Amicus again slows migalastat's NDA timeline

Amicus Therapeutics Inc. (NASDAQ:FOLD) shed $2.29 (28%) to $6.03 in early after-hours trading Monday after it revealed a new timeline for its planned NDA submission for migalastat (AT1001) to treat Fabry's disease. The company now plans to conduct a new 12-month study of the candidate, from which it expects data in 2019, prior to seeking full approval.

Amicus had already slowed the timeline for migalastat's NDA at least once. In October 2015, Amicus said it would delay the submission after FDA requested the company integrate data from the Phase III ATTRACT and FACETS studies. It had previously hoped to submit an NDA in 4Q15 seeking accelerated approval of the candidate based on FACETS, with supplemental data from ATTRACT (see BioCentury Extra, Oct. 2, 2015)...