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.
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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.
WuXi Biologics has announced its partnership with Amicus Therapeutics in celebrating the European Commission's approval of Pombiliti™ (cipaglucosidase alfa) for adults with late-onset Pompe disease. This therapy, a combined treatment with miglustat, is a significant milestone achieved through WuXi's advanced manufacturing capabilities since the therapy's inception in 2012. The approval is based on clinical data from the Phase 3 PROPEL trial, which included a diverse patient population. WuXi Biologics continues to support commercialization through its global sourcing strategy, reinforcing its position as a leader in biologics development.
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.