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) announced the positive opinion from the European Medicines Agency's CHMP for its two-component therapy, Opfolda (miglustat) combined with Pombiliti (cipaglucosidase alfa). This approval positions Pombiliti + Opfolda as the first two-component therapy for late-onset Pompe disease in the EU, anticipated to be fully approved by Q3 2023. The therapy aims to address a significant medical need for adults with late-onset Pompe disease, with clinical data suggesting meaningful improvements in patient outcomes. The CHMP's recommendation is based on Phase 3 trial results, which included both ERT-experienced and naïve patients. The company is preparing for a country-by-country reimbursement and launch process, highlighting the potential to establish a new standard of care in Pompe disease.
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