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 received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for Pombiliti® (cipaglucosidase alfa) + Opfolda® (miglustat) to treat adult patients with late-onset Pompe disease (LOPD). The approval was based on the Phase 3 PROPEL study, which uniquely evaluated both ERT-naïve and ERT-experienced participants.
This two-component therapy consists of Pombiliti, a recombinant human GAA enzyme designed for increased muscle cell uptake, and Opfolda, an enzyme stabilizer. The treatment is now approved across major markets including the U.S., E.U., U.K., Canada, Australia, Switzerland, and Japan.
Amicus Therapeutics (FOLD) has announced its participation in the Bank of America 2025 Health Care Conference in Las Vegas. The company's management will engage in a fireside chat on Wednesday, May 14, 2025, at 8:00 a.m. PT. Investors and interested parties can access a live audio webcast of the presentation through the investors section of Amicus Therapeutics' corporate website.
Amicus Therapeutics is a global biotechnology company dedicated to discovering, developing, and delivering innovative medicines for rare diseases, with a strong focus on patient care and advancing their pipeline of first- or best-in-class treatments.
Dimerix and Amicus Therapeutics have formed an exclusive license agreement for DMX-200 in the United States. The deal focuses on treating Focal Segmental Glomerulosclerosis (FSGS), a rare and fatal kidney disease with no FDA-approved therapies.
Key financial terms include:
- US$30 million upfront payment to Dimerix
- Up to US$560 million in success-based milestone payments
- Tiered royalties on U.S. sales from low-teens to low-twenties percentages
DMX-200 is currently in a pivotal Phase 3 trial called ACTION3, with positive interim results showing better performance than placebo in reducing proteinuria. The FDA has aligned on proteinuria as the primary endpoint for marketing approval. Full trial enrollment is expected by year-end 2025. Amicus will handle U.S. regulatory submissions and commercialization, while Dimerix retains rights in other territories.
Amicus Therapeutics (FOLD) has scheduled its first quarter 2025 financial results conference call and audio webcast for Thursday, May 1, 2025, at 8:30 a.m. ET. The event will cover financial performance for Q1 ending March 31, 2025.
Participants must pre-register online to receive dial-in details and a personal PIN for phone access. A live webcast and presentation materials will be available through the Investors section at ir.amicusrx.com, with recommended registration 15 minutes before the call. An archived version and slides will be accessible post-event on the company website.
Amicus Therapeutics (Nasdaq: FOLD), a patient-focused biotechnology company specializing in rare diseases, has announced its participation in two major investor conferences in March 2025:
- TD Cowen 45th Annual Health Care Conference in Boston, MA on March 4, 2025, at 9:50 a.m. ET
- Leerink Partners 2025 Global Healthcare Conference in Miami, FL on March 10, 2025, at 10:00 a.m. ET
Both presentations will be accessible via live audio webcast through the investors section of the Amicus Therapeutics corporate website. The company focuses on discovering, developing, and delivering innovative first- or best-in-class medicines for rare disease patients.
Amicus Therapeutics (FOLD) reported strong financial results for 2024, with total revenue reaching $528.3 million, marking a 33% year-over-year increase. The company's two main products showed significant growth: Galafold generated $458.1 million (+18% YoY) and Pombiliti + Opfolda contributed $70.2 million.
For 2025, Amicus projects total revenue growth of 17-24%, with Galafold expected to grow 10-15% and Pombiliti + Opfolda forecasted to increase 65-85%. The company anticipates achieving positive GAAP net income during H2 2025 and expects to surpass $1 billion in total sales by 2028.
The company's GAAP net loss for 2024 was $56.1 million ($0.18 per share), significantly improved from a $151.6 million loss in 2023. Cash position remained stable at $249.9 million as of December 31, 2024.
Amicus Therapeutics (FOLD) has scheduled a conference call and live audio webcast for February 19, 2025, at 8:30 a.m. ET to discuss their full-year 2024 financial results. Participants must pre-register online to receive dial-in details and a personal PIN for phone access. A webcast will be available through the Investors section of Amicus' website, with participants advised to register 15 minutes before the call starts.
The presentation materials and archived webcast will be accessible on the company's website after the event. Amicus Therapeutics is a global biotechnology company focused on developing and delivering medicines for rare diseases.