Amicus Therapeut Stock Price, News & Analysis

Amicus Therapeutics (Nasdaq: FOLD) announced that the European Commission has approved Pombiliti™ (cipaglucosidase alfa) for use as a long-term enzyme replacement therapy in combination with miglustat for adults with late-onset Pompe disease (LOPD). This approval is based on positive clinical data from the Phase 3 PROPEL study, which included patients needing ERT. The company believes that AT-GAA could redefine standards of care for LOPD by providing significant therapeutic benefits. A CHMP opinion for miglustat is expected in Q2 2023, marking a potential advance in treatment options for this rare condition.

Amicus Therapeutics (FOLD) reported a 16% revenue growth in 2022, totaling $329.2M, with projected Galafold revenue growth of 12-17% for 2023. The company expects non-GAAP profitability in the second half of 2023, driven by robust demand for Galafold and successful launches of AT-GAA for Pompe disease. A U.S. FDA pre-approval inspection for AT-GAA is scheduled with approvals anticipated in Q3 2023. Financials show a net loss of $236.6M in 2022, an improvement from $250.5M in 2021. Despite challenges, Amicus is focused on sustaining growth and expanding its product offerings.

Amicus Therapeutics (Nasdaq: FOLD) will participate in a fireside chat at the Cowen 43rd Annual Health Care Conference in Boston on March 6, 2023, at 9:50 a.m. E.T. Investors can access a live audio webcast of the presentation via the company’s investors section on its website. Amicus Therapeutics is dedicated to developing high-quality medicines for rare diseases, showcasing a strong patient focus and commitment to innovation. For more information, interested parties can visit the corporate website or follow the company on social media platforms.

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.