NEW YORK, June 14, 2021 (GLOBE NEWSWIRE) – Pomerantz LLP announces that a class action lawsuit has been filed against FibroGen, Inc. (âFibroGenâ or the âCompanyâ) (NASDAQ: FGEN) and certain of its officers. The class action lawsuit, filed in the United States District Court for the Northern District of California, and registered as 21-cv-03212, is in the name of a group consisting of all persons and entities other than the defendants who purchased or otherwise acquired securities of FibroGen and / or sold put options from November 8, 2019 to April 6, 2021 inclusive (the âClass Periodâ), with the aim of recovering damages in accordance with Sections 10 (b) and 20 (a) of the Securities Exchange Act of 1934 (the “Exchange Act”), 15 USC Â§Â§ 78j (b) and 78t (a), and rule 10b-5 enacted thereunder (the “Class”).
If you are a shareholder who purchased securities of FibroGen during the Class Period, you have until June 11, 2021 to ask the court to appoint you as the primary claimant for the Class Action. A copy of the complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll free, Ext. 7980. Those inquiring by e-mail are encouraged to provide their mailing address, telephone number and the number of shares purchased.
FibroGen is a biopharmaceutical company that develops drugs for the treatment of anemia, fibrotic diseases and cancer. Its most advanced product is roxadustat, 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. In 2019, the Company filed its New Drug Application (âNDAâ) with the United States Food and Drug Administration (âFDAâ) for the approval of roxadustat for the treatment of anemia due to kidney disease. chronic (“CKD”).
Anemia can be a serious condition in which patients have insufficient numbers of red blood cells and low levels of hemoglobin, a protein in red blood cells that carries oxygen to cells throughout the body. Anemia in CRF is associated with an increased risk of hospitalization, cardiovascular complications, and death, also frequently causing severe fatigue, cognitive dysfunction, and reduced quality of life. Severe anemia is common in patients with CKD, cancer, myelodysplastic syndromes, inflammatory diseases, and other serious illnesses.
Anemia is particularly prevalent in patients with CRF. The prevalence of CRF in the adult population is estimated to be 10-12% worldwide and is generally a progressive disease characterized by progressive loss of renal function which can eventually lead to renal failure or end-stage renal disease, requiring dialysis or kidney transplant to survive. Blood transfusion is used to treat severe, life-threatening anemia. However, blood transfusions reduce the patient’s chances of having a kidney transplant and increase the risk of infections and the risk of complications such as heart failure and allergic reactions.
The complaint alleges that, throughout the Class Period, the Defendants made materially false and misleading statements regarding the activities of the Company. Specifically, the Defendants have made false and / or misleading statements and / or failed to disclose: (i) that the Company’s prior disclosures of primary cardiovascular safety testing in the United States of the roxadustat Phase 3 program for the treatment of anemia submitted under IRC included one-time post-changes in stratification factors; (ii) that FibroGen analyzes with pre-specified stratification factors result in higher risk ratios (point estimates of relative risk) and 95% confidence intervals; (iii) that, on the basis of these analyzes, the Company could not conclude that roxadustat reduces the risk of (or is greater than) MACE + in dialysis, and MACE and MACE + in incident dialysis compared to epoetin -alfa; (iv) that, therefore, the Company faced significant uncertainty as to whether its NDA for roxadustat as a treatment for CKD anemia would be approved by the FDA; and (v) that as a result of the foregoing, the Defendants’ statements regarding the activities, operations and prospects of the Company were substantially misleading and / or lacked reasonable basis.
On April 6, 2021, FibroGen issued a press release “provid[ing] clarification of certain prior disclosures of US primary cardiovascular safety testing of the phase 3 roxadustat program â. The CEO of the Company said that â[a]As members of senior management were preparing for the next FDA advisory committee meeting, we realized that key cardiovascular safety analyzes included post-hoc changes in stratification factors âandâ quickly decided to clarify this issue. with the FDA and to communicate with scientists and investment communities.
Also on April 6, 2021, STAT + published an article titled “Fibrogen Admits Fake Cardiac Safety Data for Experimental Anemia Pill Shared with FDA, Investors.” The article stated, among other things, that “Fibrogen admitted on Tuesday that the company has been touting fake heart safety data for its experimental anemia pill for at least two years – a shocking revelation that raises even more questions about the drug approval “, that”[w]When these changes have been removed and the cardiac safety data of roxadustat has been analyzed as specified in the analysis plan, the results are less robust âand thanâ[a]Going through three studies involving dialysis patients, Fibrogen said it could no longer conclude that roxadustat reduced the risk of cardiovascular events or hospitalization compared to a currently approved anemia injection used as a control.
As a result of these disclosures, the company’s stock price fell $ 14.90, or 43%, to close at $ 19.74 per share on April 7, 2021, on significant volume. FibroGen shares continued to decline on April 8, 2021, to close at $ 18.81 per share, down $ 0.93 per share, or 4.7%, on a large volume basis.
Pomerantz, with offices in New York, Chicago, Los Angeles and Paris, is recognized as one of the leading firms in the areas of corporate law, securities and antitrust litigation. Founded by the late Abraham L. Pomerantz, known as the Dean of the Class Actions Bar, Pomerantz was a pioneer in the field of securities class actions. Today, more than 80 years later, Pomerantz continues the tradition it established, fighting for the rights of victims of securities fraud, breach of fiduciary duty and professional misconduct. The firm has recovered numerous multi-million dollar damages on behalf of the members of the group. See www.pomerantzlaw.com
Robert S. Willoughby
888-476-6529 ext 7980