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 Inc (FOLD) is a biotechnology leader developing innovative therapies for rare metabolic diseases. This dedicated news hub provides investors and healthcare stakeholders with essential updates on clinical advancements, regulatory milestones, and corporate developments.
Key resources include earnings reports, FDA submission announcements, research publications, and partnership disclosures. Our curated collection enables informed decision-making by tracking material events across the company's lysosomal storage disorder pipeline, including Fabry and Pompe disease programs.
Bookmark this page to efficiently monitor Amicus Therapeutics' progress in advancing precision medicines through clinical trials and commercialization efforts. Regular updates ensure you never miss critical developments in this dynamic biotech sector.
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.
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.
Amicus Therapeutics (Nasdaq: FOLD) announced that its senior leadership team will present at two upcoming virtual investor conferences. The SVB Leerink 10th Annual Global Healthcare Conference is scheduled for February 25, 2021, at 12:00 p.m. E.T., followed by the Cowen 41st Annual Health Care Conference on March 3, 2021, at 12:20 p.m. E.T. Live audio webcasts of these presentations will be available on Amicus Therapeutics' corporate website.
The company focuses on developing innovative treatments for rare metabolic diseases.
Amicus Therapeutics (Nasdaq: FOLD) will host a conference call on March 1, 2021, at 8:30 a.m. ET to discuss its financial results for the year ended December 31, 2020. Investors can join the call by dialing 877-303-5859 (U.S./Canada) or 678-224-7784 (international) with conference ID 6959755. A live audio webcast will also be available on the company's website. A replay will be accessible for seven days following the call. Amicus is focused on developing high-quality medicines for rare metabolic diseases.
Amicus Therapeutics (FOLD) announced positive topline results from its Phase 3 PROPEL Trial for AT-GAA, a therapy for late-onset Pompe disease. Patients switching to AT-GAA from alglucosidase alfa walked an average of 17 meters farther (p=0.046) and showed a 4.1% improvement in forced vital capacity (FVC) (p=0.006). AT-GAA exhibited significant improvements in biomarkers Hex-4 and CK (p<0.001). A rolling Biologics License Application (BLA) submission is expected to complete in Q2 2021, while further global regulatory submissions are anticipated throughout the year.
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