Sarepta Therapeutics (SRPT) Stock: Continues Skyward on FDA Approval

Sarepta Therapeutics Inc (NASDAQ: SRPT)

Sarepta Therapeutics saw massive gains of over 80% in yesterday’s trading session. Today, those gains are continuing, and for good reason. Yesterday, the company announced that it’s flagship candidate has been approved by the FDA. Today, we’ll talk about the news, what we’re seeing from the stock today, and what we can expect to see from SRPT moving forward. So, let’s get right to it…

SRPT Gains On FDA Approval

As mentioned above, the recent gains that we’ve seen from Sarepta Therapeutics are the result of a recent approval from the United States Food and Drug Administration. In the announcement, we learned that the FDA has approved the Exondys 51 (eteplirsen) injection.

This is massive news. In fact, the approval marks the first ever approved treatment for patients with Duchenne muscular dystropy, also known as DMD. With this treatment, SRPT is making medical history. Specifically, Exondys 51 has been approved to treat patients that have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping. This is seen in about 13% of the population that is current dealing with Duchenne muscular dystropy. In a statement surrounding the SRPT approval, Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, had the following to say…

Patients with a particular type of Duchenne muscular dystrophy will now have access to an approved treatment for this rare and devastating disease… In rare diseases, new drug development is especially challenging due to the small numbers of people affected by each disease and the lack of medical understanding of many disorders. Accelerated approval makes this drug available to patients based on initial data, but we eagerly await learning more about the efficacy of this drug through a confirmatory clinical trial that the company must conduct after approval.”

What We’re Seeing From The Stock In The Market

As investors, one of the first things that we learn is that the news moves the market. Any time positive news is released, we can expect to see gains in the value of the stock associated with the news. Of course, an FDA approval is overwhelmingly positive. So, since the news was released, we’ve been seeing massive gains. Yesterday, the stock climbed by more than 80%. Today, we’re seeing a continuation of the upward movement. Currently (3:00), SRPT is trading at $56.24 per share after a gain of $7.30 per share or 14.92% thus far today.

What We Can Expect To See Moving Forward

Moving forward, I have an overwhelmingly bullish opinion of what we can expect to see from Sarepta Therapeutics. The accelerated approval of Exondys 51 marks an exciting turning point for the company to bring this treatment from clinical to commercial stage. While there is a confirmatory study on the horizons, preliminary data is overwhelmingly positive and it seems as though the coming study is going to be incredibly positive. All in all, SRPT has come up with the first approved treatment for DMD. This is a massive milestone, and will likely lead to strong revenue in the future. All in all, I’m expecting to see gains ahead.

What Do You Think?

Where do you think SRPT is headed moving forward? Join the discussion in the comments below!