FibroGen Inc FGEN

RADNOR, Pa., May 26, 2021 /PRNewswire/ -- The law firm of Kessler Topaz Meltzer & Check, LLP reminds investors that a securities fraud class action lawsuit has been filed against FibroGen, Inc. (NASDAQ: FGEN) ("FibroGen") on behalf of those who purchased or acquired FibroGen securities and/or sold put options from October 18, 2017 through April 6, 2021, inclusive (the "Class Period").

Investor Deadline Reminder:  Investors who purchased or acquired FibroGen securities during the Class Period may, no later than June 11, 2021, seek to be appointed as a lead plaintiff representative of the class. For additional information or to learn how to participate in this litigation 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; via e-mail at info@ktmc.com; or click https://www.ktmc.com/fibrogen-class-action-lawsuit?utm_source=PR&utm_medium=Link&utm_campaign=fibrogen 

FibroGen is a biopharmaceutical company that develops medicines for the treatment of anemia, fibrotic disease, and cancer. Its most advanced product is roxadustat ("Roxa"), an oral small molecule inhibitor of hypoxia-inducible factor-prolyl hydroxylase activity that acts by stimulating the body's natural pathway for red cell production.

The Class Period commences 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, "one study in CKD [chronic kidney disease] comparing roxadustat against a branded epoetin alfa[] and one study in CKD non-dialysis comparing roxadustat against placebo." Both studies had "met their primary efficacy endpoints with no new or unexpected safety signals identified." FibroGen touted these studies' positive safety throughout the Class Period.   

Having overcome the hurdle of demonstrating to the CFDA that Roxa was safe enough to submit an NDA, FibroGen proceeded to present itself as ready to conduct Phase 3 trials sufficient to support an NDA to the U.S. Food and Drug Administration ("FDA").  In 2019, FibroGen filed its NDA with the FDA for the approval of Roxa for the treatment of anemia due to CKD.

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

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

The complaint alleges that throughout the Class Period, the defendants made false and/or misleading statements or failed to disclose that: (1) based on the safety data from FibroGen's two Phase 3 trials in China, any safety data obtained from the global Phase 3 trials would require post-hoc changes to the stratification factors to meet the FDA's requirements; (2) FibroGen's disclosures of U.S. primary cardiovascular safety analyses from the Roxa global Phase 3 program for the treatment of anemia submitted in connection with CKD included post-hoc changes to the stratification factors; (3) FibroGen's analyses with the pre-specified stratification factors resulted in higher hazard ratios (point estimates of relative risk) and 95% confidence intervals; (4) based on these analyses, FibroGen could not conclude that Roxa reduces the risk of (or is superior to) MACE+ in dialysis, and MACE and MACE+ in incident dialysis compared to epoetin-alfa; (5) as a result, FibroGen faced significant uncertainty that its NDA for Roxa as a treatment for anemia of CKD would be approved by the FDA; and (6) as a result of the foregoing, the defendants' statements about FirboGen's business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times.

FibroGen investors may, no later than June 11, 2021, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLP or other counsel, or may choose to do nothing and remain an absent class member. A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. In order to be appointed as a lead plaintiff, the Court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.

Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country involving securities fraud, breaches of fiduciary duties and other violations of state and federal law. Kessler Topaz Meltzer & Check, LLP is a driving force behind corporate governance reform, and has recovered billions of dollars on behalf of institutional and individual investors from the United States and around the world. The firm represents investors, consumers and whistleblowers (private citizens who report fraudulent practices against the government and share in the recovery of government dollars). The complaint in this action was not filed by Kessler Topaz Meltzer & Check, LLP. For more information about 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)
info@ktmc.com

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SOURCE Kessler Topaz Meltzer & Check, LLP