HomeMarket NewsMicro Cap StocksExpert Analyst Upgrades Akebia Therapeutics' Treatment for Kidney Disease-Related Anemia, Boosting Stock...

Expert Analyst Upgrades Akebia Therapeutics’ Treatment for Kidney Disease-Related Anemia, Boosting Stock Market Performance

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HC Wainwright has raised its rating of Akebia Therapeutics Inc (AKBA) from Neutral to Buy, expressing high confidence in the company’s treatment for anemia associated with chronic kidney disease.

According to analysts Ed Arce and Thomas Yip, Akebia Therapeutics recently received the official minutes from its End-of-Dispute Type A meeting with the FDA that took place in late July.

The company plans to resubmit its New Drug Application (NDA) for vadadustat, aimed at treating anemia in adult dialysis patients with chronic kidney disease, by the end of Q3 2023. The projected action date for FDA approval is March 2024.

HC Wainwright highlights that the resubmission is a focused effort, incorporating additional safety data gathered since the original NDA was filed. This includes data from two separate dosing studies and over two years of post-marketing information from Japan.

During the earnings call following the release of Q2 results, Akebia Therapeutics’ management outlined that labeling discussions were an important part of the meeting. These discussions involved data related to the risk of thromboembolic events and drug-induced liver injury, which were the primary concerns raised in the previous complete response letter.

With the confirmation of the meeting minutes, analysts now have a strong belief in the FDA’s upcoming approval of vadadustat, expected in early 2024.

Additionally, management anticipates a regulatory decision on vadadustat in Australia in 2023.

As of the latest check on Monday, AKBA shares have surged by 23.9% to $1.43.

Original Source: Benzinga.com

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