Amicus Therapeutics, Inc. (Nasdaq: FOLD) is back on investors’ radar as the rare-disease biotech extends a strong 2025 run—helped by a milestone quarter of GAAP profitability, expanding global launches for its Pompe franchise, and fresh news tied to a Phase 3 kidney-disease program it licensed earlier this year. On Monday, December 15, 2025, Amicus shares traded around $10.93 intraday after opening near $10.55, with the session range pushing into the low $11 area.
Below is a detailed look at the latest Amicus Therapeutics stock news, what Wall Street is forecasting, and the key catalysts (and risks) investors are weighing as 2025 closes.
Amicus Therapeutics stock price today: where FOLD trades on Dec. 15, 2025
As of intraday trading on Dec. 15, 2025, FOLD traded at $10.93, after opening at $10.55, and moving between $10.54 and $11.11 during the session.
That intraday push above $11 matters psychologically because the stock has recently been brushing up against fresh highs. Multiple market summaries in recent days have highlighted FOLD notching a new 52-week high (with one report pointing to $10.61 on Friday’s move, and other data sources placing the 52-week ceiling around the $11 handle). [1]
What’s driving attention on FOLD stock right now
Amicus is not a “story stock” in the classic biotech sense anymore—it’s increasingly a commercial rare-disease company with two marketed products and expanding international reimbursement coverage. Reuters’ company profile summarizes Amicus as having two marketed therapies: Galafold for Fabry disease and Pombiliti + Opfolda for adults with late-onset Pompe disease. [2]
But the near-term attention on the stock is being driven by three converging threads:
- A profitability milestone and reaffirmed 2025 outlook
- A pipeline “option” in FSGS (DMX-200) hitting a Phase 3 enrollment milestone
- Analyst targets that still sit meaningfully above the current share price (at least in consensus summaries)
Let’s take those in order.
Earnings and guidance: Amicus posted GAAP profit and reiterated 2025 targets
In its third-quarter 2025 update (results for the quarter ended Sept. 30, 2025), Amicus reported:
- Total revenue of $169.1 million in Q3 2025
- Galafold net product revenue of $138.3 million
- Pombiliti + Opfolda net product revenue of $30.7 million
- GAAP net income of $17.3 million (about $0.06 per share)
- Cash, cash equivalents and marketable securities of $263.8 million at Sept. 30, 2025 [3]
Just as important for stock narratives: management also reiterated 2025 guidance, including:
- Total revenue growth (CER): 15% to 22%
- Galafold revenue growth (CER): 10% to 15%
- Pombiliti + Opfolda revenue growth (CER): 50% to 65%
- Gross margin: mid-80%
- Non-GAAP operating expenses: $380M to $400M
- GAAP net income: positive during H2 2025 [4]
That combination—growing revenue plus stated profitability expectations—tends to change how generalist investors model a biotech. Instead of “cash burn runway” dominating the conversation, the debate shifts toward durability of the core franchise and how much operating leverage is real.
A quick reality-check using company-reported baseline numbers: Amicus reported 2024 total revenue of $528.3 million. [5] If 2025 revenue grows 15% to 22% (the reaffirmed range), that implies a rough 2025 revenue band of about $607 million to $644 million—before considering currency effects and other reporting nuances. [6]
The business underneath the ticker: two rare-disease franchises, different growth profiles
Galafold: the anchor franchise (and why IP matters)
Galafold (migalastat) remains Amicus’ largest revenue driver. A Nasdaq analysis published Dec. 5, 2025 noted Galafold generated $371.5 million in the first nine months of 2025, up about 12% year over year, and highlighted the company’s view that steady commercial execution and compliance have supported continued growth. [7]
For long-duration models, the key question becomes: how long does Galafold stay protected? Two datapoints investors keep circling:
- Nasdaq’s Dec. 5 analysis points to patent protection through 2038 as part of a “strong IP portfolio” narrative. [8]
- Amicus also announced in 2024 that it settled Galafold patent litigation with Teva, granting Teva a license to market a generic starting January 30, 2037 (if FDA-approved and subject to typical conditions). [9]
In plain English: even if the Fabry market stays competitive, delayed generic entry is one reason some analysts treat Galafold as a multi-year cash engine.
