If you are a shareholder who purchased FibroGen securities during the Class Period, you have until June 11, 2021 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at firstname.lastname@example.org or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
FibroGen is a biopharmaceutical company that develops medicines for the treatment of anemia, fibrotic disease, and cancer. Its most advanced product is roxadustat, 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. In 2019, the Company filed its New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) for the approval of roxadustat for the treatment of anemia due to chronic kidney disease (“CKD”).
Anemia can be a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin, a protein in red blood cells that carries oxygen to cells throughout the body. Anemia in CKD is associated with increased risk of hospitalization, cardiovascular complications, and death, also frequently causing significant 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 CKD. The prevalence of CKD in the adult population is estimated at 10-12% globally and is generally a progressive disease characterized by gradual loss of kidney function that may eventually lead to kidney failure, or end stage renal disease, requiring dialysis or kidney transplant to survive. Blood transfusion is used for treating life-threatening severe anemia. However, blood transfusions reduce the patient’s opportunity for 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, Defendants made materially false and misleading statements regarding the Company’s business. Specifically, Defendants made false and/or misleading statements and/or failed to disclose: (i) that the Company’s prior disclosures of U.S. primary cardiovascular safety analyses from the roxadustat Phase 3 program for the treatment of anemia submitted in connection with CKD included post-hoc changes to the stratification factors; (ii) that FibroGen’s analyses with the pre-specified stratification factors result in higher hazard ratios (point estimates of relative risk) and 95% confidence intervals; (iii) that, based on these analyses, the Company could not conclude that roxadustat reduces the risk of (or is superior to) MACE+ in dialysis, and MACE and MACE+ in incident dialysis compared to epoetin-alfa; (iv) that, as a result, the Company faced significant uncertainty that its NDA for roxadustat as a treatment for anemia of CKD would be approved by the FDA; and (v) that, as a result of the foregoing, Defendants’ statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
On April 6, 2021, FibroGen issued a press release “provid[ing] clarification of certain prior disclosures of U.S. primary cardiovascular safety analyses from the roxadustat Phase 3 program”. The Company’s Chief Executive Officer stated that “[a]s members of senior management were preparing for the upcoming FDA Advisory Committee meeting, we became aware that the primary cardiovascular safety analyses included post-hoc changes to the stratification factors” and “promptly decided to clarify this issue with the FDA and communicate with the scientific and investment communities.”
Also on April 6, 2021, STAT+ published an article entitled “Fibrogen admits false heart-safety data for experimental anemia pill shared with FDA, investors.” The article stated, among other things, that “Fibrogen acknowledged Tuesday that the company has been touting false heart-safety data for its experimental anemia pill for at least two years — a shocking revelation that raises even more questions about the drug’s approvability,” that “[w]hen those changes were removed and roxadustat’s heart-safety data were analyzed as pre-specified in the analysis plan, the results are less robust,” and that “[a]cross three studies involving dialysis patients, Fibrogen said it can no longer conclude that roxadustat reduces the risk of cardiovascular events or hospitalization compared to a currently approved anemia injection used as a control.”
Following these disclosures, the Company’s share price fell $14.90, or 43%, to close at $19.74 per share on April 7, 2021, on heavy volume. FibroGen’s shares continued to fall on April 8, 2021, to close at $18.81 per share, a decline of $0.93 per share, or 4.7%, on heavy volume.
The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com
Robert S. Willoughby
888-476-6529 ext. 7980