FOLD - Amicus shares fall 7% after FDA defers action on Pompe disease candidate application
- Amicus Therapeutics ( NASDAQ: FOLD ) shares are down 6% in after-hours trading after the US FDA informed the company it was delaying making a decision on its Biologics License Application for cipaglucosidase alfa for Pompe disease.
- The BLA has an action date of Oct. 29.
- The delay is because the agency was unable to inspect a manufacturing site in China run by WuXi Biologics.
- Cipaglucosidase alfa is the biologic component of AT-GAA, the treatment Amicus is seeking approval of. Approval of a New Drug Application for miglustat, the other component, is expected at the same time as cipaglucosidase alfa.
- Amicus ( FOLD ) noted that the FDA has not provided an anticipated new action date.
- In May, the FDA extended its review of AT-GAA .
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Amicus shares fall 7% after FDA defers action on Pompe disease candidate application