Pombiliti + Opfolda: the growth engine (and why country launches matter)
Amicus’ Pompe franchise is the faster-growing piece off a smaller base. In Q3 2025, Pombiliti + Opfolda revenue grew sharply year over year, and management emphasized global rollout progress—including recent pricing and reimbursement agreements in countries including Japan and Belgium, with a target of up to 10 new launch countries in 2025. [10]
For investors, the operational tell here isn’t just “is it approved?”—it’s how quickly reimbursement decisions convert into treated patients and whether real-world data sustains physician confidence. In the same Q3 update, Amicus pointed to new 4-year data from the PROPEL open-label extension and also noted its manufacturing partner’s Ireland facility received EMA approval as a commercial manufacturing site for Pombiliti. [11]
Today’s pipeline headline: DMX-200 Phase 3 trial completes recruitment (FSGS)
The most time-sensitive news on Dec. 15, 2025 isn’t about Galafold or Pompe—it’s about DMX-200 and the pivotal ACTION3 Phase 3 trial in focal segmental glomerulosclerosis (FSGS).
A Dec. 15 press release stated the ACTION3 trial completed recruitment, reaching its target 286th adult patient dosed, and described next steps that include seeking FDA feedback on 104-week endpoints and a potential pathway to accelerated approval in the U.S. [12]
Why should Amicus shareholders care about a Dimerix-led trial update?
Because Amicus licensed the exclusive U.S. rights to develop and commercialize DMX-200. In the SEC filing describing the agreement, Amicus disclosed that:
- Dimerix granted Amicus exclusive U.S. rights to develop/manufacture/commercialize DMX-200 (and related compounds) for FSGS and other indications
- Dimerix will continue to fund and execute the ongoing Phase 3 study
- Amicus is responsible for U.S. regulatory submissions (including the NDA) and commercialization planning [13]
The April 2025 announcement of the deal described DMX-200 as a small molecule CCR2 inhibitor in a pivotal Phase 3 study, and said the agreement included a $30 million upfront payment and additional milestones/royalties (with milestone potential extending substantially beyond initial approval events). [14]
What this means for the stock narrative
DMX-200 is not the core reason investors own Amicus today—that’s the commercial portfolio. But DMX-200 can function as a high-upside “option value” inside the equity story:
- If Phase 3 data are strong and regulators are aligned, Amicus could add a third franchise (kidney disease) without having borne the full late-stage trial cost burden. [15]
- If the program disappoints, Amicus still has Galafold and Pompe driving the P&L.
That asymmetry is exactly the kind of thing that can keep momentum alive—especially when the base business is simultaneously proving it can generate profit.
Analyst forecasts for Amicus Therapeutics stock: where Wall Street sees FOLD
Analyst targets and “forecast” pages should always be treated like weather predictions: useful for orientation, not a promise. Still, consensus snapshots help explain why investors keep hunting for upside even after a run to 52-week highs.
The consensus: mid-teens targets are common
A widely circulated Nasdaq/Zacks commentary pegs the mean price target around $15.9, describing a range of $11 to $21 across 10 targets (using that as a shorthand for ~60% upside from where the stock traded at the time). [16]
Investing.com’s analyst target summary similarly shows 10 analysts, a low estimate of $11, high of $21, and an average around $15.90, along with a “Strong Buy” consensus label in its snapshot. [17]
Meanwhile, MarketBeat’s forecast page lists an average target of $17.33 (with its own noted high/low range), implying a larger upside depending on the reference price used. [18]
Recent rating actions cited in market summaries
Market summaries published in late 2025 repeatedly cite actions like JPMorgan lifting its target to $19 while maintaining an overweight stance, and Goldman Sachs raising a target to $11 while keeping a neutral rating (as summarized in market commentary). [19]
Earnings revision momentum: a “quant” tailwind
One reason FOLD keeps appearing in Zacks/Nasdaq-style screens is earnings estimate revision momentum. The Dec. 5 Nasdaq analysis noted the Zacks consensus EPS estimate for 2025 increased from $0.31 to $0.36 over 60 days (while the 2026 estimate edged down slightly), and flagged a Zacks Rank #1 (Strong Buy) at the time. [20]
That doesn’t mean the stock must rise. It does explain why it keeps popping up in momentum and “earnings revisions” models.
Ownership and insider activity: what recent disclosures are showing
When a stock makes new highs, investors often zoom in on whether insiders are buying, selling, or simply rebalancing.
