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 (FOLD) is a biotechnology leader developing innovative therapies for rare metabolic diseases. This dedicated news hub provides investors and healthcare stakeholders with essential updates on clinical advancements, regulatory milestones, and corporate developments.
Key resources include earnings reports, FDA submission announcements, research publications, and partnership disclosures. Our curated collection enables informed decision-making by tracking material events across the company's lysosomal storage disorder pipeline, including Fabry and Pompe disease programs.
Bookmark this page to efficiently monitor Amicus Therapeutics' progress in advancing precision medicines through clinical trials and commercialization efforts. Regular updates ensure you never miss critical developments in this dynamic biotech sector.
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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