Orphazyme has fresh cash from the sale of shares in the US and Europe, which will support its lead rare disease drug through regulatory review and, if approved, a launch. But the drug fell short in key clinical trial measures, raising questions about its approvability. Now the FDA wants additional data, potentially throwing a wrench into the review timeline.

Copenhagen-based Orphazyme, which is already publicly traded in Europe, made its US stock market debut by pricing its offering of more than 3.9 million American Depositary Shares late Monday at $11 apiece. At the same time, the company sold to a group… Read more »