What's Going On With Tharimmune Shares Wednesday?
What's Going On With Tharimmune Shares Wednesday?
"We are pleased with our interactions with both the FDA and EMA," saidTharimmune, 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.
Tharimmune，Inc.（納斯達克：THAR）股價週三出現上漲，因該公司宣佈歐洲藥品管理局（EMA）對其TH104臨床項目給予總體積極反饋。
What To Know: TH104 is the company's lead clinical-stage candidate for treating moderate-to-serve pruritus in primary biliary cholangitis.
了解詳情：TH104是該公司治療原發性膽道膽汁淤積綜合徵中中度至重度癢癢症的主導臨床階段候選藥。
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.
EMA互動重點集中在TH104的2期和3期臨床項目上。EMA認爲擬議的2期研究的設計和主要特點總體可接受，並對第3期研究的設計提供了一些指導。
"We are pleased with our interactions with both the FDA and EMA," said Randy Milby, CEO of Tharimmune.
「我們很高興與FDA和EMA的互動，」Tharimmune的首席執行官Randy Milby表示。
"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."
「來自EMA的最新監管反饋在繼續與FDA的積極互動的基礎上爲TH104在PBC慢性瘙癢中提供了發展藍圖，這仍然是患有這種罕見疾病的患者所面臨的致命症狀。與監管機構的進展證明了我們在炎症和免疫領域推進創新解決方案的持續承諾。」
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.
Tharimmune計劃在未來幾個月內啓動第2期多升劑量試驗，以評估TH104的安全性和耐受性。該公司預計於2025年公佈階段性數據，並繼續與監管機構合作。
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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.
Tharimmune股價週三在高於平均交易量的情況下翻了一番。Tharimmune過去100天的平均交易量約爲34,000股。根據Benzinga Pro發佈時的數據，週三的交易量約爲56,000股。
THAR Price Action: At the time of writing, Tharimmune stock was up 107.9% at $4.25, according to data from Benzinga Pro.
THAR 價格走勢：截至撰寫本文時，Tharimmune股票上漲了107.9%，報價4.25美元，數據來源於貝寧加 Pro。
Image: Emilian Danaila from Pixabay
圖片：來自Pixabay的Emilian Danaila
譯文內容由第三人軟體翻譯。
