Mon, Feb. 9, 8:07 AM
- On a preliminary basis, Navidea Biopharmaceuticals (NYSEMKT:NAVB) generated $6.3M in total revenue in 2014, including $4.2M for Lymphoseek (technetium Tc 99m tilmanocept). For Q4, the results were $2.2M and $1.5M, respectively. Gross profit was $4.7M and $1.9M, respectively.
- Approximately 22K procedures using Lymphoseek were performed last year. Reorder rate was >80%. The number of customers was greater than 500 as of the end of December.
- CEO Rick Gonzalez will be discussing the company's plans and activities this morning at 10:00 am ET at the 17th Annual BIO CEO & Investor Conference in New York City. Interested parties can access it via a live webcast or archived version on the company's website two hours following.
Mon, Feb. 2, 4:06 PM
Wed, Jan. 21, 8:11 AM
- Navidea Biopharmaceuticals (NYSEMKT:NAVB) enters into a non-binding term sheet for an initial round of financing for its subsidiary, Macrophage Therapeutics. Navidea director and newly-named Macrophage Therapeutics CEO Michael Goldberg, M.D, leads the group of investors providing $2.5M for a 0.5% stake (implied enterprise value = $500M).
- Proceeds will fund pipeline development based on Navidea's Manocept technology, working capital and the recruitment of a scientific advisory board.
Mon, Jan. 5, 8:49 AM
- Navidea Biopharmaceuticals (NYSEMKT:NAVB) appoints Thomas J. Klima as SVP and Chief Commercial Officer. Previously, he was Head of Sales for Algeta and Senior Director of Marketing for Dendreon.
- The company also appoints Michael Tomblyn, M.D., M.S. as Executive Medical Director. Previously, he was Senior Medical Director at Algeta.
Nov. 20, 2014, 8:29 AM
- The European Commission clears Navidea Biopharmaceuticals' (NYSEMKT:NAVB) Lymphoseek (technetium Tc 99m tilmanocept) 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 company plans to launch the product in certain major markets in 2015.
Nov. 11, 2014, 7:55 AM
- The FDA refunds Navidea Biopharmaceuticals' (NYSEMKT:NAVB) $1.1M PDUFA filing fee for Lymphoseek (technetium Tc 99m tilmanocept) pursuant to its granting of Orphan Drug status for its use in sentinel lymph node detection in patients with head and neck cancer.
- Separately, the company's major investor, Platinum Partners, reaffirmed its $31.8M line of credit.
Nov. 10, 2014, 12:59 PM
Nov. 6, 2014, 7:34 AM
Nov. 5, 2014, 5:30 PM
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Oct. 15, 2014, 9:18 AM
Oct. 15, 2014, 7:30 AM
- The FDA approves Navidea Biopharmaceuticals' (NYSEMKT:NAVB) Lymphoseek (technetium Tc 99m tilmanocept) sNDA for its expanded use in mapping solid tumors and adding Sentinel Lymph Node detection for breast cancer and melanoma to its approved indications.
- Lymphoseek is now approved for lymphatic mapping using a handheld gamma counter 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 guiding Sentinel Lymph Node Biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
- The FDA also allowed the expanded utilization of Lymphoseek with or without scintigraphic imaging (lymphoscintigraphy) to enable preoperative imaging and mapping of lymph nodes to facilitate node localization during surgical procedures.
- Lymphoseek is the only FDA-approved agent for lymphatic mapping across solid tumors when used as a component of surgical management.
- NAVB is up 2% premarket on 5,500 shares.
Oct. 8, 2014, 11:16 AM
- October 16 is the PDUFA date for the FDA's review of Navidea Biopharmaceuticals' (NAVB) sNDA for an expanded label for Lymphoseek (technetium 99m tilmanocept) Injection. The applied-for label supports broader and more flexible use in imaging and lymphatic mapping procedures, including lymphoscintigraphy imaging and flexible timing of Lymphoseek administration allowing for a two-day protocol.
Sep. 26, 2014, 10:00 AM
- The EMA's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting marketing approval for Navidea Biopharmaceuticals' (NAVB +5.6%) Lymphoseek 250 mcg kit for radiopharmaceutical preparation (tilmanocept). The recommended indication is for use in imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma or head and neck oral cavity squamous cell carcinoma.
- A final decision by the European Commission generally takes ~60 days.
- The FDA approved a label expansion for Lymphoseek in June to include squamous cell carcinoma in the head and neck region.
Sep. 26, 2014, 9:14 AM
Sep. 23, 2014, 8:18 AM
- The National Cancer Institute awards a Fast Track Small Business Innovation Research grant of up to $1.67M to Navidea Biopharmaceuticals (NYSEMKT:NAVB) to fund the evaluation of Lymphoseek (technetium Tc 99m tilmanocept) Injection in women with cervical cancer.
- The grant will be awarded in two parts over a 2.5-year span. The first tranche of $165,917 has already been awarded. It will fund the company's activities in identifying and qualifying clinical trial sites and securing the requisite contracts and IRB approvals. The remaining $1.5M will fund the actual trial and data analysis.
- The study is expected to involve 40 patients and last 1.5 years.
Sep. 19, 2014, 9:24 AM
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