Welcome to our dedicated page for Amicus Therapeutics news (Ticker: FOLD), a resource for investors and traders seeking the latest updates and insights on Amicus Therapeutics 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 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.
Amicus Therapeutics (Nasdaq: FOLD), a global biotechnology company focused on rare diseases, has announced its participation in two upcoming investor conferences in September 2024. The company will present at the Morgan Stanley 22nd Annual Global Healthcare Conference on September 5 at 10:00 a.m. ET and the Cantor Global Healthcare Conference 2024 on September 17 at 1:55 p.m. ET, both in New York, NY.
Investors can access live audio webcasts of these presentations through the company's website. Amicus Therapeutics is dedicated to discovering, developing, and delivering novel high-quality medicines for people living with rare diseases. The company emphasizes its commitment to advancing a pipeline of cutting-edge, first- or best-in-class medicines for rare diseases.
Amicus Therapeutics (Nasdaq: FOLD) reported strong Q2 2024 financial results with total revenue of $126.7 million, a 34% year-over-year increase. Galafold revenue grew by 17% to $110.8 million, and Pombiliti + Opfolda revenue rose 44% from Q1 2024 to $15.9 million. The company raised its 2024 revenue growth guidance to 26%-31% and Galafold growth guidance to 14%-18%. Non-GAAP operating expenses are now expected to be between $345 million to $360 million. For Q2 2024, Amicus achieved non-GAAP profitability with a net income of $18.5 million and a GAAP net loss of $15.7 million. Cash reserves stood at $260.1 million as of June 30, 2024. The company is on track to achieve its Pombiliti + Opfolda revenue target of $62 million to $67 million for 2024.
Amicus Therapeutics (Nasdaq: FOLD) has announced its upcoming second quarter 2024 financial results conference call and webcast, scheduled for August 8, 2024, at 8:30 a.m. ET. The event will cover financial results for the quarter ended June 30, 2024. Participants can access the call via phone by registering online to receive a dial-in number and personal PIN. A live audio webcast and presentation materials will be available through the Investors section of the Amicus Therapeutics website.
Amicus Therapeutics is a global biotechnology company focused on discovering, developing, and delivering novel medicines for rare diseases. The company emphasizes patient dedication and is committed to advancing a pipeline of first- or best-in-class treatments for rare diseases.
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