Deadline Reminder: Law Offices of Howard G. Smith Reminds Investors of Looming Deadline in the Class Action Lawsuit Against FibroGen Inc. (FGEN)

<br /> Deadline Reminder: Law Offices of Howard G. Smith Reminds Investors of Looming Deadline in the Class Action Lawsuit Against FibroGen Inc. (FGEN)<br />

Investors with losses exceeding $100,000 are encouraged to contact the firm

PR Newswire


BENSALEM, Pa.

,

May 11, 2021

/PRNewswire/ — Law Offices of

Howard G. Smith

reminds investors of the upcoming


June 11, 2021


deadline to file a lead plaintiff motion in the class action filed on behalf of investors who purchased or otherwise acquired FibroGen Inc. (“FibroGen” or the “Company”) (NASDAQ: FGEN) securities between


October 18, 2017

and

April 6, 2021


, inclusive (the “Class Period”).

Investors suffering losses on their FibroGen investments are encouraged to contact the Law Offices of

Howard G. Smith

to discuss their legal rights in this class action at 888-638-4847 or by email to

[email protected]

.

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 (“HIF-PH”) activity that acts by stimulating the body’s natural pathway for red cell production. In

December 2019

, the Company filed its New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) for the approval of roxadustat for the treatment of anemia due to chronic kidney disease (“CKD”).

On

April 6, 2021

, after the market closed, FibroGen 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, the Company stated that the safety analyses “included post-hoc changes to the stratification factors.” FibroGen 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.”

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 unusually heavy trading volume.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that certain safety analyses submitted in connection with FibroGen’s NDA for roxudustat included post-hoc changes to stratification factors; (2) that, based on analyses using the pre-specified stratification factors, the Company could not conclude that roxadustat reduces the risk of major adverse cardiovascular events compared to epoetin-alfa; (3) 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 (4) as a result, Defendants’ statements about its business, operations, and prospects were materially false and misleading and/or lacked reasonable basis at all relevant times.

If you purchased or otherwise acquired FibroGen securities during the Class Period, you may move the Court no later than


June 11, 2021


to ask the Court to appoint you as lead plaintiff if you meet certain legal requirements. To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action. If you wish to learn more about this class action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact

Howard G. Smith, Esquire

, of Law Offices of

Howard G. Smith

, 3070 Bristol Pike, Suite 112,

Bensalem, Pennsylvania

19020, by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to

[email protected]

, or visit our website at

www.howardsmithlaw.com

.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.


Contacts


Law Offices of

Howard G. Smith



Howard G. Smith, Esquire


215-638-4847

888-638-4847


[email protected]



www.howardsmithlaw.com

Cision
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SOURCE Law Offices of

Howard G. Smith