Amicus Therapeutics Shares Rally On News Of Positive Regulatory Meetings

Shares of Amicus Therapeutics rallied sharply Thursday, after the biotech company said it had a positive meeting with European regulators about its application to have a treatment for Fabry disease approved. The company is planning to submit a marketing authorization application (MAA) for migalastat monotherapy and met last week with regulators, who provided positive feedback on the data the company has submitted. Amicus said it has moved forward the timing of the MAA submission for full approval to the second quarter from the middle of 2015. Separately, Amicus met this week with U.S. regulators and is planning to submit a new drug application for accelerated approval in the second half. Shares rose 22% in premarket trade.