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Stock impact report

FDA Put Brakes On Penny Stock Kezar Life Sciences' Mid-Stage Study For Lead Development Candidate After Patient Deaths [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
via teleconference with the FDA that the zetomipzomib Investigational New Drug (IND) application for lupus nephritis (LN) has been placed on clinical hold Lupus nephritis is a type of kidney disease caused by systemic lupus erythematosus link (SLE or lupus). Lupus is an autoimmune disease link—a disorder in which the body's immune system attacks the body's cells and organs. The action follows Kezar's communication to the FDA that Kezar was voluntarily suspending enrollment and dosing in its Phase 2b PALIZADE trial of zetomipzomib in lupus nephritis patients at the recommendation of the trial's Independent Data Monitoring Committee (IDMC). The IDMC's recommendation followed their review of emerging safety data, including an assessment of four Grade 5 (fatal or death) serious adverse events (SAEs) that occurred during the trial in patients enrolled in the Philippines and Argentina. The FDA indicated they will provide Kezar with an official clinical hold letter within 30 days. Show less Read more
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