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 (Nasdaq: FOLD) announced the initiation of its rolling Biologics License Application (BLA) submission to the FDA for AT-GAA, a therapy for late onset Pompe disease (LOPD). This rolling submission allows the company to submit application sections as they are completed. The FDA granted Breakthrough Therapy Designation for AT-GAA based on positive Phase 1/2 trial results. Top-line data from the global Phase 3 PROPEL study is expected in 1Q2021, with all manufacturing activities completed successfully.
Amicus Therapeutics (Nasdaq: FOLD) will participate in a fireside chat at the Evercore ISI 3rd Annual HealthCONx Conference on December 1, 2020, at 2:15 p.m. E.T. Interested parties can listen to the event through a live audio webcast available on the company’s corporate website. Amicus is dedicated to developing innovative treatments for rare metabolic diseases, reflecting its commitment to patient care and a robust pipeline of novel therapies. For more details, visit their website.
Amicus Therapeutics (Nasdaq: FOLD) reported 3Q20 revenue of $67.4 million, a 38% increase from $48.8 million in 3Q19, affirming its full-year revenue guidance of $250 million to $260 million. The revenue growth is mainly driven by strong demand for Galafold, with compliance rates exceeding 90%. The PROPEL study for AT-GAA is on track for data release in 1Q21, while positive CLN6 gene therapy data has been presented. The company maintains a strong cash position of $509.1 million, supporting ongoing operations through to self-sustainability.
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.
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