Sarepta Therapeutics Inc (NASDAQ:SRPT)

Sarepta Therapeutics stock is having an amazing day in the market today after an announcement was made about a pre-New Drug Application meeting. Today, we’ll talk about the meeting, how SRPT plans on submitting an NDA, how the market reacted, and what we can expect to see from SRPT moving forward. So, let’s get right to it…

Sarepta Therapeutics To Start A Rolling NDA Submission Soon!

SRPT announced today that it has held a pre-New Drug Application meeting with the FDA. The meeting was centered around the company’s leading product candidate known as eteplirsen; which is designed for the treatment of Duchenne muscular dystrophy (DMD). The result of the meeting with the FDA was an agreement to initiate a rolling NDA submission whereby the non-clinical and CMC components of the NDA will be submitted by the end of the week’ with final components being submitted in mid-2015. Here’s what Edward Kaye, M.D., interim CEO of Sarepta had to say….

“We will initiate a rolling NDA submission to facilitate the regulatory review of the NDA…The initiation of our NDA submission for eteplirsen marks a significant milestone for the Duchenne community and we look forward to completing the submission by the middle of the year and to continue to work with the Agency towards the goal of providing treatments to patients as quickly as possible.”

How SRPT Reacted To The News In The Market

As mentioned above, today has been an absolutely incredible day for SRPT in the market. Investor excitement has sent this thing soaring. Currently (12:25), the stock is trading at $25.18 per share after a massive gain of 53.72% so far today.

What We Can Expect From Sarepta Therapeutics Moving Forward

After learning the news of the rolling NDA submission of eteplirsen, I’ve got an incredibly bullish outlook of SRPT from both the short term and long term views. Here’s how I see it…

  • Short Term – In the short term, I’m expecting to see more positivity as investors continue to express excitement over the NDA. With the submission of the first piece of the application at the end of this week, I’m expecting to see more breakout activity before the week closes.

  • Long Term – In the long run, I’ve also got a very bullish view of SRPT. The reality is that the company is now moving from clinical phase to application phase; meaning that they are confident in the effectiveness of eteplirsen in patients suffering from DMD. With that said, I’m expecting to see the NDA submission roll out smoothly and when the FDA does approve eteplirsen, I’m expecting that we’ll start to see incredible profits. With that said, if you’re looking to run with the bulls for the long run, this may be the opportunity to do just that.