Galafold's Q4 Performance: Can This Top-of-the-Line Therapy Keep Fueling FOLD Stock's Momentum?

Will Amicus Keep Its Growth Trajectory?

As Amicus Therapeutics (FOLD) approaches its fourth-quarter earnings release, all eyes are on whether its flagship medication Galafold (migalastat) can sustain the revenue surge that’s been driving shareholder gains. Through the first three quarters of 2025, the biotech firm has demonstrated resilience in a competitive landscape, with Galafold commanding more than 80% of total product sales—a testament to its market dominance.

The Galafold Powerhouse

Galafold’s performance has been nothing short of impressive. The Fabry disease treatment racked up $371.5 million in sales during the nine-month period, representing 12% year-over-year growth. What’s particularly noteworthy is the drug’s status as a top-of-the-line therapeutic option with robust intellectual property protections. Amicus secured patent coverage extending through 2038 in the United States, creating a significant competitive moat.

The October 2024 settlement with Teva Pharmaceuticals strengthened this position considerably. Under the agreement, Teva won’t launch its generic alternative until January 2037—effectively giving Galafold over a decade of additional exclusivity. This legal victory removes a major near-term threat and should support steady sales growth as Amicus continues expanding its global footprint across developed markets.

Momentum Building Beyond Galafold

While Galafold remains the revenue engine, Amicus is diversifying its top line through complementary products. The combination therapy Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat) for late-onset Pompe disease generated $77.5 million in first-nine-months sales—a striking 61% surge year-over-year. This dual-component approach has unlocked a sizable market opportunity, and incremental contributions should provide meaningful support for Q4 results.

The Competitive Battlefield

However, Amicus operates in an increasingly crowded space. Sanofi markets Fabrazyme for Fabry disease and also dominates the Pompe segment with Myozyme/Lumizyme and Nexviazyme. Japan’s Takeda competes with Replagal for long-term enzyme replacement therapy. The intense rivalry from these established pharmaceutical giants—which command vastly greater resources—poses a structural headwind. Revenue concentration in Galafold remains a vulnerability, particularly if market share erodes.

Stock Valuation and Analyst Sentiment

FOLD shares have rallied 135.6% over the past six months, significantly outpacing the biotech industry’s 21.5% gain. However, valuation reflects this enthusiasm. At a price-to-sales ratio of 7.39, the stock trades well above the industry median of 2.43, though below its five-year historical average of 8.89.

Analyst consensus has shifted modestly. The 2025 EPS estimate rose from 31 cents to 35 cents over 60 days, yet 2026 projections declined from 70 cents to 65 cents—signaling tempered longer-term expectations. The stock currently carries a Zacks Rank #1 rating (Strong Buy), reflecting analyst conviction despite valuation premiums.

The BioMarin Factor

Looming over everything is BioMarin’s announced $4.8 billion acquisition, expected to close in Q2 2026. This transaction could reshape the investment thesis, though near-term Q4 results will likely command investor attention independent of the deal dynamics.

Bottom Line

Galafold’s ability to drive Q4 top-line results will hinge on commercial execution and maintained compliance across global markets. The Teva settlement bolsters confidence in sustained growth, while Pombiliti + Opfolda’s momentum provides genuine diversification upside. Yet heavy reliance on a single product, paired with formidable competition from larger players, tempers the outlook. Investors should monitor whether management’s expansion efforts and the combo therapy’s trajectory can offset structural vulnerabilities.