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 its participation in the 19th Annual WORLDSymposium™ 2023 from February 22-26 in Orlando, FL. The company will present two oral presentations and showcase 11 posters related to its Pompe and Fabry disease programs. Key presentations include long-term studies on cipaglucosidase alfa/miglustat's efficacy and safety for Pompe disease. Notable presenters include Barry Byrne and Benedikt Schoser, highlighting ongoing research and development in rare diseases. The event aims to share advancements in lysosomal disease management and foster interdisciplinary collaboration among researchers and clinicians.
PHILADELPHIA, Feb. 08, 2023 - Amicus Therapeutics (Nasdaq: FOLD) will participate in a fireside chat at the SVB Securities Global Biopharma Conference on February 15, 2023, at 10:40 a.m. E.T. The event will be held virtually.
Investors can access the live audio webcast through the company’s investors section on their website. Amicus Therapeutics focuses on developing high-quality medicines for rare diseases, emphasizing patient care and innovative solutions. The company is committed to advancing its pipeline, aiming for first- or best-in-class treatments for patients.
Amicus Therapeutics (Nasdaq: FOLD) reported 2022 revenue of approximately $329 million, reflecting a 16% year-over-year growth at constant exchange rates (CER). The company expects continued growth in 2023, forecasting 12-17% revenue growth for Galafold, driven by increased demand and geographic expansion. The company is also on track for multiple approvals for AT-GAA in Pompe disease and aims for non-GAAP profitability in the second half of 2023. Notably, over 2,000 patients are currently using Galafold.
Amicus Therapeutics (Nasdaq: FOLD) will have its President and CEO, Bradley Campbell, present at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023, at 2:15 p.m. PT in San Francisco, CA. Investors can access a live audio webcast of the presentation via the company's website. Amicus Therapeutics focuses on developing innovative treatments for rare diseases, showcasing a commitment to high-quality medicine delivery for patients in need.
Amicus Therapeutics (Nasdaq: FOLD) announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization for cipaglucosidase alfa, an enzyme replacement therapy for adults with late-onset Pompe disease. The decision from the European Commission is anticipated in Q1 2023. Cipaglucosidase alfa, part of the two-component therapy AT-GAA, is designed to address unmet medical needs in this patient population. The CHMP's recommendation was based on robust clinical data, including a pivotal Phase 3 study.
Amicus Therapeutics (Nasdaq: FOLD) will participate in a fireside chat at the Stifel 2022 Healthcare Conference on November 16, 2022, at 9:45 a.m. E.T., held in New York, NY. Investors can access a live audio webcast of the presentation through the investors section of the Amicus corporate website. The company is dedicated to developing innovative medicines for rare diseases, emphasizing a strong commitment to patient care and a robust pipeline of first- or best-in-class treatments. For more details, visit the Amicus website or follow them on social media.
Amicus Therapeutics (Nasdaq: FOLD) announced an update regarding its investigational therapy AT-GAA. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has altered its agenda for its November meeting, indicating that oral explanations for miglustat and cipaglucosidase alfa will not occur as previously expected on November 9. Despite this setback, Amicus remains focused on preparing for a potential CHMP opinion on AT-GAA by December 2022 and will evaluate any changes to the anticipated timelines.
Amicus Therapeutics (Nasdaq: FOLD) reported a 3% increase in Q3 2022 revenue, totaling $81.7 million, with operational growth at 14% at constant exchange rates. Year-to-date revenue grew by 8% and is on track for 15-20% growth for the full year. Non-GAAP operating expenses guidance has been updated to $430-$440 million, down from $470-$485 million. The company anticipates non-GAAP profitability in H2 2023. Regulatory reviews for AT-GAA for Pompe disease are progressing, with an EU opinion expected in December 2022, while FDA actions are deferred due to inspection delays.
The FDA has issued a deferred action letter regarding Amicus Therapeutics' Biologics License Application for cipaglucosidase alfa, a key component of AT-GAA, due to COVID-19 travel restrictions preventing a required manufacturing site inspection. The company is committed to working with the FDA to finalize plans for this inspection. The FDA has not provided any anticipated action dates while monitoring the public health situation. Despite this setback, Amicus remains optimistic about the approval timeline for AT-GAA and is also pleased with the progress of its review in the EU, expecting a CHMP opinion by year-end.
Amicus Therapeutics (Nasdaq: FOLD) announced a conference call on November 7, 2022, at 8:30 a.m. ET, to discuss its third-quarter financial results for the period ending September 30, 2022. Interested participants can register online for phone access and a live audio webcast will also be available via the company’s investor relations page. An archived version of the webcast and presentation materials will be uploaded on the company's website after the event.
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