Core Insights - Eton Pharmaceuticals has received FDA acceptance for its New Drug Application (NDA) for ET-600, with a target action date set for February 25, 2026 [1] - ET-600 is a patented formulation of desmopressin oral solution, protected until 2044, aimed at treating central diabetes insipidus in pediatric patients [1][3] - The company is preparing for a potential product launch in the first quarter of 2026, addressing a significant unmet need in pediatric endocrinology [2] Company Overview - Eton Pharmaceuticals focuses on developing and commercializing treatments for rare diseases, currently offering eight commercial products [4] - The company has five additional product candidates in late-stage development, including ET-600, Amglidia®, ET-700, ET-800, and ZENEO® hydrocortisone autoinjector [4] - ET-600 is expected to be the only oral liquid option available for pediatric patients requiring precise dosing, as current alternatives involve cutting tablets or using unapproved suspensions [2][3]

Core Insights - Eton Pharmaceuticals has received FDA approval for KHINDIVI, the first and only hydrocortisone oral solution, aimed at pediatric patients with adrenocortical insufficiency [1][3][9] - The commercial launch of KHINDIVI is expected in the week of June 2, with projected combined peak sales of KHINDIVI and ALKINDI SPRINKLE exceeding $50 million annually [1][6] Product Details - KHINDIVI is formulated as a 1mg/ml oral solution, designed for easy dosing without the need for refrigeration or mixing, making it suitable for patients with swallowing difficulties [2][4] - The product is indicated for replacement therapy in pediatric patients aged five years and older with adrenocortical insufficiency [9] Market Context - There are over 5,000 pediatric patients in the U.S. diagnosed with adrenal insufficiency, highlighting a significant market opportunity for KHINDIVI [6] - Eton's existing commercial team will promote KHINDIVI alongside ALKINDI SPRINKLE, providing additional treatment options for patients and caregivers [5][7] Strategic Partnerships - KHINDIVI will be available exclusively through Anovo, a specialty pharmacy, which will also manage the Eton Cares Program to assist patients with prescription fulfillment and financial support [7][8] Company Overview - Eton Pharmaceuticals focuses on developing treatments for rare diseases and currently has eight commercial products, including KHINDIVI and ALKINDI SPRINKLE [41]