Why Navidea Biopharmaceuticals Inc. Shares Jumped

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What: Shares of Navidea Biopharmaceuticals (NYSEMKT: NAVB  ) , a developer of diagnostics and radiopharmaceutical agents for the medical industry, jumped as much as 11% after announcing the results of a post-hoc analysis of its phase 3 clinical study of Lymphoseek in patients with head and neck cancer.

So what: According to the company's press release: "In the NEO3-06 Phase 3 study, Lymphoseek localization to lymph nodes showed a strong correlation with a full regional lymph node dissection and pathology analysis with a low false negative rate, a priority in identifying sentinel nodes. Lymphoseek was also observed to home preferentially to pathology-positive nodes at a higher rate than pathology-negative nodes." In other words, Lymphoseek was shown to be quite effective in identifying tumor-positive lymph nodes in early stages of clinical head and neck cancer, which is not only important for mapping which lymph nodes could be cancer active, but also in reducing exploratory surgery for patients with early-stage disease, and in maintaining as much lymphatic tissue as possible to help fight disease.

Now what: Sales of Lymphoseek have thus far been disappointing, to say the least. I've been quite bullish on Navidea's long-term outlook given that the need for cancer diagnostics, and a more personalized approach to cancer treatment, should only increase in the coming decade. However, Navidea's lack of a big partner may come back to haunt the company's ability to rapidly grow Lymphoseek. While still on my watchlist, I wouldn't be surprised, with profitability still a ways off, if Navidea's management team didn't try to maximize shareholder value by putting itself up on the auction block. Keep in mind this is pure speculation on my part; but with losses expected for many years down the road, this might be Navidea's best move for shareholders, and for its leading radiopharmaceutical agent.

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  • Report this Comment On June 11, 2014, at 5:10 PM, NoonanGf wrote:

    Sean William's article on NAVB is incredibly poor and adolescent. No mention of highly significant ramp up of Lymphoseek sales month after month and quarter after quarter; no mention of superbly statistically significant findings in Lymphoseek particular with ZERO false readings for Head and Neck the day after injection; no mentioned of new management and its commitment to NOT do dilutive financing in the 12-18 months going forward (*minimally); no mentioned of pending EMA (European Medical Association) deliberations; no mentioned of FDA PUDFA date this coming Monday, June 16; no mentioned of another FDA pending decision in October.

    I'd be ashamed to call myself an analysts and have written that article which I judge adolescent at best, and in the lower grades of high school at that.

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