Eton Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for ET-600, a proprietary patented formulation of desmopressin oral solution. The NDA has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 25, 2026, indicating a significant milestone in the potential approval process.
ET-600 is designed for the treatment of central diabetes insipidus, also known as arginine vasopressin deficiency (AVP-D), and the company holds a patent for its formulation through 2044. It is estimated that AVP-D impacts approximately 3,000 pediatric patients in the United States, highlighting the potential significance of ET-600 in addressing this rare disease.
The CEO of Eton Pharmaceuticals, Sean Brynjelsen, expressed enthusiasm about the progress, stating that 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. With the anticipation of a potential launch in the first quarter of 2026, the company has already initiated commercial preparation activities for ET-600.
Furthermore, Eton Pharmaceuticals is focused on developing and commercializing treatments for rare diseases, with eight commercial rare disease products currently in its portfolio. Additionally, the company has five additional product candidates in late-stage development, including ET-700 and ET-800.
As a result of these announcements, the company's shares have moved 8.76% on the market, and are now trading at a price of $15.65. If you want to know more, read the company's complete 8-K report here.
