FibroGen pays $1.25M to settle SEC allegations over manipulated roxadustat data

FibroGen has agreed to pay the SEC $1.25 million to settle claims that its former chief medical officer, Dr. Kin-Hung Peony Yu, manipulated Phase 3 anemia drug data to make roxadustat appear more effective than it was.

Backstory: Between 2019 and 2021, Yu allegedly applied “post-hoc changes” to how roxadustat's phase 3 trial data were analyzed. These changes inflated the drug's cardiovascular safety profile, helping it appear superior to competitor epoetin alfa. These claims were allegedly repeated in press releases, SEC filings, an earnings call, and an industry journal article. FibroGen admitted in 2021 that "post-hoc changes" had been made just as the FDA was reviewing the drug, with Yu having already left the company in March 2021.

Why it matters: Because of the fallout from this fraudulent data, Roxadustat (Evrenzo) is approved in China, South Korea, and Europe but not the US. The case highlights the risks of data manipulation in drug development and the scrutiny biopharma companies face from regulators. Misrepresentation not only erodes investor trust but can derail approvals, as seen when the FDA rejected roxadustat’s U.S. application.

Big picture: FibroGen has faced repeated controversies, layoffs, legal disputes with former employees, and ongoing struggles to win U.S. approval for roxadustat. Meanwhile, AstraZeneca and Astellas have kept the drug alive overseas, with AstraZeneca paying $160M earlier this year for China rights.