What's Going In With Vivek Ramaswamy-Founded Roivant Sciences Stock On Monday?
What's Going In With Vivek Ramaswamy-Founded Roivant Sciences Stock On Monday?
As previously disclosed, the batoclimab phase 2a trial in uncontrolled Graves' Disease enrolled patients who were hyperthyroid despite antithyroid drugs (ATD) therapy.Monday, Immunovant, Inc. (NASDAQ:IMVT) reported results from the Phase 2a trial of batoclimab in Graves' Disease, an immune system condition that affects the thyroid gland. It causes the body to make too much thyroid hormone.
周一，Immunovant, Inc.（纳斯达克股票代码：IMVT）公布了巴托克利单抗治疗格雷夫斯病的2a期试验结果，格雷夫斯病是一种影响甲状腺的免疫系统疾病。它会导致人体产生过多的甲状腺激素。
Immunovant is a member of the Roivant Sciences Ltd. (NASDAQ:ROIV) family of companies.
Immunovant是Roivant Sciences Ltd.（纳斯达克股票代码：ROIV）家族公司的成员。
Also Read: Vivek Ramaswamy-Founded Roivant's Anti-Inflammatory Drug Aces Mid-Stage Study.
另请阅读：维维克·拉马斯瓦米创立的Roivant的抗炎药物在中期研究中脱颖而出。
As previously disclosed, the batoclimab phase 2a trial in uncontrolled Graves' Disease enrolled patients who were hyperthyroid despite antithyroid drugs (ATD) therapy.
正如先前披露的那样，针对不受控制的格雷夫斯病的batoclimab2a期试验招收了尽管接受抗甲状腺药物（ATD）治疗后仍出现甲状腺功能亢进的患者。
Participants in the trial received 12 weeks of high-dose batoclimab, 680 mg weekly by subcutaneous injection (SC) followed by 12 weeks of lower-dose batoclimab, 340 mg weekly SC.
该试验的参与者接受了为期12周的高剂量巴托克利单抗，每周接受680毫克皮下注射（SC），随后接受了12周的低剂量巴托克利单抗，每周服用340毫克。
At the end of the first 12 weeks, participants experienced a mean IgG reduction of 77%, leading to a 76% Response rate.
在前12周结束时，参与者的平均IgG减少了77％，反应率为76％。
In addition, by the end of 12 weeks of higher dose batoclimab, 56% achieved an ATD-Free Response.
此外，到更高剂量的巴托克利单抗12周结束时，有56％的人实现了无ATD反应。
Despite benefiting from a lower starting IgG level after 12 weeks of 680mg therapy, during Weeks 13 to 24, the lower 340mg dose of batoclimab resulted in a mean IgG reduction of 65% (vs. 77% on 680mg dose) with a corresponding lower responder rate of 68%.
尽管在接受680mg治疗12周后受益于较低的起始IgG水平，但在第13至24周期间，较低的340mg剂量的巴托克利单抗导致平均IgG降低了65％（而680mg剂量的77％），相应的缓解率较低，为68％。
In the second 12 weeks, a 36% lower ATD-Free Response rate was also observed.
在接下来的12周中，还观察到无ATD反应率降低了36％。
Finally, patients who achieved at least a 70% IgG reduction at the end of the trial had nearly a threefold higher ATD-Free Response rate than those who did not (60% vs. 23%).
最后，在试验结束时达到至少 70% IgG 降低的患者的无ATD反应率比未降低 70% 的患者高出近三倍（60% 对 23%）。
"We find the correlation between clinical response and IgG lowering impressive and believe this creates not only a potential first-in-class but also a potential best-in-class opportunity for IMVT-1402. We are very pleased to have aligned with the FDA on a pivotal trial design that we expect to initiate by the end of the year," said Pete Salzmann, CEO of Immunovant.
“我们发现临床反应与IgG降低之间的相关性令人印象深刻，并相信这不仅为IMVT-1402创造了潜在的同类首创机会，而且还创造了潜在的同类最佳机会。Immunovant首席执行官皮特·萨尔兹曼说，我们很高兴与美国食品药品管理局就一项关键试验设计达成一致，我们预计该设计将于今年年底启动。
Immunovant also announced alignment with the FDA and Investigational New Drug Application clearance, with the initiation of a pivotal trial of IMVT-1402 in Graves' Disease expected by December 31, 2024.
Immunovant还宣布与美国食品药品管理局和研究性新药申请许可保持一致，预计将于2024年12月31日启动一项针对格雷夫斯病的IMVT-1402的关键试验。
Price Action: ROIV stock is up 4.67% at $12.88, and IMVT stock is down 0.32% at $33.92 at last check Monday.
价格走势：周一最后一次查看时，ROIV股价上涨4.67％，至12.88美元，imVT股价下跌0.32％，至33.92美元。
- FDA Gives Green Signal To Rezolute's Genetic Disorder Treatment.
- 美国食品药品管理局向Rezolute的遗传病治疗发出绿色信号。
