Navidea Biopharmaceuticals, Inc. (NAVB)
For informational purposes only. Not financial advice. Analysis by Sedat Aydin, Founder & Editor-in-Chief | AI-powered analysis. Data sourced from SEC filings and institutional-grade financial providers. Editorially reviewed. Not financial advice.
Navidea Biopharmaceuticals, Inc. (NAVB) with AI Score 43/100 (Weak). Navidea Biopharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing precision immunodiagnostic agents and immunotherapeutics. Market cap: 0, Sector: Healthcare.
Last analyzed: Mar 17, 2026Navidea Biopharmaceuticals, Inc. (NAVB) Healthcare & Pipeline Overview
Navidea Biopharmaceuticals, Inc. develops immunodiagnostic agents and immunotherapeutics, leveraging its Manocept platform to target the CD206 mannose receptor. The company's focus on macrophage-targeted therapies positions it within the competitive biotechnology sector, addressing unmet needs in inflammatory and immune-related diseases. Currently traded on the OTC market, NAVB is developing diagnostic and therapeutic products.
Investment Thesis
Navidea Biopharmaceuticals, Inc. presents a high-risk, high-reward investment opportunity within the biotechnology sector. The company's Manocept platform, targeting the CD206 mannose receptor, offers potential for both diagnostic and therapeutic applications in immune-mediated diseases. Key value drivers include the successful advancement of its clinical pipeline, particularly NAV3-33 in Phase III trials for rheumatoid arthritis. However, the company's negative profit margin of -23117.6% and gross margin of -259.4% highlight significant financial challenges. Successful commercialization of its pipeline assets and strategic partnerships are crucial for long-term sustainability. Upcoming data readouts from clinical trials represent potential catalysts, while the company's reliance on external funding and the inherent risks associated with drug development pose significant risks. The company's current market capitalization of $0.00B reflects the speculative nature of this investment.
Based on FMP financials and quantitative analysis
Key Highlights
- Navidea Biopharmaceuticals operates in the Diagnostic Substances and Therapeutic Development Programs segments.
- The company's core technology is the Manocept platform targeting the CD206 mannose receptor.
- NAV3-31 has completed Phase IIb clinical trials for rheumatoid arthritis imaging.
- NAV3-33 is currently in Phase III clinical trials for rheumatoid arthritis.
- The company's profit margin is -23117.6% and gross margin is -259.4%.
Competitors & Peers
Strengths
- Proprietary Manocept platform.
- Pipeline of diagnostic and therapeutic candidates.
- Focus on macrophage-targeted therapies.
- Completed Phase IIb and ongoing Phase III clinical trials.
Weaknesses
- Negative profit and gross margins.
- Reliance on external funding.
- Limited commercial infrastructure.
- OTC market listing.
Catalysts
- Upcoming: Data readout from Phase III clinical trial of NAV3-33 for rheumatoid arthritis.
- Upcoming: Potential strategic partnerships for therapeutic development.
- Ongoing: Expansion of Manocept platform applications to other immune-mediated diseases.
- Ongoing: Development of companion diagnostics to enhance therapeutic programs.
- Ongoing: Potential out-licensing or sale of assets to generate revenue.
Risks
- Potential: Clinical trial failures for pipeline candidates.
- Potential: Regulatory hurdles in obtaining approval for new products.
- Ongoing: Competition from established pharmaceutical companies.
- Potential: Patent expirations impacting revenue streams.
- Ongoing: Reliance on external funding to support operations.
Growth Opportunities
- Advancement of NAV3-33 into late-stage development: The successful completion of the Phase III clinical trial for NAV3-33 in rheumatoid arthritis represents a significant growth opportunity for Navidea. Positive results could lead to regulatory approval and commercialization, addressing a substantial market need in RA diagnostics. The timeline for potential market entry is estimated within the next 2-3 years, pending trial outcomes and regulatory reviews. This could establish Navidea as a key player in RA imaging.
- Expansion of Manocept platform applications: Navidea's Manocept platform has the potential to be expanded beyond rheumatoid arthritis to other immune-mediated diseases. Exploring applications in cardiovascular disease, Kaposi's sarcoma, and tuberculosis could unlock new revenue streams and diversify the company's product pipeline. This expansion strategy could be pursued over the next 3-5 years, contingent on research and development efforts and strategic collaborations.
- Strategic partnerships for therapeutic development: Collaborating with larger pharmaceutical companies or research institutions can accelerate the development and commercialization of Navidea's therapeutic programs. Partnerships can provide access to funding, expertise, and distribution networks, enhancing the company's ability to bring novel therapies to market. These partnerships could be established within the next 1-2 years, depending on the progress of clinical trials and business development initiatives.
- Development of companion diagnostics: The development of companion diagnostics to identify patients who are most likely to respond to specific therapies represents a growth opportunity for Navidea. By developing diagnostic tools that can predict treatment response, Navidea can enhance the value of its therapeutic programs and improve patient outcomes. This strategy aligns with the growing trend towards personalized medicine and could be implemented over the next 2-4 years.
