San Francisco, California--(Newsfile Corp. - April 12, 2021) - On April 12, 2021, Berman Tabacco's California office filed a class action lawsuit for violations of the federal securities laws against FibroGen, Inc. ("FibroGen" or the "Company") (NASDAQ: FGEN), and certain of its current and former officers and directors, on behalf of all other persons and entities who purchased or otherwise acquired FibroGen securities and/or sold put options from November 8, 2019, through and including April 6, 2021 (the "Class Period").
The lawsuit was filed in U.S. District Court in the Northern District of California and asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, 15 U.S.C. §§78j(b) and 78t(a). The case is captioned Xu v. FibroGen, Inc., et al., No. 3:21-cv-02623. A copy of the complaint is available on the firm's website https://bit.ly/3uXOY1l.
The complaint alleges that, on August 18, 2019, the Company issued a press release announcing, "Positive Phase 3 Pooled Roxadustat Safety and Efficacy Results" and that shortly thereafter on December 23, 2019, FibroGen announced that it had submitted a New Drug Application to the Food and Drug Administration for roxadustat.
The complaint further alleges that on April 6, 2021, the Company revealed that its previously disclosed safety data included undisclosed post-hoc changes to the stratification factors and did not include analyses based on the pre-specified stratification factors. As a result of these changes, the complaint alleges, FibroGen was forced to concede that roxadustat, contrary to prior representations, did not reduce the risk of cardiovascular events or hospitalization as compared to a currently approved anemia injection used as a control based on pre-specified stratification factors. On this news, the Company's share price fell $14.90, or 43%, to close at $19.74 per share on April 7, 2021, on heavy volume.
The complaint alleges that Defendants failed to disclose to investors: (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 of 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.
If you wish to serve as Lead Plaintiff for the Class, you must file a motion to serve as Lead Plaintiff with the Court no later than sixty (60) days from the date of this notice. Any member of the proposed Class may either move the Court to serve as Lead Plaintiff through counsel of their choice, or choose to do nothing and remain a member of the proposed Class.
If you wish to discuss this action or have any questions concerning this notice or your rights or interests, please visit: https://www.bermantabacco.com/case/fibrogen-inc/.
Berman Tabacco is a national law firm representing institutions and individuals in lawsuits, seeking to recoup losses caused by corporate and board misconduct and violations of the securities and antitrust laws. The firm has offices in San Francisco, California and Boston, Massachusetts.
This notice may constitute attorney advertising.
Jeffrey Miles, Esq.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/80182