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. (symbol: FOLD) is a global biotechnology company that specializes in discovering, developing, and delivering high-quality medicines for individuals suffering from rare metabolic diseases. The company's central focus revolves around addressing lysosomal storage disorders, such as Fabry disease and Pompe disease, through its innovative platform technologies and medicines.
Amicus Therapeutics operates with a patient-centric approach, ensuring that the needs of those in the rare disease community are at the forefront of their scientific research, commercial activities, and clinical programs. The company is dedicated to creating significant impacts on the lives of patients and their caregivers, striving to provide advanced therapeutic solutions where none previously existed.
The company's product pipeline includes:
- Galafold® (migalastat): An oral chaperone therapy approved for the treatment of adults with Fabry disease who have amenable genetic variants. Galafold works by stabilizing the body’s own dysfunctional enzyme to clear the accumulated substrate.
- Pombiliti™ and Opfolda™: A novel, two-component therapy designed for the treatment of late-onset Pompe disease, showcasing Amicus's commitment to addressing the complexities of metabolic disorders.
- Rare Disease Gene Therapy Portfolio: A set of advanced gene therapies aimed at providing long-lasting solutions for various rare metabolic diseases.
Amicus Therapeutics is focused on expanding its pipeline with first-in-class or best-in-class treatments, underscoring its commitment to innovative medical solutions. Financially, the company maintains a strong position, actively pursuing strategic priorities to sustain growth and enhance shareholder value.
With a presence in 27 countries, Amicus Therapeutics leverages a global footprint to address unmet medical needs across diverse patient populations. The company continuously seeks opportunities to broaden its impact and foster collaborations that advance its mission.
Recent developments include regulatory approvals and strategic partnerships aiming to enhance the reach and effectiveness of their therapies. By building strong relationships with stakeholders, Amicus Therapeutics ensures a collaborative effort in combating rare diseases.
Overall, Amicus Therapeutics Inc. embodies a profound dedication to transforming the lives of those affected by rare diseases through innovative science, patient-focused care, and robust therapeutic development.
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.
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.
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