Welcome to our dedicated page for Navidea Biopharm news (Ticker: NAVB), a resource for investors and traders seeking the latest updates and insights on Navidea Biopharm stock.
Navidea Biopharmaceuticals, Inc. (NAVB) is a biopharmaceutical company that describes its focus as the development of precision immunodiagnostic agents and immunotherapeutics built on its proprietary Manocept platform. Company news frequently highlights developments related to this platform, including clinical research involving Tc99m tilmanocept, which Navidea identifies as the first product developed and commercialized from Manocept.
News releases from Navidea cover a range of topics that are relevant to investors, creditors, and other stakeholders. These include updates on clinical programs, such as exploratory analyses in rheumatoid arthritis trials using Tc99m tilmanocept imaging, as well as shifts in focus toward therapeutic assets. Corporate strategy communications often reference the company’s Fix, Fund, Propel framework, which Navidea links to operational changes, financing activities, and efforts to advance its technology toward potential market applications.
Navidea’s news flow also includes significant corporate and capital structure events. Examples disclosed by the company include the NYSE American’s decision to suspend trading and initiate delisting proceedings for its common stock, the transition to trading on over-the-counter markets, the adoption and extension of a Section 382 Rights Plan aimed at protecting tax attributes, and the filing of Form 15 to deregister its securities and suspend SEC reporting obligations.
More recently, Navidea announced that it filed a voluntary petition for relief under Chapter 11, Subchapter V of the U.S. Bankruptcy Code, stating that the process is intended to support an orderly restructuring of its financial obligations while continuing limited operations. Visitors to this news page can review these types of announcements to understand how Navidea describes its business focus, technology platform, strategic framework, and material corporate events over time.
Navidea Biopharmaceuticals (NYSE American: NAVB) is preparing a conference call on November 10, 2021 at 5:00 p.m. EST to discuss third-quarter financial results and corporate developments. Dr. Michael Rosol and Erika Eves will present updates and engage with submitted questions. The call will not accommodate live inquiries but allows pre-submitted questions. Navidea focuses on developing precision immunodiagnostic agents and immunotherapeutics, leveraging its Manocept platform for enhanced diagnostic accuracy and treatment.
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.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) has appointed Michel Mikhail, Ph.D., as Chief Regulatory Officer effective October 1, 2021. Dr. Mikhail brings over 30 years of experience in regulatory affairs from his roles at various multinational pharmaceutical companies. His expertise includes navigating drug development through regulatory processes. Navidea's Chief Executive Officer, Jed Latkin, expressed enthusiasm about Dr. Mikhail's leadership to advance their Manocept platform for improved patient care. The company is focused on developing precision diagnostic agents.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) announced changes in its Board of Directors. On September 14, 2021, Dr. S. Kathryn Rouan retired as Chair, with Claudine Bruck also stepping down as a director. Alexander L. Cappello was appointed as the new Chair, while John K. Scott became Vice Chair. Additionally, Cappello joined the Audit Committee, enhancing its leadership role. CEO Jed Latkin expressed gratitude to the retiring directors for their contributions, highlighting a combined 60 years of experience in the clinical field.
Navidea Biopharmaceuticals (NAVB) reported Q2 2021 net revenues of $261,000, a decline from $271,000 in Q2 2020. Year-to-date revenues also fell to $385,000 from $427,000. The company’s R&D expenses increased to $1.5 million in Q2 2021, compared to $1.3 million in Q2 2020. Net loss for Q2 2021 was $2.7 million or $0.09 per share, versus $2.4 million or $0.11 per share in the same quarter last year. Navidea is preparing for a crucial FDA meeting on September 1, 2021, and has strengthened its board with three new appointments.
Navidea Biopharmaceuticals (NYSE American: NAVB) will host a conference call on August 11, 2021, at 5:00 p.m. EDT to discuss Q2 2021 financial results and corporate developments. CEO Jed Latkin, CMO Dr. Michael Rosol, and VP Erika Eves will present the information and answer questions. The call can be accessed via conference dial-ins and a live webcast on Navidea's website. This session aims to provide updates on Navidea's precision immunodiagnostic agents and immunotherapeutics development, focusing on financial performance and clinical progress.
Navidea Biopharmaceuticals (NYSE American: NAVB) announced the enrollment of over 110 subjects in its NAV3-35 Phase 2b study aimed at creating a normative database for rheumatoid arthritis (RA) imaging using Tc99m tilmanocept. The trial's target is 135 participants, with a focus on differentiating RA-inflamed joints from healthy ones. The database will enhance automated image analysis for improved accuracy. Dr. Michael Rosol emphasized its critical role in future data analysis and commercialization, while CEO Jed Latkin noted the rapid enrollment reflects the company's commitment to advancing RA diagnostic products.
Navidea Biopharmaceuticals (NYSE American: NAVB) announced that the FDA has granted a meeting to discuss the advancement of its Rheumatoid Arthritis (RA) program to a pivotal Phase 3 trial. Scheduled for September 1, 2021, the meeting will focus on results from the Phase 2b NAV3-31 study and the proposed Phase 3 trial protocol. Interim analyses indicated that Tc99m tilmanocept imaging could serve as an early indicator of treatment response in RA patients. This development could significantly benefit over 1.3 million RA patients in the U.S. by providing a noninvasive method for monitoring treatment efficacy.
Navidea Biopharmaceuticals (NYSE American: NAVB) announced a court ruling on June 23, 2021, in favor of its subsidiary Macrophage Therapeutics against former CEO Dr. Michael Goldberg. The Delaware Court found that Dr. Goldberg breached his fiduciary duties to MT by attempting to misappropriate intellectual property. Although the Court awarded nominal damages, it rejected MT's claims for conversion and denied Goldberg's motions to hold MT's directors in contempt or dismiss the lawsuit. This ruling reinforces MT's legal standing and addresses past governance issues.
Navidea Biopharmaceuticals announced the issuance of U.S. patent 11,007,272, protecting its mannosylated dextran-based drug delivery vehicles for treating viral infections, effective until October 7, 2037. The patent targets flaviviruses, including those causing dengue, yellow fever, and Zika, which together affect an estimated 100-400 million individuals annually. This innovation aims to address significant medical needs and may extend to other diseases, such as HIV and hepatitis C.