Litigation Releases (Kin-Hung Peony Yu)

U.S. SECURITIES AND EXCHANGE COMMISSION

Litigation Release No. 26394 / Sept. 10, 2025

Securities and Exchange Commission v. Kin-Hung Peony Yu, No. 3:25-cv-07593 (N.D. Cal. filed Sept. 5, 2025)

SEC Charges Former FibroGen Chief Medical Officer for False and Misleading Claims about Clinical Trial Results

On September 5, 2025, the Securities and Exchange Commission filed charges against Dr. Kin-Hung Peony Yu, the former Chief Medical Officer of FibroGen, Inc., for allegedly making false and misleading statements about the cardiovascular safety of FibroGen's then-primary drug candidate, roxadustat.

According to the SEC's complaint, during the period from November 2019 to March 2021, Dr. Yu misled investors with claims that the results of key studies established that roxadustat, a potential therapy for the treatment of anemia in chronic kidney disease patients, was superior in cardiovascular safety to the primary existing treatment. But Dr. Yu allegedly failed to disclose to investors that she had reverse engineered the results. Specifically, the complaint alleges that the initial analyses showed the treatment was, at best, comparable to the existing treatment and that, after viewing the initial results, Dr. Yu directed changes to make roxadustat appear superior. Dr. Yu is alleged to have made the false and misleading claims in a range of forums, including a high-profile industry presentation and accompanying press release, multiple SEC filings, an earnings call, and a published article in a leading industry journal. After Dr. Yu's departure, new FibroGen management issued a corrective disclosure in an April 6, 2021 press release, in which they admitted that FibroGen's previously disclosed results were based on post-hoc changes to the analyses and disclosed the less favorable initial results.

The SEC's complaint, filed in the U.S. District Court for the Northern District of California, charges Dr. Yu with violating the antifraud provisions of Section 17(a)(2) of the Securities Act of 1933 and Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5(b) thereunder. The complaint 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. The matter was supervised by J. Lee Buck II and Pei Y. Chung. The SEC's litigation will be led by Daniel J. Maher and supervised by David A. Nasse.