Healthcare Business

Why This Rheumatoid Arthritis Study Is Huge for Navidea Biopharma

Navidea Biopharmaceuticals Inc. (NYSE: NAVB) shares more than doubled to close out the week after the company provided an update from its midstage study in patients with active rheumatoid arthritis (RA).

Specifically, the company announced positive preliminary results from its second interim analysis of its ongoing NAV3-31 Phase 2B study in patients with active RA.

An analysis demonstrated that these interim data further corroborate Navidea’s hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and that this imaging can provide an early indicator of treatment efficacy in patients with active RA.

These interim data are supportive of Navidea’s hypotheses that Tc99m tilmanocept imaging can provide quantifiable imaging assessment of RA-involved joints that enables early prediction of clinical response as well as longitudinal monitoring of clinical status.

RA is a chronic disease affecting over 1.3 million Americans and as much as 1% of the worldwide population.

Michael Rosol, chief medical officer for Navidea, commented:

We are encouraged by these interim results, which are in line with our hypotheses, support the continuation of the current Phase 2B study, and will be fundamental to speaking with the FDA about moving forward into the Phase 3 trial later this year. We are excited that we are on track to possibly providing rheumatologists and those suffering with RA a noninvasive, quantifiable, early indicator of whether or not an anti-TNF alpha treatment is working. This could bring enormous benefit to these patients by assisting physicians in putting them on the right course of treatment earlier than would otherwise be possible today.

Shares were last seen up 100% at $2.54, in a 52-week range of $0.49 to $3.50. The consensus price target is $3.50.