Eton Pharmaceuticals posts 99% revenue growth, raises 2026 guidance to over $145 million

Eton Pharmaceuticals reported financial results for the quarter ended June 30, 2026 on August 13, 2026. Second quarter 2026 revenues reached $37.6 million, compared to $18.9 million in the prior year period, with the increase attributed to added sales from HEMANGEOL along with growth across the broader portfolio.¹

On the pipeline side, Eton announced the licensing of product candidate ASN-001 for treatment of moderate infantile hemangiomas, with plans to start a bioavailability study and target an NDA submission after the study completes in the second half of 2027.¹ Separately, the company completed a KHINDIVI label expansion study and submitted a Prior Approval Supplement to the FDA after the new formulation showed bioequivalence to ALKINDI SPRINKLE, opening the door to a potential approval in the first half of 2027.¹

AMGLIDIA, a pediatric endocrinology candidate, received FDA Fast Track designation, and Eton plans to start a bioavailability study for it later in the month with an NDA submission still targeted by the end of 2026.¹ In the Wilson disease program, the company's pilot study of ET-700, an extended-release zinc acetate formulation, is underway comparing it to GALZIN and placebo, with a pivotal study planned for early 2027 if pilot results are positive.¹ Eton also received FDA clearance to proceed with an INCRELEX label harmonization study intended to broaden the U.S. definition of severe primary IGF-1 deficiency to match the E.U. standard, a change that could expand the addressable population from about 200 to 1,000 patients, and has begun preparation work aiming to dose the first patients by the end of 2026.¹

On guidance, Eton now expects 2026 revenue to exceed $145 million, up from prior guidance of more than $120 million, and raised its Adjusted EBITDA margin outlook to at least 35%, up from at least 30%.¹

As of June 30, 2026, the company reported cash and cash equivalents of $26.8 million.¹