PTC Therapeutics, Inc. (NASDAQ: PTCT)
PTC Therapeutics is having an incredibly strong start in the pre-market hours today, and for good reason. Early this morning, investors received some good news surrounding the FDA. Below, we’ll talk about what we’re seeing from the stock, why, and what we’ll be watching for with regard to PTCT ahead.
What We’re Seeing From PTCT
After closing the day with no gain on Friday, PTC Therapeutics investors were looking for good news today, and it seems as though they’ve gotten it. Early this morning, the company released news it had received from the FDA, leading to pre-market excitement and strong gains. At the moment (8:51), the stock is trading at $11.02 per share after a gain of $1.21 per share or 12.33% thus far today.
Why The Stock Is Gaining
As is usually the case, our partners at Trade Ideas were the first to notify us of the gains on PTCT. As soon as we received the alert, the CNA Finance team went to work to see if we could dig up the reason for the gains. It didn’t take long to uncover the story, the gains are ultimately the result of news that the company received from the FDA.
Early this morning, it was announced that the US FDA has acknowledged the filing over protest of the PTC Therapeutics’ NDA for Translarna(TM). As a result, the PDUFA date for the treatment has been set and investors are looking for approval. The treatment is already approved in Europe and available in more than 25 countries. In a statement, Stuart W. Peltz, Ph.D., CMO at PTCT had the following to offer…
“We look forward to working closely with the FDA and the DMD community to bring this much-needed therapy to patients… We believe that the totality of clinical data in our NDA, which includes the results of two of the largest placebo-controlled DMD clinical trials ever conducted, demonstrates Translarma’s benefit to patients and merits a full and fair review by the FDA, including an advisory committee meeting.”
What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on PTCT. In particular, we’ll be watching the communications between the company and the FDA surrounding the NDA that has now been accepted. Nonetheless, we’ll be watching the story closely and bringing the news to you as it breaks!
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