FibroGen is a biopharmaceutical company. One of its lead drugs is roxadustat, which promotes red blood cell production. Roxadustat is currently approved for sale in China, Japan and Chile for treatment of anemia for patients with chronic kidney disease. FibroGen submitted a New Drug Application (NDA) to the FDA for roxadustat in December 2019. On March 1, 2021, the FDA informed FibroGen that the Cardiovascular and Renal Drugs Advisory Committee would hold an advisory committee meeting to review the NDA for roxadustat. That news was unexpected and caused FibroGen's stock price to fall almost 25% to $38.07 per share.
After the market closed on April 6, 2021, FibroGen announced that while it was preparing for the Advisory Committee meeting, it became "aware that the primary cardiovascular safety analyses included post-hoc changes to the stratification factors" and that it "promptly decided to clarify this issue with the FDA." Adam Feuerstein, the biotech reporter at STAT+, said "Fibrogen acknowledged Tuesday that the company has been touting false heart-safety data for its experimental anemia pill for at least two years — a shocking revelation that raises even more questions about the drug's approvability."
In early morning trading on April 7, 2021, FibroGen's stock price fell $12.42 per share to trade at $22.22.
For more information, FibroGen investors with trading losses of over $50,000 should contact Joshua Ruthizer at (212) 451-9668 or at jruthizer mailto:@wolfpopper.com.
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