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.
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.
Amicus Therapeutics (Nasdaq: FOLD) announced that four poster presentations showcasing its Pompe disease development program will be presented at the 27th International Hybrid Annual Congress of the World Muscle Society from October 11-15, 2022, in Halifax, Canada. The presentations include long-term studies and patient surveys highlighting the impacts of Pompe disease. Notable abstracts focus on treatment comparisons and patient experiences during the COVID-19 pandemic. The posters will be accessible on Amicus's website following the congress.
Amicus Therapeutics (Nasdaq: FOLD) announced that three poster presentations on its Pompe disease program will be featured at the 2022 AANEM Annual Meeting, occurring from September 21-24 in Nashville, TN. The studies include an open-label Phase I/II trial of cipaglucosidase alfa/miglustat, a Phase III study on immunogenicity compared to alglucosidase alfa, and an analysis of pharmacokinetic profiles. The posters will be published on the company's website following the presentations, underscoring its commitment to innovative therapies for rare metabolic diseases.
Amicus Therapeutics (Nasdaq: FOLD) announced participation in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference, scheduled for September 14, 2022, at 12:20 p.m. E.T. in New York City. The event will be accessible via a live audio webcast on the company’s investor relations website. Amicus Therapeutics focuses on developing innovative therapies for rare metabolic diseases, emphasizing high-quality patient care and a commitment to expanding its pipeline of medicines.
Amicus Therapeutics (Nasdaq: FOLD) reported Galafold revenue of $159.4 million for H1 2022, showing an 11% increase year-over-year, driven by 18% operational growth, despite a 7% currency impact. The company anticipates a full-year revenue growth of 15-20% at constant exchange rates. Key regulatory reviews for AT-GAA are advancing, with FDA action dates set for August 29 and October 29, 2022. Amicus has strengthened its patent portfolio with 17 new U.S. patents and aims for non-GAAP profitability by 2023. Cash reserves stood at $386.8 million as of June 30, 2022.
Amicus Therapeutics (Nasdaq: FOLD) will host a conference call on August 4, 2022, at 8:30 a.m. ET to discuss its financial results for Q2 2022, which ended on June 30, 2022. Participants can access the call by dialing 1-833-634-2601 or 1-412-902-4113 for international callers. A live audio webcast will also be available on the company's investor website. A replay will be accessible for seven days following the event. Amicus focuses on developing therapies for rare metabolic diseases and has a commitment to a robust pipeline of innovative medicines.
Amicus Therapeutics (Nasdaq: FOLD) will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on June 15, 2022, at 11:20 a.m. P.T. The event will be held in Rancho Palos Verdes, CA. Investors can access a live audio webcast of the presentation on the company's investor relations website. Amicus focuses on developing innovative medicines for rare metabolic diseases, showcasing its commitment to patient-centered care and a robust pipeline of novel treatments.
Amicus Therapeutics (Nasdaq: FOLD) announced a 90-day extension to the FDA review period for the Biologics License Application (BLA) of cipaglucosidase alfa and the New Drug Application (NDA) for miglustat, both components of AT-GAA. The new action dates are August 29, 2022, and October 29, 2022, respectively. This extension allows additional time for the FDA to review submitted information and to complete pre-license inspections at the manufacturing site. The company remains optimistic about FDA approval for AT-GAA as a treatment for Pompe disease.
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