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 (Nasdaq: FOLD) announced the issuance of U.S. Patent No. 11,304,940, extending patent protection for Galafold (migalastat) through 2038. This new patent focuses on methods to treat Fabry disease patients with renal impairments and is part of a total of 35 issued patents in the U.S. for Galafold. CEO John Crowley emphasized the significance of this patent in strengthening the company’s intellectual property portfolio, which supports ongoing commercialization efforts of this novel precision medicine.
Amicus Therapeutics (Nasdaq: FOLD) released promising results from its Phase 1/2 study of AT-GAA for Pompe disease. Over 36 months, participants showed significant improvements in motor function, six-minute walk test distances, and reductions in muscle damage biomarkers. The therapy's safety profile remains consistent with prior data. Regulatory reviews are ongoing, with the FDA's PDUFA dates set for May 29 and July 29, 2022. The data may position AT-GAA as a new standard of care for Pompe disease, addressing both ERT-experienced and ERT-naïve patients.
Amicus Therapeutics (Nasdaq: FOLD) announced that its development program for Pompe disease will be featured in an oral presentation and two posters at the 2022 MDA Clinical & Scientific Conference. The oral presentation titled Long-term follow-up of cipaglucosidase alfa/miglustat is scheduled for March 16, 2022. In addition, two posters will discuss Immunogenicity of cipaglucosidase alfa versus alglucosidase alfa and the impact of COVID-19 on patients living with Pompe disease. Presentations will be available on the company’s website after the conference.
Amicus Therapeutics (Nasdaq: FOLD) will participate in a fireside chat at the Cowen 42nd Annual Health Care Conference on March 8, 2022, at 9:10 a.m. E.T. A live audio webcast of the event will be available on the company’s investor website.
Amicus Therapeutics is focused on developing innovative medicines for rare metabolic diseases, showcasing its commitment to patient care through a robust pipeline of treatments.
Amicus Therapeutics (Nasdaq: FOLD) reported a 17% year-over-year revenue growth to $306 million in 2021, driven by strong sales of Galafold. The company anticipates Galafold revenue of $350 million to $365 million in 2022, maintaining double-digit growth. Amicus aims for profitability in 2023, aided by $400 million in projected operating expense savings through 2026. Regulatory filings for AT-GAA are under review, with launch preparations ongoing. The planned business combination with ARYA IV has been terminated due to adverse market conditions.
Amicus Therapeutics (Nasdaq: FOLD) will host a conference call on February 24, 2022, at 8:30 a.m. ET to discuss its financial results for the year ending December 31, 2021. Interested participants can join by dialing 877-303-5859 (U.S./Canada) or 678-224-7784 (international) with conference ID 1792414. A live audio webcast will also be available on the company’s website. A replay will be accessible for seven days post-call at designated numbers. Amicus focuses on developing high-quality medicines for rare metabolic diseases.
Amicus Therapeutics (FOLD) announced participation at the 18th Annual WORLDSymposium™ 2022, showcasing two oral presentations and 11 posters on its innovative therapies for rare diseases.
Key presentations include a randomized study on the immunogenicity of cipaglucosidase alfa/miglustat in late-onset Pompe disease and a study on gene transfer for Pompe therapy. The event, scheduled from February 7-11 in San Diego, CA, aims to enhance understanding of lysosomal diseases and showcase latest research findings.
Amicus Therapeutics (FOLD) reported 2021 Galafold revenue of ~$306 million, marking a 17% YoY growth. The company anticipates 2022 revenue between $350M and $365M, guided by a projected 15-20% growth. Regulatory reviews for AT-GAA in Pompe disease are progressing, with launch preparations actively underway. The company expects to achieve self-sustainability and profitability by 2023, supported by a strong cash position and strategic investments.
Amicus Therapeutics (Nasdaq: FOLD) will present at the 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 3:45 p.m. E.T. This event is virtual, allowing investors to access a live audio webcast through the company's website. Amicus is dedicated to developing innovative medicines for rare metabolic diseases, emphasizing a robust pipeline of first- or best-in-class treatments. For more details, visit their investor relations page.
Amicus Therapeutics (Nasdaq: FOLD) announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Applications (MAA) for AT-GAA, a two-component therapy for Pompe disease. The EMA's acceptance triggers an assessment process. The MAA is supported by data from Phase 1/2 and Phase 3 PROPEL studies. CEO John F. Crowley emphasized the urgency to provide new treatments for Pompe disease. Additionally, AT-GAA has received Breakthrough Therapy designation from the FDA, which has set action dates for related applications in May and July 2022.
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