Welcome to our dedicated page for Tharimmune news (Ticker: THAR), a resource for investors and traders seeking the latest updates and insights on Tharimmune stock.
Tharimmune Inc (THAR) is a clinical-stage biotechnology company pioneering treatments for rare immune and inflammatory disorders through innovative buccal film delivery and multispecific antibody platforms. This page provides timely updates on their therapeutic pipeline, including the TH104 program for primary biliary cholangitis (PBC) and early-stage immuno-oncology candidates.
Investors and industry observers will find authoritative coverage of clinical trial milestones, regulatory interactions with agencies like the FDA, and strategic partnerships. Our news collection focuses on scientifically validated developments, including progress in Phase 1/2 studies and novel drug delivery advancements.
Key updates include trial design approvals, patient recruitment status, pharmacokinetic data disclosures, and licensing agreements impacting therapeutic development. All content is vetted for accuracy and relevance to long-term value creation in rare disease markets.
Bookmark this page for consolidated access to Tharimmune's verified progress reports and scientific presentations. Check regularly for neutral, comprehensive updates on their mission to address unmet needs in chronic pruritus management and cancer immunotherapy.
Tharimmune (Nasdaq:THAR), a clinical-stage biotech company focused on inflammation and immunology therapeutics, announces participation in two upcoming conferences. Randy Milby, CEO, will attend the 2024 Spartan Capital Investor Conference on November 4, 2024, in New York, conducting one-on-one meetings. Additionally, Dr. Nir Barak, Chief Medical Advisor, will present new Phase 1 trial results for TH104 at the 75th AASLD Annual Conference on November 18, 2024, in San Diego. The presentation will focus on the correlation between TH104 pharmacokinetics and pruritus relief in cholestatic pruritus patients.
Tharimmune (NASDAQ:THAR) received positive feedback from the European Medicines Agency (EMA) regarding its TH104 clinical program for treating chronic pruritus in primary biliary cholangitis (PBC). The EMA endorsed the company's strategy, indicating no need for additional animal studies and accepting the Article 10(3) hybrid application approach. The Agency found the proposed Phase 2 study design acceptable and provided guidance for future Phase 3 studies. Tharimmune plans to initiate a Phase 2 multiple-ascending dose trial in the coming months, with topline data expected in 2025.
Tharimmune (NASDAQ:THAR) presented favorable Phase 1 clinical data for TH104, its lead candidate for moderate-to-severe pruritus in chronic liver disease, at the American College of Gastroenterology 2024 Annual Scientific Meeting. The single-dose trial showed no opioid withdrawal effects and demonstrated a mean 33.3% reduction in itch scores 24 hours post-dose across all subjects. The study, conducted in two cohorts of patients with different liver disease severities, reported no serious adverse events. The company plans to initiate a Phase 2 multiple-ascending dose trial with topline data expected in 2025.
Tharimmune (NASDAQ:THAR), a clinical-stage biotech company, announces participation in two major conferences. At the American College of Gastroenterology Annual Scientific Meeting (October 25-30, Philadelphia), Dr. Nir Barak will present Phase 1 trial results of TH104 in a poster focused on safety and tolerability in cholestatic liver disease patients.
Additionally, CEO Randy Milby will present at the 2024 ThinkEquity Conference on October 30 in New York, offering one-on-one meetings with investors. The ThinkEquity presentation will be available via webcast, with replay access for 90 days.
Tharimmune (NASDAQ:THAR) and Intract Pharma have signed a nonbinding letter of intent for a merger, aiming to create a transformative oral biologic therapeutics company. The deal, expected to close in Q1 2025, will see Intract shareholders owning 49% of the combined entity, which will retain the Tharimmune name and NASDAQ listing. This merger is set to expand Tharimmune's product pipeline and strengthen its position in the multibillion-dollar biologics market.
