Amicus Therapeutics Inc. (NASDAQ:FOLD) has announced its Q3 2020 financial results for the quarter ended September 30, 2020, in which Galafold revenue was $67.4 million. The company also provided program updates and reaffirmed its full-year guidance.
Amicus posts 38% YoY growth in Galafold revenue
The CEO and Chairman of Amicus Therapeutics John Crowley said that the company made considerable progress in the quarter, and it is on track to attaining its 2020 strategic priorities. Amicus is on track to launch its global Fabry commercial launch, advancing its lead gene therapy pipeline and late-stage development of the Pompe program. Crowley said that through the initiatives, the company is well-positioned to achieve its vision of bringing ground-breaking novel treatments to patients with rare diseases.
The company reported a 38% YoY growth in total Galafold® to $67.4 million in the third quarter. The strong Galafold performance was due to strong patient demand as global adherence and compliance rates continue to surpass 90%.
Late-onset Pompe disease updates
The global third Phase PROPEL clinical trial of AT-GAA in late-onset Pompe disease (LOPD) is on track with top-line results expected in Q1 2021. So far, the company has completed 97% of the more than 3,100 planned infusions of the PROPEL study on time. Amicus plans to commence a rolling BLA for AT-GAA in Q4 2020, with the final submission expected in 1H 2020. To company highlighted new natural history data from its POM-002 chart review trial in people with LOPD that have received long-term standard of care treatment, alglucosidase alfa. Results are consistent with medical literature, which further affirms the design assumptions of PROPEL.
Recently the company presented 1/2 CLN6 data at the Child Neurology Society Annual Meeting. The results showed a significant effect in reducing disease progression relative to natural history. Currently, regulatory interactions are in progress, and Amicus expects to offer feedback on the way forward next year.
Also, the company’s AAV gene therapy has been picked for IND supporting studies in Fabry disease. The therapy showed better GL-3 reduction compared with one with wild-type GLA.
