The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's 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 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. 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.]"