Amicus Therapeutics, Inc. (NASDAQ: FOLD) is having an overwhelmingly strong time in the pre-market this morning, and for good reason. News was announced that the FDA has reversed a decision, allowing the company to file for a rare-disease drug. Of course, this is leading to excitement among investors, who are sending the stock skyward. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:55), FOLD is trading at $13.57 per share after a gain of $3.31 per share (32.26%) thus far today.
FOLD Gains On Ability To File
As mentioned above, Amicus Therapeutics is having a strong day in the market after the United States Food and Drug Administration announced that it has reversed a key decision. The original decision was made last November when the FDA said that it would not consider approving migalastat. This is a key experimental treatment created by FOLD to treat a rare disorder called Fabry disease. In their note to the company, the FDA said that more data needed to be collected. This collection process was expected to take until between 2019 and 2020. However, that seems to have changed.
Early this morning, FOLD announced that the FDA has reversed its decision, offering up a clear path to approval for migalastat. In fact, Amicus said that it is now planning on filing the New Drug Application for the treatment by the end of the year. Of course, we know that approval will take about 6 months following the submission of the application, should all go as planned. Ultimately, this will cut a few years off of approval time if the treatment is approved on the first application.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on FOLD. In particular, we’re interested in following the process to bring migalastat to the market. Of course, given today’s news, things are looking positive to say the least. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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