Why Is Pfizer Partner BioNTech Stock Trading Lower On Monday?
Why Is Pfizer Partner BioNTech Stock Trading Lower On Monday?
The FDA has shared with MediLink concerns that BNT326/YL202 may, at higher doses, expose human subjects to an unreasonable and significant risk of illness or injuries.BioNTech SE's (NASDAQ:BNTX) partner MediLink Therapeutics (Suzhou) Co., Ltd says the FDA has placed a partial clinical hold on the Phase 1 trial.
BioNTech SE（納斯達克股票代碼：BNTX）的合作伙伴MediLink Therapeutics（蘇州）有限公司表示，美國FDA對第1階段臨床試驗進行了部分臨床限制。
The MediLink-sponsored trial evaluates the early-stage antibody-drug conjugate product candidate BNT326/YL202 as a later-line treatment in heavily pre-treated patients with advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer or HR+/HER2-negative breast cancer.
MediLink贊助的試驗評估了早期抗體-藥物聯合物候選產品BNT326 / YL202，作爲晚期治療的後線治療方法，適用於接受過大量治療的晚期或轉移性表皮生長因子受體突變非小細胞肺癌或HR + / HER2-陰性乳腺癌患者。
The partial hold affects the enrollment of new patients in the trial in the U.S., BioNTech said in an SEC filing.
在美國招募新患者的時候，部分限制會影響這次試驗，BioNTech在SEC表格中表示。文件.
The FDA has shared with MediLink concerns that BNT326/YL202 may, at higher doses, expose human subjects to an unreasonable and significant risk of illness or injuries.
FDA與MediLink分享了他們的擔憂，即BNT326/YL202在更高的劑量下可能會讓人類受到不合理和重大的疾病或傷害風險。
Certain steps need to be taken to address the FDA requests, including reviewing clinical and safety data, sharing available pharmacological data with the Agency, and providing additional information in the investigators' brochure regarding the safety findings, including grade 5 adverse events observed in studies YL202-INT-101-01 and YL202-CN-201-01.
要採取一些措施來應對FDA的要求，包括審查臨床和安全數據，與FDA共享可用的藥理學數據，並在調查者手冊中提供更多的信息，包括在YL202-INT-101-01和YL202-CN-201-01研究中觀察到的5級不良事件的安全發現。
MediLink has taken actions to pause enrollment of new patients in the U.S. and address the FDA requirements.
MediLink已經採取措施，在美國暫停了新患者的招募，並處理了FDA的要求。
Price Action: BNTX shares are down 5.04% at $87.44 at last check Monday.
股價走勢：截至上週一的最後一次覈查，BNTX股票下跌了5.04％，報87.44美元。
譯文內容由第三人軟體翻譯。