According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that:
- approximately 20% of the patients enrolled in the SYMMETRY study, a trial that purportedly tested its lead product candidate, efruxifermin (“EFX”) in patients with Non-alcoholic Steatohepatitis (“NASH”) induced cirrhosis, had cryptogenic cirrhosis and did not have definitive NASH at baseline;
- the cryptogenic cirrhotic patients included in the SYMMETRY study did not have biopsy-proven compensated cirrhosis due to definitive NASH;
- the results from the cryptogenic cirrhosis patients were to be excluded from the calculation of the NASH resolution secondary endpoints;
- 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;
- 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
- 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 EFX would become a commercial treatment for NASH cirrhotics.
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