Navidea Biopharmaceuticals Inc (NYSEAMERICAN: NAVB) is making a run for the top in the market this morning, trading on gains of more than 45% early on. The gains come after the company released positive interim data from a key clinical trial. Here’s what’s going on:
NAVB Stock Soars On Positive Clinical Data
Navidea Biosciences issued a press release early this morning, announcing positive results from a Phase 2B study. The results came from the first interim analysis of the NAV3-31 clinical study.
According to the release, the interim data support the company’s hypotheses that Tc 99m Tilmanocept imaaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis.
Importantly, NAVB said that the data suggest that this imaging is stable, reproducible, and can define joints with and without RA-involved inflammation.
The interim analysis examined data from Arms 1 and 2 in this 3 arm study. 30 patients were included, 18 healthy controls and 12 patients with RA. The company said that image sets acquired on the same day at multiple time points demonstrated quantitative repeatability and stability of signal.
Importantly, NAVB said that images from patients with active RA showed the same localization patterns on images taken one week apart. In fact, there was a notable agreement between qualitative and quantitative assessment of joint-specific localization across all time points.
In a statement, Michael Rosol, CMO at NAVB, had the following to offer:
These results support our hypotheses for Arms 1 and 2 of this trial and are key for the path forward to the Phase 3. The demonstration that Tc 99m tilmanocept imaging is stable and has low variability enables us to proceed with confidence in testing our hypothesis that this can be an early indicator of therapeutic efficacy in these patients.” Dr. Rosol continued, “With these exciting results in hand, we continue to enroll subjects as planned to complete this Phase 2B and prepare for the upcoming Phase 3.
The above statement was followed up by Jed Latkin, Navidea’s CEO. Here’s what he had to offer:
I am very pleased that the results of this interim analysis are so encouraging. It reaffirms that we are heading in the right direction with our clinical trial pipeline in rheumatoid arthritis. I look forward to continuing this momentum into the Phase 3.
Why This News Is So Exciting
At the end of the day, for biotechnology companies, there are few bits of news that are more exciting than the release of positive data. But investors seem to be overly excited here with such strong gains being seen. Here’s why the news is so exciting:
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