Histogenics Corp (NASDAQ: HSGX) is having an incredibly strong start to the trading session this morning, and for good reason. However, that reason may be hard to find as the company hasn’t provided any press releases or SEC filings. Nonetheless, there is a good reason for the gains. Today, we’ll talk about:
- Why HSGX is headed up;
- what we’re seeing from the stock; and
- what we’ll be watching for ahead.
Here’s Why HSGX Is Up
As mentioned above, Histogenics is having an incredibly strong start to the trading session this morning, but the company hasn’t released any news. So, what’s the deal? Well, it seems as though the gains are the result of investors anticipating coming news.
It all surrounds the company’s most recent release, which was issued in late november. In the release, the company provided an update with regard to the NeoCart regulatory pathway based on discussions with the FDA.
In the release, HSGX said that since its initial Type C meeting with the FDA in October, the two parties have continued their discussions on the clinical data generated to date. However, the company said that the FDA had not made any decisions as of yet. Nonetheless, in the release, the company said that it plans on providing an update by the end of 2018 or in early 2019 when it receives additional information from the FDA. While that update hasn’t come yet, based on this timeline, it should be just around the corner.
In a statement, Adam Gridley, President and CEO at HSGX had the following to offer with regard to the regulatory pathway update in late November:
We very much appreciate the FDA’s consideration and active review of our request to evaluate the existing Phase 3 clinical data for a potential NeoCart BLA submission. We continue to work very closely with the FDA to review the data from the NeoCart development program. Our discussions have covered many areas including the clinical data, patient population and related statistics from the NeoCart Phase 3 clinical trial, potential alternative pathways for the BLA as well as the current treatment paradigms for knee cartilage defects in relation to the design of the NeoCart Phase 3 clinical trial… We continue to believe, based on the totality of the data, that NeoCart, if the BLA were accepted and approved by the FDA, may offer patients a treatment alternative that provides a more rapid recovery from pain and return to daily activity than other currently available options to treat damaged knee cartilage.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. When it comes to Histogenics, while the company hasn’t released any news, there is a regulatory path update that’s likely just days away. So, it’s not surprising to see that excited investors are sending the stock up in anticipation of what they hope to be good news. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (11:23), HSGX is trading at $0.095 per share after a gain of $0.0066 per share or 7.47% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the iWatch Markets team will continue to keep a close eye on HSGX. In particular, we’re interested in following the story surrounding the company’s continued work to bring its NeoCart system to market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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