In a recent announcement on June 6, 2024, Faruqi & Faruqi, LLP, a prominent national securities law firm, revealed its ongoing investigation into possible claims against Akero Therapeutics, Inc. ("Akero" or "the Company") (NASDAQ: AKRO). The firm is reminding investors of the approaching June 25, 2024, deadline to become the lead plaintiff in a federal securities class action lawsuit filed against Akero.
The law firm's Securities Litigation Partner, James (Josh) Wilson, is urging investors who incurred losses exceeding $75,000 from investments in Akero stock or options between September 13, 2022, and October 9, 2023, to contact him for a discussion about their legal rights and options.
Faruqi & Faruqi, LLP, a firm with offices in New York, Pennsylvania, California, and Georgia, has a strong track record in securities litigation, having secured hundreds of millions of dollars for investors since its inception in 1995.
Akero Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing treatments for nonalcoholic steatohepatitis (NASH), a severe liver disease. The company's primary product candidate is efruxifermin (EFX). During the relevant period, Akero was evaluating EFX in two Phase 2 clinical trials: the "HARMONY" trial for pre-cirrhotic NASH patients and the "SYMMETRY" trial for patients with NASH-induced cirrhosis.
The lawsuit alleges that Akero and its executives violated federal securities laws by making false or misleading statements. Specifically, the company is accused of: (i) enrolling about 20% of patients in the SYMMETRY study with cryptogenic cirrhosis, who did not have confirmed NASH at baseline; (ii) including patients in the study without biopsy-proven compensated cirrhosis due to definitive NASH; (iii) excluding results from cryptogenic cirrhosis patients in calculating NASH resolution secondary endpoints; (iv) introducing a confounding factor into the SYMMETRY study, which could affect the study's outcomes and increase the risk of not meeting the primary endpoint; (v) misaligning the SYMMETRY study with FDA guidelines for testing drugs in NASH cirrhotic patients as Akero did not rule out alternative causes of cirrhosis; and (vi) misrepresenting the validity of the SYMMETRY trial and its potential to support a new drug application.
On October 10, 2023, Akero disclosed disappointing interim results from its Phase 2b SYMMETRY trial for EFX in NASH patients. The data revealed that while there were some improvements in fibrosis stages among EFX recipients, these changes were not statistically significant. Additionally, 12 patients, 11 of whom were in the EFX groups, had to discontinue the trial due to drug-related adverse events.
Following this news, Akero's stock price plummeted by 62.61%, from $48.54 to $18.15 per share.
The appointed lead plaintiff in this case will be the investor with the most substantial financial interest in the relief sought by the class, ensuring they are adequate and representative of class members. Investors have the option to move the Court to serve as the lead plaintiff through their chosen counsel or remain passive class members. Choosing whether or not to serve as lead plaintiff does not impact an investor's ability to participate in any recovery.
Faruqi & Faruqi, LLP is also encouraging individuals with relevant information regarding Akero's actions, including whistleblowers, former employees, and shareholders, to come forward.
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