SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in FibroGen, Inc. of Class Action Lawsuit and Upcoming Deadline
NEW YORK, June 1, 2021 / PRNewswire / – Pomerantz LLP announces that a class action lawsuit has been filed against FibroGen, Inc. (“FibroGen” or the “Company”) (NASDAQ: FGEN) and some of its officers. The class action filed in The United States District Court for the Northern District of California, and registered at 21-cv-03212, is on behalf of a class consisting of all individuals and legal entities other than the Defendants who have bought or otherwise purchased and / or sold put options of FibroGen Securities November 8, 2019, through and including April 6, 2021 (the “Collection Period”) to seek damages under Sections 10 (b) and 20 (a) of the Securities Exchange Act of 1934 (the “Exchange Act”), 15 USC Sections 78j (b) and 78t (a) and Rule 10b-5 published below (the “class”).
If you are a shareholder who purchased FibroGen securities during the class action period, you have up to June 11, 2021 ask the court to appoint you as the lead plaintiff for the class action. A copy of the complaint is available at www.pomerantzlaw.com. To discuss this action, please contact Robert S. Willoughby at the [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, extension. 7980. Inquiries by email are encouraged to include their postal address, telephone number, and the number of shares purchased.
[Click here for information about joining the class action]
FibroGen is a biopharmaceutical company developing drugs to treat anemia, fibrotic diseases, and cancer. The 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 red blood cell production. In 2019, the company filed its new drug application (“NDA”) with the US Food and Drug Administration (FDA) for approval of roxadustat for the treatment of anemia due to chronic kidney disease (“CKD”).
Anemia can be a serious condition in which patients have too few 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 an increased risk of hospitalization, cardiovascular complications, and death, and often leads to significant fatigue, cognitive dysfunction, and decreased quality of life. Severe anemia is common in people with CKD, cancer, myelodysplastic syndromes, inflammatory diseases, and other serious illnesses.
Anemia is particularly common in people with CKD. The prevalence of CKD in the adult population is estimated at 10-12% worldwide and is generally a progressive disease characterized by gradual loss of kidney function that can eventually lead to kidney failure or end-stage kidney disease that is essential for survival Requires dialysis or a kidney transplant. Blood transfusions are used to treat life-threatening severe anemia. However, blood transfusions decrease the patient’s chance for a kidney transplant and increase the risk of infection and the risk of complications such as heart failure and allergic reactions.
The lawsuit alleges that defendants made essentially false and misleading statements about the company’s business during the class action period. Specifically, Defendants made false and / or misleading statements and / or failed to disclose: (i) that the Company’s previous disclosures related to primary cardiovascular safety testing in the United States from the Roxadustat Phase 3 anemia treatment program related to were submitted with CRF, post-hoc changes in stratification factors; (ii) FibroGen’s analyzes with the pre-determined stratification factors lead to higher hazard ratios (point estimates of the relative risk) and 95% confidence intervals; (iii) based on these analyzes, the Company has not been able to conclude that Roxadustat reduces (or is superior to) the risk of MACE + on dialysis and MACE and MACE + on incident dialysis compared to epoetin alfa; (iv) as a result, the Company faced significant uncertainty as to whether its NDA for roxadustat for the treatment of anemia in 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 improperly based.
On April 6, 2021, FibroGen published a press release “provided”[ing] Clarification of certain prior disclosures of primary cardiovascular safety analyzes in the United States from the Roxadustat Phase 3 program. “The Company’s Chief Executive Officer stated that”[a]As senior management prepared for the upcoming FDA Advisory Committee meeting, realizing that the primary cardiovascular safety analyzes included post-hoc changes in stratification factors, “we immediately decided to work with the FDA to resolve this issue to communicate to science “. and investment communities.”
On too April 6, 2021, STAT + published an article titled “Fibrogen Provides Incorrect Cardiac Safety Data for Experimental Anemia Pills, which has been shared with the FDA and investors.” The article said, among other things, “Fibrogen confirmed on Tuesday that the company has been promoting 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 approval.” “[w]When these changes were removed and the Roxadustat cardiac safety data analyzed as specified in the analysis plan, the results are less robust.[a]After three studies with dialysis patients, Fibrogen can no longer conclude that roxadustat reduces the risk of cardiovascular events or hospitalization compared to a currently approved anemia injection as a control.
After these releases, the company’s share price fell $ 14.90, or 43% to close around $ 19.74 per share April 7, 2021, at high volume. FibroGen’s shares continued to attract attention April 8, 2021, to close $ 18.81 per share a decrease of $ 0.93 per share or 4.7% for high volumes.
The Pomerantz company with offices in new York, Chicago, The angel, and Paris is recognized as one of the leading law firms in the areas of corporate, securities and antitrust litigation. Founded by the late Abraham L. Pomerantz, known as the Dean of the Class Action Chamber, Pomerantz was a pioneer in the field of securities class actions. Today, more than 80 years later, the Pomerantz law firm continues the tradition he founded and fights for the rights of victims of securities fraud, breaches of duty of loyalty and corporate misconduct. The company has collected numerous millions of dollars in damages on behalf of class members. See www.pomerantzlaw.com
Robert S. Willoughby
888-476-6529 ext. 7980
SOURCE Pomerantz LLP