Amicus Therapeut Stock Price, News & Analysis

Amicus Therapeutics (Nasdaq: FOLD) reported a 17% year-over-year revenue growth to $306 million in 2021, driven by strong sales of Galafold. The company anticipates Galafold revenue of $350 million to $365 million in 2022, maintaining double-digit growth. Amicus aims for profitability in 2023, aided by $400 million in projected operating expense savings through 2026. Regulatory filings for AT-GAA are under review, with launch preparations ongoing. The planned business combination with ARYA IV has been terminated due to adverse market conditions.

Amicus Therapeutics (Nasdaq: FOLD) will host a conference call on February 24, 2022, at 8:30 a.m. ET to discuss its financial results for the year ending December 31, 2021. Interested participants can join by dialing 877-303-5859 (U.S./Canada) or 678-224-7784 (international) with conference ID 1792414. A live audio webcast will also be available on the company’s website. A replay will be accessible for seven days post-call at designated numbers. Amicus focuses on developing high-quality medicines for rare metabolic diseases.

Amicus Therapeutics (FOLD) announced participation at the 18th Annual WORLDSymposium™ 2022, showcasing two oral presentations and 11 posters on its innovative therapies for rare diseases.

Key presentations include a randomized study on the immunogenicity of cipaglucosidase alfa/miglustat in late-onset Pompe disease and a study on gene transfer for Pompe therapy. The event, scheduled from February 7-11 in San Diego, CA, aims to enhance understanding of lysosomal diseases and showcase latest research findings.

Amicus Therapeutics (FOLD) reported 2021 Galafold revenue of ~$306 million, marking a 17% YoY growth. The company anticipates 2022 revenue between $350M and $365M, guided by a projected 15-20% growth. Regulatory reviews for AT-GAA in Pompe disease are progressing, with launch preparations actively underway. The company expects to achieve self-sustainability and profitability by 2023, supported by a strong cash position and strategic investments.

Amicus Therapeutics (Nasdaq: FOLD) will present at the 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 3:45 p.m. E.T. This event is virtual, allowing investors to access a live audio webcast through the company's website. Amicus is dedicated to developing innovative medicines for rare metabolic diseases, emphasizing a robust pipeline of first- or best-in-class treatments. For more details, visit their investor relations page.

Amicus Therapeutics (Nasdaq: FOLD) announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Applications (MAA) for AT-GAA, a two-component therapy for Pompe disease. The EMA's acceptance triggers an assessment process. The MAA is supported by data from Phase 1/2 and Phase 3 PROPEL studies. CEO John F. Crowley emphasized the urgency to provide new treatments for Pompe disease. Additionally, AT-GAA has received Breakthrough Therapy designation from the FDA, which has set action dates for related applications in May and July 2022.

Amicus Therapeutics (Nasdaq: FOLD) will participate in the 4th Annual Evercore ISI HealthCONx Virtual Conference on December 1, 2021, at 8:50 a.m. E.T. Senior leadership will hold a fireside chat, which can be accessed through a live audio webcast on the company’s investor relations page. Amicus focuses on developing high-quality medicines for rare metabolic diseases, emphasizing patient dedication and a robust pipeline of innovative treatments. For more information, visit their website.

Amicus Therapeutics (Nasdaq: FOLD) announced its participation in the 14th International Congress of Inborn Errors of Metabolism from November 21-23, 2021. The company is presenting two digital posters: one on the long-term efficacy of migalastat in patients with amenable GLA variants and another on the incidence of Fabry disease in children. Both presentations highlight key findings relevant to the treatment of rare metabolic diseases. Interested parties can access these presentations through the Investors section of the Amicus website.

Amicus Therapeutics (FOLD) announced that the PROPEL trial results, published in The Lancet Neurology, demonstrate that AT-GAA provides significant improvements in treatment outcomes for adults with late-onset Pompe disease. The trial showed enhanced muscle strength, pulmonary, and motor function compared to the standard treatment, alglucosidase alfa. As a two-component therapy, AT-GAA includes cipaglucosidase alfa and miglustat. The FDA has granted Breakthrough Therapy designation for AT-GAA, with key review dates set for May and July 2022.