- Out-licensing or sale of assets: Navidea could explore the out-licensing or sale of specific assets within its pipeline to generate near-term revenue and focus its resources on core programs. This strategy can provide non-dilutive funding and allow the company to streamline its operations. The timeline for potential out-licensing or sale transactions is variable, depending on market conditions and the attractiveness of individual assets.
Opportunities
- Expansion of Manocept platform applications.
- Strategic partnerships for therapeutic development.
- Development of companion diagnostics.
- Out-licensing or sale of assets.
Threats
- Clinical trial failures.
- Regulatory hurdles.
- Competition from established pharmaceutical companies.
- Patent expirations.
Competitive Advantages
- Proprietary Manocept platform targeting the CD206 mannose receptor.
- Patent protection for its diagnostic and therapeutic agents.
- Clinical data supporting the efficacy of its products.
- Expertise in immunodiagnostics and immunotherapeutics.
About NAVB
Navidea Biopharmaceuticals, Inc., established in 1983 and headquartered in Dublin, Ohio, is a biopharmaceutical company dedicated to the development and commercialization of precision immunodiagnostic agents and immunotherapeutics. Originally incorporated as Neoprobe Corporation, the company rebranded to Navidea Biopharmaceuticals, Inc. in January 2012, signaling a strategic shift towards its current focus. The company operates through two segments: Diagnostic Substances and Therapeutic Development Programs. Navidea's core technology is the Manocept platform, which targets the CD206 mannose receptor expressed on activated macrophages. This platform is designed to enable a range of diagnostic modalities, including single photon emission computed tomography (SPECT), positron emission tomography (PET), gamma-scanning, and intra-operative and/or optical-fluorescence detection. Furthermore, the Manocept platform facilitates the delivery of therapeutic compounds that target macrophages, addressing diseases involving immune and inflammatory responses. Navidea's pipeline includes NAV3-31, which has completed Phase IIb clinical trials for evaluating imaging repeatability, reproducibility, and stability, as well as the capacity of Tc99m tilmanocept imaging for treatment of anti-tumor necrosis factor alpha therapy in patients with moderate to severe rheumatoid arthritis (RA). Other assets in development include NAV3-35, currently in a Phase IIb clinical trial for RA imaging; NAV3-33, in a Phase III clinical trial for RA; and NAV3-32, in a Phase 2b trial for RA-involved joints. The company is also exploring the use of Tc99m tilmanocept for cardiovascular, Kaposi's sarcoma, tuberculosis, and other immunotherapeutic applications.
What They Do
- Develops precision immunodiagnostic agents.
- Develops immunotherapeutics.
- Focuses on the Manocept platform targeting the CD206 mannose receptor.
- Develops diagnostic modalities including SPECT and PET.
- Develops therapies targeting macrophages.
- Addresses immune- and inflammation-involved diseases.
- Conducts clinical trials for rheumatoid arthritis imaging.
Business Model
- Develops and patents diagnostic and therapeutic agents.
- Conducts clinical trials to validate the efficacy and safety of its products.
- Seeks regulatory approval for its products from agencies like the FDA.
- Commercializes approved products through partnerships or direct sales.
Industry Context
Navidea Biopharmaceuticals operates within the competitive biotechnology industry, characterized by high research and development costs, lengthy clinical trial processes, and stringent regulatory requirements. The market for immunodiagnostic agents and immunotherapeutics is driven by the increasing prevalence of immune-mediated diseases, such as rheumatoid arthritis, and the demand for personalized medicine. Companies like ACORQ, CRXM, GDBYF, GLSHQ, and GNBT represent Navidea's peers, each vying for market share in specialized therapeutic areas. Success in this industry hinges on innovation, clinical trial outcomes, and strategic partnerships.
Key Customers
- Hospitals and imaging centers using diagnostic agents.
- Pharmaceutical companies partnering for therapeutic development.
- Patients with immune-mediated diseases.
- Research institutions involved in clinical trials.
Financials
Chart & Info
Navidea Biopharmaceuticals, Inc. (NAVB) stock price: Price data unavailable
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Analyst Consensus
Consensus Rating
Aggregated Buy/Hold/Sell recommendations from Benzinga, Yahoo Finance, and Finnhub for NAVB.
Price Targets
Wall Street price target analysis for NAVB.
MoonshotScore
What does this score mean?
The MoonshotScore rates NAVB's growth potential on a scale of 0-100 across multiple factors including innovation, market disruption, financial health, and momentum.
Leadership: Craig A. Dais CPA
CEO
Craig A. Dais is the Chief Executive Officer of Navidea Biopharmaceuticals, Inc. He is a Certified Public Accountant (CPA) and brings financial expertise to the leadership role. Information about his detailed career history, education, and previous roles is not available in the provided data. As CEO, he is responsible for overseeing the company's strategic direction and operations.
