Eton Pharma Plans FDA Submitting For ET-600 Oral Desmopressin Subsequent Month, Eyes 2026 Launch – Eton Prescription drugs (NASDAQ:ETON)

On Friday, Eton Prescription drugs, Inc ETON revealed outcomes from its bioequivalence examine of ET-600, a proprietary, patented oral resolution of desmopressin below growth for central diabetes insipidus.

Central diabetes insipidus (CDI), or arginine vasopressin deficiency, is a situation the place the physique doesn’t produce sufficient antidiuretic hormone (ADH) or vasopressin, resulting in extreme urination and thirst.

In a bioequivalence examine performed in 75 human topics, ET-600 demonstrated pharmacokinetic equivalence to the U.S. Meals and Drug Administration (FDA)-approved reference product of the identical energetic ingredient.

Eton anticipates submitting a advertising and marketing utility to the FDA for ET-600 in April 2025. If accredited, ET-600 could be the one FDA-approved oral liquid formulation of desmopressin.

“…We anticipate to submit the NDA shortly and have begun pre-launch business readiness actions in anticipation of a possible launch within the first quarter of 2026,” stated Sean Brynjelsen, CEO of Eton Prescription drugs.

In February, Eton Prescription drugs introduced that the FDA prolonged the Prescription Drug Consumer Price Act (PDUFA) objective date for the New Drug Utility (NDA) for ET-400. The brand new PDUFA objective date is Could 28, 2025.

The corporate was notified that the FDA requires further time to conduct a full overview of supplemental data offered in December in response to an FDA request.

In February, the USA Patent and Trademark Workplace granted the corporate U.S. Patent No. 12,214,010, overlaying its ET-600 product candidate’s proprietary formulation of desmopressin oral resolution. The patent expires in 2044.

ET-600 beforehand handed a pilot bioequivalence examine in 2024.

In January, Eton Prescription drugs acquired Galzin (zinc acetate).

Galzin is FDA-approved as a upkeep remedy of sufferers with Wilson Illness who’ve been initially handled with a chelating agent.

Worth Motion: ETON inventory is up 4.62% at $15.28 on the final verify Friday.

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