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, Inc. (NASDAQ: ETON) is a pharmaceutical company focused on developing and commercializing treatments for rare diseases, with particular emphasis on pediatric endocrinology and other rare endocrine and metabolic disorders. Its 2025 press releases highlight a growing portfolio of eight commercial rare disease products, including KHINDIVI, INCRELEX, ALKINDI SPRINKLE, GALZIN, PKU GOLIKE, Carglumic Acid, Betaine Anhydrous, and Nitisinone, along with late-stage candidates such as ET-600, Amglidia, ET-700, ET-800, and the ZENEO hydrocortisone autoinjector.
The ETON news feed features updates on FDA regulatory milestones, product launches, financial results, and corporate developments. Examples include the U.S. FDA approval of KHINDIVI (hydrocortisone) Oral Solution for pediatric adrenocortical insufficiency, the FDA’s acceptance of the New Drug Application for ET-600 (desmopressin oral solution) with a specified PDUFA target action date, and quarterly earnings reports detailing product sales growth and pipeline investment. The company also reports on its acquisition and relaunch of INCRELEX and GALZIN, and on its inclusion in the Russell 2000 and Russell 3000 indexes.
Investors following ETON news can track how Eton’s commercial portfolio and pipeline evolve through regulatory decisions, label expansion efforts, clinical study plans, and conference participation. Regular press releases also discuss non-GAAP metrics such as Adjusted EBITDA, providing additional context for financial performance. This news page aggregates these company-issued updates so readers can review Eton’s rare disease strategy, key product milestones, and ongoing engagement with the healthcare and investment communities.
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.
Eton Pharmaceuticals (Nasdaq: ETON) announced U.S. FDA approval of DESMODA (desmopressin acetate) oral solution for central diabetes insipidus in adults and pediatric patients.
Key points: first FDA-approved desmopressin oral liquid; commercial launch March 9, 2026; ready-to-use 0.05 mg/mL formulation; estimated >13,000 U.S. patients; expected peak sales $30–50 million annually; patent protection through 2044. DESMODA will be distributed exclusively via Anovo with patient support through the Eton Cares program.
Eton Pharmaceuticals (Nasdaq: ETON) announced its executive leadership will hold one-on-one meetings at the Leerink Partners Global Healthcare Conference on Wednesday, March 11, 2026 in Miami, Florida. Investors and institutional representatives can schedule 1x1 meetings through their Leerink Partners institutional sales representative.
Eton Pharmaceuticals (Nasdaq: ETON) licensed U.S. marketing rights to an ultra-rare disease product candidate currently under FDA review, targeting approval and launch in mid-2026.
The product would be the first generic alternative for an ultra-rare condition affecting fewer than 100 patients in the U.S., and the company says the asset complements its commercial infrastructure and patient-support programs.
Eton Pharmaceuticals (Nasdaq: ETON) will present a fireside chat at the Piper Sandler 37th Annual Healthcare Conference in New York City on Thursday, December 4, 2025 at 9:30 AM ET.
Members of the company's executive leadership team will host the session at the Lotte New York Palace. Investors seeking a one-on-one meeting should contact their Piper Sandler institutional sales representative to schedule engagements.
Eton Pharmaceuticals (Nasdaq: ETON) said members of its executive leadership will host 1x1 meetings at the 16th Annual Craig-Hallum Alpha Select Conference on November 18, 2025 in New York, NY.
Investors or institutional representatives seeking a meeting are instructed to contact their Craig-Hallum institutional sales representative to schedule a 1x1.