Kessler Topaz Meltzer & Check, LLP Announces a Securities Fraud Class Action Lawsuit Filed Against FibroGen, Inc. (FGEN)
RADNOR, Pa., May 26, 2021 / PRNewswire / – Kessler Topaz Meltzer & Check, LLP law firm reminds investors that a class action lawsuit has been filed against FibroGen, Inc. (NASDAQ: FGEN) (“FibroGen”) on behalf of those who have purchased or acquired FibroGen – Securities and / or put options sold by October 18, 2017 by April 6, 2021including (the “Class Period”).
Investor deadline reminder: Investors who bought or acquired FibroGen securities during the class period can do so no later than June 11, 2021try to be appointed as the plaintiff’s principal representative of the class. For more 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; per email 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 developing drugs to treat anemia, fibrotic diseases, and cancer. Its most advanced product is Roxadustat (“Roxa”), an oral low molecular weight inhibitor of hypoxia-inducible factor prolylhydroxylase activity, which stimulates the body’s natural pathway to produce red blood cells.
The lesson begins on October 18, 2017 when FibroGen announced that the Chinese Food and Drug Administration (“CFDA”) had accepted its new drug application (“NDA”) for Roxa based on two Phase 3 studies China“A study in CRF [chronic kidney disease] Comparison of Roxadustat with a brand name epoetin alfa and a non-dialysis CKD study comparing roxadustat with placebo. “Both studies had” met their primary efficacy endpoints without identifying any new or unexpected safety signals. “FibroGen indicated the positive safety of these studies throughout the classroom.
After FibroGen overcome the hurdle of demonstrating to the CFDA that Roxa was safe enough to file an NDA, it presented itself as ready to conduct Phase 3 studies sufficient to obtain an NDA in the U.S. Food and Drug Administration (“FDA”) support. In 2019, FibroGen filed its NDA with the FDA for approval of Roxa for the treatment of anemia due to CRF.
The truth was beginning to show March 1, 2021 When FibroGen announced after market close that the FDA was planning a meeting of the Advisory Committee to review Roxa’s NDA, well over a year after its initial filing. An advisory committee meeting this late in the review process indicates that there is a problem with the application and, at best, could delay the FDA’s approval decision and, at worst, signal that the FDA may not approve the drug. Following the news, FibroGen’s share price fell $ 12.46 per share or 25%.
Then further April 6, 2021After the market closed, FibroGen issued a press release stating that FibroGen’s previously released safety data included undisclosed post-hoc changes in stratification factors and no analysis based on the specified stratification factors. As a result of these changes, the complaint alleges that FibroGen was forced to admit that, contrary to previous statements, Roxa does not reduce the risk of cardiovascular events or hospitalization compared to a currently approved anemia injection, which was used as a control based on preliminary studies have decreased. specified stratification factors. Following the news, FibroGen’s share price fell $ 14.90or 43% to close at $ 19.74 per share on April 7, 2021.
The complaint alleges that throughout the classroom the defendants made false and / or misleading statements or failed to disclose: (1) Based on the safety data from the two Phase 3 studies of FibroGen in ChinaAny safety data obtained from the global phase 3 trials would require post hoc changes in stratification factors to meet FDA requirements. (2) FibroGen’s US primary cardiovascular safety analysis from Roxa’s global Phase 3 program for the treatment of CKD-related anemia included post-hoc changes in stratification factors. (3) FibroGens analyzes with the specified stratification factors led to higher hazard rates (point estimates of the relative risk) and 95% confidence intervals; (4) Based on these analyzes, FibroGen was unable to conclude that Roxa reduced (or was superior to) the risk of MACE + on dialysis and MACE and MACE + on dialysis compared to epoetin-alfa. (5) As a result, FibroGen faced significant uncertainty that its NDA for Roxa for the treatment of CKD anemia would be approved by the FDA. and (6) as a result of the foregoing, Defendants’ statements about FirboGen’s business, operations and prospects were materially false and misleading and / or had no reasonable basis at all relevant times.
FibroGen investors may at the latest June 11, 2021, attempt to be appointed as the class lead plaintiff by Kessler Topaz Meltzer & Check, LLP, or other attorney, or 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 dispute. To be named 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 is adequately representing the class. Your ability to get involved in a recovery will not be affected by whether or not you will be the lead plaintiff.
Kessler Topaz Meltzer & Check, LLP, pursues class action lawsuits in state and federal courts across the country involving securities fraud, fiduciary violations, and other violations of federal and state law. Kessler Topaz Meltzer & Check, LLP, is a driving force behind corporate governance reform and has collected billions of dollars on behalf of institutional and individual investors The United States and all over the world. The company represents investors, consumers and whistleblowers (individuals who report fraudulent practices against the government and are involved in recovering government dollars). The complaint in this lawsuit was not filed by Kessler Topaz Meltzer & Check, LLP. Further information on Kessler Topaz Meltzer & Check, LLP can be found at www.ktmc.com.
Kessler Topaz Meltzer & Check, LLP
James Maro Jr., Esq.
Adrienne Bell, Esq.
280 Street of the King of Prussia
Radnor, PA 19087
(844) 887-9500 (toll free)
SOURCE Kessler Topaz Meltzer & Check, LLP