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0 0 0.00405063291139252 0.00405063291139252 0.00405063291139252 -0.00253164556962012 -0.00253164556962012 -0.00253164556962012
Stock impact report

FDA places hold on Kezar Life Sciences' trial for lupus nephritis treatment [Yahoo! Finance]

Kezar Life Sciences, Inc. (KZR) 
Last kezar life sciences, inc. earnings: 8/7 04:05 pm Check Earnings Report
Company Research Source: Yahoo! Finance
Kezar suspended the dosing and enrolment based on the recommendation from the trial's independent data monitoring committee (IDMC), which reviewed the emerging trial safety data. These findings included an assessment of four Grade five (fatal) serious adverse events (SAEs) that occurred during the trial in patients enrolled in the Philippines and Argentina. The IDMC's review indicated that three of the fatalities shared a pattern of symptoms and occurred close to the time of dosing. Additional non-fatal SAEs also displayed a similar timing about dosing. Kezar remains unaware of which patients received zetomipzomib or the placebo. The FDA has communicated that it will provide Kezar with an official clinical hold letter within 30 days. A severe complication of systemic lupus erythematosus (SLE), LN affects approximately 50% of SLE patients within ten years of diagnosis. The disease is characterised by a range of vascular, glomerular, and tubulointerstitial lesions and is as Show less Read more
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