Akebia Therapeutics Securities Lawsuit Investigation

Shamis & Gentile P.A., a law firm that advocates for investors who are victims of securities fraud, is investigating potential claims against Akebia Therapeutics, Inc. (AKBA)

If you purchased or acquired Akebia Therapeutics securities and suffered losses, you may be eligible to join this securities investigation and seek compensation.

About Akebia Therapeutics

Akebia Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutics for patients with kidney disease. The company’s core product is Vafseo, a treatment designed for patients with chronic kidney disease (CKD), particularly those who are not on dialysis.

Potential Concerns Under Investigation

Attorneys are reviewing whether Akebia Therapeutics and certain executives made false or misleading statements or failed to disclose material information about the VALOR Phase 3 trial of Vafseo (vadadustat) and its regulatory prospects.

Between March and October 2025, Akebia allegedly told investors that the VALOR study remained on track. On March 13, 2025, during the Q4 2024 earnings call, management stated that Akebia expected to initiate the VALOR study in U.S. non-dialysis patients in the second half of the year. Similar statements were made in updates on May 8 and August 7, 2025, emphasizing that the company continued to work toward launching the trial before year-end.

However, on October 28, 2025, Akebia disclosed that the U.S. Food and Drug Administration had not agreed to the proposed trial design and that the company no longer planned to initiate VALOR. The company said the FDA required a much larger patient population than anticipated, making the study too costly and time-consuming to pursue.

This announcement appears to mark the first time Akebia publicly confirmed that the expansion trial would not proceed as previously represented.

Following the disclosure, Akebia’s stock fell approximately 32%, from $3.09 on October 28 to $2.10 at close the next trading day. Industry reports confirmed that the FDA feedback effectively ended plans to expand Vafseo’s label to non-dialysis CKD patients.

Lawyers are investigating whether Akebia accurately disclosed its communications with the FDA and whether statements about the VALOR trial’s progress misled investors about the company’s regulatory and commercial outlook.

Your Rights and Next Steps

This is an ongoing investigation and not a filed lawsuit. Investors who purchased or otherwise acquired Akebia Therapeutics securities between March 13, 2025 and October 28, 2025, and suffered financial losses may have legal rights. If evidence shows that investors were misled, a class action may be filed to recover damages for affected shareholders.

Lawyers are available to help investors review their options and determine whether they qualify to participate. There is no cost or obligation to join the investigation, and participation is confidential.

You May Be Entitled to Compensation

Securities investigations can move quickly, and there are often deadlines to take action. If you purchased or acquired Akebia Therapeutics securities between March 13, 2025 and October 28, 2025, you may be eligible to join this securities investigation and seek compensation.

To protect your rights and be considered for any potential recovery, complete the form below to join the investigation. Lawyers are ready to help answer questions and guide investors through the next steps.