About Akebia Therapeutics (AKBA)

Akebia Therapeutics Inc (AKBA) is a biopharmaceutical company that focuses on developing and commercializing innovative therapies for patients with kidney disease. The company's primary product candidate, vadadustat, is an oral therapy that is being evaluated for the treatment of anemia associated with chronic kidney disease (CKD). CKD is a common and serious condition that affects millions of people worldwide, and anemia is a common complication of the disease. Currently, the standard of care for the treatment of anemia in CKD patients is injectable erythropoiesis-stimulating agents (ESAs), which have limitations and safety concerns. Vadadustat has the potential to be a new and improved treatment option for CKD patients with anemia.

Akebia Therapeutics Inc (AKBA) has experienced both positive and negative developments in recent years. In 2019, the company announced positive top-line results from its global Phase 3 program evaluating vadadustat for the treatment of anemia in CKD patients. The results showed that vadadustat met the primary and key secondary endpoints, demonstrating non-inferiority and superiority to ESAs in increasing hemoglobin levels. This was a significant milestone for the company and highlighted the potential of vadadustat as a new standard of care for anemia in CKD. However, in 2020, Akebia Therapeutics faced a setback when the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for vadadustat. The FDA requested additional data to further evaluate the cardiovascular safety of vadadustat before considering its approval. Akebia Therapeutics is currently working on addressing the FDA's concerns and resubmitting the NDA.