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 three poster presentations on its Pompe disease program will be featured at the 2022 AANEM Annual Meeting, occurring from September 21-24 in Nashville, TN. The studies include an open-label Phase I/II trial of cipaglucosidase alfa/miglustat, a Phase III study on immunogenicity compared to alglucosidase alfa, and an analysis of pharmacokinetic profiles. The posters will be published on the company's website following the presentations, underscoring its commitment to innovative therapies for rare metabolic diseases.
Amicus Therapeutics (Nasdaq: FOLD) announced participation in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference, scheduled for September 14, 2022, at 12:20 p.m. E.T. in New York City. The event will be accessible via a live audio webcast on the company’s investor relations website. Amicus Therapeutics focuses on developing innovative therapies for rare metabolic diseases, emphasizing high-quality patient care and a commitment to expanding its pipeline of medicines.
Amicus Therapeutics (Nasdaq: FOLD) reported Galafold revenue of $159.4 million for H1 2022, showing an 11% increase year-over-year, driven by 18% operational growth, despite a 7% currency impact. The company anticipates a full-year revenue growth of 15-20% at constant exchange rates. Key regulatory reviews for AT-GAA are advancing, with FDA action dates set for August 29 and October 29, 2022. Amicus has strengthened its patent portfolio with 17 new U.S. patents and aims for non-GAAP profitability by 2023. Cash reserves stood at $386.8 million as of June 30, 2022.
Amicus Therapeutics (Nasdaq: FOLD) will host a conference call on August 4, 2022, at 8:30 a.m. ET to discuss its financial results for Q2 2022, which ended on June 30, 2022. Participants can access the call by dialing 1-833-634-2601 or 1-412-902-4113 for international callers. A live audio webcast will also be available on the company's investor website. A replay will be accessible for seven days following the event. Amicus focuses on developing therapies for rare metabolic diseases and has a commitment to a robust pipeline of innovative medicines.
Amicus Therapeutics (Nasdaq: FOLD) will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on June 15, 2022, at 11:20 a.m. P.T. The event will be held in Rancho Palos Verdes, CA. Investors can access a live audio webcast of the presentation on the company's investor relations website. Amicus focuses on developing innovative medicines for rare metabolic diseases, showcasing its commitment to patient-centered care and a robust pipeline of novel treatments.
Amicus Therapeutics (Nasdaq: FOLD) announced a 90-day extension to the FDA review period for the Biologics License Application (BLA) of cipaglucosidase alfa and the New Drug Application (NDA) for miglustat, both components of AT-GAA. The new action dates are August 29, 2022, and October 29, 2022, respectively. This extension allows additional time for the FDA to review submitted information and to complete pre-license inspections at the manufacturing site. The company remains optimistic about FDA approval for AT-GAA as a treatment for Pompe disease.
Amicus Therapeutics reported a strong first quarter of 2022, with Galafold® revenue reaching $78.7 million, an 18.5% year-over-year increase. The company strengthened its intellectual property with new patents extending protection through 2038. Regulatory reviews for AT-GAA in Pompe Disease are progressing, with the FDA's action dates set for May 29 and July 29, 2022. Amicus anticipates continued double-digit growth for Galafold, projecting $350 million to $365 million in revenue for the year. However, the net loss for the quarter was $85.3 million.
Amicus Therapeutics (Nasdaq: FOLD) announced participation in a fireside chat at the Bank of America 2022 Healthcare Conference on May 11, 2022, at 12:00 p.m. P.T. The event will take place in Las Vegas, NV. A live audio webcast will be available on the company's investor website. Amicus Therapeutics is dedicated to developing novel therapies for rare metabolic diseases, focusing on patient needs and advancing a robust pipeline of innovative medicines. For further details, visit their website or access the webcast.
Amicus Therapeutics (Nasdaq: FOLD) will host a conference call and live audio webcast on May 9, 2022, at 8:30 a.m. ET to discuss financial results for Q1 2022, covering the period ended March 31, 2022. Investors can participate by calling 877-303-5859 (U.S./Canada) or 678-224-7784 (international) and using conference ID 7867383. Additionally, a replay will be available for seven days post-call. The company focuses on developing innovative therapies for rare metabolic diseases and is dedicated to patient-centric care. For further information, visit their corporate website.
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