Amicus Therapeutics, Inc. (NASDAQ: FOLD) is watching its shares drop on Tuesday after the company provided an update on its regulatory pathway for its Fabry Disease treatment. After the company had several collaborative discussions with the U.S. Food and Drug Administration (FDA), Amicus plans to collect additional data on gastrointestinal (GI) symptoms in Fabry patients who have an amenable mutation.
During its review of the briefing document submitted and in discussions with Amicus, the FDA acknowledged that significant unmet medical need exists in Fabry disease. The agency also indicated....More>>>