Track Record: With limited information available, it is difficult to assess Craig A. Dais's specific achievements and strategic decisions at Navidea. His tenure and impact on company milestones cannot be determined from the provided data. His leadership is focused on guiding the company through its clinical development programs and navigating the challenges of the biotechnology industry.
NAVB OTC Market Information
The OTC Other tier represents the lowest tier of the OTC market, indicating that Navidea Biopharmaceuticals, Inc. may not meet the minimum financial standards or disclosure requirements for higher tiers like OTCQX or OTCQB. Companies in this tier often have limited trading volume and may be subject to less regulatory oversight compared to companies listed on major exchanges like the NYSE or NASDAQ. This tier typically involves higher risks for investors due to the potential for limited information and price volatility.
- OTC Tier: OTC Other
- Disclosure Status: Unknown
- Limited financial disclosure due to OTC listing.
- Low trading volume and liquidity.
- Potential for price manipulation.
- Higher risk of delisting or trading suspension.
- Limited regulatory oversight compared to major exchanges.
- Verify the company's financial statements and SEC filings (if any).
- Assess the company's management team and their experience.
- Evaluate the company's business model and competitive landscape.
- Review the company's legal and regulatory compliance.
- Analyze the company's capital structure and debt levels.
- Monitor news and press releases for any material developments.
- Consult with a financial advisor before investing.
- Focus on developing precision immunodiagnostic agents and immunotherapeutics.
- Development of Manocept platform targeting the CD206 mannose receptor.
- Pipeline of diagnostic and therapeutic candidates.
- Completed Phase IIb and ongoing Phase III clinical trials.
What Investors Ask About Navidea Biopharmaceuticals, Inc. (NAVB)
What does Navidea Biopharmaceuticals, Inc. do?
Navidea Biopharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing precision immunodiagnostic agents and immunotherapeutics. The company's core technology is the Manocept platform, which targets the CD206 mannose receptor expressed on activated macrophages. This platform is designed to enable a range of diagnostic modalities and facilitate the delivery of therapeutic compounds, addressing diseases involving immune and inflammatory responses. Their pipeline includes candidates in various stages of clinical trials for rheumatoid arthritis and other immunotherapeutic applications.
What do analysts say about NAVB stock?
AI analysis is currently pending for NAVB stock. Without analyst consensus, key valuation metrics, and growth considerations are unavailable. Investors should conduct their own thorough research and due diligence before making any investment decisions. The company's financial performance, clinical trial results, and regulatory milestones should be closely monitored to assess its potential for future growth and profitability. The OTC market listing and limited information availability add to the complexity of evaluating this stock.
What are the main risks for NAVB?
Navidea Biopharmaceuticals, Inc. faces several key risks, including the inherent uncertainties associated with clinical trial outcomes and regulatory approvals. The company's reliance on external funding and its current negative profit and gross margins pose significant financial challenges. Competition from larger, more established pharmaceutical companies also represents a threat. Additionally, the company's OTC market listing and limited financial disclosure increase the risk for investors due to potential liquidity issues and price volatility.
What are the key factors to evaluate for NAVB?
Navidea Biopharmaceuticals, Inc. (NAVB) currently holds an AI score of 43/100, indicating low score. Key strength: Proprietary Manocept platform.. Primary risk to monitor: Potential: Clinical trial failures for pipeline candidates.. This is not financial advice.
How frequently does NAVB data refresh on this page?
NAVB prices update in real time during U.S. market hours (9:30 AM-4:00 PM ET, weekdays). Fundamentals refresh after quarterly or annual filings. Analyst ratings and AI insights update daily. News is aggregated continuously from financial sources.
What has driven NAVB's recent stock price performance?
Recent price movement in Navidea Biopharmaceuticals, Inc. (NAVB) can be influenced by earnings results, analyst revisions, sector rotation, and broader market sentiment. Notable catalyst: Proprietary Manocept platform.. Check the News and Technical Analysis tabs for the latest drivers. Past performance does not predict future results.
Should investors consider NAVB overvalued or undervalued right now?
Determining whether Navidea Biopharmaceuticals, Inc. (NAVB) is overvalued or undervalued requires examining multiple metrics. Compare valuation ratios (P/E, P/S, EV/EBITDA) against sector peers for a comprehensive view.
What research should beginners do before buying NAVB?
Before investing in Navidea Biopharmaceuticals, Inc. (NAVB), research these four areas: (1) the company's revenue model and competitive position (see Company Overview), (2) financial health through revenue growth, margins, and cash flow (see MoonshotScore), (3) what Wall Street analysts recommend and their price targets (see Analyst tab), and (4) specific risk factors that could impact the stock (see Risk Factors section).
Disclaimer: This content is for informational purposes only and does not constitute investment advice. Always do your own research and consult a financial advisor.
Official Resources
Data provided for informational purposes only.
- Limited financial information available for comprehensive analysis.
- OTC market listing increases investment risk.
- AI analysis pending for NAVB stock.