Tharimmune Receives Positive FDA Feedback for TH104 Prophylaxis Program Against Respiratory Depression from Fentanyl and Ultrapotent Opioids
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 13 2025
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Should l Buy THAR?
Source: PRnewswire
FDA Feedback on TH104: Tharimmune's lead clinical asset, TH104 (nalmefene buccal film), received positive feedback from the FDA regarding its pharmacokinetic simulation modeling plan, which is crucial for advancing its development as a treatment for respiratory depression caused by opioids.
Operational Milestones: The company is set to initiate a comprehensive Chemistry, Manufacturing, and Controls (CMC) plan to ensure the quality and consistency of TH104, marking a significant step towards advanced clinical development and commercial readiness.
Simulation Analysis Findings: The pharmacokinetic simulation analysis indicated that TH104 could provide rapid onset of protection within 30 minutes and sustained protection for about 24 hours, offering a potential advantage over existing treatments like naloxone.
Digital Asset Strategy: In addition to its biotechnology efforts, Tharimmune is developing a digital asset treasury strategy utilizing the Canton Coin to enhance the digitization of traditional financial markets through the Canton Network.
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About THAR
Tharimmune, Inc. is a clinical-stage biotechnology company. The Company is engaged in developing therapeutic candidates for inflammatory and immunologic conditions with unmet need. It has a transmucosal film product, TH104, is a Phase II ready clinical candidate and an oral biologic as well as two bispecific biologics in pre-clinical development. TH104 is a transmucosal buccal film embedded with the active compound nalmefene onto a thin film which adheres inside of the mouth on the cheek and biodegrades. TH104 is an ideal product candidate for multiple liver-related and other pruritogenic inflammatory conditions. It is also developing an early-stage pipeline of novel therapeutic candidates targeting validated high value immune-oncology targets including human epidermal growth factor receptor 2, human EGF receptor 3 and programmed cell death protein. The Company is developing antibodies, including bispecific antibodies, antibody drug conjugates, among others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- New COO Appointment: Angela Radkowski has been appointed as Chief Operating Officer, tasked with overseeing operational control functions and enterprise processes, bringing valuable management insights and efficiency improvements from her previous roles at DRW Holdings and Citadel LLC.
- Positive Market Reaction: Tharimmune's stock price rose 7.63% in pre-market trading to $4.23, reflecting investor optimism regarding the new executive appointments, which may signal future growth potential for the company.
- Strategic Implications: This executive transition not only strengthens internal management but also positions Tharimmune to enhance its competitiveness in the biotechnology sector, particularly in a rapidly evolving market landscape.
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- Background Experience: Radkowski brings extensive operational and financial system experience from DRW Holdings and Citadel, and her appointment is seen as a strategic move to strengthen leadership at a pivotal moment, optimizing the company's strategy in the digital asset space.
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See More
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- Market Transparency Enhancement: The programmable privacy features of the Canton Network allow market participants to achieve instantaneous settlement while maintaining confidentiality of critical information, further solidifying Tharimmune's strategic position in the transformation of global financial infrastructure.
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See More
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- Executive Changes: Tharimmune announced that CEO Mark Wendland will become Chairman effective February 5, 2026, succeeding Vincent LoPriore, who has served as Chairman since May 2025 and will remain on the board, ensuring continuity and stability in governance.
- New COO Appointment: Angela Radkowski has been appointed as Chief Operating Officer, tasked with overseeing operational control functions and enterprise processes, bringing valuable management insights and efficiency improvements from her previous roles at DRW Holdings and Citadel LLC.
- Positive Market Reaction: Tharimmune's stock price rose 7.63% in pre-market trading to $4.23, reflecting investor optimism regarding the new executive appointments, which may signal future growth potential for the company.
- Strategic Implications: This executive transition not only strengthens internal management but also positions Tharimmune to enhance its competitiveness in the biotechnology sector, particularly in a rapidly evolving market landscape.
See More
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- Leadership Changes: Tharimmune has appointed Mark Wendland as Chairman of the Board and Angela Radkowski as Chief Operating Officer, aiming to enhance operational efficiency and market competitiveness in executing the Canton Network strategy.
- Strategic Execution: Angela Radkowski will oversee operational control functions and enterprise processes, particularly implementing the Canton Network's quarterly research initiative and Super Validator activation, which is expected to accelerate institutional adoption and value creation.
