Am­i­cus maps out a 3-year de­lay at the FDA for lead drug, send­ing shares in­to a tail­spin

More than a year af­ter Am­i­cus Ther­a­peu­tics was forced to do a sud­den about-face and walk back promis­es of a quick sub­mis­sion for its lead drug mi­gala­s­tat, the biotech has laid out plans for a new tri­al that will be need­ed to win an FDA ap­proval — push­ing back any prospect of an OK for treat­ing Fab­ry dis­ease by at least three more years.

The Cran­bury, NJ-based biotech’s shares $FOLD cratered on the news, drop­ping 28%.

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