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NAVIDEA BIOPHARMACEUTICALS, INC. (symbol: NAVB) is a prominent biopharmaceutical company focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutics. The company operates through two main segments: Diagnostic Substances and Therapeutic Development Programs.
At the heart of Navidea's innovation is the Manocept Platform, designed to target the CD206 mannose receptor expressed on activated macrophages. This platform has broad applications across various diagnostic modalities, including Single Photon Emission Computed Tomography (SPECT), Positron Emission Tomography (PET), imaging, and topical gamma-scanning. Additionally, it facilitates intra-operative and/or optical-fluorescence detection, and the delivery of therapeutic compounds targeting macrophages and diseases involving immune and inflammation responses.
Navidea's product portfolio features NAV4694, a fluorine-18 labeled PET imaging agent used for imaging and evaluating patients exhibiting signs of Alzheimer's disease and mild cognitive impairment. This product underscores the company's commitment to addressing urgent medical needs through advanced diagnostics.
In terms of current projects and partnerships, Navidea continues to build strategic alliances to enhance its product offerings and broaden its market reach. Financially, the company remains focused on strategic investments and operational efficiencies to bolster its position in the biopharmaceutical sector.
Navidea Biopharmaceuticals (NYSE American: NAVB) has signed a Sponsored Research Agreement with the University of Pennsylvania to explore Tc99m tilmanocept imaging in glioblastoma. This imaging aims to evaluate tumor growth rates and overall survival, targeting M2-type Tumor Associated Macrophages (TAMs). The project, led by Dr. Ali Nabavizadeh, seeks to correlate imaging results with therapeutic responses. Navidea emphasizes the potential of its tilmanocept platform to improve cancer treatment outcomes.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) has settled ongoing litigation with Platinum-Montaur Life Sciences LLC, resolving claims for approximately $1.9 million. This settlement ends the litigation while allowing Navidea to continue trading on NYSE American, despite receiving a compliance letter on January 28, 2022, regarding listing standards violations. Navidea must submit a compliance plan by February 27, 2022, to avoid delisting risks by July 28, 2023. The company's stock will trade under the designation '.BC' due to this non-compliance status.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) has launched the NAV3-33 Phase 3 clinical trial to evaluate the efficacy of Tc99m tilmanocept imaging in predicting treatment response in patients with moderate to severe rheumatoid arthritis (RA) switching to anti-TNFα therapy. This trial aims to reduce the lengthy trial-and-error process of treatment selection, providing an early, objective assessment of treatment efficacy by measuring macrophage density changes in joints. Results from a previous Phase 2b trial support the hypothesis that this imaging can facilitate timely adjustments in patient treatment.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) has completed full enrollment in the NAV3-35 Phase 2b clinical study focused on establishing a normative database for rheumatoid arthritis (RA) imaging with Tc99m tilmanocept. The study will help in quantifying RA-related inflammation by comparing healthy subjects' joint images to those of RA patients. The trial includes 120 healthy volunteers in Arm 1 and aims to enhance the accuracy of RA treatment predictions. This crucial step supports the development of advanced imaging tools and prepares for an upcoming Phase 3 trial.
Navidea Biopharmaceuticals (NYSE American: NAVB) has terminated its Stock Purchase Agreement initially executed on
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) has announced a third-party asset valuation of its Rheumatoid Arthritis diagnostic product candidate, Tc99m tilmanocept. Conducted by LifeSci Partners, the valuation suggests potential peak U.S. sales of $1 billion annually, with an upside scenario reaching $1.8 billion. The product aims to evaluate treatment efficacy of anti-TNFα therapy in RA. A Phase 3 trial is planned to assess its ability as an early treatment response predictor. The company emphasizes its commitment to addressing unmet medical needs in RA patients.
Navidea Biopharmaceuticals (NYSE American: NAVB) announced a conference call for
Navidea Biopharmaceuticals (NAVB) announced its Q3 2021 financial results, reporting total net revenues of $96,000, down from $268,000 in Q3 2020. For the first nine months, revenues were $481,000, compared to $695,000 in the same period last year. The net loss for Q3 was $2.4 million, or $0.08 per share, a decrease from $3.3 million, or $0.13 per share, in Q3 2020. The company is advancing its clinical programs in Rheumatoid Arthritis and ended Q3 with $7.2 million in cash. A conference call is scheduled for November 10, 2021 at 5:00 PM EST to provide further updates.
Navidea Biopharmaceuticals (NYSE American: NAVB) is preparing a conference call on
Navidea Biopharmaceuticals has announced the resignation of Jed A. Latkin as CEO, CFO, COO, and Board member, effective October 24, 2021. The company is currently forming an Office of the CEO with three Board members, including the Chairman, to lead operations during the interim period while seeking a new CEO with an executive search firm.
This leadership change may impact the direction and strategy of the company, which is focused on developing precision immunodiagnostic agents. Details of Latkin's severance agreement are under discussion.
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