast posted about two hours after the event and available for 30 days.
Eton Pharmaceuticals (Nasdaq: ETON) announced the relaunch of HEMANGEOL (propranolol) oral solution on May 1, 2026, now distributed exclusively through Anovo Specialty Pharmacy with integrated Eton Cares patient support.
Key elements: $0 co-pay for eligible commercially insured patients, expanded patient assistance, orphan drug indication for proliferating infantile hemangioma, treatment window typically five weeks to five months, and an estimated 5,000–10,000 infants treated annually in the U.S.
Eton Pharmaceuticals (Nasdaq: ETON) announced first patient dosing in a pilot clinical study of ET-700, an extended-release zinc acetate formulation for Wilson disease. The double-blind, placebo-controlled PET imaging study (n=36) compares GALZIN 50 mg TID, ET-700 75 mg BID plus placebo, and placebo TID.
Topline results are expected in the second half of 2026; a pivotal study could start in early 2027 if results are positive. The primary endpoint is change in hepatic 64Cu uptake by PET.
Eton Pharmaceuticals (Nasdaq: ETON) announced Judith M. Matthews will become Chief Financial Officer effective June 1, 2026. Matthews brings more than 25 years of finance leadership in pharma and biotech. Current CFO James Gruber will remain through May 31, 2026 and then enter a six-month consulting agreement.
Eton Pharmaceuticals (NASDAQ: ETON) reported strong fourth quarter and full-year 2025 results with Q4 product sales of $21.3 million (up 83% year‑over‑year) and full‑year revenue of $80 million, more than double 2024. The company launched DESMODA, acquired U.S. rights to HEMANGEOL, and ended 2025 with $25.9 million cash. Management expects 2026 revenue to exceed $110 million with an Adjusted EBITDA margin above 30%.
Eton Pharmaceuticals (Nasdaq: ETON) will report fourth quarter and full year 2025 financial results on Thursday, March 19, 2026. Management will host a conference call and live audio webcast at 4:30 p.m. ET (3:30 p.m. CT).
Investors may join the participant call or webcast, submit live questions, or email questions to investorrelations@etonpharma.com. An archived webcast will be available on the company investor website approximately two hours after the event and remain for 30 days.
Eton Pharmaceuticals (Nasdaq: ETON) has in-licensed U.S. commercialization rights to HEMANGEOL oral solution, the only FDA-approved treatment for infantile hemangioma that requires systemic therapy. Effective May 1, 2026, Eton will commercialize HEMANGEOL in the U.S. and distribute through its Eton Cares program with a $0 co-pay option for qualifying patients.
The company said the transaction will be financed with cash on hand and is expected to be accretive to 2026 earnings. Pierre Fabre will continue global commercialization and U.S. commercialization through April 30, 2026.