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0 0.00074850299401196 -0.00449101796407189 -0.00299401197604797 -0.0209580838323353 -0.0359281437125749 -0.0261976047904191 -0.034431137724551
Stock impact report

OS endpoint focus will realign industry to “ultimate goal” [Yahoo! Finance]

Immuneering Corporation - Class A (IMRX) 
Company Research Source: Yahoo! Finance
However, the US Food and Drug Administration (FDA) has made a bid to set OS's key role in oncology in stone – debuting industry draft guidance recommending it as a key pre-specified endpoint in all cancer clinical trials. In a statement to Clinical Trials Arena , the US regulator noted that it is taking this course to ensure that “the pursuit of efficacy endpoints does not overshadow critical safety concerns,” which are rife in the oncology sector due to the aggressive nature of its associated therapies. This is particularly true for hard-to-treat malignancies such as pancreatic cancer, which the FDA specifically mentions in its guidance. The agency likely calls out pancreatic cancer due to its strong reliance on toxic treatment regimens like chemotherapy in the first line, which can cause patient deaths before the disease takes hold. Meanwhile, the new guidance also states that trials must now “plan for survival assessment upfront, with specific attention to interim analyses f Show less Read more
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