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. (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) will host a conference call on November 9, 2021, at 8:30 a.m. ET to discuss its third-quarter financial results ending September 30, 2021. Interested parties can join via dial-in or access a live audio webcast on the company's investor website. A replay will be available for seven days post-call. Amicus Therapeutics is dedicated to developing treatments for rare metabolic diseases and is focused on expanding its pipeline of first- or best-in-class medicines. For more details, visit their corporate website.
Amicus Therapeutics (FOLD) announced a merger with ARYA Sciences Acquisition Corp IV to spin off its gene therapy segment into a new company, Caritas Therapeutics. The deal is projected to yield approximately $400 million in total funding, with Amicus retaining a 36% stake in Caritas. This transaction aims to strengthen Amicus' financial profile, enhance focus on rare diseases, and support the commercialization of its lead products, Fabry and Pompe therapies. Amicus plans to achieve profitability in 2023.
Amicus Therapeutics (Nasdaq: FOLD) announced that the FDA has accepted its New Drug Application (NDA) for miglustat and Biologics License Application (BLA) for cipaglucosidase alfa, both part of the AT-GAA therapy for Pompe disease. The PDUFA action dates are set for May 29, 2022, and July 29, 2022, respectively. This therapy aims to address a significant unmet need for Pompe disease patients in the U.S. The company is also progressing towards a Marketing Authorization Application (MAA) submission in the EU by Q4 2021.
Amicus Therapeutics (Nasdaq: FOLD) presented two posters at the 26th International Annual Congress of the World Muscle Society, held from September 20-24, 2021. The posters highlight the company’s development program for Pompe disease, including a study comparing cipaglucosidase alfa/miglustat with alglucosidase alfa/placebo in late-onset Pompe disease. The investigational therapy is not yet approved by regulatory agencies. Details on the presentations will be available on Amicus's website following the congress.
Amicus Therapeutics (Nasdaq: FOLD) has announced its participation in three upcoming virtual investor conferences. The events include the Morgan Stanley 19th Annual Global Healthcare Conference on September 10, 2021, the Bank of America Global Healthcare Conference on September 15, 2021, and the Cantor Global Healthcare Conference on September 27, 2021. Live audio webcasts for each presentation will be accessible through the Investors section of their website. Amicus focuses on developing high-quality medicines for rare metabolic diseases.
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.
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