NEW YORK, May 28, 2024 (GLOBE NEWSWIRE) -- The law firm of Kirby McInerney LLP reminds investors 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 October 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.
[Click here to learn more about the class action]
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.
If you purchased or otherwise acquired Akero securities, have information, or would like to learn more about this investigation, please contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@kmllp.com, or by filling out this CONTACT FORM, to discuss your rights or interests with respect to these matters without any cost to you.
Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website.
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
Contacts
Kirby McInerney LLP
Thomas W. Elrod, Esq.
212-699-1180
https://www.kmllp.com
investigations@kmllp.com
