Payoneer Global Inc. (PAYO)
Whether directors and officers of Payoneer Global Inc. (PAYO) breached their fiduciary duties to the company and its shareholders.
Investigation
04/12/2021
Initial Lawsuit
04/12/2021
Lawsuit Progression
08/30/2021
Investigation regarding FibroGen’s primary cardiovascular safety analysis of roxadustat Phase 3 program for the treatment of anemia of chronic kidney disease, notably post-hoc changes to the stratification factors included in the NDA submitted to the FDA.
04/06/2021
FibroGen discloses “additional” information on roxadustat:
“As members of senior management were preparing for the upcoming FDA Advisory Committee meeting, we became aware that the primary cardiovascular safety analyses included post-hoc changes to the stratification factors,” said Enrique Conterno, Chief Executive Officer, FibroGen. “While all of the analyses set forth below, including the differences in the stratification factors, were included in the NDA, we promptly decided to clarify this issue with the FDA and communicate with the scientific and investment communities.”
Mr. Conterno continued, “It is important to emphasize that this does not impact our conclusion regarding the comparability, with respect to cardiovascular safety, of roxadustat to epoetin-alfa in dialysis-dependent (DD) patients and to placebo in non-dialysis dependent (NDD) patients. We continue to have confidence in roxadustat’s benefit risk profile.”
FibroGen continues to prepare for the FDA Advisory Committee meeting and will work closely with the FDA to bring this important new treatment to patients living with anemia of CKD.
There is no change in the underlying roxadustat data, or to the efficacy analyses from the Phase 3 program. The Company has begun a comprehensive internal review to ensure such issues do not occur in the future.
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$19.74 | $34.64 | $-14.9 | -43.01% |
This is a federal class action brought individually and 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.
According to the complaint, 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 allegedly 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 certain safety analyses submitted in connection with 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;
(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.
08/30/2021
The court issued an order appointing the lead plaintiff and lead counsel.
10/29/2021
Lead Plaintiffs bring this amended complaint on behalf of all investors who purchased or otherwise acquired the common stock of FibroGen between December 20, 2018 through July 15, 2021, inclusive.
Operative complaint
01/14/2022
A motion to dismiss was filed with the court.
Whether directors and officers of Payoneer Global Inc. (PAYO) breached their fiduciary duties to the company and its shareholders.
Whether directors and officers of Builders FirstSource, Inc. (BLDR) breached their fiduciary duties to the company and its shareholders.
Whether directors and officers of LegalZoom.com, Inc. (LZ) breached their fiduciary duties to the company and its shareholders.
Whether directors and officers of Kewaunee Scientific Corporation (KEQU) breached their fiduciary duties to the company and its shareholders.
Whether directors and officers of Amicus Therapeutics, Inc. (FOLD) breached their fiduciary duties to the company and its shareholders.
Whether directors and officers of Inari Medical, Inc. (NARI) breached their fiduciary duties to the company and its shareholders.