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(RTTNews) - Eton Pharmaceuticals Inc. (ETON), a commercial-stage pharmaceutical company focused on rare diseases, announced that the FDA has approved DESMODA (desmopressin acetate) oral solution for the management of central diabetes insipidus, as an antidiuretic replacement therapy for patients of all ages.

Central diabetes insipidus, also known as arginine vasopressin deficiency (AVP-D), is a rare but serious condition caused by inadequate production of the hormone vasopressin, a hormone that helps regulate the body's water balance from the hypothalamus/posterior pituitary.

Eton Pharma estimates that more than 13,000 patients in the U.S. have central diabetes insipidus, including approximately 3,000-4,000 pediatric patients.

DESMODA (desmopressin acetate), also known as ET-600, is a vasopressin analog supplied as a ready-to-use oral solution (0.05 mg/mL) that does not require tablet splitting, crushing, refrigeration, mixing, or shaking. It is the first and only FDA-approved oral liquid formulation of desmopressin, developed to support precise, individualised dosing in a disease where careful titration is essential to maintaining water balance.

The product is expected to be available on March 9, 2026, exclusively through Anovo Co Ltd, a specialty pharmacy.

Eton pharma expects DESMODA to achieve peak annual sales in the range of $30 million to $50 million, with patent protection extending through 2044.

DESMODA marks the company's ninth approved product. Its other 8 commercial products include: INCRELEX indicated for severe primary insulin-like growth factor-1 (IGF-1) deficiency in children; ALKINDI SPRINKLE and KHINDIVI to treat pediatric adrenal insufficiency; GALZIN, used for Wilson disease, and PKU GOLIKE, a medical nutritional formula for managing phenylketonuria (PKU). Additionally, Carglumic Acid addresses hyperammonemia resulting from N-acetylglutamate synthase (NAGS) deficiency, Betaine Anhydrous treats homocystinuria, and Nitisinone is indicated for hereditary tyrosinemia type 1 (HT-1), together forming a comprehensive rare-disease speciality portfolio.

For the third quarter that ended on September 30, 2025, the firm reported a loss of $1.93 million or $0.07 per share compared to a net profit of $0.63 million or $0.02 per share in the prior year primarily driven by increased cost of sales.

Net revenue for the third quarter increased to $22.46 million from $10.32 million in the prior year.

ETON has traded between $11.09 and $23 in the last year. The stock closed Monday's trade at $17.65, down 3.45%. In the overnight trade ,ETON is up 1.76% at $17.96.

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