Feb. 2 at 4:49 PM
Eton Pharmaceuticals announced it has licensed U.S. commercialization rights for a product candidate targeting an ultra-rare disease, with a potential launch expected in 2026. The FDA is currently reviewing the product, which, if approved, would become the first and only generic alternative for a condition affecting fewer than 100 patients in the U.S.
The company expects regulatory approval and a mid-2026 launch, with the treatment integrated into its Eton Cares patient support program. Management said the asset fits well with Eton’s existing commercial infrastructure and supports its strategy to build one of the largest ultra-rare disease portfolios. Further product details will be disclosed following FDA approval.
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