FOLD at 52-Week Peak: What Investors Need to Know Before Making a Move

Amicus Therapeutics FOLD recently climbed to a 52-week high of $11.14 on December 15, currently trading near $10.88. Over the past six months, the stock has gained an impressive 87.6% compared to the industry average of 21%, substantially outpacing both the broader healthcare sector and the S&P 500 Index. This rally reflects growing market confidence in FOLD’s expanding commercial portfolio, particularly its marquee product Galafold (migalastat) and the newer combination therapy Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat). For investors eyeing this biotech name, high time has come to dig into the fundamentals.

Understanding the Growth Drivers Behind FOLD’s Rally

FOLD’s ascent appears justified when examining its product performance. The company’s marketed drugs are delivering tangible revenue growth that’s capturing investor attention. Let’s break down what’s actually driving this momentum and whether the rally has room to run.

Galafold Remains the Cornerstone Revenue Engine

Galafold, indicated for treating Fabry disease in patients with specific genetic variants, continues to establish itself as FOLD’s financial backbone. The drug carries approvals across major markets—the United States, European Union, United Kingdom, and Japan—and has demonstrated consistent commercial traction since its market debut.

Through the first nine months of 2025, Galafold generated $371.5 million in sales, representing approximately 12% year-over-year growth. This steady upward trajectory reflects successful market penetration across all regions coupled with strong patient adherence. Looking ahead to 2026, this momentum appears poised to accelerate.

A critical advantage for Amicus lies in Galafold’s robust intellectual property moat. The drug maintains patent protection in the United States extending through 2038, providing nearly two decades of market exclusivity. This protection was further solidified in October 2024 when Amicus resolved patent litigation with Teva Pharmaceuticals TEVA through a licensing settlement. Under the agreement’s terms, Teva’s generic equivalent cannot enter the U.S. market until January 2037, effectively guaranteeing FOLD’s revenue stream from Galafold through the mid-2030s.

The Rising Star: Pombiliti + Opfolda Combo Therapy

Beyond Galafold, Amicus has successfully expanded its commercial reach with Pombiliti + Opfolda, a dual-component treatment for adults diagnosed with late-onset Pompe disease. This combination therapy has gained notable momentum since its approval, capturing a substantial market opportunity that was previously untapped.

During the first nine months of 2025, this combo generated $77.5 million in revenue, marking a robust 61.5% year-over-year increase. This accelerating trajectory indicates strong market adoption and suggests meaningful upside potential as awareness and uptake continue climbing. For a company of Amicus’ scale, landing another revenue driver of this magnitude represents a meaningful milestone.

Competitive Pressures and Market Risks to Monitor

Despite impressive product performance, FOLD faces legitimate headwinds that warrant investor caution. The company remains heavily dependent on Galafold for revenues—a concentration risk that could prove problematic if market conditions shift. Additionally, the pipeline remains shallow, limiting future growth catalysts.

Competition in both the Fabry disease and Pompe disease markets is intense. Sanofi SNY markets Fabrazyme for Fabry disease treatment, while Japan-based Takeda Pharmaceuticals offers Replagal for the same indication. In Pompe disease, Sanofi dominates with Myozyme, Lumizyme, and Nexviazyme. These established players possess substantially deeper resources, broader commercial infrastructure, and existing market relationships—all advantages that smaller biotech firms like Amicus cannot easily replicate.

Valuation Picture: Premium Pricing Amid Mixed Forecast Revisions

From a valuation perspective, FOLD commands a premium relative to industry peers. The stock trades at a price-to-sales ratio of 5.64, compared to the industry median of 2.46—a meaningful gap. However, this premium sits below the five-year historical average of 8.99, suggesting the current valuation isn’t at extreme levels.

Earnings estimates paint a nuanced picture. Over the past 60 days, the 2025 consensus EPS forecast has increased from 31 cents to 36 cents—a positive revision. Conversely, 2026 EPS guidance has been trimmed from 70 cents to 67 cents, raising questions about near-term growth sustainability.

The Investment Case: Weighing Opportunity Against Risk

For investors considering FOLD at current levels, high time exists to carefully weigh the opportunity. The company’s expanding product portfolio and demonstrated commercial execution present genuine upside potential. Galafold’s protected revenue stream and Pombiliti + Opfolda’s accelerating adoption create a credible growth narrative for both 2026 and beyond.

However, heavy concentration on a single blockbuster drug, a limited development pipeline, and stiff competition from larger, better-resourced pharmaceutical companies temper the bull case. The modest downward revision in 2026 EPS estimates also deserves attention.

Taking everything into account, Amicus represents a compelling opportunity for investors with conviction in the company’s ability to expand market share while maintaining pricing power in its target indications. The stock’s recent strength reflects fundamental improvements rather than pure speculation, though downside risks exist if product adoption disappoints or competitive pressures accelerate.

FOLD currently holds a Zacks Rank #1 designation, underscoring analyst confidence in near-term performance potential.