Amicus Therapeutics, Inc. (NASDAQ:FOLD) stock was flying high today on positive news from the U.S. Food and Drug Administration (FDA).
Amicus Therapeutics, Inc. says that the FDA is allowing it to submit a new drug application for migalastat. This is the company’s oral precision medicine to treat Fabry disease. FOLD stock is on the rise after the company said it will submit this new drug application in the fourth quarter of 2017.
“The FDA’s willingness to review migalastat data reflects what we believe is the gold standard in science-based, data-driven, patient-centric therapeutic development,” Jay Bart, CMO at Amicus Therapeutics, Inc., said in a statement. “We believe that we have a robust data package for this NDA submission, and we look forward to advancing toward a planned pathway for U.S. approval for migalastat.”
Amicus Therapeutics, Inc. notes that there are roughly 3,000 people in the United States that suffer from Fabry disease. The drug migalastat is designed to treat those with amenable genetic mutations. The European Union already approved the drug for patients that are 16 or older last year.
The good news for FOLD stock was a switch from the previous decision made by the FDA last November. This would have required the biotechnology company to collect more data before it could file for a new drug application. It would have taken the company until 2019 or 2020 to accomplish this goal, reports Forbes.
FOLD stock was up 27% as of Tuesday afternoon and is up 158% year-to-date.
As of this writing, William White did not hold a position in any of the aforementioned securities.
