Eton posts record Q3 revenue, raises 2026 guidance, advances rare disease pipeline

Eton Pharmaceuticals reported third quarter 2026 financial results on November 5, 2026, alongside updates across its pipeline. The company said third quarter 2026 revenue reached $57.9 million, compared to $22.5 million in the prior year period, driven by the addition of HEMANGEOL sales and higher sales for INCRELEX, ALKINDI SPRINKLE, KHINDIVI, GALZIN, DESMODA and Carglumic Acid.¹ Based on this performance, Eton raised 2026 revenue guidance to more than $175 million from a prior forecast of more than $145 million, and increased its expected Adjusted EBITDA margin to at least 40% from the previous 35% target.¹

On the pipeline, Eton said it licensed patent rights from Baylor College of Medicine covering use of IGF-1 for infantile and epileptic spasms, and has submitted a research IND to the FDA for a Phase 2 study evaluating INCRELEX in epileptic spasms, which it expects to begin enrolling and dosing patients in the first quarter of 2027.¹ Separately, in a proof-of-concept PET study of ET-700, the company reported that treatment-related adverse events occurred in 1 of 12 ET-700 participants compared with 8 of 12 GALZIN participants, while hepatic copper uptake fell 12% with ET-700 versus a 46% decrease with GALZIN and an 11% increase with placebo.¹ Eton said it plans additional study arms in 2027 testing faster-release formulations aimed at improving copper absorption inhibition while preserving the safety profile.¹

On regulatory matters, the company said the FDA accepted for review a Prior Approval Supplement to expand the KHINDIVI label to children under five, assigning a PDUFA date of May 28, 2027.¹ For LIBERVANT, obtained through licensing, Eton noted the product has an NDA under FDA review with a March 29, 2027 PDUFA date that would add ages 6 to 11 to its label, with launch anticipated in April 2027.¹

Eton reported cash and cash equivalents of $55.6 million as of September 30, 2026.¹