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) 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.
Tharimmune, a clinical-stage biotechnology company, announced a $2.08 million private placement for 659,545 shares of common stock and 329,771 warrants at $3.16 per share. The warrants are exercisable at $3.09 per share, starting six months post-issuance, expiring five and a half years later. The closing is set for June 21, 2024, led by President Street Global as the exclusive placement agent. The financing is spearheaded by SDS Capital Group with contributions from Gravitas Capital and other biotech investors. The funds will support Tharimmune's clinical development and working capital, primarily for their lead candidate, TH104, aimed at treating chronic pruritus in primary biliary cholangitis.
Tharimmune has received positive feedback from the FDA for its Phase 2 clinical trial of TH104, a transmucosal buccal film containing nalmefene, for treating moderate-to-severe pruritus in primary biliary cholangitis (PBC). This feedback supports Tharimmune's plan to pursue a 505(b)(2) approval pathway, allowing the use of existing data on the approved active ingredient. The FDA acknowledged that the nonclinical studies are adequate for Phase 2 trial initiation and provided recommendations on study design, patient inclusion, primary endpoints, and monitoring for adverse events. Tharimmune aims to start the trial in late 2024.
Tharimmune, a clinical-stage biotech firm, announced positive Phase 1 trial results for TH104, its lead candidate for moderate-to-severe pruritus in primary biliary cholangitis (PBC). The study in healthy subjects showed that the pharmacokinetic (PK) profile of oral transmucosal TH104 was comparable to intravenous nalmefene. Safety and tolerability were also on par, with mild side effects reported. The trial met its primary endpoint, demonstrating a 45.9% bioavailability for TH104. Planning for a Phase 2 trial in 2024 is on track, with discussions ongoing with the FDA.
The study involved 20 healthy subjects in a single-dose, open-label, randomized 2-way crossover format. Findings indicated that TH104 has a median time to maximum concentration (Cmax) of 2.0 hours and a half-life (T1/2) of 14 hours. Mild adverse effects like dizziness, nausea, and somnolence were noted. No serious adverse events occurred.
Tharimmune, a clinical-stage biotech firm specializing in inflammation and immunology therapies, will present at the 2024 BIO International Convention from June 3-6 in San Diego. The company will showcase its therapeutic candidates and hold one-on-one meetings with investors and industry leaders. The presentation is scheduled for June 3 at 1:45 p.m. PT in Company Presentation Theater 3. Interested parties can arrange meetings via the BIO One-on-One Partnering system or by contacting Tirth Patel of LHA Investor Relations.
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