Amicus falls on delay for Fabry's compound

Amicus Therapeutics Inc. (NASDAQ:FOLD) fell $0.65 (20%) to $2.54 on Monday after announcing that FDA said 12-month data from a Phase III trial of Amigal migalastat to treat Fabry's disease would not support approval of an NDA. The news came at a meeting Amicus had with the agency to discuss six-month data from the Phase III FACETS (Study 011) trial of Amigal. In February, Amicus had said the 12-month data, which are expected in 4Q13, would "add to the entirety of the data that FDA has indicated would support a potential U.S. conditional approval." Amicus reported six-month data from FACETS in December showing that Amigal missed the primary endpoint (see BioCentury Extra, Feb. 15).

Amicus said it now plans to meet with FDA in 2H14 to discuss a potential U.S. approval pathway for Amigal. The company also expects to report top-line data from the Phase III ATTRACT (Study 012) trial evaluating Amigal vs. enzyme replacement therapy (ERT) for Fabry's in 2H14. ...