Akebia Therapeutics, Inc. Image
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Akebia Therapeutics, Inc.

Class Action
  • Active
Investigation
03/14/2022
Initial Lawsuit
03/14/2022
Lawsuit Progression
05/13/2022

Investigation

Investors investigation into statements made by Akebia about its vadadustat PRO2TECT Program primary safety endpoint prospects and subsequent stock price decline.

  • Investigation Date
    03/14/2022
  • Hypothetical Affected Period
    June 28, 2018 to September 2, 2020
  • Hypothetical Transgression
    Securities Violation
Main Event

Safety Comes First?

09/03/2020

SEC Filing

Akebia announces results from its PRO2TECT Phase 3 clinical trial evaluating the efficacy and safety of vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), versus darbepoetin alfa for the treatment of anemia due to chronic kidney disease (CKD) in adult patients not on dialysis.

“Vadadustat achieved the primary and key secondary efficacy endpoint in each of the two PRO2TECT studies, demonstrating non-inferiority (NI) to darbepoetin alfa as measured by a mean change in hemoglobin (Hb) between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52). 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 major adverse cardiovascular events (MACE), which is the composite of all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke across both PRO2TECT studies.“

The stock impact compares the closing price immediately preceding the date of the event and the following closing price. The price difference also reflects the overall mix of information.

Stock Impact

Close Previous close Price variation Percentage variation
$2.65 $10.00 $-7.35 -73.5%
See more on Factual Timeline

Initial Lawsuit

First Complaint - 03/14/2022

This is a federal securities class action on behalf of a class consisting of all persons and entities other than defendants that purchased or otherwise acquired Akebia securities between June 28, 2018 and September 2, 2020, both dates inclusive.

Allegations

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 that:

(i) vadadustat was not assafe 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.

Defendants

  • Company
    Akebia Therapeutics, Inc.
  • Chief Executive Officer
    John P. Butler
  • Chief Financial Officer
    David A. Spellman
  • Chief Financial Officer
    Jason A. Amello

Lawsuit progression

  • Docket Number
    1:22-cv-01411
  • Court
    New York Eastern District Court

The lead plaintiff deadline has passed, we will update this page as the lawsuit progresses.
Last event retrieved on 09/19/2022.

Factual Timeline

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