InVivo Therapeutics Holdings Corp (NASDAQ: NVIV) is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company announced that it has received positive news from the FDA surrounding a pivotal clinical trial. Of course, this led to excitement among investors, sending the stock on a run for the top. Today, we’ll talk about the news, what we’re seeing from NVIV, and what we’ll be watching for ahead.
NVIV Announces FDA News
In the release, NVIV said that the 20-patient trial is a randomized, controlled trial that was designed to enhance the existing clinical evidence for the Neuro-Spinal Scaffold that came from the INSPIRE study. In a statement, Richard Toselli, M.D., President and CEO at NVIV, had the following to offer:
We are pleased to announce the FDA’s approval of this randomized, controlled trial and appreciate the agency’s collaboration with us on the development of a protocol to address the substantial unmet needs in this patient population. We believe this now sets us in a direction towards a clear and efficient path to approval under the HDE regulatory program, and we are focused on engaging with the investment community and exploring financial mechanisms to support this approved randomized study. We look forward to providing further updates as we obtain clarity on financing and the timing for our second pivotal trial.
What We’re Seeing From The Stock
As investors, one of the first lessons that we learn is that the news moves the market. In this particular case, the news proved to be overwhelmingly positive.With the FDA’s approval in mind, the company can now advance the development of this product. So, it’s no surprise to see that the stock is making a run for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:59), NVIV is trading at $0.91 per share after a gain of $0.38 per share (73.32%) thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on NVIV. In particular, we’ll be following this clinical trial closely, as it could lead to regulatory approval. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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