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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) has appointed Sébastien Martel as Senior Vice President of Strategy and Business Development. With 25 years in the pharmaceutical and biotechnology sectors, Martel previously led Global Rare Diseases at Sanofi. His expertise encompasses corporate strategy and commercialization in rare diseases. Amicus CEO John F. Crowley highlighted Martel's experience as crucial for advancing the company's growth strategies and enhancing its portfolio of rare disease therapeutics.
Amicus Therapeutics (Nasdaq: FOLD) has announced the acceptance of two abstracts for the American Society of Gene & Cell Therapy 24th Annual Meeting, occurring virtually from May 11-14, 2021. The presentations will feature preclinical data from the company's gene therapy programs targeting Fabry and Pompe diseases. The Pompe disease abstract, presented by Ali Ramezani, focuses on muscle pathology reversal, while the Fabry disease abstract, by CJ Song, discusses the efficacy of a new transgene. These insights underscore Amicus's commitment to rare metabolic diseases.
Amicus Therapeutics (NASDAQ:FOLD) announced the successful completion of a Type B Pre-Biologics License Application (BLA) meeting with the FDA for its investigational therapy AT-GAA, aimed at treating Pompe disease. They are on track to complete the rolling BLA submission by the end of Q2 2021, including data from Phase 1/2 and Phase 3 studies. AT-GAA has previously received Breakthrough Therapy Designation from the FDA. The company plans to submit marketing applications to the EMA in the latter half of 2021, focusing on improving the lives of Pompe disease patients.
Amicus Therapeutics (Nasdaq: FOLD) will host a conference call and live audio webcast on May 10, 2021, at 8:30 a.m. ET, to discuss its financial results for Q1 2021, ended March 31, 2021. Investors can join by dialing 877-303-5859 (U.S./Canada) or 678-224-7784 (international), using conference ID: 5767104. A replay will be available for seven days starting at 11:30 a.m. ET. Amicus focuses on developing medicines for rare metabolic diseases, emphasizing a patient-centric approach.
Amicus Therapeutics (Nasdaq: FOLD) announced its participation in the 2021 MDA Virtual Clinical & Scientific Conference from March 15-18, showcasing advancements in its Pompe disease program. The event features an oral presentation on the phase 3 trial of AT-GAA (cipaglucosidase alfa/miglustat) and two poster presentations. The oral presentation will occur on March 18, focusing on efficacy and safety comparisons with existing treatments. Materials will be available on Amicus's website post-presentation.
Amicus Therapeutics reported $260.9 million in total Galafold revenue for 2020, marking a 43% year-on-year increase. The company anticipates 2021 revenue for Galafold to be between $300 million and $315 million, driven by robust global growth. The AT-GAA BLA submission for Pompe disease is scheduled for completion in 2Q21, alongside other global submissions. The FDA granted Fast Track Designation for the CLN6 gene therapy, bolstering its pipeline. As of December 31, 2020, Amicus held $483.3 million in cash, sufficient for self-sustainability.
Amicus Therapeutics (Nasdaq: FOLD) announced that its senior leadership team will present at two upcoming virtual investor conferences. The SVB Leerink 10th Annual Global Healthcare Conference is scheduled for February 25, 2021, at 12:00 p.m. E.T., followed by the Cowen 41st Annual Health Care Conference on March 3, 2021, at 12:20 p.m. E.T. Live audio webcasts of these presentations will be available on Amicus Therapeutics' corporate website.
The company focuses on developing innovative treatments for rare metabolic diseases.
Amicus Therapeutics (Nasdaq: FOLD) will host a conference call on March 1, 2021, at 8:30 a.m. ET to discuss its financial results for the year ended December 31, 2020. Investors can join the call by dialing 877-303-5859 (U.S./Canada) or 678-224-7784 (international) with conference ID 6959755. A live audio webcast will also be available on the company's website. A replay will be accessible for seven days following the call. Amicus is focused on developing high-quality medicines for rare metabolic diseases.
Amicus Therapeutics (FOLD) announced positive topline results from its Phase 3 PROPEL Trial for AT-GAA, a therapy for late-onset Pompe disease. Patients switching to AT-GAA from alglucosidase alfa walked an average of 17 meters farther (p=0.046) and showed a 4.1% improvement in forced vital capacity (FVC) (p=0.006). AT-GAA exhibited significant improvements in biomarkers Hex-4 and CK (p<0.001). A rolling Biologics License Application (BLA) submission is expected to complete in Q2 2021, while further global regulatory submissions are anticipated throughout the year.
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