Can Galafold Drive Amicus' Growth Through the Rest of 2025?

Amicus Therapeutics’ FOLD lead product, Galafold (migalastat), has been driving the majority of the company’s revenues. The drug remains a key top-line driver for the company.

Galafold is the first oral precision medicine approved for treating patients with Fabry disease who have amenable genetic variants. The drug is approved in several countries across the world, including the United States, the European Union, the United Kingdom and Japan.

Amicus’ first marketed product, Galafold, has shown solid uptake since its launch. The sales of the drug have been rising consistently year over year. In the first six months of 2025, Galafold generated sales worth $233.1 million, which increased around 11% on a year-over-year basis. Our model estimates for Galafold sales suggest a CAGR of 11.7% over the next three years.

Label expansion, combined with approvals in additional geographies, has been driving Galafold sales in recent quarters, and the momentum is expected to continue in the remainder of 2025. The drug also has a strong IP portfolio in the United States, providing patent protection through 2038.

Last October, Amicus signed a licensing agreement with Teva Pharmaceuticals TEVA, resolving the patent lawsuit that it had filed earlier. The litigation arose after Teva submitted an abbreviated new drug application seeking approval to sell a generic version of Amicus' Galafold 123 mg capsules before the related patents expired.

Per the settlement terms, TEVA will not be able to sell its generic version of Galafold in the United States until January 2037.

Besides Galafold, Amicus is also making good progress with Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat), a two-component therapy, which is approved for treating adults with late-onset Pompe disease (LOPD). The approval of Pombiliti + Opfolda helped FOLD tap into a market with a significant commercial opportunity.

During the first six months of 2025, the combo drug generated sales worth $46.8 million, up around 74% on a year-over-year basis.

FOLD’s Dependence on Galafold & Competition in the Target Market

Currently, Amicus remains heavily dependent on Galafold for its overall revenue growth, making the company vulnerable to any regulatory setbacks for the drug. Though Pombiliti + Opfolda has been approved in Europe and the United States, it is yet to generate incremental sales. Any regulatory setback for the approved drugs will hinder the company’s growth prospects.

Also, competition looms large from established players in the target market. Several pharmaceutical and biotechnology companies currently market and sell products for treating lysosomal storage disorders, including Fabry disease. French pharma giant Sanofi SNY markets Fabrazyme, which is approved for treating Fabry disease. Japan-based Takeda Pharmaceuticals’ Replagal, is also indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease.

Sanofi also markets its Pompe disease drugs, Myozyme/Lumizyme, as well as Nexviazyme. Stiff competition from established players like Sanofi in the Pompe disease market remains a headwind.

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This article originally published on Zacks Investment Research (zacks.com).

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