Insider sales reported in late November
Investing.com reported that Amicus CEO Bradley L. Campbell sold 14,587 shares for roughly $146,522 on Nov. 24, 2025, and also exercised options for the same number of shares (at a listed exercise price), leaving him with over 1.1 million shares held directly afterward. [21]
The same outlet also reported a sale by Amicus’ Chief People Officer on Nov. 24, 2025, noting it was executed under a pre-arranged Rule 10b5-1 plan (a common structure that can reduce the informational signal of a sale). [22]
Institutional position changes cited in filings summaries
A MarketBeat report dated Dec. 15, 2025 highlighted that one firm reduced its position substantially in a quarterly filing, while also describing other institutions adding or initiating stakes. The same report cited aggregated stats on recent insider selling totals and repeated the “Moderate Buy” consensus framing and a consensus target figure in the high teens. [23]
The important takeaway: insider selling exists in the tape, but it’s occurring alongside broad institutional activity and after a major run-up—so investors typically weigh it as one input, not a single smoking gun.
Risks investors are watching in Amicus Therapeutics stock
Amicus has momentum, but the risk list is not imaginary. Here are the big ones that keep showing up in analysis:
Concentration risk: Galafold still dominates
A Dec. 5 Nasdaq analysis explicitly notes that heavy reliance on Galafold for revenue remains a concern—even while acknowledging the company’s progress and IP position. [24]
Competition in Fabry and Pompe
The same Nasdaq analysis points to entrenched competitors in Fabry (including Sanofi’s Fabrazyme and Takeda’s Replagal) and in Pompe (Sanofi’s Myozyme/Lumizyme and Nexviazyme), arguing that competing against large pharma players can be a headwind. [25]
Execution risk in international reimbursement
For Pompe in particular, the story is increasingly about launch sequencing, reimbursement timing, and durable real-world uptake—things that can move slower than investors want, especially across multiple health systems. [26]
Pipeline uncertainty: DMX-200 is promising, not proven
Yes, completing recruitment is a milestone. It is not efficacy data. The Dec. 15 release emphasizes ongoing data collection across a two-year treatment period and the intent to engage FDA on endpoints and potential accelerated approval—but regulatory outcomes and clinical results remain uncertain until data mature and regulators weigh in. [27]
What to watch next for FOLD stock into 2026
With December 2025 in view, investors tracking Amicus often focus on a short list of concrete checkpoints:
- Pompe rollout cadence: additional reimbursement wins and launches (and whether they translate into sustained quarter-over-quarter growth) [28]
- Durability of profitability: whether GAAP profitability in 2025 becomes a repeatable pattern rather than a one-quarter milestone [29]
- DMX-200 timeline clarity: FDA alignment on endpoints and what that implies for submission timing after the 104-week dataset matures [30]
- Updates to forward guidance: any tightening (up or down) of the 2025 growth range as the year closes out [31]
Bottom line: why Amicus Therapeutics stock is in focus on Dec. 15, 2025
As of Dec. 15, 2025, Amicus Therapeutics stock sits at an interesting crossroads: it’s behaving less like a binary biotech wager and more like a commercial rare-disease company that’s proving operating leverage—while still carrying a pipeline “option” that can create real upside if it hits.
The market’s current fascination with FOLD is essentially the overlap of:
- commercial execution (Galafold + Pompe) [32]
- profitability signaling (GAAP net income and reaffirmed H2 profitability guidance) [33]
- pipeline headlines (DMX-200 Phase 3 recruitment completion) [34]
- forecast narratives (mid-teens consensus targets vs. ~$11 stock price today) [35]
References
1. uk.investing.com, 2. www.reuters.com, 3. www.globenewswire.com, 4. www.globenewswire.com, 5. www.globenewswire.com, 6. www.globenewswire.com, 7. www.nasdaq.com, 8. www.nasdaq.com, 9. www.globenewswire.com, 10. www.globenewswire.com, 11. www.globenewswire.com, 12. www.prnewswire.com, 13. www.sec.gov, 14. www.globenewswire.com, 15. www.sec.gov, 16. www.nasdaq.com, 17. www.investing.com, 18. www.marketbeat.com, 19. www.marketbeat.com, 20. www.nasdaq.com, 21. www.investing.com, 22. www.investing.com, 23. www.marketbeat.com, 24. www.nasdaq.com, 25. www.nasdaq.com, 26. www.globenewswire.com, 27. www.prnewswire.com, 28. www.globenewswire.com, 29. www.globenewswire.com, 30. www.prnewswire.com, 31. www.globenewswire.com, 32. www.globenewswire.com, 33. www.globenewswire.com, 34. www.prnewswire.com, 35. www.nasdaq.com
