Sarepta Therapeutics Inc (NASDAQ: SRPT) is having an incredibly strong start to the trading session this morning, and for good reason. The company announced that the FDA has lifted a clinical hold, exciting investors who are pushing the stock for the top. Today, we’ll talk about:
- The lifted clinical hold;
- what we’re seeing from SRPT stock as a result; and
- what we’ll be watching for ahead.
SRPT Climbs On Lifted Clinical Hold
As mentioned above, Sarepta Therapeutics is having an incredibly strong start to the trading session this morning after the company announced that the FDA has lifted a clinical hold. In a press release issued early this morning, the company said that the FDA has lifted the clinical hold for the company’s DMD micro-dystrophin gene therapy program.
On July 25, 2018, SRPT announced that the FDA placed a hold on the program due to he presence of trace amounts of DNA fragment in research-grade third-party supplied plasmid in a manufacturing lot. As a result, an action plan was developed by SRPT and submitted to the FDA. This plan included an audit of the plasmid supplier and a commitment to use GMP-s plasmid for all future production lots. As a result, the FDA has lifted the clinical hold. In a statement, Doug Ingram, CEO at SRPT, had the following to offer:
Thanks to the diligent and rapid work of my Sarepta colleagues and Nationwide Children’s Hospital in compiling and submitting a complete response and the expeditious evaluation by the FDA in reviewing the response and removing this clinical hold, we have been able to address the clinical hold in record time and without delay to this profoundly important clinical program… Our focus now is on meeting with the Division to take guidance and gain alignment around what we hope to be our registration trial for our micro-dystrophin program and achieving our goal of commencing that trial by year-end 2018.
What We’re Seeing From The Stock
One of the first things that we learn when we start to work in the market is that the news leads to moves. In the case of Sarepta Therapeuitcs, the news proved to be overwhelmingly positive. After all, with the clinical hold lifted, the company is now able to move forward with the continued development of its DMD candidate. So, it comes as no surprise that excited investors are lifting the value of the stock this morning. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:19), SRPT is trading at $151.00 per share after a gain of $3.41 per share or 2.31% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will coninue to keep a close eye on SRPT. In particular, we’re interested in following the company’s continued development of its DMD candidate. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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