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 (FOLD) announced its participation at the 21st Annual WORLDSymposium™ 2025, featuring two oral presentations and 20 posters focused on Fabry and Pompe diseases. The presentations include key findings on miglustat, a first-in-class enzyme stabilizer for late-onset Pompe disease, and improvements in patients switching to cipaglucosidase alfa plus miglustat treatment.
The extensive poster sessions cover various aspects of both diseases, including patient experiences, treatment outcomes, and clinical studies. Notable presentations include long-term safety data of migalastat in Fabry disease patients, real-world evidence studies, and results from the PROPEL study showing clinical improvements in Pompe disease patients.
Amicus Therapeutics (FOLD) reported preliminary 2024 total revenue of $528.5M, showing significant growth of 32% year-over-year. The company's performance was driven by two key products: Galafold, with net sales of $458.2M (18% growth), serving ~2,730 Fabry disease patients, and Pombiliti + Opfolda, with net sales of $70.3M, treating ~220 patients in its first full launch year.
For 2025, Amicus projects total revenue growth of 17-24% at constant exchange rates, with Galafold expected to grow 10-15% and Pombiliti + Opfolda 65-85%. The company secured multiple pricing and reimbursement agreements in late 2024/early 2025, including Italy, Sweden, Switzerland, and Czech Republic. A settlement with Teva ensures no generic migalastat in the U.S. until 2037. Amicus anticipates reaching positive GAAP Net Income in H2 2025 and surpassing $1 billion in total sales by 2028.
Amicus Therapeutics (Nasdaq: FOLD), a global biotechnology company focused on rare diseases, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Bradley Campbell, President and Chief Executive Officer, will deliver a presentation in San Francisco on Monday, January 13, 2025, at 3:00 p.m. PT.
The presentation will be accessible through a live audio webcast via the investors section of the Amicus Therapeutics corporate website. The company, dedicated to discovering, developing, and delivering novel medicines for rare diseases, maintains a commitment to advancing its pipeline of first- or best-in-class medicines.
Amicus Therapeutics reported strong Q3 2024 financial results with total revenue of $141.5M, up 37% year-over-year. Galafold revenue reached $120.4M (20% increase), while Pombiliti + Opfolda revenue hit $21.1M (33% increase from Q2). The company achieved non-GAAP profitability with net income of $30.8M ($0.10 per share). Based on strong performance, Amicus raised its 2024 total revenue growth guidance to 30-32% and reduced non-GAAP operating expense guidance to $340M-$350M. The company also announced a settlement with Teva regarding Galafold patent litigation, securing market exclusivity until January 2037.
Amicus Therapeutics (Nasdaq: FOLD) has announced its participation in three major investor conferences in November 2024. The company will present at the Guggenheim Healthcare Innovation Conference in Boston on November 12 at 2:30 p.m. ET and the Jefferies London Healthcare Conference on November 19 at 8:00 a.m. GMT. Management will also attend the J.P. Morgan Equity Opportunities Forum on November 13.
Live audio webcasts of the presentations will be available through the investors section of the Amicus Therapeutics website. The company focuses on developing and delivering medicines for rare diseases, maintaining a strong commitment to patient care and advancing its pipeline of first- or best-in-class medicines.
Amicus Therapeutics (Nasdaq: FOLD) has announced it will host a conference call and live audio webcast on Wednesday, November 6, 2024, at 8:30 a.m. ET to discuss financial results for the third quarter ended September 30, 2024. Participants must register online to receive dial-in details. A live webcast and presentation materials will be available through the Investors section of the company's website. The event will be archived for later viewing. Amicus Therapeutics is a global biotechnology company focused on developing medicines for rare diseases.
Amicus Therapeutics (Nasdaq: FOLD) has announced a settlement in the Galafold® (migalastat) patent litigation with Teva Pharmaceuticals. The key points of the agreement are:
1. Amicus grants Teva a license to market a generic version of Galafold® in the United States starting January 30, 2037, subject to FDA approval.
2. The ongoing Hatch-Waxman litigation between Amicus and Teva regarding Galafold® patents will be terminated.
3. Litigation continues against Aurobindo, while the stay remains in place for Lupin.
4. The confidential license agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
This settlement resolves the patent dispute initiated by Amicus in response to Teva's Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Galafold® before the expiration of applicable patents.
Amicus Therapeutics (Nasdaq: FOLD) has announced its participation in the 29th Annual Congress of the World Muscle Society, taking place from October 8-12, 2024, in Prague, Czechia. The company will present three posters focusing on its Pompe disease development program:
1. Cipaglucosidase alfa + miglustat in late-onset Pompe disease: Two non-ambulatory patients switching from high-dose, high-frequency alglucosidase alfa
2. Post-baseline outcomes of the UK Early Access to Medicines Scheme registry for cipaglucosidase alfa plus miglustat in late-onset Pompe disease
3. Miglustat: a first-in-class enzyme stabilizer for late-onset Pompe disease
All posters will be presented on Friday, October 11, from 3:45 – 4:45 p.m. CET in the Forum Hall of The Prague Congress Centre.
Amicus Therapeutics (Nasdaq: FOLD), a global biotechnology company focused on rare diseases, has announced its participation in several investor conferences in September 2024. The company will present at the Morgan Stanley 22nd Annual Global Healthcare Conference on September 5 and the Cantor Global Healthcare Conference 2024 on September 17, both in New York. Additionally, management will attend the 2024 Wells Fargo Healthcare Conference on September 6.
Live audio webcasts of the presentations will be available through the investors section of the Amicus Therapeutics website. This series of conference appearances underscores the company's commitment to engaging with investors and showcasing its progress in developing treatments for rare diseases.
Amicus Therapeutics (Nasdaq: FOLD) announced its participation in the Society for the Study of Inborn Errors of Metabolism (SSIEM) 2024 Annual Symposium in Porto, Portugal, from September 3-6, 2024. The company will present five posters across its development programs, focusing on Fabry Disease and Pompe Disease.
The presentations include three posters on Fabry Disease, discussing patient-reported outcomes from the FollowME Fabry Pathfinders registry, quality of life in migalastat-treated adolescents, and the journey of patients living with Fabry disease in Poland. Two posters on Pompe Disease will cover post-baseline outcomes of the UK Early Access to Medicines Scheme registry for cipaglucosidase alfa plus miglustat, and miglustat as a first-in-class enzyme stabilizer for late-onset Pompe disease.
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