Investing.com -- Shares of Eton Pharmaceuticals Inc (NASDAQ: ETON ) climbed 3.3% premarket following the announcement that the U.S. Food and Drug Administration (FDA) approved KHINDIVI™ (hydrocortisone) Oral Solution, a new treatment for pediatric patients with adrenocortical insufficiency. The approval marks a significant milestone for the company, which specializes in developing treatments for rare diseases.

KHINDIVI is the only FDA-approved oral liquid formulation of hydrocortisone, specifically designed for children five years and older who require replacement therapy for adrenocortical insufficiency. The drug’s unique liquid form, which does not require refrigeration, mixing, or shaking, is tailored for accurate dosing and ease of administration, especially for patients with difficulty swallowing tablets or those with special administration needs like a gastric tube.

Eton’s CEO, Sean Brynjelsen, expressed the company’s readiness to commercialize KHINDIVI swiftly, indicating that their commercial team is prepared to engage with pediatric endocrinologists across the United States within the first week of approval. The introduction of KHINDIVI is expected to complement Eton’s existing portfolio, including ALKINDI SPRINKLE, another FDA-approved hydrocortisone treatment for pediatric adrenocortical insufficiency.

The company estimates that there are over 5,000 U.S. patients between the ages of 5 and 17 who suffer from this condition. Eton anticipates that peak sales of KHINDIVI, in combination with ALKINDI SPRINKLE, will surpass $50 million annually.

In addition to the FDA approval, Eton Pharmaceuticals received a positive nod from analysts. H.C. Wainwright analyst Swayampuka Ramakanth increased the target price on Eton from $33 to $35 and maintained a Buy rating. The analyst’s comment underscores the company’s commercial prowess: "Having relaunched Increlex in January and GALZIN in March, Eton would have launched three new drugs including Khindivi within the first six months of 2025. Based on management’s strength in commercial execution to date, we believe these additions could make 2025 a year of revenue inflection."

KHINDIVI will be distributed in the U.S. exclusively through Anovo, a specialty pharmacy that serves patients with rare and chronic conditions. The Eton Cares Program, a partnership between Anovo and Eton Pharmaceuticals, will offer comprehensive support for patients, including prescription fulfillment, educational support, and financial assistance for those who qualify, ensuring that the therapy is accessible to those in need.

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