Akero Therapeutics, Inc.
Case Overview
38 Days Left to Seek Lead Plaintiff
Lead Plaintiff Deadline: | Lead Plaintiff Deadline: 06/25/2024 |
Status: | Status: Investigating |
Company Name: | Company Name: Akero Therapeutics, Inc. |
Court: | Court: Eastern District of California |
Case Number: | Case Number: 09/13/2022 - 10/09/2023 |
Class Period: | Class Period: 4:24cv02534 |
Ticker: | Ticker: AKRO |
Related Attorneys: | Lead Attorneys: Thomas W. Elrod |
Related Practices: | Related Practices: Securities |
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the Northern District of California on behalf of those who acquired Akero Therapeutics, Inc. (“Akero” or the “Company”) (NASDAQ: AKRO) securities during the period of September 13, 2022 through Ocober 9, 2023, inclusive (“the Class Period”). Investors have until June 25, 2024 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
On October 10, 2023, Akero disclosed the results of its Phase 2b SYMMETRY study, which the Company had represented would research the effect of its lead drug candidate EFX on treating nonalcoholic steatohepatitis (NASH) induced cirrhosis. Akero filed with the SEC a Form 8-K and issued a press release stating that the SYMMETRY study had failed to meet its primary endpoint. In an investor call that same day, the Company admitted that its pretrial protocol had specified that cryptogenic cirrhotics would be excluded from the secondary endpoint calculation, despite the fact that this information was contrary to what the Company had told investors regarding the trial’s design. On this news, the price of Akero shares declined by $30.39 per share, or approximately 62.6%, from $48.54 per share on October 9, 2023 to close at $18.15 on October 10, 2023.
The lawsuit alleges that throughout the Class Period, Akero 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.
On October 10, 2023, Akero disclosed the results of its Phase 2b SYMMETRY study, which the Company had represented would research the effect of its lead drug candidate EFX on treating nonalcoholic steatohepatitis (NASH) induced cirrhosis. Akero filed with the SEC a Form 8-K and issued a press release stating that the SYMMETRY study had failed to meet its primary endpoint. In an investor call that same day, the Company admitted that its pretrial protocol had specified that cryptogenic cirrhotics would be excluded from the secondary endpoint calculation, despite the fact that this information was contrary to what the Company had told investors regarding the trial’s design. On this news, the price of Akero shares declined by $30.39 per share, or approximately 62.6%, from $48.54 per share on October 9, 2023 to close at $18.15 on October 10, 2023.
The lawsuit alleges that throughout the Class Period, Akero 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.