Akebia Therapeutics, Inc.

Investigation
03/14/2022

Initial Lawsuit
03/14/2022

Lawsuit Progression
05/13/2022

Investigation

Continous Holding
June 28, 2018 to September 2, 2020
Proposed Claim
Securities Violation

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

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%

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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.

Filing Date
03/14/2022
Class Period
06/28/2018 to 09/02/2020
Transgression
Securities Violation
Filing Firms
Bronstein, Gewirtz & Grossman, LLC
Pomerantz LLP
Case Title
Deputy v. Akebia Therapeutics, Inc. et al
Docket Number
1:22-cv-01411
Court
New York Eastern District Court
Free File
Complaint

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.