SEC Remains Focused on Public Disclosures Made By Life Sciences Companies

On September 5, 2025, the U.S. Securities and Exchange Commission (SEC) announced a US$1.25 million settlement with biopharmaceutical company, FibroGen, Inc. (FibroGen), finding that FibroGen made false and misleading statements regarding the results of cardiovascular safety analyses of FibroGen’s anemia drug candidate, Roxadustat.

Allegations

According to the SEC order, from November 8, 2019 to April 6, 2021, FibroGen, through its then-Chief Medical Officer, publicly promoted favorable cardiovascular safety results for Roxadustat. Those results, however, were based on post-hoc changes to certain statistical stratification factors made after unblinding of the clinical data. The original blinded results had shown Roxadustat was not inferior, but also not superior, in cardiovascular safety risk compared to existing therapies.

The SEC also found that on an earnings call, FibroGen’s Chief Medical Officer suggested that the FDA had agreed with the company’s statistical approach, which the SEC determined was misleading.

According to the SEC order, medical and financial communities viewed the safety data as essential to evaluating potential FDA approval. FibroGen’s share price increased approximately 10% when the allegedly misleading results were initially published and dropped approximately 43% when FibroGen issued a press release disclosing the original results and that the previously announced results had relied on post-hoc changes to the stratification factors.

Remedies and Takeaways

The SEC found that FibroGen violated anti-fraud provisions of the federal securities laws prohibiting false and misleading statements and imposed a US$1.25 million penalty and an undertaking requiring that the Company and its employees cooperate with the SEC in connection with additional related proceedings. The SEC noted the Company’s cooperation with the investigation, its undertaking of continued cooperation, and its remedial efforts in determining to accept the Company’s offer of settlement.

This action underscores the SEC’s ongoing focus on the accuracy of public disclosures by life sciences companies, particularly where clinical trial results and FDA approval prospects are involved. Companies should ensure clinical data statements are transparent, avoid overstating regulatory positions, and be mindful of investor reliance on safety and efficacy disclosures. Cooperation and remediation remain important in managing SEC investigations.

This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.