Amicus Therapeut Stock Price, News & Analysis

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.

Amicus Therapeutics (Nasdaq: FOLD) will participate in a fireside chat at the Stifel 2021 Virtual Healthcare Conference on November 16, 2021, at 8:00 a.m. E.T. The event will feature key members of the senior leadership team discussing the company's initiatives.

A live audio webcast of the presentation can be accessed via Amicus Therapeutics' investor section on their corporate website.

Amicus is dedicated to developing high-quality medicines for rare metabolic diseases, emphasizing innovation and patient care.

Amicus Therapeutics reported a total revenue of $79.5 million for Q3 2021, marking an 18% increase from Q3 2020. The company reiterated its 2021 revenue guidance of $300 million to $315 million. The FDA has accepted the BLA and NDA for AT-GAA for Pompe disease, with target action dates set for May 29 and July 29, 2022, respectively. Following a merger with ARYA IV, Amicus aims to launch Caritas Therapeutics in late 2021 or early 2022, with a cash position sufficient for achieving self-sustainability by 2023.

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.