A recent class action lawsuit has been filed against Akero Therapeutics, Inc. alleging violations of the Securities Exchange Act of 1934. The lawsuit claims that Akero and certain executive officers made false and misleading statements regarding the company’s clinical trials for its lead product candidate, efruxifermin (EFX), which is intended to provide treatment for nonalcoholic steatohepatitis (NASH), a serious liver disease.
During the Class Period, Akero stated that it was evaluating EFX in two Phase 2 clinical trials: the “HARMONY” trial for pre-cirrhotic NASH patients and the “SYMMETRY” trial for NASH-induced cirrhosis patients. However, the class action suit alleges that approximately 20% of the patients enrolled in the SYMMETRY study had cryptogenic cirrhosis, not definitive NASH, and that their results should have been excluded from the calculation of the study’s endpoints. It further claims that Akero failed to align with FDA guidance for testing a drug in treating NASH cirrhotics by not ruling out other potential causes of each patient’s cirrhosis.
The market only learned the truth about the study’s results when Akero disclosed them on October 10, 2023. The price of Akero stock plummeted nearly 70% in response, leading to substantial losses and damages for investors.
Investors who purchased Akero common stock during the Class Period have the opportunity to seek appointment as lead plaintiff in the class action lawsuit. Lead plaintiffs act on behalf of all other class members and can select a law firm to litigate the case. However, an investor’s ability to share in any potential recovery is not dependent on serving as lead plaintiff.
Robbins Geller Rudman & Dowd LLP, a prominent class action firm with extensive experience in securities fraud cases, is representing the plaintiff. The firm has a successful track record in recovering substantial amounts for investors in similar lawsuits.
It is important to note that the filing of a class action lawsuit does not guarantee a specific outcome. Past results do not guarantee future outcomes. Investors who suffered losses during the specified period are encouraged to seek legal counsel to explore their options.
In addition to the information provided in the article, here are some additional facts, current market trends, forecasts, and key challenges or controversies associated with the subject:
1. Current Market Trends: The biopharmaceutical industry, including companies like Akero Therapeutics, has been experiencing significant growth due to the increasing demand for innovative treatments for various medical conditions. The market for drugs targeting nonalcoholic steatohepatitis (NASH) has been particularly promising, as NASH is a prevalent liver disease with limited treatment options.
2. Forecasts: The NASH market is expected to grow at a compound annual growth rate (CAGR) of over 20% in the coming years. Several pharmaceutical companies are investing in the development of drugs targeting NASH, with a focus on achieving positive clinical trial results and gaining regulatory approval.
3. Key Challenges or Controversies: One of the key challenges in developing drugs for NASH is the complex nature of the disease and the need for rigorous clinical trials to demonstrate efficacy and safety. Clinical trials in this space often face challenges related to patient recruitment, designing appropriate endpoints, and ensuring the accuracy and integrity of the trial data.
4. Advantages and Disadvantages: The advantage of filing a class action lawsuit for investors is the opportunity to seek compensation for the losses they incurred due to alleged misrepresentation of clinical trial results. By appointing a lead plaintiff and selecting an experienced law firm, investors can increase their chances of recovering substantial amounts. However, the outcome of a class action lawsuit is not guaranteed, and there may be lengthy legal proceedings and associated costs involved.
For more information on NASH treatment advancements, market trends, and challenges, you can visit reputable sources such as FirstWord Pharma or BioPharma Dive. Please note that it is important to verify the validity of the URLs provided before accessing them for the latest news and insights in the biopharmaceutical industry.