A lawsuit was filed on behalf of investors in FibroGen, Inc. (NASDAQ:FGEN) shares over alleged securities laws violations.

San Diego, CA -- (SBWire) -- 04/27/2021 --An investor, who purchased NASDAQ: FGEN shares, filed a lawsuit against FibroGen, Inc over alleged Securities Laws violations.

Investors who purchased shares of FibroGen, Inc. (NASDAQ: FGEN) have certain options and for certain investors are short and strict deadlines running. Deadline: June 11, 2021. NASDAQ: FGEN investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

San Francisco, CA based FibroGen, Inc., a biopharmaceutical company, discovers, develops, and commercializes therapeutics to treat serious unmet medical needs.

On August 18, 2019, FibroGen, Inc. announced "Positive Phase 3 Pooled Roxadustat Safety and Efficacy Results" and that shortly thereafter on December 23, 2019, FibroGen, Inc. announced that it had submitted a New Drug Application to the Food and Drug Administration for roxadustat.

On April 6, 2021, after the market closed, FibroGen, Inc. issued a statement "provid[ing] clarification of certain prior disclosures of U.S. primary cardiovascular safety analyses from the roxadustat Phase 3 program for the treatment of anemia of chronic kidney disease ('CKD')." Specifically, FibroGen, Inc. stated that the safety analyses "included post-hoc changes to the stratification factors." FibroGen, Inc. further revealed that, based on analyses using the pre-specified stratification factors, the Company "cannot 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."

The plaintiff claims that between November 8, 2019 and April 6, 2021, the Defendants failed to disclose to investors 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, that FibroGen's analyses with the pre-specified stratification factors result in higher hazard ratios (point estimates of relative risk) and 95% confidence intervals, 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, 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 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.

Those who purchased shares of FibroGen, Inc. (NASDAQ: FGEN) have certain options and should contact the Shareholders Foundation.

Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, , which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigation, and/or settlements are not filed/reached and/or related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.