Amicus Therapeutics, Inc. (NASDAQ: FOLD)
Amicus Therapeutics had a rough end of the week last week as the FDA requested more data with regard to its prime candidate. However, today, the stock seems to be working to recover. So today, we’ll talk about what we saw from the FDA, how FOLD reacted, what we’re seeing today and what we can expect to see from the stock moving forward.
FDA Requests More Information From FOLD
On Friday, Amicus Therapeutics was informed that it will not be able to file for US approval with regard to its experimental pill treatment for Fabry disease, migalastat, by it’s end of the year target. The FDA informed the company that it would need more information before accepting an application. The information that regulators are requesting includes data from previous clinical trials of the drug. Accourding to Amicus, this will take some time to complete. As a result of the news, John Crowley, CEO of FOLD had the following to say…
“Amicus remains committed to making migalastat available to Fabry patients with amenable mutations in the U.S. as rapidly as possible. We are appreciative of the FDA’s ongoing collaboration in this program.”
How The Market Reacted To The News
Generally, anytime there’s a set back with regard to a biotechnology company, we tend to see declines. That’s exactly what happened when Amicus Therapeutics announced that the NDA for migalastat would be delayed. On Friday, FOLD fell by more than 50% in a single trading session.
What We’re Seeing In The Market Today
Today things are looking up for FOLD. Currently (11:23), the stock is trading at $7.03 per share after a gain of 10.02% so far today. However, it’s important in times like these to remember that price movements in the market generally happen through a series of overreactions. After massive declines in the last trading session, it’s justified that we would see decent gains today. Nonetheless, today’s gains don’t take away from overall concerns about the company’s ability to get migalastat approved.
What We Can Expect To See Moving Forward
At this point, the forward looking picture is a bit up in the air. The reality here is that there’s got to be a reason that the FDA requested more data with regard to the drug before accepting an application. Only time will tell what that reason is, but for now, things aren’t looking great. Nonetheless, it is possible that FOLD will produce the data that the FDA expects and the regulatory agency will accept an application. Again, only time will tell. Currently however, I would stay away from FOLD as an investment.
What Do You Think?
Where do you think FOLD is headed and why? Let us know in the comments below!
[Image Courtesy of Business Climate]