Case Background:
This is a federal securities fraud class action lawsuit on behalf of those who purchased or otherwise acquired Akero Therapeutics, Inc. (“Akero”) (NASDAQ: AKRO) common stock between September 13, 2022 and October 9, 2023, inclusive (the “Class Period”).
Akero is a clinical-stage biopharmaceutical company focused on the development of therapies for people with serious metabolic diseases. Its lead product candidate, efruxifermin (“EFX”), purported to provide a new treatment for patients with a serious liver disease called nonalcoholic steatohepatitis (“NASH”). Akero launched its SYMMETRY study, which was said to be evaluating EFX in patients with biopsy-confirmed NASH.
The complaint alleges that, throughout the Class Period, Defendants made false and/or misleading statements and/or failed to disclose that: (1) approximately 20% of the patients enrolled in the SYMMETRY study had cryptogenic cirrhosis and did not have definitive NASH at baseline; (2) the cryptogenic cirrhotic patients included in the SYMMETRY study did not have biopsy-proven compensated cirrhosis due to definitive NASH; (3) the results from the cryptogenic cirrhosis patients were to be excluded from the calculation of the NASH resolution secondary endpoints; (4) Akero had introduced a confounding factor into the SYMMETRY study's design, materially influencing the study's potential results and increasing the risks that the study would fail to meet its primary endpoint; (5) the SYMMETRY study did not align with U.S. Food & Drug Administration guidance for testing a drug in treating NASH cirrhosis because Akero had not ruled out potential causes of each patient's cirrhosis other than NASH; (6) consequently, Akero had materially misrepresented the nature of the SYMMETRY trial, its usefulness in supporting any new drug application, the likelihood that the SYMMETRY trial would be successful as measured by its primary endpoint, and the likelihood that EFX would become a commercial treatment for NASH cirrhosis; and (7) as a result of the foregoing, Defendants’ statements about the company’s business, operations, and prospects were materially false and/or misleading and/or lacked a reasonable basis at all relevant times.
Current Status of Case:
On August 15, 2025, the Court granted Defendants’ Motion to Dismiss the Amended Complaint. On September 12, 2025, the Lead Plaintiffs appealed the dismissal to the United States Court of Appeals for the Ninth Circuit. The appeal is currently being briefed by the parties. This action is ongoing.
If you wish to discuss this action or have any questions, please contact Kessler Topaz Meltzer & Check, LLP: Jon Naji, Esq. (484) 270-1453; toll-free at (844) 887-9500; or via e-mail at info@ktmc.com. If you would like additional information about the suit, please click on the link "Submit Your Information" above and fill out the form as promptly as possible.