Pomerantz Appointed Co-Lead Counsel in Akebia Therapeutics Securities Litigation

On May 27, 2022, U.S. Magistrate Judge Vera M. Scanlon of the Eastern District of New York appointed Pomerantz LLP as Co-Lead Counsel on behalf of Abraham Kiswani, the Co-Lead Plaintiff, and the class, in Deputy v. Akebia Therapeutics, Inc., 22-cv-1411 (E.D.N.Y.). This securities action alleges that Akebia Therapeutics, Inc. ("Akebia" or the "Company") misled the market regarding the efficacy of its lead product, vadadustat, and overstated the regulatory and commercial prospects for the drug.

Akebia is a biopharmaceutical company that focuses on the development and commercialization of therapeutics for patients suffering from kidney disease. The Company’s lead product, vadadustat, is in phase 3 of clinical trials, which include the PRO₂TECT Program for dialysis-dependent and non-dialysis dependent (“NDD”) adults living with chronic kidney disease (“CKD”). The PRO₂TECT Program’s primary safety endpoint was defined as non-inferiority of vadadustat versus darbepoetin alfa, its competitor, in time to first occurrence of major adverse cardiovascular events.

Allegations include that the company failed to disclose that: (i) vadadustat was not as safe in treating NDD-CKD patients with anemia as Defendants had represented; (ii) as a result, Defendants overstated the PRO₂TECT Program’s clinical prospects; (iii) accordingly, Defendants also overstated vadadustat’s overall commercial and regulatory prospects; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.

The truth emerged on September 3, 2020, when Akebia announced that vadadustat had failed to meet its primary safety endpoint in the PRO₂TECT study. Specifically, the Company’s press release stated that “Vadadustat did not meet the primary safety endpoint of the PRO₂TECT program, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of [MACE], which is the composite of all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke across both PRO₂TECT studies.”

On this news, Akebia’s share price fell by 73.5%.