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Akero Therapeutics, Inc.

Case Details

Class Period: September 13, 2022 - October 9, 2023
Date Filed: April 26, 2024
Case Number: 4:24-cv-02534
Jurisdiction: Northern District of California
icon-casetype Case Type: Securities Case
Days Left to
Seek Plaintiff:
12

Case Summary

Akero is a clinical stage biopharmaceutical company focused on advancing its lead product candidate efruxifermin (“EFX”) to provide a new treatment for patients with nonalcoholic steatohepatitis (“NASH”), a serious liver disease. During the Class Period, Akero claimed to be evaluating EFX in two Phase 2 clinical trials in patients with biopsy-confirmed NASH: (i) Akero’s “HARMONY” trial that tested EFX in pre-cirrhotic NASH patients; and (ii) Akero’s “SYMMETRY” trial that purportedly tested EFX in patients with NASH-induced cirrhosis.

The Akero class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (i) approximately 20% of the patients enrolled in the SYMMETRY study had cryptogenic cirrhosis and did not have definitive NASH at baseline; (ii) the cryptogenic cirrhotic patients included in the SYMMETRY study did not have biopsy-proven compensated cirrhosis due to definitive NASH; (iii) the results from the cryptogenic cirrhosis patients were to be excluded from the calculation of the NASH resolution secondary endpoints; (iv) 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; (v) the SYMMETRY study did not align with U.S. Food & Drug Administration 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 (vi) 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 cirrhotics.

It was not until Akero disclosed the study’s 36-week results on October 10, 2023 that the market finally began to learn the truth, with investors suffering substantial losses and damages under the federal securities laws as the price of Akero stock plummeted nearly 70% in response, according to the Akero class action lawsuit.

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Complaint