UPDATED: FibroGen shares take a beating as CEO reveals safety data manipulation for its blockbuster contender roxadustat
FibroGen $FGEN backtracked on some of the key safety data used to boost hopes for their anemia drug roxadustat, eliminating its claim of superiority over ESAs for a large segment of the patient population. And investors quickly crushed its shares in retaliation for the surprise discrepancies.
According to CEO Enrique Conterno, FibroGen execs became “aware” that their analysis included post hoc changes to stratification factors used to assess the hazard ratio of their drug — essentially manipulating the data to enhance how much the therapy reduced key risks for patients and sharing that false profile with investors and regulators. Using pre-specified stratification factors raised the risk on key safety endpoints, which revolved primarily around MACE, a composite endpoint of all-cause mortality, stroke, and myocardial infarction.
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