Akebia is a biopharmaceutical company that focuses on the development and commercialization of renal therapeutics for patients with kidney diseases. The Companys lead investigational product candidate is vadadustat, an oral therapy, which is in Phase 3 development for the treatment of anemia due to chronic kidney disease (CKD) in dialysis-dependent and non-dialysis dependent (NDD) adult patients. Akebias Phase 3 clinical programs for vadadustat include, among others, the PRO2TECT program in NDD-CKD patients with anemia (the PRO2TECT Program). The PRO2TECT Programs primary safety endpoint was defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of major adverse cardiovascular events (MACE). The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Companys business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or 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 Programs clinical prospects; (iii) accordingly, Defendants also overstated vadadustats overall commercial and regulatory prospects; and (iv) as a result, the Companys public statements were materially false and misleading at all relevant times. On September 3, 2020, Akebia issued a press release announcing top-line results from the PRO2TECT Program, disclosing that [v]adadustat 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.] On this news, Akebias common stock price fell $7.35 per share, or 73.5%, to close at $2.65 per share on September 3, 2020.
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