Tharimmune, Inc. (THAR) shares surged higher on Wednesday after the company announced positive feedback from the European Medicines Agency (EMA) regarding its TH104 clinical program. This program focuses on developing TH104, Tharimmune’s lead clinical-stage candidate for treating moderate-to-severe pruritus in primary biliary cholangitis (PBC).
The EMA interactions specifically focused on the Phase 2 and Phase 3 clinical programs of TH104. The EMA deemed the design and main features of the proposed Phase 2 study acceptable and provided guidance for the design of the Phase 3 study. This positive feedback is a significant milestone for Tharimmune, building upon previous positive interactions with the FDA.
Randy Milby, CEO of Tharimmune, expressed his enthusiasm: “We are pleased with our interactions with both the FDA and EMA. The recent regulatory feedback from the EMA builds on the previous positive interactions with the FDA while providing a roadmap for TH104 for chronic pruritus in PBC, which continues to be a debilitating symptom for patients suffering from this rare condition. The progress with regulatory agencies is a testament to our continued commitment to advance innovative solutions in inflammation and immunology.”
Tharimmune’s dedication to developing innovative solutions is evident in their plans to initiate a Phase 2 multiple-ascending dose trial in the coming months to assess the safety and tolerability of TH104. The company anticipates topline data in 2025 and continues to collaborate closely with regulatory authorities.
This news has sent THAR shares soaring, more than doubling in value on Wednesday. This surge in share price is accompanied by above-average session volume, indicating strong investor confidence and excitement surrounding the potential of TH104. With its focus on tackling a debilitating symptom of PBC, Tharimmune is poised to become a key player in the field of inflammatory and immunology treatments.
The EMA’s positive feedback, combined with Tharimmune’s commitment to innovation and regulatory progress, is a testament to the potential of TH104 to provide much-needed relief to patients suffering from chronic pruritus in PBC. The future for Tharimmune looks bright, with the company poised to continue its journey towards developing a successful treatment for this rare and challenging condition.
