Shares of Amicus Therapeutics Inc. FOLD, -2.24% shot up 40% toward a 22-month high in active premarket trade Tuesday, after the biotechnology company said the Food and Drug Administration cleared the company to submit a new drug application for its Fabry disease treatment. Volume approached 600,000 shares about 90 minutes before the open, making the stock the most actively traded in the premarket session. The company said it plans to submit an NDA for oral precision medicine migalastat in the fourth quarter of 2017. “We are moving ahead expeditiously with our NDA submission and accelerating the U.S. pathway for migalastat,” said Chief Executive John Crowley. “Today is a seminal moment in the development of migalastat and a testament to the dedication and perseverance of the patients, physicians and employees who have worked so hard on the development of this precision medicine.” The stock had doubled year to date through Monday, while the iShares Nasdaq Biotechnology ETF IBB, +0.25% has climbed 17% and the S&P 500 SPX, +0.62% has gained 8.4%.
