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- Tharimmune secured approximately $5.47 million in equity financing during Q2/Q3 2025 to advance its lead asset TH104, a buccal film formulation of nalmefene designed to protect military personnel and first responders from weaponized fentanyl exposure. - The FDA confirmed that no additional clinical trials are required for TH104's 505(b)(2) NDA submission for temporary prophylaxis against high-potency opioid contamination, utilizing an expedited "in silico" pathway. - TH023, the company's oral monoclonal antibody targeting TNF-alpha, demonstrated successful oral delivery of infliximab in preclinical studies using the proprietary Soteria® platform, with plans for first-in-human trials within 12 months. - The company strengthened its leadership team with key appointments including James Gordon Liddy, a former Navy SEAL commander, as Board Director and Strategic Advisor for national security initiatives.
- Tharimmune completed a $1.74 million registered direct public offering to fund working capital and general corporate purposes. - The clinical-stage biotechnology company is developing TH104 via a 505(b)2 pathway for opioid-induced respiratory depression in military personnel. - The company's expanded pipeline includes TH104 for chronic pruritus in primary biliary cholangitis and TH023 for autoimmune diseases. - Tharimmune's proprietary EpiClick Technology platform targets multiple solid tumors through multispecific biologics.
- Tharimmune announced key leadership changes with Sireesh Appajosyula becoming CEO and Vincent LoPriore appointed Executive Chairman in June 2025. - The company added James Gordon Liddy, a retired Navy SEAL Commander with national security expertise, to its board of directors to support TH104 development. - TH104 is a buccal film formulation designed to deliver opioid antagonist therapy for military personnel and first responders exposed to weaponized fentanyl and high-potency opioids. - The leadership appointments strengthen Tharimmune's strategic position as it advances its lead candidate through the 505(b)2 regulatory pathway for respiratory and nervous system depression prevention.
- Tharimmune received positive FDA feedback allowing a 505(b)(2) NDA submission for TH104 as prophylaxis against ultrapotent opioid exposure, with no additional clinical trials required. - The buccal film formulation of nalmefene (TH104) leverages existing safety and efficacy data, enabling an "in silico" submission using pharmacokinetic modeling to predict drug performance. - Beyond its original development for chronic pruritus in primary biliary cholangitis, TH104 now targets protection for military personnel and first responders entering areas contaminated with high-potency opioids.
- Tharimmune's novel oral antibody TH023 demonstrated successful delivery of infliximab in preclinical studies, achieving serum concentrations higher than required for therapeutic efficacy in standard injection treatments. - The proprietary enzyme stabilization platform enables both local intestinal tissue delivery and systemic circulation, making it potentially effective for inflammatory bowel disease and other systemic inflammatory conditions. - The company plans to advance TH023 to first-in-human clinical trials within 12 months, targeting a portion of the global infliximab market that generated $6.3 billion in 2022 and could reach $9 billion within a decade.
- Tharimmune plans to initiate a Phase 2 clinical trial in 2025 to evaluate TH104 for moderate-to-severe pruritus associated with primary biliary cholangitis (PBC). - The Phase 2 trial will be a multicenter, randomized, double-blind, placebo-controlled study enrolling approximately 40 patients across the U.S., Europe, and the UK. - TH104 demonstrated a favorable pharmacokinetic profile and a mild side-effect profile in a Phase 1 clinical trial, with positive regulatory feedback from the FDA and EMA. - The company also reported corporate achievements, including licensing agreements and the appointment of Sanam Parikh to its Board of Directors.
- The FDA is creating a more accessible regulatory environment for cell and gene therapy companies, according to executives at BioFuture 2024. - Tharimmune's stock soared following positive feedback from the EMA regarding its phase II study of TH-104 for pruritus associated with primary biliary cholangitis (PBC). - Lexeo Therapeutics experienced a stock dip despite releasing positive interim results from its phase I/II study of LX-1001 for APOE4-associated Alzheimer’s disease. - Biogen and Neomorph have entered into a partnership worth up to $1.45 billion to develop molecular glue degraders for neurological and immunological diseases.
- Tharimmune received positive feedback from the EMA regarding its Phase 2 and Phase 3 clinical program for TH104, targeting moderate-to-severe pruritus in primary biliary cholangitis (PBC). - The EMA indicated that a hybrid application under Article 10(3) is acceptable, potentially allowing the use of existing non-clinical and safety data for TH104. - Tharimmune plans to initiate a Phase 2 multiple-ascending dose trial to assess the safety, tolerability, and efficacy of TH104 in PBC patients, with topline data expected in 2025.
- The EMA has endorsed Tharimmune's TH104 clinical program for chronic pruritus in primary biliary cholangitis (PBC), supporting the company's development strategy. - The agency has accepted the Article 10(3) hybrid application, potentially streamlining the approval process by leveraging existing safety data. - Tharimmune plans to initiate a Phase 2 multiple-ascending dose trial soon, with topline data expected in 2025, offering hope for a new therapeutic option. - The EMA's positive feedback aligns with previous interactions with the FDA, strengthening the global development strategy for TH104.