The combined company will leverage Intract's innovative oral biologics delivery platform, which protects molecules as they pass through the gastrointestinal tract. This technology has the potential to revolutionize biologic administration, improving patient compliance and quality of life. The merger builds on a previous licensing agreement between the two companies for INT-023/TH023, an oral anti-TNF alpha monoclonal antibody.
Tharimmune (NASDAQ:THAR) has entered a strategic partnership with Intract Pharma, acquiring an exclusive global license for INT-023/TH023, an oral formulation of infliximab. This collaboration aims to develop a pill form of the anti-TNF-α monoclonal antibody, traditionally administered intravenously. The agreement includes rights to Intract's Soteria® and Phloral® delivery platforms, enabling targeted delivery to the colon or small intestine.
Key points:
- Upfront payment and potential future milestones for Intract Pharma
- Mid-single digit royalties on net product sales
- Option to license Intract's platform for up to four additional targets
- Potential to improve patient compliance and reduce healthcare burden
- Opportunity for Tharimmune to compete in a multibillion-dollar global market
This partnership represents a significant advancement in treating chronic inflammatory diseases, aligning with Tharimmune's mission to develop more convenient and accessible treatment options.
Tharimmune (NASDAQ:THAR), a clinical-stage biotechnology company, has appointed Prof. David Jones of Newcastle University to its Scientific Advisory Board (SAB). Prof. Jones, an expert in autoimmune liver disease, leads the UK-PBC research consortium and has contributed to stratified therapy in rare liver disease. He joins a newly formed SAB that includes experts from various prestigious institutions.
The company is advancing its lead drug candidate TH104 for pruritus secondary to primary biliary cholangitis (PBC). Tharimmune recently reported positive Phase 1 results for TH104 and received FDA feedback for its upcoming Phase 2 trial, expected to start in the second half of 2024.
Tharimmune, Inc. (Nasdaq: THAR), a clinical-stage biotechnology company focused on inflammation and immunology, has appointed David H. Clarke as a Strategic Advisor to its executive management team. Clarke brings extensive experience in corporate governance, financial planning, and leadership across multiple industries, including biotechnology. His appointment is expected to provide strategic guidance as Tharimmune advances TH104 for treating pruritus in patients with primary biliary cholangitis and expands its pipeline.
Clarke's background includes serving as Chairman and CEO of United Pacific Industries and Jacuzzi Brands, as well as Vice Chairman and CEO of Hanson's U.S. division. His expertise in public company operations and leadership is anticipated to strengthen Tharimmune's organization and support its mission to deliver innovative treatments for unmet medical needs.
Tharimmune (NASDAQ:THAR), a clinical-stage biotech company, has launched a new website at www.tharimmune.com. The redesigned platform offers comprehensive information about the company's research, clinical trials, and corporate developments. CEO Randy Milby emphasized the website's role in enhancing communication with stakeholders.
Concurrently, Tharimmune is continuing discussions with the FDA regarding the design and initiation of a Phase 2 clinical trial for TH104, their lead candidate. The trial aims to address moderate-to-severe chronic pruritis in primary biliary cholangitis. The company expects to launch the Phase 2 trial in Q3 2024, following a productive Type C meeting with the FDA.
Tharimmune announced the appointment of Jules Haimovitz as a Strategic Advisor. Jules brings decades of experience in biotechnology, having served on several notable Boards of Directors. His expertise in corporate governance, strategic planning, and industry trends is expected to enhance Tharimmune's efforts in developing treatments for unmet medical needs.
CEO Randy Milby highlighted Jules' potential to strengthen Tharimmune's clinical and preclinical programs. This appointment is timely, aligning with recent positive FDA feedback on Tharimmune's Phase 2 program for TH104, a leading candidate for treating pruritus in patients with primary biliary cholangitis (PBC).
Jules, President of Haimovitz Consulting, Inc., also serves as a Director at Armata Pharmaceuticals and Innoviva. His experience will be important during Tharimmune's critical Phase 2 testing phase, expected to be a significant value inflection point for the company.
