Amicus Therapeut Stock Price, News & Analysis

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.

Amicus Therapeutics (FOLD) reported 2Q21 Galafold revenue of $77.4 million, marking a 24% increase year-over-year. The company is on track to achieve its 2021 revenue guidance of $300M-$315M. Amicus completed rolling BLA and NDA submissions for AT-GAA, with regulatory support from the EMA. Cash and equivalents stood at $383.1 million. Despite a net loss of $51.2 million, expenses decreased by 2.5% to $93.5 million on a non-GAAP basis. The company is confident in its operational growth with ongoing clinical studies and expansion of Galafold's EU label.

Amicus Therapeutics (Nasdaq: FOLD) announced its participation in the BTIG Virtual Biotechnology Conference on August 9, 2021, at 9:00 a.m. E.T. A live audio webcast will be available on the company's investor section of their website. Amicus is dedicated to developing innovative treatments for rare metabolic diseases, emphasizing a patient-focused approach. For more details about the conference and the company’s initiatives, please visit their website.

Amicus Therapeutics has received European Commission approval for Galafold® (migalastat) as the first oral therapy for the long-term treatment of adolescents aged 12 to <16 years with Fabry disease and an amenable mutation. This marks a significant milestone for the Fabry community, providing a treatment option not available for over 15 years. Supported by interim data from a pediatric study, Amicus aims to facilitate rapid access for eligible patients, further expanding Galafold, which is already approved in several countries, including the U.S. and Japan.