Akero Therapeutics, Inc.

On October 10, 2023, Akero announced the results of its Phase 2b SYMMETRY trial, revealing that the study had failed to meet its primary endpoint. On this news, Akero’s stock price fell $30.39, or 62.6%, to close at $18.15 per share on October 10, 2023, thereby injuring investors.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that approximately 20% of the patients enrolled in the SYMMETRY study had cryptogenic cirrhosis and did not have definitive NASH at baseline (an NAFLD activity score of greater than or equal to 3, with a score of at least 1 in each of the components of steatosis, ballooning, and inflammation); (2) that the cryptogenic cirrhotic patients included in the SYMMETRY study did not have biopsy-proven compensated cirrhosis due to definitive NASH; (3) that the results from the cryptogenic cirrhosis patients – i.e., those who did not have definitive NASH – were to be excluded from the calculation of the NASH resolution secondary endpoints; (4) that, as a result of the inclusion of cryptogenic cirrhotics in the SYMMETRY study and in the calculation of the study’s primary endpoint, Akero had introduced a confounding factor into the 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) that the SYMMETRY study did not align with FDA guidance for testing a drug in treating NASH cirrhotics because Akero had not ruled out potential causes of each patient’s cirrhosis other than NASH; and (6) that, as a result of the foregoing, defendants had materially misrepresented the nature of the SYMMETRY trial, its usefulness in supporting any new drug application filed by Akero in supporting approval for cirrhotic NASH patients, 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 cirrhotics; and (7) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.