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DEER PARK, Ill. - Eton Pharmaceuticals, Inc (NASDAQ:ETON), a company specializing in rare disease treatments, has received U.S. Food and Drug Administration (FDA) approval for KHINDIVI™, a hydrocortisone oral solution indicated for pediatric patients with adrenocortical insufficiency. This marks the first FDA-approved oral solution form of hydrocortisone, designed to simplify dosing and administration for children five years and older. The company’s stock, currently trading at $20.08, has delivered an impressive 458% return over the past year, reflecting strong investor confidence in its growth strategy. According to InvestingPro analysis, the company shows promising growth potential, with analysts expecting increased sales and net income this year.
KHINDIVI comes in a 1mg/ml strength, ready-to-use without the need for refrigeration, mixing, or shaking, which addresses the challenges of administering precise doses to pediatric patients. The product is set to be commercially available the week of June 2nd through Anovo, a specialty pharmacy.
According to Eton’s CEO, Sean Brynjelsen, the approval represents a significant step for pediatric patients with adrenal insufficiency, offering a more manageable treatment option. Dr. Kyriakie Sarafoglou from the University of Minnesota highlighted the importance of accurate dosing for children’s growth and development, while Dina Matos of the CARES Foundation underscored the benefit of easier dosing for children with congenital adrenal hyperplasia (CAH).
Eton Pharmaceuticals estimates that over 5,000 U.S. children between 5 and 17 years old suffer from adrenocortical insufficiency. The company projects that peak annual sales for KHINDIVI, alongside ALKINDI SPRINKLE® (hydrocortisone) Oral Granules, will surpass $50 million. The Eton Cares Program will support patients with prescription fulfillment, educational support, and financial assistance, including a $0 co-pay for qualifying individuals.
The FDA approval of KHINDIVI does not cover increased dosing during stress or acute events, requiring a different hydrocortisone-containing product. The medication comes with a warning of potential adverse effects, including adrenal crisis, systemic reactions due to inactive ingredients, immunosuppression, growth retardation, and psychiatric symptoms, among others.
This article is based on a press release statement.
In other recent news, Eton Pharmaceuticals reported a strong first quarter for 2025, with revenue reaching $17.3 million, a 117% increase compared to the same period last year. This growth was driven by robust product sales and licensing revenue, with product sales contributing $14 million. Despite a net loss of $1.6 million, the company exceeded revenue expectations, surpassing the forecast of $14.34 million by approximately 20.6%. Eton Pharmaceuticals maintains a solid cash position with $17.4 million on hand and aims for a $100 million revenue run rate in the near term.
Additionally, Eton Pharmaceuticals has been actively expanding its product portfolio. The company recently relaunched two high-value commercial assets, Inkalex and Galzin, and has been advancing its pipeline candidates. Analysts have shown interest in the progress of product launches, particularly ET400, expected to generate initial revenue in the latter half of 2025. The company has also licensed Incrolex’s international rights to a study of pharmaceuticals, receiving an upfront payment of $4.3 million.
Regarding analyst perspectives, the firm B. Riley noted the company’s performance as "firing on all cylinders," reflecting positive sentiment about Eton’s trajectory. Eton Pharmaceuticals is also preparing for the potential launch of ET400, with expectations of a rapid uptake due to pent-up demand for an oral solution. The company continues to focus on expanding its presence in the ultra-rare disease market, with plans for multiple product launches between 2025 and 2027.
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