Tharimmune, Inc. (NASDAQ:THAR) shares are moving higher Wednesday after the company announced it received overall positive feedback from the European Medicines Agency (EMA) on its TH104 clinical program.
What To Know: TH104 is the company's lead clinical-stage candidate for treating moderate-to-serve pruritus in primary biliary cholangitis.
The EMA interactions specifically focused on both the Phase 2 and Phase 3 clinical program of TH104. EMA found the design and main features of the proposed Phase 2 study overall acceptable and provided some guidance for the design of the Phase 3 study.
"We are pleased with our interactions with both the FDA and EMA," said Randy Milby, CEO of Tharimmune.
"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 plans to initiate a Phase 2 multiple-ascending dose trial in the coming months to assess the safety and tolerability of TH104. The company expects topline data in 2025 and continues to engage with regulatory authorities.
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Tharimmune shares have more than doubled on above-average session volume Wednesday. Tharimmune's average session volume over the past 100 days is about 34,000. Wednesday's trading volume was around 56,000 at the time of publication, per Benzinga Pro.
THAR Price Action: At the time of writing, Tharimmune stock was up 107.9% at $4.25, according to data from Benzinga Pro.
Image: Emilian Danaila from Pixabay
