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) announced that the FDA has accepted its New Drug Application (NDA) for miglustat and Biologics License Application (BLA) for cipaglucosidase alfa, both part of the AT-GAA therapy for Pompe disease. The PDUFA action dates are set for May 29, 2022, and July 29, 2022, respectively. This therapy aims to address a significant unmet need for Pompe disease patients in the U.S. The company is also progressing towards a Marketing Authorization Application (MAA) submission in the EU by Q4 2021.
Amicus Therapeutics (Nasdaq: FOLD) presented two posters at the 26th International Annual Congress of the World Muscle Society, held from September 20-24, 2021. The posters highlight the company’s development program for Pompe disease, including a study comparing cipaglucosidase alfa/miglustat with alglucosidase alfa/placebo in late-onset Pompe disease. The investigational therapy is not yet approved by regulatory agencies. Details on the presentations will be available on Amicus's website following the congress.
Amicus Therapeutics (Nasdaq: FOLD) has announced its participation in three upcoming virtual investor conferences. The events include the Morgan Stanley 19th Annual Global Healthcare Conference on September 10, 2021, the Bank of America Global Healthcare Conference on September 15, 2021, and the Cantor Global Healthcare Conference on September 27, 2021. Live audio webcasts for each presentation will be accessible through the Investors section of their website. Amicus focuses on developing high-quality medicines for rare metabolic diseases.
Amicus Therapeutics (FOLD) reported 2Q21 Galafold revenue of $77.4 million, marking a 24% increase year-over-year. The company is on track to achieve its 2021 revenue guidance of $300M-$315M. Amicus completed rolling BLA and NDA submissions for AT-GAA, with regulatory support from the EMA. Cash and equivalents stood at $383.1 million. Despite a net loss of $51.2 million, expenses decreased by 2.5% to $93.5 million on a non-GAAP basis. The company is confident in its operational growth with ongoing clinical studies and expansion of Galafold's EU label.
Amicus Therapeutics (Nasdaq: FOLD) announced its participation in the BTIG Virtual Biotechnology Conference on August 9, 2021, at 9:00 a.m. E.T. A live audio webcast will be available on the company's investor section of their website. Amicus is dedicated to developing innovative treatments for rare metabolic diseases, emphasizing a patient-focused approach. For more details about the conference and the company’s initiatives, please visit their website.
Amicus Therapeutics has received European Commission approval for Galafold® (migalastat) as the first oral therapy for the long-term treatment of adolescents aged 12 to 16 years with Fabry disease and an amenable mutation. This marks a significant milestone for the Fabry community, providing a treatment option not available for over 15 years. Supported by interim data from a pediatric study, Amicus aims to facilitate rapid access for eligible patients, further expanding Galafold, which is already approved in several countries, including the U.S. and Japan.
Amicus Therapeutics (Nasdaq: FOLD) will host a conference call and live audio webcast on August 5, 2021, at 8:30 a.m. ET to discuss its financial results for Q2 2021, ended June 30, 2021. Investors can join the call by dialing 877-303-5859 (U.S./Canada) or 678-224-7784 (international) with conference ID 7374935. A live audio webcast will be available on the company’s website. A replay will be accessible for seven days starting at 11:30 a.m. ET, with specific access numbers for both U.S./Canada and international participants.
Amicus Therapeutics (Nasdaq: FOLD) has appointed Dr. Eiry W. Roberts to its Board of Directors. Dr. Roberts brings nearly 30 years of drug development experience, having previously served as Chief Medical Officer at Neurocrine Biosciences and held senior roles at Eli Lilly. She has led numerous late-stage development programs to global regulatory approvals, contributing significantly to her former company’s portfolio. Her expertise in healthcare strategy is expected to enhance Amicus’s mission of developing therapies for rare diseases.
Amicus Therapeutics (FOLD) announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted a positive scientific opinion for AT-GAA under the Early Access to Medicines Scheme. This allows eligible adults with late-onset Pompe disease to access AT-GAA prior to marketing authorization. The decision underscores the high unmet medical need in this patient group. AT-GAA, a two-component therapy, has shown promising results in clinical studies. Marketing Authorization Applications for AT-GAA are expected in the UK and EU in late 2021.
Amicus Therapeutics (Nasdaq: FOLD) will participate in the Goldman Sachs 42nd Annual Global Healthcare Conference on June 9, 2021, at 5:30 p.m. E.T. The event will include a fireside chat featuring members of Amicus' senior leadership team. Investors can listen to the live audio webcast via the company’s investor relations page. Amicus focuses on developing innovative medicines for rare metabolic diseases, underscoring its commitment to patient care and advancing a strong pipeline of therapies.