Sarepta Therapeutics Inc (NASDAQ: SRPT)
Sarepta Therapeutics is having an incredible day in the market today, and for good reason. The company is awaiting approval with regard to a New Drug Application it submitted a while ago. While the FDA has announced that its decision will be slightly delayed, investors are excited, sending the value of the stock upward. Today, we’ll talk about the delay, what we’re seeing in the market today, and what we can expect to see from SRPT moving forward.
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SRPT & The FDA
Sarepta has been working on a drug that’s designed to treat Duchenne muscular dystrophy for some time now. In fact, the drug, known as eteplirsen, is currently awaiting approval, as SRPT has already submitted the New Drug Application to the United States Food and Drug Administration. Previously, it was expected that the treatment would either be approved or rejected tomorrow, May 26th. This expectation was based on time limitations set forth by the Prescription Drug User Fee Act, also known as PDUFA. However, the FDA has announced that it will not be able to complete its work on the treatment proposed by SRPT by this date. However, they have also stated that they are committed to completing the NDA process as quickly as possible.
What We’re Seeing From Sarepta Therapeutics Today
In general, the day before the FDA is scheduled to make a decision with regard to an investigational new drug, we tend to see the value of the stock rise exponentially. Because the FDA is scheduled to provide its approval or denial of eteplirsen tomorrow, we’re seeing strong gains in the value of the stock today, although it seems as though some investors may have missed the memo that the process would be delayed past the PDUFA date. Nonetheless, we’re seeing incredibly strong gains in the value of SRPT today. Currently (10:01), the stock is trading at $22.14 per share after a gain of $3.70 per share or 20.09% thus far today.
What We Can Expect To See Moving Forward
Moving forward, I have a relatively mixed expectation of what we can expect to see from Sarepta Therapeutics; and that opinion revolves around eteplirsen. First and foremost, I have been watching SRPT for quite some time and paying very close attention to the releases of data the company has offered following the trials associated with the treatment. That being said, I’m impressed with the results I’ve seen, and, if it was up to me, the treatment would be approved. However, it’s not up to me, it’s up to the FDA, which leads to a bit of concern.
I have to admit that I am concerned about the fact that the FDA announced that it would not bee meeting the PDUFA date. The reality is that if there were no problems, I have a hard time imagining that the approval of the treatment would take much longer. So, it’s my opinion that the FDA may have found a problem with the application or the treatment itself. Why else would they delay the approval process, other than to look at corresponding data to ensure that the treatment is safe, after finding something concerning? With that said, I’m very uncertain about what we can expect from the FDA, and that leads to uncertainty with regard to what we can expect to see from SRPT. While I continue to hope for approval, I’m also preparing for a denial from the FDA.
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What Do You Think?
Where do you think SRPT is headed moving forward? Join the discussion at the CNA Finance forum!
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