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
Sep. 18, 2014, 5:16 PM
- The FDA designates Navidea Biopharmaceuticals' (NAVB +14%) Lymphoseek (technetium Tc 99m tilmanocept) an Orphan Drug for use in sentinel lymph node detection in patients with cancer of the head and neck.
- Orphan Drug status provides for a seven-year period of exclusivity, SPA assistance, tax credits and qualifies the company to request a refund of previously-paid filing fees up to $1.1M.
Sep. 4, 2014, 8:36 AM
- Navidea Biopharmaceuticals (NYSEMKT:NAVB) enters into an exclusive agreement with a wholly-owned subsidiary of Hainan Sinotau Pharmaceutical Co., Ltd., to develop and commercialize Lymphoseek (technetium Tc 99m tilmanocept) Injection in China.
- Under the terms of the agreement, Navidea will earn royalties on units sales, an upfront payment of $300K, up to $700K in development milestone payments and up to $1.5M in sales-related milestones.
- Sinotau is responsible for funding and conducting clinical studies and regulatory submissions to the China Food and Drug Administration. It will be responsible for all sales and marketing activities post approval in China exclusive of Hong Kong, Macau and Taiwan.
Aug. 11, 2014, 8:19 PM
Aug. 6, 2014, 9:30 AM
- Navidea Biopharmaceuticals (NYSEMKT:NAVB) Q2 results: Total Revenues: $1.1M (+450.3%); Gross Profit: $804.2K (+795.5%); Operating Expenses: $10.0M (+17.6%); Operating Loss: ($9.2M) (-9.0%); Net Loss: ($10.2M) (+1.0%); Loss Per Share: ($0.07) (+22.2%); Quick Assets: $17.5M (-46.8%).
- No guidance given.
Aug. 6, 2014, 7:33 AM
Aug. 5, 2014, 5:30 PM
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Jul. 16, 2014, 4:38 PM
- Navidea Biopharmaceuticals (NAVB) teams up with Rheumco LLC in a joint venture to develop and commercialize radiolabeled diagnostics and therapeutics for rheumatologic and arthritic diseases. The joint enterprise, named R-NAV LLC, will combine Navidea's Manocept CD206 macrophage targeting platform and Rheumco's Tin-117m radioscope technology to address high unmet needs in 1) the detection of rheumatoid arthritis (RA), 2) the treatment of RA, 3) the detection and treatment of human and veterinary osteoarthritis (OA) and 4) the treatment of pediatric hemophilic arthropathy, a rare rheumatologic condition. Each area is a separate subsidiary of R-NAV.
- R-NAV LLC will be funded initially with a $4M investment from Infinity Capital III, a fund of Houston-based McRay Money Management. Navidea has committed an additional $1M to be paid in equal installments over three years.
- Navidea has a three-year call option to acquire all of the equity in subsidiary 1 (bullet #1) prior to the launch of a Phase 3 clinical trial and all the equity in subsidiary 2 (bullet #2) upon the completion of radiochemistry and biodistribution studies for its development program. It also has a 30% equity position in R-NAV and each subsidiary on a fully converted basis.
Jun. 13, 2014, 10:48 AM
- The FDA approves the use of Navidea Biopharmaceuticals' (NAVB -7.4%) radioactive imaging agent Lymphoseek for use in sentinel lymph node biopsies. Sentinel lymph nodes are those closest to a primary tumor for cancer. This new indication allows for more limited lymph node surgery in patients with sentinel nodes negative for cancer.
- Last year, the regulator cleared the product as an aide in the identification of lymph nodes closest to a primary tumor in patients with breast cancer or melanoma.
Jun. 2, 2014, 7:04 PM
- As disclosed on May 19, Navidea Biopharmaceuticals (NAVB +5.7%) terminates the contract of CEO Mark J. Pykett, V.M.D, Ph.D. effective May 30 as he transitions to a consulting role. Board member Michael M. Goldberg, M.D. takes over on an interim basis for no additional compensation.
- Under the terms of the separation agreement, Dr. Pykett receives a severance payment of $750,000 payable in two equal installments on June 9, 2014 and January 2, 2015 plus $32,277.44 for accrued vacation, 100% expense reimbursement, $10,000 for the legal expenses in drawing up the contract, continuation of all options rights and 300,000 shares of stock that will fully vest by December 1, 2014. In addition, he and his family will continue to participate in the company health benefit plan for executives for the duration of his consulting contract (June 1 - December 31, 2014) and 18 months thereafter. For his services, the company pays him 40,000 shares of restricted stock, half of which are milestone-dependent.
May. 19, 2014, 7:29 AM
- Navidea Biopharmaceuticals (NAVB) appoints Michael Goldberg, M.D. interim CEO replacing Dr. Mark Pykett who will step down to head up Manocept technology development. A search for a permanent CEO with global sales experience is underway.
- The firm is working to establish new sources of non-dilutive funding such as collaborations as it cuts spending to a level that can be offset by Lymphoseek revenue.
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