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Stock Alert: FibroGen Down 35% After Clarifying With FDA Certain Data Classification

Shares of FibroGen Inc. (FGEN) tanked over 35% on Wednesday morning after the biotech company clarified with the FDA certain disclosures it had made regarding its roxadustat phase 3 program for the treatment of anemia of chronic kidney disease.

The company said while preparing for an advisory committee meeting ahead of potential approval of roxadustat, it realized that it submitted altered information to the FDA about the drug's cardiovascular safety.

FGEN is currently trading at $22.25, down $12.39 or 35.77%, on the Nasdaq.

According to CEO Enrique Conterno, the company became aware that the primary cardiovascular safety analyses included post-hoc changes to the stratification factors.

"While all of the analyses set forth below, including the differences in the stratification factors, were included in the NDA, we promptly decided to clarify this issue with the FDA and communicate with the scientific and investment communities," Enrique Conterno said.

The FDA has tentatively scheduled a Cardiovascular and Renal Drug Advisory Committee on July 1.

FibroGen said it cannot "conclude" that roxadustat reduces the risk of or is "superior" compared to alternate treatment epoetin-alfa.

"There is no change in the underlying roxadustat data, or to the efficacy analyses from the Phase 3 program. The Company has begun a comprehensive internal review to ensure such issues do not occur in the future," the company said in a statement.

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