FOLD Shares Hit 52-Week High: Time to Buy, Sell or Hold the Stock?

Shares of Amicus Therapeutics FOLD touched a 52-week high of $11.14 on Dec. 15. The stock is currently trading at $10.88.

Shares of Amicus have surged 87.6% in the past six months compared with the industry’s increase of 21%. The stock has also outperformed the sector and the S&P 500 Index in this time frame.

The share price rally can be attributed to growing investor optimism related to FOLD’s set of marketed products, including lead drug, Galafold (migalastat) and the combo drug Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat), which has been witnessing a steady sales uptake.

FOLD Outperforms Industry, Sector & S&P 500 Index

Let us delve into FOLD’s fundamentals, potential growth prospects, challenges and valuation levels to make a prudent choice in this scenario.

Galafold Sales Aid FOLD’s Top Line

Galafold is approved for treating Fabry disease in patients 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.

Galafold has shown solid uptake since its launch. The drug has remained a key top-line driver for Amicus over the past quarters. In the first nine months of 2025, Galafold generated sales worth $371.5 million, which increased around 12% on a year-over-year basis.

The drug’s sales have been rising steadily, owing to commercial execution in all markets and strong compliance and the momentum is likely to continue heading into 2026. The drug also has a strong IP portfolio in the United States, providing patent protection through 2038.

Additionally, the recent settlement of the Galafold patent litigation with Teva Pharmaceuticals TEVA marks a significant step forward in Amicus' efforts to support the Fabry community with Galafold.

In October 2024, Amicus signed a licensing agreement with Teva, resolving the patent lawsuit that it had filed earlier. Per the settlement terms, TEVA will not be able to sell its generic version of Galafold in the United States until January 2037.

This is likely to help Amicus to protect Galafold sales from generic erosion in the United States.

FOLD’s Other Products and Competition in the Target Market

Besides Galafold, Amicus is also making good progress with Pombiliti + Opfolda, a two-component therapy, which is approved for treating adults with late-onset Pompe disease.

The drugs have been witnessing a steady launch so far, which continues to build momentum. In the first nine months of 2025, the combo drug generated sales worth $77.5 million, up around 61.5% on a year-over-year basis. The approval of Pombiliti + Opfolda helped FOLD tap into a market with a significant commercial opportunity.

Though Amicus is riding on the success of Galafold, the company’s heavy reliance on the drug for revenues remains a concern. Rising competition in the target market also remains a headwind, as several 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 in the Pompe disease market also remains a concern for Amicus, whose resources are limited compared with a large drug maker like SNY.

FOLD’s Valuation and Estimates

From a valuation standpoint, Amicus is trading at a premium to the industry. Going by the price-to-sales (P/S) ratio, the company’s shares currently trade at 5.64, higher than 2.46 for the industry. The stock is trading below its five-year mean of 8.99.

The Zacks Consensus Estimate for 2025 earnings per share (EPS) has increased from 31 cents to 36 cents over the past 60 days. During the same time frame, EPS estimates for 2026 have declined from 70 cents to 67 cents.

How to Play FOLD Stock

We remain optimistic about Amicus, buoyed by the strong sales performance of its marketed products during the first nine months of 2025. We expect growth in Galafold sales to continue to boost the top line. Incremental contributions from Pombiliti + Opfolda should also aid Amicus’ top line.

However, the company’s heavy reliance on Galafold, the lack of a deep pipeline and potential competition from established players in the target market remain concerns. While competitive risks remain from large drugmakers, Amicus’ recent developments, growing commercial portfolio and improving earnings estimates highlight its strong upside potential.

We believe there is more room for growth and recommend the stock to prospective investors on the back of strong fundamentals and impressive returns in recent times for meaningful gains in both the short and long term.

FOLD currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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

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