Eton Pharmaceuticals (ETON) said Monday it submitted a new drug application to the US Food and Drug Administration for ET-600, its proprietary oral solution of desmopressin developed to treat central diabetes insipidus.

The company said it expects a standard 10-month review, potentially leading to approval and launch in Q1 2026.

ET-600 is protected by a US patent valid through 2044, with additional patents pending, Eton said.

Shares were 0.5% higher in recent premarket activity.