Robbins LLP is Investigating Allegations that Akero Therapeutics, Inc. (AKRO) Misled Investors Regarding the Viability and Efficacy of its Trial Drug Candidate

Robbins LLP informs investors that a shareholder filed a class action on behalf of all persons and entities that purchased or otherwise acquired Akero Therapeutics, Inc. (NASDAQ: AKRO) securities between September 13, 2022 and October 9, 2023. Akero is a clinical stage biopharmaceutical company that was founded to develop transformational medicines for patients with serious metabolic diseases that lack effective treatment options.  The Company is currently focused on advancing its lead product candidate efruxifermin (“EFX”) to provide a new treatment for patients with nonalcoholic steatohepatitis ("NASH"), a serious liver disease.

The Allegations

According to the complaint, during the class period, defendants failed to disclose: (a) 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); (b) that the cryptogenic cirrhotic patients included in the SYMMETRY study did not have biopsy-proven compensated cirrhosis due to definitive NASH; (c) 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; (d) 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; (e) 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 (f) that, as a result of (a)-(e) above, 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.

When the truth was revealed, the price of Akero stock closed down $30.39 per share on October 10, 2023, and $3.11 per share on October 11, 2023, on higher than average volume – a decline of nearly 70% from the stock’s closing price of $48.54 per share on October 9, 2023.

What Now: You may be eligible to participate in the class action against Akero Therapeutics, Inc. Shareholders who want to serve as lead plaintiff for the class must file their motions with the court by June 25, 2024. A lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation.  You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member.

All representation is on a contingency fee basis. Shareholders pay no fees or expenses.