Shares of Eton Pharmaceuticals Inc (NASDAQ:ETON) saw a 3.3% boost in premarket trading after the company announced U.S. Food and Drug Administration (FDA) approval of KHINDIVI™ (hydrocortisone) Oral Solution. The new treatment, developed for pediatric patients with adrenocortical insufficiency, represents a key achievement for Eton, which focuses on therapies for rare conditions.
KHINDIVI stands out as the first and only FDA-approved oral liquid version of hydrocortisone formulated specifically for children aged five and older. Unlike existing options, it does not require refrigeration, shaking, or mixing – features that make it particularly suited for children who have difficulty swallowing tablets or require alternative delivery methods, such as via gastric tubes.
Eton’s Chief Executive Officer Sean Brynjelsen emphasized the company’s preparedness to roll out the product swiftly, stating, “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.”
Eton’s team is set to begin outreach to pediatric endocrinologists across the U.S. within the first week following approval. KHINDIVI is intended to complement ALKINDI SPRINKLE, the company’s other FDA-approved hydrocortisone therapy for younger pediatric patients with the same condition.
The company estimates that more than 5,000 children in the U.S. between the ages of 5 and 17 live with adrenocortical insufficiency. With both KHINDIVI and ALKINDI SPRINKLE on the market, Eton anticipates peak annual sales from the hydrocortisone franchise could exceed $50 million.
Analysts responded positively to the FDA news. H.C. Wainwright’s Swayampuka Ramakanth increased Eton’s price target from $33 to $35 while maintaining a Buy rating. The analyst noted Eton’s momentum in launching new products and its ability to execute commercially.
KHINDIVI will be distributed in the U.S. exclusively through Anovo, a specialty pharmacy catering to patients with chronic and rare conditions. As part of the Eton Cares Program, Anovo will also provide patient support services, including help with prescriptions, educational resources, and financial aid for eligible patients—ensuring that access to treatment is as seamless as possible.