NEW YORK--(BUSINESS WIRE)--Scott+Scott Attorneys at Law LLP (“Scott+Scott”), an international shareholder and consumer rights litigation firm, announces the filing of a class action lawsuit against FibroGen, Inc. (“FibroGen” or the “Company”) (NASDAQ: FGEN) and certain of its officers, alleging violations of federal securities laws. If you purchased FibroGen securities between November 8, 2019 through April 6, 2021 (the “Class Period”), and have suffered a loss, you are encouraged to contact attorney Rhiana Swartz for additional information at (844) 818-6980 or firstname.lastname@example.org.
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.
The complaint alleges that throughout the Class Period, the defendants made false and/or misleading statements or failed to disclose that: (1) based on the safety data from FibroGen's two Phase 3 trials in China, any safety data obtained from the global Phase 3 trials would require post-hoc changes to the stratification factors to meet the FDA's requirements; (2) FibroGen's disclosures of U.S. primary cardiovascular safety analyses from the roxadustat global Phase 3 program for the treatment of anemia submitted in connection with Chronic Kidney Disease (“CKD”) included post-hoc changes to the stratification factors; (3) FibroGen's analyses with the pre-specified stratification factors resulted in higher hazard ratios (point estimates of relative risk) and 95% confidence intervals; (4) based on these analyses, FibroGen 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; (5) as a result, FibroGen faced significant uncertainty that its NDA for roxadustat as a treatment for anemia of CKD would be approved by the FDA; and (6) as a result of the foregoing, the defendants' statements about FibroGen's business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times.
On March 1, 2021, FibroGen filed its Annual Report on Form 10-K. In the 10-K, the Company announced that the FDA had informed the Company it would hold an advisory committee meeting to review the roxadustat NDA. On this news, FibroGen’s stock price fell $12.46 per share, or 24.66%, to close at $38.07 per share on March 2, 2021.
Then, on April 6, 2021, FibroGen shocked the market by admitting that the Company had altered stratification factors of its data after-the-fact in order to make roxadustat’s hazard ratios indicate a lower risk relative to EPO. As a result of this admitted data manipulation, FibroGen CEO, Enrique Conterno, stated that the Company “can no longer make the conclusion that we have a statistically superior result when it comes to MACE relative to [erythropoietin injectable therapies] in [incident-dialysis patients].”
On this news, the price of FibroGen shares plummeted another 43%, to close at $19.74 on April 7, 2021. In addition, several analysts slashed FibroGen price targets and reduced investment recommendations.
What You Can Do
If you purchased FibroGen securities between November 8, 2019 through April 6, 2021, or if you have questions about this notice or your legal rights, you are encouraged to contact attorney Rhiana Swartz at (844) 818-6980 or email@example.com. The lead plaintiff deadline is June 11, 2021.
Scott+Scott has significant experience in prosecuting major securities, antitrust, and consumer rights actions throughout the United States. The firm represents pension funds, foundations, individuals, and other entities worldwide with offices in New York, London, Amsterdam, Connecticut, California, Virginia, and Ohio.