Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the Company’s New Drug Application (NDA) for ET-600, a proprietary patented formulation of desmopressin oral solution, has been accepted for review by the U.S. Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 25, 2026.
“We are thrilled to be one step closer to bringing ET-600 to patients and addressing another significant unmet need within the pediatric endocrinology community. Currently, caregivers are often forced to cut fractional tablets or use unapproved liquid suspensions from compounding pharmacies to accommodate the precise, titratable doses required to treat pediatric patients. If approved, ET-600 is expected to be the only oral liquid option on the market, providing a much-needed avenue for delivering accurate doses for children,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “ET-600 represents yet another high-value near term product launch opportunity for Eton and our team has already initiated commercial preparation activities in anticipation of a potential launch in the first quarter of 2026.”
ET-600 is a proprietary formulation of desmopressin oral solution developed for the treatment of central diabetes insipidius, also known as arginine vasopressin deficiency (AVP-D). The company has been issued a patent for ET-600’s formulation that extends to 2044 and has an additional patent application under review by the United States Patent and Trademark Office. AVP-D is estimated to impact approximately 3,000 pediatric patients in the United States.
