Eton Pharmaceuticals reported second quarter 2026 financial results on August 13, 2026. The company achieved record revenue of $37.6 million, a 99% increase from the prior year period, driven by HEMANGEOL sales and growth across its portfolio. GAAP net income was $11.6 million ($0.35 per diluted share), compared to a net loss in the previous year. The company raised its full-year revenue guidance to exceed $145 million, up from over $120 million, and increased Adjusted EBITDA margin guidance to at least 35%. Key operational highlights include the successful relaunch of HEMANGEOL with 95% patient conversion, the licensing of late-stage candidate ASN-001 for a potential 2027 NDA submission, FDA Fast Track designation for AMGLIDIA, and the acquisition of U.S. commercialization rights to IMPAVIDO. Eton Pharmaceuticals is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases.

Eton Pharmaceuticals entered into a license agreement on July 31, 2026, to acquire U.S. rights for ASN-001 (timolol topical gel) from Auson Pharmaceuticals for treating proliferating superficial infantile hemangiomas. Eton paid a $3.0 million upfront fee and will conduct a bioavailability bridging study, targeting an NDA submission in the second half of 2027. Upon FDA approval, milestone payments range from $5 million to $10 million based on sales thresholds up to $280 million, with tiered royalties between 10% and 15%. ASN-001 showed elimination or near-elimination rates of 42-56% in Phase II/III trials. Eton Pharmaceuticals is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases.

Eton Pharmaceuticals appointed Danka Radosavljevic as Chief Operating Officer effective July 31, 2026. Ms. Radosavljevic previously served as Executive Vice President of Operations for over five years and has been with the company since 2017. Her compensation includes an annual base salary of $520,800 and a target discretionary incentive bonus equal to 50% of her base salary. Eton Pharmaceuticals operates in the pharmaceutical industry, specializing in the development and commercialization of generic and specialty drugs.

Eton Pharmaceuticals submitted a Prior Approval Supplement to the FDA on July 29, 2026, seeking to expand the approved indication for KHINDIVI (hydrocortisone) oral solution to include younger pediatric patients. The submission is based on data demonstrating that the new formulation achieved bioequivalence with ALKINDI SPRINKLE. Currently approved for children aged five and older, expanding the label aims to address the significant unmet need in the under-five demographic within the adrenal insufficiency market. Eton anticipates a potential approval decision in the first half of 2027. This regulatory development could broaden the product's commercial addressable population and accelerate adoption rates for this rare disease therapy.