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

Core Insights - Amicus Therapeutics (FOLD) shares reached a 52-week high of $11.14 on December 15, currently trading at $10.88, with a significant 87.6% increase over the past six months compared to the industry's 21% growth [1][4][9] Company Performance - The stock's rally is driven by investor optimism regarding Amicus' marketed products, particularly Galafold (migalastat) and the combination therapy Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat), which are experiencing steady sales growth [2][20] - Galafold generated sales of $371.5 million in the first nine months of 2025, reflecting a 12% year-over-year increase, and is a key revenue driver for the company [7][9] - Pombiliti + Opfolda sales reached $77.5 million in the same period, marking a 61.5% year-over-year growth, indicating strong market uptake [9][13] Market Position and Competition - Amicus has successfully resolved patent litigation with Teva Pharmaceuticals, ensuring Galafold's market protection until January 2037, which is expected to safeguard sales from generic competition [10][11] - Despite the success of Galafold, the company's heavy reliance on this drug for revenue poses a risk, especially with increasing competition from established players like Sanofi and Takeda in the Fabry and Pompe disease markets [14][15][16] Valuation and Financial Estimates - Amicus is currently trading at a price-to-sales (P/S) ratio of 5.64, which is above the industry average of 2.46, but below its five-year mean of 8.99 [17] - The Zacks Consensus Estimate for 2025 earnings per share (EPS) has increased from 31 cents to 36 cents, while estimates for 2026 have decreased from 70 cents to 67 cents [18] Future Outlook - The company is expected to continue benefiting from strong sales of Galafold and incremental contributions from Pombiliti + Opfolda, indicating potential for growth [20] - Despite concerns regarding reliance on Galafold and competition, recent developments and improving earnings estimates suggest strong upside potential for Amicus [21][22]