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News Breaks
May 15, 2014
16:37 EDTNAVBNavidea refocuses resources to align funding of pipeline, names interim CEO
The Board of Directors of Navidea Biopharmaceuticals announced that it is refocusing the company's resources to better align the funding of the pipeline programs with the expected growth in Lymphoseek revenue. To facilitate the refocusing effort, the Board has asked Michael Goldberg, M.D. to serve as interim CEO while a search for a new CEO is conducted. The Navidea Board believes that the market is not currently giving appropriate value to its Phase III pipeline products and is likely penalizing the company for allocating resources to these exciting programs. The company is also working to establish new sources of non-dilutive funding, including collaborations that can augment the balance sheet as the company works to reduce spending to levels that can be more closely offset by growing Lymphoseek revenue. In particular, substantial progress on the Manocept platform has resulted in some very exciting partnering opportunities that will further expand the company's pipeline while requiring much less funding than the two ongoing Phase III programs. Dr. Mark Pykett has agreed to step down from the CEO position, effective on or about May 31, to work full time on maximizing the potential of the Manocept program. Dr. Pykett will also continue to serve as a Director of Navidea until the 2014 Annual Meeting. Navidea remains committed to expanding the Lymphoseek label and realizing the full potential of the product. It intends to work closely with its partners to continue the strong growth of this important product. The company believes that the resources being devoted to drive Lymphoseek sales will eventually provide returns to the point where developmental stage programs can be substantially funded from cash flow from operations. The company is focused on expanding the market for Lymphoseek in all relevant markets. To this end, the Compensation, Nominating and Governance Committee of the Board of Directors has initiated a search for a CEO who will bring experience in global product sales, especially related to expanding the market for commercial products.
News For NAVB From The Last 14 Days
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November 20, 2014
07:31 EDTNAVBNavidea granted marketing authorization for Lymphoseek by European Commission
Navidea Biopharmaceuticals has announced that the European Commission has granted marketing authorization for Lymphoseek 250 micrograms kit for radiopharmaceutical preparation. Lymphoseek is now approved in the European Union for use in imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity. The sentinel node detection label in Europe may now allow Lymphoseek to be used in approximately 367,000, 83,000 and 55,000 new cases of breast cancer, melanoma and oral cavity cancers diagnosed in Europe annually, respectively. Lymphoseek is approved in the U.S. for use in lymphatic mapping to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management and for guiding Sentinel Lymph Node Biopsy using a handheld gamma counter in patients with node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
November 11, 2014
07:31 EDTNAVBNavidea receives $1.1M PDUFA filing free refund for award of orphan drug status
Navidea Biopharmaceuticals announced it has received a $1.1M refund of the previously paid Prescription Drug User Fee Act filing fee related to the granting of orphan drug status of Lymphoseek injection in head and neck cancers. Lymphoseek was granted Orphan Drug Designation by the FDA in September 2014 for use in sentinel lymph node detection in patients with cancer of the head and neck. Additionally, Platinum Partners, Navidea’s major investor, reaffirmed its support of the company through the remaining $31.8M available under the previously announced line of credit. “We believe we have sufficient capital resources to attain our immediate goals and realize the full commercial potential for Lymphoseek,” said Rick Gonzalez, Navidea CEO. “We are in a position to manage our available cash with our expected growth in revenue and gross profit, our ability to further reduce our operating costs and, if needed, our access to capital under the line of credit from Platinum Partners.”

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