NEW YORK, May 25, 2021 (GLOBE NEWSWIRE) – Scott + Scott Lawyers LLP (“Scott + Scott”), a global shareholder and consumer rights law firm, has announced that it has filed a class action lawsuit against FibroGen, Inc. (“FibroGen” or the “Company”) (NASDAQ: FGEN) and some of its officers who allege violations of federal securities laws. If you purchased FibroGen securities between November 8, 2019 and April 6, 2021 (the “Class Period”) and suffered a loss, please contact Attorney Rhiana Swartz for more information at (844) 818-6980 or to receive [email protected].
FibroGen is a biopharmaceutical company developing drugs to treat anemia, fibrotic diseases, and cancer. The most advanced product is Roxadustat, an oral low molecular weight inhibitor of hypoxia-inducible factor prolylhydroxylase activity, which stimulates the body’s natural pathway to produce red blood cells.
The complaint alleges that throughout the classroom, the defendants made or failed to disclose false and / or misleading statements: (1) Based on the safety data from the two Phase 3 trials of FibroGen in China, all safety data from the global phase 3 studies would require post hoc changes in stratification factors to meet FDA requirements; (2) FibroGen’s US Primary Cardiovascular Safety Assessments from Roxadustat’s Phase 3 Global Program for the Treatment of Chronic Kidney Disease Anemia (“CKD”) included post-hoc changes in stratification factors. (3) FibroGens analyzes with the specified stratification factors led to higher hazard rates (point estimates of the relative risk) and 95% confidence intervals; (4) Based on these analyzes, FibroGen was unable to conclude that Roxadustat reduced (or superior to) the risk of MACE + on dialysis and of MACE and MACE + on dialysis compared to epoetin-alfa. (5) As a result, FibroGen faced significant uncertainty that its NDA for roxadustat for the treatment of CKD anemia would be approved by the FDA. and (6) as a result of the foregoing, Defendants’ statements about the business, operations and prospects of FibroGen were materially false and misleading and / or were unfounded at all relevant times.
On March 1, 2021, FibroGen submitted its annual report on Form 10-K. In the 10-K, the company announced that the FDA had notified the company it would hold a meeting of the advisory committee to review the Roxadustat NDA. In the news, FibroGen’s share 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 retrospectively changed the stratification factors of its data to make Roxadustat’s exposure rates indicate a lower risk compared to the EPA. As a result of this admitted data manipulation, Enrique Conterno, CEO of FibroGen, stated that the company “can no longer conclude that we are achieving a statistically superior result on MACE compared to MACE [erythropoietin injectable therapies] in the [incident-dialysis patients]. ”
In that news, FibroGen stock fell another 43%, closing at $ 19.74 on April 7, 2021. In addition, several analysts lowered the FibroGen price targets and reduced the investment recommendations.
What you can do
If you bought FibroGen Securities between November 8, 2019 and April 6, 2021If you have any questions about this notice or your statutory rights, please contact Attorney Rhiana Swartz at (844) 818-6980 or [email protected] The lead plaintiff’s deadline is June 11, 2021.
About Scott + Scott
Scott + Scott has extensive experience pursuing major securities, antitrust, and consumer law litigation in the United States. The company represents pension funds, foundations, individuals and other companies worldwide with offices in New York, London, Amsterdam, Connecticut, California, Virginia and Ohio.
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