ETON News & Events

Eton Pharmaceuticals has in-licensed U.S. commercialization rights to HEMANGEOL oral solution from Pierre Fabre Medicament. HEMANGEOL is an Orphan Drug indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy. Infantile hemangiomas are non-cancerous vascular tumors which typically appear in the first days or weeks of a newborn's life. In severe cases, infantile hemangiomas can lead to serious complications including loss of vision, trouble breathing, or physical deformities, and require intervention with systemic therapy. Treatment with HEMANGEOL is typically initiated between ages five weeks to five months and continues for approximately six months. It is estimated that approximately 5,000-10,000 infants are treated with HEMANGEOL annually in the United States. The transaction is expected to be accretive to 2026 earnings and will be financed with the company's cash on hand. Pierre Fabre will continue commercializing HEMANGEOL globally, and in the U.S. until April 30. Effective May 1, Eton will commercialize HEMANGEOL in the U.S. Eton plans to administer the Company's best-in-class Eton Cares Program which provides prescription fulfillment, insurance benefits investigation, educational support, financial assistance for qualified patients, and other services designed to help patients access treatment. Eton Cares will offer co-pay assistance with $0 co-pay for qualifying patients.

Eton Pharmaceuticals announced the U.S. Food and Drug Administration approval of a New Drug Application for Desmoda Oral Solution for the management of central diabetes insipidus, also known as arginine vasopressin deficiency, as antidiuretic replacement therapy for patients of all ages. Desmoda is the first and only FDA-approved oral liquid formulation of desmopressin, developed to support precise, individualized dosing in a disease where careful titration is essential to maintaining water balance. Desmoda is supplied as a ready-to-use oral solution that does not require tablet splitting, crushing, refrigeration, mixing, or shaking. Eton estimates that there are more than 13,000 patients with central diabetes insipidus in the U.S., including approximately 3,000-4,000 pediatric patients. The company expects product peak sales of $30M-$50M annually.