Pfenex Inc (NYSEAMERICAN: PFNX) is having an overwhelmingly strong start to the trading session this morning after the company announced a positive clinical update. Of course, the positive update led to excitement among investors who are sending the stock screaming for the top. Today, we’ll talk about:
- The clinical update;
- what we’re seeing from PFNX;
- and what we’ll be watching for ahead.
PFNX Announces Clinical Update
As mentioned above, Pfenex is having an overwhelmingly strong start to the trading session this morning after announcing a clinical update. In a press release issued early this morning, the company announced top-line results from its PF708-301 study. The data released showed comparable overall profiles between PF708 and Forteo® after 24 weeks of daily injection in osteoporosis patients. As a result of the strong clinical data, PFNX now expects that it will submit a New Drug Application (NDA) surrounding the treatment to the United States Food and Drug Administration (FDA), in the third quarter of 2018. In a statement, Eef Schimmelpennink, CEO at PFNX, had the following to offer:
We are pleased with the results of the PF708-301 study, which show comparable overall profiles between PF708 and Forteo… We expect that these results from the PF708-301 study, along with the previously announced bioequivalence findings from the PF708-101 study in healthy subjects, will support the PF708 NDA submission. We are on-track for submission to the FDA in the third quarter of 2018, with a potential commercial launch in the United States as early as the third quarter of 2019, subject, of course, to FDA approval of the application.
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 causes moves. In this particular case, the news proved to be overwhelmingly positive. Not only did the company report positive top line data from a pivotal clinical study, Pfenex also announced that an NDA is coming down the line relatively soon. So, it’s no surprise that excited investors are pushing the stock for the top in the market this morning. At the moment (9:30), PFNX is trading at $7.09 per share after a gain of $0.99 per share or 16.23% 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 PFNX. In particular, we’re interested in following the story surrounding the company’s work to bring PF708 to market as it seems as though commercialization may be just around the corner. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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