FibroGen stock drops as biotech clarifies data classification in study data

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FibroGen Inc.
FGEN,
-2.78%
shares fell in the extended session Tuesday after the biotech drug maker said an analysis of data for its anemia drug revealed inconsistencies in how some safety data was classified. FibroGen shares dropped 22% after hours, following a 2.8% decline to close at $34.62 in the regular session. The company said that it wanted to clarify that safety analyses of its drug roxadustat, which is intended to treat anemia that stems from chronic kidney disease, included stratifications that had been changed. “As members of senior management were preparing for the upcoming FDA Advisory Committee meeting, we became aware that the primary cardiovascular safety analyses included post-hoc changes to the stratification factors,” said Enrique Conterno, FibroGen chief executive, in a statement. The company said it was conducting an “internal review to ensure such issues do not occur in the future.”

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