FDA Accepts Eton Pharmaceuticals’ NDA for Pediatric Diabetes Insipidus Drug
FDA Accepts Eton Pharmaceuticals’ NDA for Pediatric Diabetes Insipidus Drug

FDA Accepts Eton Pharmaceuticals’ NDA for Pediatric Diabetes Insipidus Drug

News summary

Eton Pharmaceuticals announced that the FDA has accepted its New Drug Application for ET-600, a patented desmopressin oral solution designed to treat central diabetes insipidus in pediatric patients, with a target action date set for February 25, 2026. ET-600 would be the only oral liquid option for this rare condition, addressing a significant unmet need affecting around 3,000 children in the U.S., who currently rely on cutting tablets or unapproved liquid compounding. The company has secured patent protection for ET-600’s formulation extending to 2044 and has already begun commercial preparations for a potential launch in early 2026. Eton Pharmaceuticals has experienced strong revenue growth recently and focuses on developing treatments for rare diseases, with eight commercial products and multiple candidates in late-stage development. The stock reacted positively to the FDA announcement, rising sharply in premarket trading. CEO Sean Brynjelsen emphasized the importance of ET-600 in providing accurate dosing options for pediatric endocrinology patients and described the product launch as a high-value near-term opportunity for the company.

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