- Background Experience: Radkowski brings extensive operational and financial system experience from DRW Holdings and Citadel, and her appointment is seen as a strategic move to strengthen leadership at a pivotal moment, optimizing the company's strategy in the digital asset space.
- Digital Asset Strategy: Since November 2025, Tharimmune has established a unique digital asset treasury strategy, planning to drive institutional utility and adoption in capital markets through Canton Coin acquisition and Super Validator operations, further solidifying its market position.
See More
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- Leadership Changes: Tharimmune has appointed Mark Wendland as Chairman of the Board and Angela Radkowski as Chief Operating Officer, aiming to enhance the company's governance structure and operational efficiency in executing its digital asset strategy aligned with the Canton Network.
- Strengthened Strategy Execution: Angela Radkowski's extensive experience at DRW Holdings and Citadel will support Tharimmune's operational control and enterprise processes, particularly in implementing the quarterly research initiative and activating the Super Validator, which is expected to accelerate institutional adoption of the Canton Network.
- Digital Asset Strategy: Since establishing its unique digital asset treasury strategy in November 2025, Tharimmune plans to drive institutional utility and adoption across capital markets through Canton Coin acquisition and operating as a Super Validator, thereby enhancing shareholder value.
- Market Positioning: As the first publicly traded company supported by the Canton Foundation, Tharimmune's strategy focuses not only on digital assets but also on clinical-stage biotech research and development, showcasing its pioneering role in the digital transformation of financial markets.
See More
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- New Board Members: Tharimmune appointed former CFTC Commissioner Jill Sommers and DRW COO William Wiley to its Board effective February 1, 2026, aiming to enhance governance and advance the Canton Network's financial infrastructure modernization through their regulatory and market expertise.
- Rich Regulatory Experience: Sommers brings nearly 30 years of experience in derivatives and financial markets, having served as a CFTC Commissioner, and her addition is expected to strengthen Tharimmune's strategic capabilities in compliance and blockchain financial systems, bolstering the company's leadership in the digital asset space.
- Global Operations Leadership: Wiley's extensive background in capital markets and global operations, particularly his management experience at DRW's multi-asset electronic trading platform, will provide crucial support for Tharimmune's digital asset strategy and drive investment in applications on the Canton Network.
- Digital Asset Strategy: Tharimmune has implemented a digital asset treasury strategy since November 2025, planning to drive institutional utility and adoption in capital markets through Canton Coin acquisitions and its role as a Super Validator, further solidifying its market position in the blockchain sector.
See More
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- Super Validator Role: Tharimmune has been approved as a super validator on the Canton Network, processing over 700,000 daily transactions with a monthly volume of $9 trillion, thereby enhancing its competitive edge in the digital asset space.
- Successful Fundraising: The company completed a direct offering worth approximately $55 million on January 23, 2026, issuing 1.80 million shares of common stock, with proceeds aimed at expanding its Canton digital asset strategy and general corporate purposes.
- Clinical Candidate Progress: TH104, Tharimmune's lead clinical candidate, has completed its Phase 1 trial and is ready for Phase 2, targeting ultrapotent opioid exposure and chronic pruritus in primary biliary cholangitis patients.
- Positive FDA Feedback: TH104 received constructive guidance from the FDA, planning to integrate specific technical elements to optimize its prophylactic program against ultrapotent opioids, showcasing its potential for military and chemical incident responders.
See More
Tharimmune Advances Digital Asset Strategy via Canton Network
- Super Validator Role: Tharimmune has been approved to operate as a Super Validator on the Canton Network, responsible for over 700,000 daily transactions totaling $9 trillion in monthly volume, thereby enhancing its influence and revenue potential in the digital asset space.
- Digital Asset Strategy: Since November 2025, Tharimmune has established a unique digital asset treasury strategy that drives institutional utility and adoption across capital markets through CC acquisition and Super Validator operations.
- Market Transparency Enhancement: The programmable privacy features of the Canton Network allow market participants to achieve instantaneous settlement while maintaining confidentiality of critical information, further solidifying Tharimmune's strategic position in the transformation of global financial infrastructure.
- Quarterly Research and Engagement: Tharimmune will provide in-depth quarterly research and community development news, fostering dialogue among ecosystem participants and enhancing its leadership position in the digital asset domain.
See More
