Welcome to our dedicated page for Amicus Therapeut news (Ticker: FOLD), a resource for investors and traders seeking the latest updates and insights on Amicus Therapeut stock.
News for Amicus Therapeutics, Inc. (NASDAQ: FOLD) centers on its role as a global, patient-dedicated biotechnology company focused on rare diseases, along with updates on its commercial therapies and corporate developments. Company press releases describe Amicus as developing and commercializing medicines for Fabry disease and late-onset Pompe disease, as well as advancing programs in focal segmental glomerulosclerosis (FSGS).
Investors following FOLD news will see regular quarterly financial results, where Amicus reports net product revenues for Galafold (migalastat) and Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat). These updates often discuss revenue growth at constant exchange rates, progress toward profitability measures and cash position, giving context for how its rare disease portfolio is performing.
Clinical and medical news items highlight data from the Phase 3 PROPEL study and its open-label extension in adults with late-onset Pompe disease, as well as new analyses and publications in journals such as Muscle and Nerve. These releases summarize outcomes related to six-minute walk distance, pulmonary function, muscle strength, biomarkers and patient-reported measures, and they provide details on long-term safety and efficacy observations for Pombiliti + Opfolda.
Regulatory and market access announcements include approvals and reimbursement milestones for Pombiliti + Opfolda in regions such as Japan, the U.S., European Union, United Kingdom, Canada, Australia and Switzerland. News also covers conference presentations at major healthcare and investor events, where Amicus discusses its rare disease programs and business outlook.
A significant corporate headline is the December 19, 2025 announcement that BioMarin Pharmaceutical Inc. entered into a definitive agreement to acquire Amicus in an all-cash transaction. Updates related to this proposed acquisition, alongside ongoing financial and clinical disclosures, make the FOLD news feed a key source of information on the company’s evolution in the rare disease biotechnology space.
Amicus Therapeutics (Nasdaq: FOLD) reported 2025 total revenue of $634.2M (+17% CER) and cash, cash equivalents and marketable securities of $293.5M at year-end. GAAP net loss narrowed to $27.1M for 2025; non-GAAP net income was $96.8M. The company agreed to a $14.50-per-share all-cash acquisition by BioMarin (~$4.8B), expected to close in Q2 2026, subject to customary conditions.
Amicus Therapeutics (Nasdaq: FOLD) presented new long-term clinical and real-world data for Galafold (migalastat) in Fabry disease and POMBILITI + OPFOLDA (cipaglucosidase alfa plus miglustat) in late-onset Pompe disease at the 22nd Annual WORLDSymposium™ 2026. Highlights include registry analyses and long-term outcomes including 208-week and 90-month data across oral presentations and poster sessions. Galafold is approved in >40 countries and is indicated for adults with amenable GLA variants; Amicus estimates ~35–50% of patients have amenable variants. Safety and usage considerations for both therapies are included.
BioMarin (Nasdaq: BMRN) agreed to acquire Amicus Therapeutics for $14.50 per share, valuing the deal at approximately $4.8 billion. The transaction, approved by both boards, is expected to close in Q2 2026 subject to customary approvals. The deal adds marketed therapies Galafold and Pombiliti + Opfolda that generated $599 million in net product revenue over the past four quarters and resolves U.S. Galafold patent litigation with U.S. exclusivity expected through Jan 2037. BioMarin expects the acquisition to be accretive to Non-GAAP diluted EPS within 12 months and substantially accretive in 2027 and plans to finance with cash plus about $3.7 billion of debt.
Amicus Therapeutics (Nasdaq: FOLD) reported Q3 2025 total revenue $169.1M (CER +17%), GAAP net income $17.3M (EPS $0.06), and cash, cash equivalents and marketable securities of $263.8M (a $33M increase in Q3).
Product sales: Galafold $138.3M (+15% YoY) and Pombiliti + Opfolda $30.7M (+45% YoY). Non-GAAP operating expenses were $95.4M (+15% YoY). Company reiterated 2025 guidance: total revenue growth 15–22%, Pombiliti + Opfolda growth 50–65%, non-GAAP Opex $380–400M, and expects GAAP profitability in H2 2025.
Amicus Therapeutics (Nasdaq: FOLD) said company management will present at two investor conferences in November 2025: the UBS Global Healthcare Conference in Palm Beach Gardens, FL on November 10, 2025 at 2:45 p.m. ET, and the Jefferies Global Healthcare Conference in London on November 18, 2025 at 4:30 p.m. GMT.
Live audio webcasts of both presentations will be available via the company’s investor relations website at https://ir.amicusrx.com/events-and-presentations. Contact details for investor and media relations were provided.
Amicus Therapeutics (Nasdaq: FOLD) will announce third quarter 2025 financial results and host a conference call and live audio webcast on Tuesday, November 4, 2025 at 8:30 a.m. ET.
Phone participants must register online to receive a dial-in number and personal PIN; web participants can register at ir.amicusrx.com (recommended 15 minutes before the call). An archived webcast and slides will be posted on the company website shortly after the live event.
Investor and media contacts are listed for follow-up.
Amicus Therapeutics (Nasdaq: FOLD) presented new 4-year data from the PROPEL open-label extension study of Pombiliti® + Opfolda® in adults with late-onset Pompe disease (LOPD). The analysis focused on 82 patients, including 62 ERT-experienced and 20 ERT-naïve individuals.
Key findings in ERT-experienced patients after 208 weeks showed improvements across multiple metrics: +2.3% in six-minute walk distance, +1.6 points in lower extremity manual muscle test score, and notable improvements in other functional measures. The treatment demonstrated a favorable safety profile with no new safety signals identified, though 41 patients experienced treatment-related adverse events.
The data supports the durability and efficacy of Pombiliti + Opfolda in treating LOPD patients who are not improving on current enzyme replacement therapy (ERT).
Amicus Therapeutics (Nasdaq: FOLD), a global biotechnology company focused on rare diseases, has announced its participation in two major healthcare investor conferences in September 2025. The company will present at the Cantor Global Healthcare Conference on September 3 at 10:20 a.m. ET and the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9 at 3:20 p.m. ET.
Both presentations will be accessible via live audio webcast through the investor relations section of Amicus Therapeutics' corporate website. The company continues its commitment to developing first- and best-in-class medicines for rare diseases.
Amicus Therapeutics (Nasdaq: FOLD) reported strong Q2 2025 financial results with total revenue of $154.7M, up 18% at constant exchange rates. The company's performance was driven by two commercial therapies: Galafold revenue reached $128.9M (up 12%) and Pombiliti + Opfolda achieved $25.8M (up 58%).
Key highlights include Japanese regulatory approval for Pombiliti + Opfolda in adult LOPD patients, progress in the ACTION3 Study of DMX-200 for FSGS, and anticipated GAAP profitability in H2 2025. The company maintains its 2025 guidance with projected revenue growth of 15-22% and expects to exceed $1 billion in total revenue by 2028.
Q2 GAAP net loss was $24.4M ($0.08 per share), while non-GAAP net income was $1.9M ($0.01 per share). Cash position stood at $231.0M as of June 30, 2025.
Amicus Therapeutics (Nasdaq: FOLD), a global biotechnology company focused on rare diseases, will host a conference call and audio webcast on Thursday, July 31, 2025, at 8:30 a.m. ET to discuss its second quarter 2025 financial results.
Participants must pre-register online to receive dial-in details and a personal PIN for the call. A live webcast and presentation materials will be available through the Investors section at ir.amicusrx.com, with web participants encouraged to register 15 minutes before the call. An archived version of the webcast and slides will be available after the event.