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 reported a strong first quarter of 2022, with Galafold® revenue reaching $78.7 million, an 18.5% year-over-year increase. The company strengthened its intellectual property with new patents extending protection through 2038. Regulatory reviews for AT-GAA in Pompe Disease are progressing, with the FDA's action dates set for May 29 and July 29, 2022. Amicus anticipates continued double-digit growth for Galafold, projecting $350 million to $365 million in revenue for the year. However, the net loss for the quarter was $85.3 million.
Amicus Therapeutics (Nasdaq: FOLD) announced participation in a fireside chat at the Bank of America 2022 Healthcare Conference on May 11, 2022, at 12:00 p.m. P.T. The event will take place in Las Vegas, NV. A live audio webcast will be available on the company's investor website. Amicus Therapeutics is dedicated to developing novel therapies for rare metabolic diseases, focusing on patient needs and advancing a robust pipeline of innovative medicines. For further details, visit their website or access the webcast.
Amicus Therapeutics (Nasdaq: FOLD) will host a conference call and live audio webcast on May 9, 2022, at 8:30 a.m. ET to discuss financial results for Q1 2022, covering the period ended March 31, 2022. Investors can participate by calling 877-303-5859 (U.S./Canada) or 678-224-7784 (international) and using conference ID 7867383. Additionally, a replay will be available for seven days post-call. The company focuses on developing innovative therapies for rare metabolic diseases and is dedicated to patient-centric care. For further information, visit their corporate website.
Amicus Therapeutics (Nasdaq: FOLD) announced the issuance of U.S. Patent No. 11,304,940, extending patent protection for Galafold (migalastat) through 2038. This new patent focuses on methods to treat Fabry disease patients with renal impairments and is part of a total of 35 issued patents in the U.S. for Galafold. CEO John Crowley emphasized the significance of this patent in strengthening the company’s intellectual property portfolio, which supports ongoing commercialization efforts of this novel precision medicine.
Amicus Therapeutics (Nasdaq: FOLD) released promising results from its Phase 1/2 study of AT-GAA for Pompe disease. Over 36 months, participants showed significant improvements in motor function, six-minute walk test distances, and reductions in muscle damage biomarkers. The therapy's safety profile remains consistent with prior data. Regulatory reviews are ongoing, with the FDA's PDUFA dates set for May 29 and July 29, 2022. The data may position AT-GAA as a new standard of care for Pompe disease, addressing both ERT-experienced and ERT-naïve patients.
Amicus Therapeutics (Nasdaq: FOLD) announced that its development program for Pompe disease will be featured in an oral presentation and two posters at the 2022 MDA Clinical & Scientific Conference. The oral presentation titled Long-term follow-up of cipaglucosidase alfa/miglustat is scheduled for March 16, 2022. In addition, two posters will discuss Immunogenicity of cipaglucosidase alfa versus alglucosidase alfa and the impact of COVID-19 on patients living with Pompe disease. Presentations will be available on the company’s website after the conference.
Amicus Therapeutics (Nasdaq: FOLD) will participate in a fireside chat at the Cowen 42nd Annual Health Care Conference on March 8, 2022, at 9:10 a.m. E.T. A live audio webcast of the event will be available on the company’s investor website.
Amicus Therapeutics is focused on developing innovative medicines for rare metabolic diseases, showcasing its commitment to patient care through a robust pipeline of treatments.
Amicus Therapeutics (Nasdaq: FOLD) reported a 17% year-over-year revenue growth to $306 million in 2021, driven by strong sales of Galafold. The company anticipates Galafold revenue of $350 million to $365 million in 2022, maintaining double-digit growth. Amicus aims for profitability in 2023, aided by $400 million in projected operating expense savings through 2026. Regulatory filings for AT-GAA are under review, with launch preparations ongoing. The planned business combination with ARYA IV has been terminated due to adverse market conditions.
Amicus Therapeutics (Nasdaq: FOLD) will host a conference call on February 24, 2022, at 8:30 a.m. ET to discuss its financial results for the year ending December 31, 2021. Interested participants can join by dialing 877-303-5859 (U.S./Canada) or 678-224-7784 (international) with conference ID 1792414. A live audio webcast will also be available on the company’s website. A replay will be accessible for seven days post-call at designated numbers. Amicus focuses on developing high-quality medicines for rare metabolic diseases.
Amicus Therapeutics (FOLD) announced participation at the 18th Annual WORLDSymposium™ 2022, showcasing two oral presentations and 11 posters on its innovative therapies for rare diseases.
Key presentations include a randomized study on the immunogenicity of cipaglucosidase alfa/miglustat in late-onset Pompe disease and a study on gene transfer for Pompe therapy. The event, scheduled from February 7-11 in San Diego, CA, aims to enhance understanding of lysosomal diseases and showcase latest research findings.