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Fibrogen Slumps on Safety Data Inconsistencies

Stock Markets8 minutes ago (Apr 07, 2021 11:02AM ET)

(C) Reuters.

By Christiana Sciaudone — Fibrogen plummeted 37% after saying Tuesday there were inconsistencies in how some safety data were classified for its roxadustat drug for chronic kidney disease.

That led to a slew of downgrades as the company said it cannot conclude that the medicine cuts the risk of heart failure, stroke or other cardiovascular events compared to dialysis and other current treatments, Fibrogen said in a statement.

Mizuho Securities lowered the stock to neutral from buy, reducing the price target to $29 from $72 on higher risk and uncertainty around timelines to regulatory approvals following the clarification of previously disclosed cardiovascular safety analyses on roxadustat, according to StreetInsider.

Fibrogen previously tumbled after saying March 1 that the U.S. Food and Drug Administration would hold an advisory committee meeting to review the new drug application for roxadustat in the U.S.

Mizuho said clinical data previously shared with the scientific and investment community included post-hoc adjustments resulting in more favorable safety data. New data presented using pre-specified criteria still support the benefit/risk profile of roxa,

“We were surprised by the news and believe this creates higher risk in the near term, and uncertainty around timelines to potential approval,” Mizuho analyst Difei Yang wrote in a note.

Fibrogen Slumps on Safety Data Inconsistencies

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