Scan of Amicus label ‘doesn’t raise any major questions,’ says Stifel

After Amicus announced that the U.S. Food and Drug Administration has approved Pombiliti + Opfolda 65mg capsules for adults living with late-onset Pompe disease who are not improving on their current enzyme replacement therapy, or ERT, Stifel analyst Dae Gon Ha said investor expectations were “skewed towards approval.” A “brief scan of the label doesn’t raise any major questions for us,” but “what intrigues us… is the reasoning behind the specified weight cutoff” of 40 kg for Pombiliti, added the analyst, who has a Buy rating and $17 price target on Amicus shares. Near midday, shares are down $1.03, or 8%, to $11.85.