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
- ANR, AOL, APO, ARIA, AVA, AVT, BRKR, CEQP, CHK, CLH, CMLS, CNP, CONE, CSTE, CTSH, DBD, DISH, DNR, DVN, DWSN, EE, ELOS, GEO, GOV, GWPH, HFC, HNT, INXN, IPXL, ITC, KELYA, LINC, LIOX, MDLZ, MEMP, MVIS, NAVB, NUS, PERI, PH, PKD, POWR, RDC, RL, ROC, SBGI, SE, SEP, SF, SJI, SKYW, STWD, TAP, THI, TRGT, TWX, VC, VIAB, VITC, VOYA, WD, WIX, WPX, ZINC
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.
May 7, 2014, 8:11 AM
May 7, 2014, 7:36 AM
May 6, 2014, 5:30 PM
- AGN, ALE, AOL, ARIA, ARQL, ATRO, AVA, AYR, BAM, BUD, CHK, CLH, COT, CTSH, DUK, DVN, DWSN, DX, EE, ENB, END, FWLT, GTIV, GWPH, HNT, HTZ, HUM, INXN, KELYA, KING, LAMR, LGND, LINC, LMIA, MDLZ, MEMP, MZOR, NAVB, NJR, NTLS, NVDQ, POM, PRGO, QRE, RIGL, ROC, SBGI, SE, SEP, SFUN, SNSS, SPAR, SPB, STRA, SUSP, SUSS, TAP, THI, TLM, TMHC, TPC, TRGT, USAC, VOYA, VSI, WBAI, WPX, WRES, XEC.
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