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 the presentation of two posters at the virtual 16th International Congress on Neuromuscular Diseases on May 21-22 and 28-29, 2021. The posters focus on its development program for Pompe disease, including:
- Enhancing Delivery of Acid Alpha-Glucosidase to Skeletal Muscle by Nithya Selvan, Ph.D.
- Efficacy and Safety of Cipaglucosidase Alfa/Miglustat versus Alglucosidase Alfa/Placebo in Late-Onset Pompe Disease presented by Benedikt Schoser, MD.
The posters will be available on the Amicus website after the presentations.
Amicus Therapeutics reported Q1 2021 revenue of $66.4 million for Galafold, a 9.8% increase year-over-year, and remains on track to meet its full-year guidance of $300M-$315M. Patient demand for Galafold has risen, and compliance exceeds 90%. The company is progressing with the rolling BLA submission for AT-GAA in Pompe disease, anticipating completion in Q2 2021. Amicus maintains a cash position of $417.4 million, sufficient for operations through to self-sustainability.
Amicus Therapeutics (Nasdaq: FOLD) announced participation in two upcoming virtual investor conferences in May 2021. The Bank of America 2021 Health Care Conference is scheduled for May 12 at 1:15 p.m. E.T., followed by the UBS Global Healthcare Virtual Conference on May 24 at 10:00 a.m. E.T.. Investors can access live webcasts of these presentations on the company’s corporate website. Amicus Therapeutics is dedicated to developing innovative therapies for rare metabolic diseases.
Amicus Therapeutics (Nasdaq: FOLD) has appointed Sébastien Martel as Senior Vice President of Strategy and Business Development. With 25 years in the pharmaceutical and biotechnology sectors, Martel previously led Global Rare Diseases at Sanofi. His expertise encompasses corporate strategy and commercialization in rare diseases. Amicus CEO John F. Crowley highlighted Martel's experience as crucial for advancing the company's growth strategies and enhancing its portfolio of rare disease therapeutics.
Amicus Therapeutics (Nasdaq: FOLD) has announced the acceptance of two abstracts for the American Society of Gene & Cell Therapy 24th Annual Meeting, occurring virtually from May 11-14, 2021. The presentations will feature preclinical data from the company's gene therapy programs targeting Fabry and Pompe diseases. The Pompe disease abstract, presented by Ali Ramezani, focuses on muscle pathology reversal, while the Fabry disease abstract, by CJ Song, discusses the efficacy of a new transgene. These insights underscore Amicus's commitment to rare metabolic diseases.
Amicus Therapeutics (NASDAQ:FOLD) announced the successful completion of a Type B Pre-Biologics License Application (BLA) meeting with the FDA for its investigational therapy AT-GAA, aimed at treating Pompe disease. They are on track to complete the rolling BLA submission by the end of Q2 2021, including data from Phase 1/2 and Phase 3 studies. AT-GAA has previously received Breakthrough Therapy Designation from the FDA. The company plans to submit marketing applications to the EMA in the latter half of 2021, focusing on improving the lives of Pompe disease patients.
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Amicus Therapeutics (Nasdaq: FOLD) will host a conference call and live audio webcast on May 10, 2021, at 8:30 a.m. ET, to discuss its financial results for Q1 2021, ended March 31, 2021. Investors can join by dialing 877-303-5859 (U.S./Canada) or 678-224-7784 (international), using conference ID: 5767104. A replay will be available for seven days starting at 11:30 a.m. ET. Amicus focuses on developing medicines for rare metabolic diseases, emphasizing a patient-centric approach.
Amicus Therapeutics (Nasdaq: FOLD) announced its participation in the 2021 MDA Virtual Clinical & Scientific Conference from March 15-18, showcasing advancements in its Pompe disease program. The event features an oral presentation on the phase 3 trial of AT-GAA (cipaglucosidase alfa/miglustat) and two poster presentations. The oral presentation will occur on March 18, focusing on efficacy and safety comparisons with existing treatments. Materials will be available on Amicus's website post-presentation.
Amicus Therapeutics reported $260.9 million in total Galafold revenue for 2020, marking a 43% year-on-year increase. The company anticipates 2021 revenue for Galafold to be between $300 million and $315 million, driven by robust global growth. The AT-GAA BLA submission for Pompe disease is scheduled for completion in 2Q21, alongside other global submissions. The FDA granted Fast Track Designation for the CLN6 gene therapy, bolstering its pipeline. As of December 31, 2020, Amicus held $483.3 million in cash, sufficient for self-sustainability.