Deadline for investors is approaching: Kessler Topaz Meltzer &

RADNOR, Pa., May 23, 2021 (GLOBE NEWSWIRE) – Law firm Kessler Topaz Meltzer & Check, LLP announces that a securities fraud class action lawsuit has been filed in the United States District Court for the Northern District of California against FibroGen, Inc. (NASDAQ: FGEN) (FibroGen) on behalf of those who bought or acquired FibroGen securities and / or sold put options from October 18, 2017 to April 6, 2021 inclusively (the course period).

Deadline reminder for investors: investors who bought or acquired FibroGen securities during the Recourse Period may, no later than June 11, 2021, seeks to be appointed principal representative of the applicants of the group. For more information or to find out how to participate in this dispute, please contact Kessler Topaz Meltzer & Check, LLP: James Maro, Esq. (484) 270-1453 or Adrienne Bell, Esq. (484) 270-1435; toll free at (844) 887-9500; by e-mail to [email protected]; or Click on https://www.ktmc.com/fibrogen-class-action-lawsuit?utm_source=PR&utm_medium=Link&utm_campaign=fibrogen

FibroGen is a biopharmaceutical company that develops drugs for the treatment of anemia, fibrotic diseases and cancer. Its most advanced product is roxadustat (Roxa), an oral small molecule inhibitor of hypoxia-inducible factor prolyl hydroxylase activity which works by stimulating the body’s natural pathway for the production of red blood cells.

The class period begins on October 18, 2017 when FibroGen announced that the China Food and Drug Administration (CFDA) had accepted its new drug application (NDA) for Roxa based on two Phase 3 studies in China, a study on IRC. [chronic kidney disease] compare roxadustat to a branded epoetin alfa[] and a non-dialysis CRF study comparing roxadustat to placebo. Both studies met their primary efficacy endpoints without any new or unexpected safety signals being identified. FibroGen touted the positive safety of these studies throughout the class period.

After overcoming the hurdle of demonstrating to the CFDA that Roxa was safe enough to submit an NDA, FibroGen proceeded to present itself as being prepared to conduct sufficient Phase 3 trials to support an NDA to the Food and Drug Administration (FDA ) the United States. In 2019, FibroGen filed its NDA with the FDA for approval of Roxa for the treatment of anemia due to CRF.

The truth began to emerge on March 1, 2021 when, after the market closed, FibroGen announced that the FDA was planning an advisory board meeting to review Roxas NDA, well over a year after its initial submission. An advisory committee meeting this late in the review process indicates that there is an issue with the application and could, at best, delay the FDA approval decision and at worst signal that the FDA may not approve. medication. Following this news, the FibroGens share price fell $ 12.46 per share, or 25%.

Then on April 6, 2021, after the market closed, FibroGen issued a press release that revealed that the safety data previously disclosed by FibroGens included undisclosed post-hoc changes in stratification factors and did not include ‘analyzes based on predefined stratification factors. As a result of these changes, the complaint alleges that FibroGen was forced to admit that Roxa, contrary to previous claims, did not reduce the risk of cardiovascular events or hospitalization compared to an injection of anemia currently. approved used as a control based on specified pre-stratification factors. Following this news, the FibroGens share price fell $ 14.90, or 43%, to close at $ 19.74 per share on April 7, 2021.

The complaint alleges that throughout the appeal period, the defendants made false and / or misleading statements or failed to disclose that: (1) based on the safety data of FibroGens two Phase 3 trials in China, all safety data obtained from global phase 3 trials would require post-hoc modifications of stratification factors to meet FDA requirements; (2) Disclosures made by FibroGens on the US primary cardiovascular safety analyzes of Roxa’s Global Phase 3 Comprehensive Anemia Program submitted in connection with CRF included post-hoc changes in stratification factors; (3) FibroGens analyzes with predefined stratification factors resulted in higher risk ratios (point estimates of relative risk) and 95% confidence intervals; (4) Based on these analyzes, FibroGen could not conclude that Roxa reduces the risk of (or is greater than) MACE + on dialysis, and MACE and MACE + on incident dialysis compared to epoetin-alfa ; (5) as a result, FibroGen faced significant uncertainty as to whether its NDA for Roxa as a treatment for CKD anemia would be approved by the FDA; and (6) as a result of the foregoing, the defendants’ statements regarding the business, operations and prospects of FirboGens were materially false and misleading and / or lacked reasonable basis at all material times.

FibroGen investors can, no later than June 11, 2021, seek to be appointed as the principal representative of class claimants through Kessler Topaz Meltzer & Check, LLP or another lawyer, or may choose to do nothing and remain an absent class member. A principal plaintiff is a representative party who acts on behalf of all class members in directing the litigation. To be appointed as the Principal Plaintiff, the Court must determine that the Class Members’ claim is typical of the claims of other Class Members and that the Class Member will adequately represent the Class. Your ability to participate in any recovery is not affected by the decision whether or not to serve as the principal applicant.

Kessler Topaz Meltzer & Check, LLP is pursuing class actions in state and federal courts across the country relating to securities fraud, breaches of fiduciary duty, and other violations of state and federal law. Kessler Topaz Meltzer & Check, LLP is a driving force behind corporate governance reform and has raised billions of dollars on behalf of institutional and individual investors in the United States and around the world. The company represents investors, consumers and whistleblowers (private citizens who report fraudulent practices against the government and participate in the recovery of public funds). The complaint in this action was not filed by Kessler Topaz Meltzer & Check, LLP. For more information on Kessler Topaz Meltzer & Check, LLP, please visit www.ktmc.com.

CONTACT:

Kessler Topaz Meltzer & Check, LLP
James Maro, Jr., Esq.
Adrienne Bell, Esq.
280 King of Prussia Road
Radnor, PA 19087
(844) 887-9500 (toll free)
[email protected]