Beur schreef op 27 juni 2018 08:25:
Amicus Therapeutics -10% on missed CMA in Europe
Jun. 26, 2018 6:30 PM ET
Amicus Therapeutics (NASDAQ:FOLD) is 9.9% lower after hours after it announced updates to its development program for AT-GAA for
Pompe Disease, which didn't get a Conditional Marketing Authorization.Meetings with the European Medicines' Agency's Scientific Advice Working Party suggested that efficacy data looked "promising" but insufficient for now.
SAWP was supportive of adding additional patient populations, which Amicus will pursue in 2019, to gather more data.
It will also be able to start Process Performance Qualification runs at commercial scale (1,000 liters).