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.
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