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.
Amicus Therapeutics was a Nasdaq-listed biotechnology company focused on medicines for rare diseases. Company news centered on Galafold® (migalastat) for adults with Fabry disease who have amenable GLA variants and POMBILITI® + OPFOLDA® for adults with late-onset Pompe disease, including clinical and real-world data presentations, regulatory language, financial results, and corporate updates.
Amicus also reported investor-conference participation, operating performance, material agreements, governance matters, shareholder voting topics, and capital-structure developments. In 2026, the company completed a merger and became a wholly owned subsidiary of BioMarin Pharmaceutical Inc., making later coverage part of its corporate-status history.
Amicus Therapeutics (Nasdaq: FOLD) announced positive results from its Phase 3 OLE study (ATB200-07) for AT-GAA, targeting late-onset Pompe disease. Patients showed significant improvements in six-minute walk distance (6MWD) and stable pulmonary function after 104 weeks. Biomarker reductions indicate a beneficial effect on muscle tissue. The safety profile of AT-GAA remains consistent with prior data, showing mostly mild to moderate adverse events. The findings will be presented at the 2023 WORLD Symposium. This data fosters optimism that AT-GAA could set a new standard of care for Pompe disease.
Amicus Therapeutics (Nasdaq: FOLD) has announced a conference call and live audio webcast scheduled for March 1, 2023, at 8:30 a.m. ET to discuss its financial results for the year ended December 31, 2022. Investors can register for the call through an online form and will receive details for dial-in access. A live audio webcast and presentation materials will also be available on the company’s investor website. An archived version of the webcast will be accessible shortly after the event. Amicus Therapeutics is focused on developing novel medicines for rare diseases.
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.