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 that CEO John F. Crowley will speak at the Credit Suisse 29th Annual Virtual Healthcare Conference on November 9, 2020, at 8:00 a.m. ET. The event will provide insights into the company's focus on rare metabolic diseases.
Investors can access a live audio webcast of the presentation via the Amicus Therapeutics website. The company is dedicated to developing high-quality medicines for those affected by rare diseases.
Amicus Therapeutics (Nasdaq: FOLD) will host a conference call and live audio webcast on November 5, 2020, at 8:30 a.m. ET to discuss its third-quarter financial results for the period ending September 30, 2020. Participants can join the call by dialing specific numbers and using the conference ID 7788189. A live audio webcast will also be available on the company's investor website. A replay of the call will be accessible for seven days post-event. Amicus Therapeutics focuses on developing innovative medicines for rare metabolic diseases.
Amicus Therapeutics (Nasdaq: FOLD) announced positive interim results from its AT-GTX-501 gene therapy program for CLN6 Batten disease. Data presented at the Child Neurology Congress indicates safety is well-maintained across 13 children, with efficacy shown in 12 patients at 12 months, and 8 at 24 months. The therapy slowed decline in motor and language function significantly compared to natural history cohorts. Regulatory discussions are ongoing, with the company expecting additional feedback in 2021.
Amicus Therapeutics (Nasdaq: FOLD) announced that the European Medicines Agency (EMA) granted Priority Medicines (PRIME) designation to AT-GTX-501, a gene therapy for children with variant late infantile neuronal ceroid lipofuscinosis 6 (CLN6 Batten disease). The PRIME designation aims to enhance support for development and expedite regulatory evaluations. This decision is based on Phase 1/2 clinical trial data, and additional results are expected at the Child Neurology Society Annual Meeting in October. In the U.S., AT-GTX-501 has already received Rare Pediatric Disease and Orphan Drug designations.
Amicus Therapeutics (Nasdaq: FOLD) announced its senior leadership team's participation in three virtual investor conferences in September 2020. Events include Citi's 15th Annual BioPharma Virtual Conference on September 10 at 8:55 a.m. E.T., Cantor Virtual Global Healthcare Conference on September 16 at 10:00 a.m. E.T., and Bank of America Global Healthcare Conference on September 18 at 4:45 p.m. B.S.T. Live audio webcasts can be accessed via the company's Investors section on their website.
Amicus focuses on developing innovative treatments for rare metabolic diseases.
Amicus Therapeutics (Nasdaq: FOLD) will host a conference call on August 10, 2020, at 8:30 a.m. ET to discuss its financial results for Q2 2020, which ended June 30, 2020. CEO John F. Crowley and the senior leadership team will lead the call. Investors can participate by dialing designated numbers or accessing it via a live audio webcast on the company's investor website. A replay will be available for seven days post-event. Amicus focuses on developing innovative medicines for rare metabolic diseases.
Amicus Therapeutics (FOLD) announced a $400 million credit facility with Hayfin Capital Management, paving a path to profitability without future dilutive financings. The financing aims to support the company's growth in rare diseases and retire a prior term loan. The facility features a 6.5% interest rate above LIBOR, requiring interest-only payments until mid-2024, and will be fully drawn at closing. Amicus expects Galafold revenues between $250 million and $260 million for 2020, emphasizing prudent expense management and a strong financial foundation.
Amicus Therapeutics (Nasdaq: FOLD) announces that CEO John F. Crowley will participate in a fireside chat at the Goldman Sachs 41st Annual Global Healthcare Conference on June 10, 2020, at 8:00 a.m. ET. This event will take place virtually, allowing interested parties to access a live audio webcast via the company's Investor Relations page. Amicus Therapeutics focuses on developing innovative medicines for rare metabolic diseases, furthering its commitment to patients through a robust pipeline of advanced therapies. For details, visit www.amicusrx.com.
Amicus Therapeutics (Nasdaq: FOLD) announced the acceptance of multiple abstracts for the American Society of Gene & Cell Therapy 23rd Annual Meeting on May 12-15, 2020. The presentation includes preclinical data from the Pompe gene therapy program, alongside CLN6 and CLN8 Batten disease programs. The oral presentation is scheduled for May 14, showcasing a study on gene therapy for Pompe disease. Poster presentations will cover data on CLN6 and CLN8 Batten diseases. Pompe disease affects 5,000-10,000 people globally and is characterized by severe muscle weakness.
Amicus Therapeutics (Nasdaq: FOLD) announced acceptance of several abstracts for the American Society of Gene & Cell Therapy 23rd Annual Meeting held virtually from May 12-15, 2020. The highlights include:
- Oral Presentation: Preclinical data on Pompe gene therapy on May 14, 2020.
- Poster Presentations: Research on CLN6 Batten disease on May 12 and CLN8 Batten disease on May 13.
POMPE and Batten diseases are rare genetic disorders affecting muscle and neurological function, respectively.
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