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 (FOLD) reported 2021 Galafold revenue of ~$306 million, marking a 17% YoY growth. The company anticipates 2022 revenue between $350M and $365M, guided by a projected 15-20% growth. Regulatory reviews for AT-GAA in Pompe disease are progressing, with launch preparations actively underway. The company expects to achieve self-sustainability and profitability by 2023, supported by a strong cash position and strategic investments.
Amicus Therapeutics (Nasdaq: FOLD) will present at the 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 3:45 p.m. E.T. This event is virtual, allowing investors to access a live audio webcast through the company's website. Amicus is dedicated to developing innovative medicines for rare metabolic diseases, emphasizing a robust pipeline of first- or best-in-class treatments. For more details, visit their investor relations page.
Amicus Therapeutics (Nasdaq: FOLD) announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Applications (MAA) for AT-GAA, a two-component therapy for Pompe disease. The EMA's acceptance triggers an assessment process. The MAA is supported by data from Phase 1/2 and Phase 3 PROPEL studies. CEO John F. Crowley emphasized the urgency to provide new treatments for Pompe disease. Additionally, AT-GAA has received Breakthrough Therapy designation from the FDA, which has set action dates for related applications in May and July 2022.
Amicus Therapeutics (Nasdaq: FOLD) will participate in the 4th Annual Evercore ISI HealthCONx Virtual Conference on December 1, 2021, at 8:50 a.m. E.T. Senior leadership will hold a fireside chat, which can be accessed through a live audio webcast on the company’s investor relations page. Amicus focuses on developing high-quality medicines for rare metabolic diseases, emphasizing patient dedication and a robust pipeline of innovative treatments. For more information, visit their website.
Amicus Therapeutics (Nasdaq: FOLD) announced its participation in the 14th International Congress of Inborn Errors of Metabolism from November 21-23, 2021. The company is presenting two digital posters: one on the long-term efficacy of migalastat in patients with amenable GLA variants and another on the incidence of Fabry disease in children. Both presentations highlight key findings relevant to the treatment of rare metabolic diseases. Interested parties can access these presentations through the Investors section of the Amicus website.
Amicus Therapeutics (FOLD) announced that the PROPEL trial results, published in The Lancet Neurology, demonstrate that AT-GAA provides significant improvements in treatment outcomes for adults with late-onset Pompe disease. The trial showed enhanced muscle strength, pulmonary, and motor function compared to the standard treatment, alglucosidase alfa. As a two-component therapy, AT-GAA includes cipaglucosidase alfa and miglustat. The FDA has granted Breakthrough Therapy designation for AT-GAA, with key review dates set for May and July 2022.
Amicus Therapeutics (Nasdaq: FOLD) will participate in a fireside chat at the Stifel 2021 Virtual Healthcare Conference on November 16, 2021, at 8:00 a.m. E.T. The event will feature key members of the senior leadership team discussing the company's initiatives.
A live audio webcast of the presentation can be accessed via Amicus Therapeutics' investor section on their corporate website.
Amicus is dedicated to developing high-quality medicines for rare metabolic diseases, emphasizing innovation and patient care.
Amicus Therapeutics reported a total revenue of $79.5 million for Q3 2021, marking an 18% increase from Q3 2020. The company reiterated its 2021 revenue guidance of $300 million to $315 million. The FDA has accepted the BLA and NDA for AT-GAA for Pompe disease, with target action dates set for May 29 and July 29, 2022, respectively. Following a merger with ARYA IV, Amicus aims to launch Caritas Therapeutics in late 2021 or early 2022, with a cash position sufficient for achieving self-sustainability by 2023.
Amicus Therapeutics (Nasdaq: FOLD) will host a conference call on November 9, 2021, at 8:30 a.m. ET to discuss its third-quarter financial results ending September 30, 2021. Interested parties can join via dial-in or access a live audio webcast on the company's investor website. A replay will be available for seven days post-call. Amicus Therapeutics is dedicated to developing treatments for rare metabolic diseases and is focused on expanding its pipeline of first- or best-in-class medicines. For more details, visit their corporate website.
Amicus Therapeutics (FOLD) announced a merger with ARYA Sciences Acquisition Corp IV to spin off its gene therapy segment into a new company, Caritas Therapeutics. The deal is projected to yield approximately $400 million in total funding, with Amicus retaining a 36% stake in Caritas. This transaction aims to strengthen Amicus' financial profile, enhance focus on rare diseases, and support the commercialization of its lead products, Fabry and Pompe therapies. Amicus plans to achieve profitability in 2023.