(RTTNews) - Eton Pharmaceuticals Inc (ETON), a company focused on developing treatments for rare diseases, on Thursday, announced that the FDA has postponed the decision on the New Drug Application for ET-400 to May 28, 2025.
ET-400, a proprietary room temperature stable formulation of oral hydrocortisone solution, is proposed for treating pediatric adrenal insufficiency. The original decision date was set for February 28, 2025.
The three-month extension has been granted to allow the FDA more time to review supplemental information that Eton provided in December 2024, in response to the FDA's request.
Eton is confident that it has addressed all of the FDA's questions and expects no further issues to arise during the review process.
ETON closed Wednesday's (FEB.05 2025) trading at $18.25 up by 1.61%. In premarket trading Wednesday the stock is up by 1.37% at $18.00
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