Navidea Biopharmaceuticals (NAVB +0.3%) says researchers from Montreal Neurological Institute have found that the company's NAV4694 beta-amyloid imaging agent performed better than the gold-standard agent (PiB) in identifying amyloid deposits in a post-mortem examination of brains. Amyloid deposits have been linked to Alzheimer's disease. NAV4694, which is in Phase IIb and III trials, may enable earlier identification of AD and improve the monitoring of the disease. (PR)
Navidea Biopharmaceuticals (NAVB +2.3%) is set to close higher after announcing that the Australian Imaging, Biomarker & Lifestyle Flagship Study of Ageing intends to switch to using NAVB's Fluorine-18 labeled amyloid imaging candidate, NAV4694, for its research initiative on Alzheimer's disease and mild cognitive impairment.
Navidea Biopharmaceuticals (NAVB +4.7%) trades up today after reporting results of its 2013 Annual Meeting of Stockholders held earlier today. NAVB made a series of presentations to shareholders highlighting Lymphoseek's U.S commercialization and indication expansion development activities, selection of a specialty pharma partner for its commercialization in Europe, and initiation of a pivotal NAV4694 Phase 3 registration study.
Navidea Biopharmaceuticals (NAVB) enrolls the first subject in a Phase III trial for its NAV4694 imaging agent, which is designed to identify whether patients have Alzheimer's disease, which can only be confirmed during autopsy. Yesterday, Navidea secured tens of millions of dollars in financing. (PR)
Navidea Biopharmaceuticals (NAVB) closes a $25M debt financing led by GE Capital (GE) and it boosts its credit facility with Platinum-Montaur Life Sciences to over $53M from $8M. Montaur also forgives $4.8M of $8M debt that Navidea had taken out in return for exercising warrants for 7.7M series B shares. (PR)
Navidea Biopharmaceuticals' (NAVB +3%) announces "positive results" from a meta-analysis study of two Phase III trials that compared its Lymphoseek radiopharmaceutical injection with a commonly used agent. Lymphoseek "demonstrated reliable detection of lymph nodes" in patients with breast cancer and melanoma over a period of 15 minutes up to 30 hours, a time range that may be encountered in a clinic. (PR)
Navidea Biopharmaceuticals (NAVB) says it's entered into an agreement with Nordion (NDZ -1%) to produce and supply its (123) labeled I-drug NAV5001 for late-phase clinical trials. NDZ will manufacture and supply of NAV5001 clinical trial material by radiolabeling NAVB's precursor drug product with Iodine-123 to form (123)I NAV5001, and then manage the logistics and shipping arrangements to third-party clinical trial sites. The agreement could be a precursor to a commercial supply arrangement in the future.
Navidea Biopharmaceuticals (NAVB -1.5%) says results from a clinical trial of NAV4694 in healthy subjects and those with diagnosed forms of dementia demonstrated imaging characteristics nearly identical to those of an acknowledged benchmark, gold-standard amyloid imaging agent, 11C-labeled Pittsburgh Compound-B. The authors believe these results show that NAV4694 may be useful in the early and differential diagnosis of Alzheimer’s disease.