Akebia Therapeutics Securities Fraud Investigation

Shamis & Gentile, P.A. is investigating claims on behalf of investors of Akebia Therapeutics ("Akebia Therapeutics" or the "Company") (AKBA). Impacted investors are advised to contact the firm now.

The law firm is investigating whether Akebia Therapeutics and certain of its officers and directors may have made false or misleading statements or failed to disclose material information about the status and prospects of the VALOR Phase 3 clinical trial of Vafseo (vadadustat) for non-dialysis chronic kidney disease (CKD) patients between March 13, 2025, and October 28, 2025.

Throughout this period, Akebia repeatedly indicated that the VALOR study remained on track. On March 13, 2025, during the Company’s 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 issued on May 8 and August 7, 2025, emphasizing continued progress toward launching the trial before year-end. However, on October 28, 2025, Akebia disclosed that the U.S. Food and Drug Administration (FDA) 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.

Following the disclosure, Akebia’s stock fell approximately 32%, from $3.09 on October 28 to $2.10 at close the next trading day, causing significant losses to investors.

If you purchased or otherwise acquired Akebia Therapeutics (AKBA) securities between March 13 and October 28, 2025, you may be eligible to seek compensation for losses. Contact Shamis & Gentile, P.A. today to discuss your options.

Shamis & Gentile, P.A. stands out as an advocate for investors who are victims of securities fraud. The firm is committed to securing recoveries for investors who have incurred damages due to false and misleading statements or other corporate misconduct by public companies. Shamis & Gentile has recovered over $1 billion for consumers nationwide. Its extensive experience, expertise and resources enable the firm to resolve disputes in a wide range of matters, including class actions, mass torts and mass arbitrations.

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