Akebia Therapeutics, Inc. (AKBA) stock prices were up by a marginal 0.29% as of the market closing on May 28th, 2021, bringing the price per share up to USD$3.51 at the end of the trading day. Subsequent pre-market fluctuations have seen the stock rise by a significant 9.97%, bringing it up to USD$3.86.
NDA Submission of Vadadustat
The biopharmaceutical giant and its collaborative partner, Otsuka Pharmaceutical Co., Ltd, announced on June 1st, 2022 that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application for vadadustat. Vadadustat is designed to treat anemia arising from chronic kidney disease (CKD) in adult patients both on dialysis, and otherwise.
Forecast of Development
The FDA has set a target action date of March 29th, 2022 for the Prescription Drug User Fee Act (PDUFA) and has assigned the application standard review. The FDA is not currently planning to conduct an Advisory Committee meeting to discuss the application. The acceptance of the NDA for vadadustat is a significant milestone for the collaborative duo, AKBA, and Otsuka, as the pair continue to develop a new oral treatment option to patients living with anemia arising from CKD.
Bright Future for Vadadustat
The company is confident in both the clarity of their data, and its quality, and looks forward to collaborating with the FDA during the application review. AKBA continues to work with its collaborative partners to ensure the company is well situated to facilitate a successful commercial launch of vadadustat, pending approval by the FDA.
Vadadustat is being developed for commercialization around the world by AKBA and Otsuka, with the treatment forecasted to proliferate the U.S, European, Chinese, Russian, Canadian Australian, Middle Eastern, and other territories. The two companies are also collaborating to prepare a Marketing Authorization Application for vadadustat that is forecasted to be submitted to the European Medicines Agency later in the fiscal year 2021.
Solid Liquidity Position
As of March 31st, 2021, AKBA reported cash, cash equivalents, and available-for-sale securities amounting to USD$272.8 million. The company anticipates allocating the cash resources towards the funding of its existing operating plan beyond the expected launch of vadadustat in the U.S. This forecast hinges on the timely regulatory approval of the treatment, as well as the receipt of associated reulgatory milestones.
Future Outlook for AKBA
Armed with a solid liquidity position, the company is keen to push forward with the commercization and global proliferation of vadadastut, thus ushering in further growth. Current and potential investors are hopeful that AKBA will continue to leverage the resources at its disposal to facilitate significant and sustained increases in shareholder value.