Kessler Topaz Meltzer & Check, LLP Reminds Investors of Class Action Lawsuit Against FibroGen, Inc. (FGEN)
RADNOR, PA / ACCESSWIRE / June 6, 2021 / Law firm Kessler Topaz Meltzer & Check, LLP reminds investors that a securities fraud class action has been brought against FibroGen, Inc. (NASDAQ: FGEN) (“FibroGen”) on behalf of those who have bought or acquired FibroGen securities and / or sold put options from October 18, 2017 through April 6, 2021 (the “Class Period”).
Investor Deadline Reminder: Investors who have purchased or acquired FibroGen Securities during the Class Action Period may be appointed as Class Class Representatives no later than June 11, 2021. For more information or information on 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; by email to email@example.com; 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 prolyl hydroxylase activity, which works by stimulating the body’s natural pathway for red blood cell production.
The class period begins on October 18, 2017, when FibroGen announced that the Chinese Food and Drug Administration has accepted its new drug application (“NDA”) for Roxa based on two Phase 3 studies in China, “a study to CKD “. [chronic kidney disease] Comparison of Roxadustat with a brand name epoetin alfa and a non-dialysis-free CKD study comparing roxadustat to placebo. “Both studies had” met their primary efficacy endpoints without identifying any new or unexpected safety signals. “
On April 6, 2021, after market close, FibroGen released a press release revealing that FibroGen’s previously published safety data contained undisclosed post-hoc changes in stratification factors and did not include analyzes based on the pre-established stratification factors. As a result of these changes, the complaint alleged that FibroGen was forced to admit that, contrary to previous representations, Roxa reduced the risk of cardiovascular events or hospitalization compared to a currently approved anemia injection, which was used as a control based on pre-specified stratification factors. Following this news, FibroGen’s share price fell $ 14.90, or 43%, to close at $ 19.74 per share on April 7, 2021.
The story goes on
The complaint alleges that during the class action period, defendants made false and / or misleading information or failed to disclose: (1) Based on the safety data from the two Phase 3 trials of FibroGen in China, all safety data from the global Phase 3 trials would require subsequent changes to the stratification factors to meet the requirements of the US Food and Drug Administration (“FDA”); (2) FibroGen’s publications on primary cardiovascular safety assessments in the United States from Roxa’s global Phase 3 program for the treatment of anemia submitted for CKD included post-hoc changes in stratification factors; (3) The analyzes of FibroGen with the previously defined stratification factors led to higher hazard ratios (point estimates of the relative risk) and 95% confidence intervals; (4) Based on these analyzes, FibroGen was unable to conclude that Roxa reduced (or superior to) the risk of MACE + on dialysis and MACE and MACE + on incident dialysis compared to epoetin-alfa; (5) As a result, FibroGen faced significant uncertainty that its NDA for Roxa for the treatment of anemia in CKD would be FDA approved; and (6) as a result of the foregoing, Defendants’ statements regarding FirboGen’s business, operations and prospects were materially false and misleading and / or were inadequate at all relevant times.
FibroGen investors can apply no later than June 11, 2021 to be appointed as lead class agent by Kessler Topaz Meltzer & Check, LLP, or other legal counsel, or they can choose to do nothing and remain an absent group member. A lead plaintiff is a representative party who acts on behalf of all class members in the conduct of the dispute. To be appointed as a lead plaintiff, the court must determine that the class plaintiff’s claim is typical of the claims of other class plaintiffs and that the class plaintiff is adequately representing the class action. Your ability to participate in a recovery will not be affected by whether or not you want to be the lead plaintiff.
Kessler Topaz Meltzer & Check, LLP pursues class actions in state and federal courts across the country involving securities fraud, fiduciary violations, and other violations of state and federal laws. Kessler Topaz Meltzer & Check, LLP is a driving force behind corporate governance reform and has collected billions of dollars on behalf of institutional and private investors from the US and around the world. The firm represents investors, consumers and whistleblowers (individuals who report fraudulent practices to the government and participate in recovery of government dollars). For more information on Kessler Topaz Meltzer & Check, LLP, please visit www.ktmc.com.
Kessler Topas Meltzer & Check, LLP
James Maro, Jr., Esq.
Adrienne Bell, Esq.
Radnor, PA 19087
(844) 887-9500 (toll free)
SOURCE: Kessler Topas Meltzer & Check, LLP
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