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Navidea up 57% on positive Tc 99m Tilmanocept data

  • Thinly traded nano cap Navidea Biopharmaceuticals (NYSE:NAVB +56.9%) is up on a whopping 207x surge in volume in reaction to the results from the first interim analysis of an open-label Phase 2b clinical trial, NAV3-31, evaluating the use of Tc 99m Tilmanocept imaging in patients with active rheumatoid arthritis (RA).
  • Whole body and hand/wrist image sets acquired on the same day at multiple time points showed quantitative repeatability and stability of signal. Images taken a week apart from patients with active RA showed the same localization patterns. There was "notable agreement"  between qualitative and quantitative assessments of joint-specific localization across all time points.
  • The company says the trial data will provide the necessary input to establish quantitative "cut points" to differentiate between joints with and without inflammation seen in RA, potentially enabling the establishment of metrics to measure the change in disease status (way to determine if a prescribed therapy is working).
  • Management will host a conference call today at 5:00 pm ET to discuss the results.
  • The FDA approved the diagnostic agent, branded as Lymphoseek, in March 2013 as an aid in locating lymph nodes in breast cancer or melanoma patients who are undergoing surgery to remove tumor-draining lymph nodes.

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Navidea Biopharmaceuticals, Inc.