DOC REVERSED TRIAL RESULTS TO FAKE DRUG SAFETY!

SEC v. Kin-Hung Peony Yu — U.S. Securities and Exchange Commission Litigation Release No. 26394, dated September 5, 2025.

The SEC charged Dr. Kin-Hung Peony Yu, former Chief Medical Officer of FibroGen, Inc., for allegedly misleading investors about the cardiovascular safety of the drug roxadustat. Dr. Yu is accused of manipulating clinical trial data analyses to make the drug appear safer than it was compared to existing treatments. These misleading claims were made in various public forums, including presentations, SEC filings, and a published article.

In Plain English

Imagine a doctor in charge of testing a new medicine. They found out the medicine wasn't as safe as they hoped, but instead of telling everyone the truth, they changed how they looked at the test results. This made the medicine look better than it really was. They then told investors and the public that the medicine was safe, hiding the fact that they had tweaked the data. Later, new management at the company revealed the truth about the data changes.

Disclaimer: all facts are drawn from the SEC's own filings; the claims described are allegations unless and until a court rules or the parties settle, and some cases end in dismissal.

How the Alleged Scheme Worked

1. Initial Trial Results In late 2019, initial analyses of clinical trial results for roxadustat, FibroGen's main drug candidate for anemia, showed that its cardiovascular safety was comparable to existing treatments, not superior.
2. Data Manipulation Directive After reviewing these initial, less favorable results, Dr. Kin-Hung Peony Yu, the Chief Medical Officer, allegedly directed changes to the data analysis methods.
3. Reverse Engineering Results These directed changes were described as 'reverse engineering' the results, aiming to make roxadustat appear superior in cardiovascular safety compared to the primary existing treatment.
4. Misleading Investor Claims From November 2019 to March 2021, Dr. Yu allegedly made false and misleading claims to investors, stating that the studies established roxadustat's superior cardiovascular safety.
5. Public Presentations These misleading claims were disseminated through various channels, including a high-profile industry presentation and an accompanying press release.
6. SEC Filings and Publications Further misleading statements were made in multiple SEC filings, an earnings call, and a published article in a leading industry journal.
7. Departure and Corrective Disclosure Following Dr. Yu's departure from FibroGen, new management issued a corrective disclosure on April 6, 2021.
8. Admission of Data Changes The corrective disclosure admitted that the previously disclosed results were based on post-hoc changes to the analyses and revealed the less favorable initial results.

The Enforcement Action

On September 5, 2025, the SEC filed charges against Dr. Kin-Hung Peony Yu, former Chief Medical Officer of FibroGen, Inc., in the U.S. District Court for the Northern District of California. The SEC alleges that Dr. Yu made false and misleading statements about the cardiovascular safety of FibroGen’s drug candidate, roxadustat, between November 2019 and March 2021. The complaint asserts that Dr. Yu directed changes to data analyses to make roxadustat appear safer than it was, failing to disclose these manipulations to investors. The SEC seeks permanent injunctive relief, an officer-and-director bar, disgorgement of ill-gotten gains plus prejudgment interest, and a civil penalty. The SEC's investigation was conducted by Edward B. Gerard and assisted by Kelly V. Silverman, supervised by J. Lee Buck II and Pei Y. Chung. The litigation will be led by Daniel J. Maher and supervised by David A. Nasse.

Named in this action: Kin-Hung Peony Yu.

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