NEWTOWN, Pa., May 13, 2024 (GLOBE NEWSWIRE) -- Edelson Lechtzin LLP, a leading class action law firm, is investigating securities fraud claims on behalf of investors in Akero Therapeutics, Inc. (NASDAQ: AKRO) between September 13, 2022, and October 9, 2023, inclusive (the “Class Period”).
Investors who purchased Akero stock may move the U.S. District Court for the Northern District of California to appoint them as lead plaintiff, no later than June 25, 2024. Please contact Edelson Lechtzin LLP at 844-696-7492 to discuss your investment losses, or by e-mail at elechtzin@edelson-law.com. A copy of the class action complaint can be viewed HERE.
Background on Akero Therapeutics, Inc.
Akero Therapeutics, Inc. is a clinical-stage company developing treatments for serious metabolic diseases with high unmet medical needs. Akero’s lead product candidate, EFX, is a protein that was engineered to mimic the effect of fibroblast growth factor 21 (“FGF21”), a naturally occurring human hormone that protects against cellular stress and regulates whole-body metabolism and tissue-specific stress responses.
Over the past several years, Akero has designed and overseen a series of clinical trials to test the efficacy and safety of EFX in treating nonalcoholic steatohepatitis (“NASH”), a serious form of nonalcoholic fatty liver disease (“NAFLD”) that is estimated to affect 17 million Americans. The most reliable diagnosis and staging of NASH is achieved by examining a liver biopsy specimen under a microscope. During the Class Period, Akero’ SYMMETRY study claimed to be evaluating EFX in two Phase 2 clinical trials in patients with biopsy-confirmed NASH.
The Securities Fraud Claims
The Complaint alleges claims that throughout the Class Period, Defendants made materially false and misleading statements and omissions concerning the SYMMETRY study, as follows: (i) around 20% of patients who participated in the SYMMETRY study had cryptogenic cirrhosis and did not exhibit definitive NASH symptoms at the beginning of the study, i.e., they did not have a NAFLD; (ii) the SYMMETRY study did not include biopsy-proven cirrhosis due to definitive NASH; (iii) the NASH resolution secondary endpoints excluded results from cryptogenic cirrhosis patients without definitive NASH; (iv) 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; (v) 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. As a result of the foregoing, defendants had materially misrepresented the nature of the SYMMETRY study, 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.
On October 10, 2023, Akero announced the results of the EFX Phase 2b SYMMETRY trial. This revealed that the trial did not meet its primary goal. During a call with investors discussing the trial, Akero’s Chief Development Officer revealed that patients with cryptogenic cirrhosis were included in the study. This information had not been disclosed before, and stock analysts reacted negatively to this revelation. On this news, the price of Akero stock fell $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.
For more information, please contact:
Marc H. Edelson, Esq.
Eric Lechtzin, Esq.
EDELSON LECHTZIN LLP
411 S. State Street, Suite N-300
Newtown, PA 18940
Phone: 844-696-7492 or 215-867-2399 ext. 1
Email: medelson@edelson-law.com
Email: elechtzin@edelson-law.com
Web: www.edelson-law.com
Edelson Lechtzin LLP is a leading class action law firm with offices in Pennsylvania and California. In addition to cases involving securities and investment fraud, our lawyers focus on class and collective litigation in cases alleging violations of the federal antitrust laws, employee benefit plans under ERISA, wage theft and unpaid overtime, consumer fraud, and dangerous and defective drugs and medical devices.
This press release may be considered Attorney Advertising in some jurisdictions. No class has been certified in this case, so you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. Your ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.
