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 (FOLD) reported 2Q21 Galafold revenue of $77.4 million, marking a 24% increase year-over-year. The company is on track to achieve its 2021 revenue guidance of $300M-$315M. Amicus completed rolling BLA and NDA submissions for AT-GAA, with regulatory support from the EMA. Cash and equivalents stood at $383.1 million. Despite a net loss of $51.2 million, expenses decreased by 2.5% to $93.5 million on a non-GAAP basis. The company is confident in its operational growth with ongoing clinical studies and expansion of Galafold's EU label.
Amicus Therapeutics (Nasdaq: FOLD) announced its participation in the BTIG Virtual Biotechnology Conference on August 9, 2021, at 9:00 a.m. E.T. A live audio webcast will be available on the company's investor section of their website. Amicus is dedicated to developing innovative treatments for rare metabolic diseases, emphasizing a patient-focused approach. For more details about the conference and the company’s initiatives, please visit their website.
Amicus Therapeutics has received European Commission approval for Galafold® (migalastat) as the first oral therapy for the long-term treatment of adolescents aged 12 to <16 years with Fabry disease and an amenable mutation. This marks a significant milestone for the Fabry community, providing a treatment option not available for over 15 years. Supported by interim data from a pediatric study, Amicus aims to facilitate rapid access for eligible patients, further expanding Galafold, which is already approved in several countries, including the U.S. and Japan.
Amicus Therapeutics (Nasdaq: FOLD) will host a conference call and live audio webcast on August 5, 2021, at 8:30 a.m. ET to discuss its financial results for Q2 2021, ended June 30, 2021. Investors can join the call by dialing 877-303-5859 (U.S./Canada) or 678-224-7784 (international) with conference ID 7374935. A live audio webcast will be available on the company’s website. A replay will be accessible for seven days starting at 11:30 a.m. ET, with specific access numbers for both U.S./Canada and international participants.
Amicus Therapeutics (Nasdaq: FOLD) has appointed Dr. Eiry W. Roberts to its Board of Directors. Dr. Roberts brings nearly 30 years of drug development experience, having previously served as Chief Medical Officer at Neurocrine Biosciences and held senior roles at Eli Lilly. She has led numerous late-stage development programs to global regulatory approvals, contributing significantly to her former company’s portfolio. Her expertise in healthcare strategy is expected to enhance Amicus’s mission of developing therapies for rare diseases.
Amicus Therapeutics (FOLD) announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted a positive scientific opinion for AT-GAA under the Early Access to Medicines Scheme. This allows eligible adults with late-onset Pompe disease to access AT-GAA prior to marketing authorization. The decision underscores the high unmet medical need in this patient group. AT-GAA, a two-component therapy, has shown promising results in clinical studies. Marketing Authorization Applications for AT-GAA are expected in the UK and EU in late 2021.
Amicus Therapeutics (Nasdaq: FOLD) will participate in the Goldman Sachs 42nd Annual Global Healthcare Conference on June 9, 2021, at 5:30 p.m. E.T. The event will include a fireside chat featuring members of Amicus' senior leadership team. Investors can listen to the live audio webcast via the company’s investor relations page. Amicus focuses on developing innovative medicines for rare metabolic diseases, underscoring its commitment to patient care and advancing a strong pipeline of therapies.
Amicus Therapeutics (Nasdaq: FOLD) announced the presentation of two posters at the virtual 16th International Congress on Neuromuscular Diseases on May 21-22 and 28-29, 2021. The posters focus on its development program for Pompe disease, including:
- Enhancing Delivery of Acid Alpha-Glucosidase to Skeletal Muscle by Nithya Selvan, Ph.D.
- Efficacy and Safety of Cipaglucosidase Alfa/Miglustat versus Alglucosidase Alfa/Placebo in Late-Onset Pompe Disease presented by Benedikt Schoser, MD.
The posters will be available on the Amicus website after the presentations.
Amicus Therapeutics reported Q1 2021 revenue of $66.4 million for Galafold, a 9.8% increase year-over-year, and remains on track to meet its full-year guidance of $300M-$315M. Patient demand for Galafold has risen, and compliance exceeds 90%. The company is progressing with the rolling BLA submission for AT-GAA in Pompe disease, anticipating completion in Q2 2021. Amicus maintains a cash position of $417.4 million, sufficient for operations through to self-sustainability.
Amicus Therapeutics (Nasdaq: FOLD) announced participation in two upcoming virtual investor conferences in May 2021. The Bank of America 2021 Health Care Conference is scheduled for May 12 at 1:15 p.m. E.T., followed by the UBS Global Healthcare Virtual Conference on May 24 at 10:00 a.m. E.T.. Investors can access live webcasts of these presentations on the company’s corporate website. Amicus Therapeutics is dedicated to developing innovative therapies for rare metabolic diseases.
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