Navidea Biopharmaceuticals Inc (NYSEAMERICAN: NAVB) is making a run for the top in the market this morning, and for good reason. The company issued a regulatory update, exciting investors and sending the stock screaming for the top. Today, we’ll talk about:
- The regulatory update;
- what we’re seeing from NAVB stock as a result; and
- what we’ll be watching for ahead.
NAVB Announces Regulatory Update
As mentioned above, Navidea Biopharmaceuticals is having a great day in the market today after announcing a regulatory update. The update came by way of press release early this morning.
In the release, the company said that it received feedback from the FDA with regard to its planned clinical studies to evaluate joint disease in patients with Rheumatoid Arthritis and monitor patient response to therapy.
In the release, NAVB said that the FDA has communicated that the first study, a Phase 2b trial, is aligned with expectations for studies. Moreover, the FDA will continue to work with the company as they progress into Phase 3 trials.
The company also said that it is now prepared to initiate a study of NAV3-31. The study will also provide confirmatory support necessary to initiate its Phase 3 program.
In a statement, Dr. Michael Rosol, CMO at NAVB, had the following to offer:
We are delighted to have received the news from the FDA that we are progressing in the right direction with our upcoming Phase 2b study. This study is designed to enable us to establish objective, quantifiable Tc99m tilmanocept imaging metrics of the joints of healthy subjects and patients with active RA.
The robust establishment of the range of TUVs from healthy subjects and RA patients is a critical step to set us up for the greater validation of our imaging readout as an early biomarker of patient response to therapy, method for longitudinal monitoring of treatment, and potentially for RA pathobiology subtype discrimination. Our entire clinical team has been pushing hard in preparation and this important trial is set to begin in the near future. We plan to proceed with our timelines and will ensure we remain in line with FDA requirements.
The above statement was followed up by Jed Latkin, CEO at NAVB. Here’s what he had to say:
This is an important step along the path to approval of our RA diagnostic product candidate and represents Navidea’s continued dedication to the execution of our goals and to enhance value for stockholders. We will continue to work with the FDA as data from NAV3-31 becomes available. We will also continue to be transparent with the market and give updates to our stockholders and all interested parties, as appropriate.
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 Navidea Biopharmaceuticals, the news proved to be overwhelmingly positive.
With the clear to move forward with the Phase 2b trial and a path toward a pivotal Phase 3 study, the company’s development of NAV3-31 is progressing well. So, it’s not surprising to see that excited investors are pushing the stock on a run for the top.
As is just about always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:33), NAVB is trading at $0.19 per share after a gain of $0.05 per share or 35.71% 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 NAVB. In particular, we’re interested in following the story surrounding the continued development of NAV3-31 as the asset is progressing well. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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