New York, New York--(Newsfile Corp. - May 1, 2024) - Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law firm, notifies investors that a class action lawsuit has been filed against Akero Therapeutics, Inc. ("Akero" or "the Company") (NASDAQ: AKRO) and certain of its officers.
Class Definition:
This lawsuit seeks to recover damages against Defendants for alleged violations of the federal securities laws on behalf of all persons and entities that purchased or otherwise acquired Akero securities between September 13, 2022 and October 9, 2023, inclusive (the "Class Period"). Such investors are encouraged to join this case by visiting the firm's site: bgandg.com/AKRO.
Case Details:
According to the Complaint, Akero is a clinical stage biopharmaceutical company that was founded to develop transformational medicines for patients with serious metabolic diseases that lack effective treatment options. The Company is currently focused on advancing its lead product candidate efruxifermin ("EFX"), formerly known as AKR-001, to provide a new treatment for patients with nonalcoholic steatohepatitis ("NASH"), a serious liver disease.
Akero has a limited operating history, according to the Complaint. The Company has yet to generate any revenues because the FDA has not approved any of its drug candidates for sale. Because funding drug development, clinical trials, and commercialization is capital-intensive, Akero has suffered significant recurring losses since its inception, including over $290 million in losses during the years 2020 to 2022 alone. To finance the Company's operations, Akero conducted two secondary stock offerings and one at-the-market stock offering during the Class Period, raising over $577 million.
The Complaint alleges that throughout the Class Period Akero made statements that were materially false and misleading when made because the Company failed to disclose the following adverse facts pertaining to Akero's business, operations, and financial condition, which were known to or recklessly disregarded by defendants as follows:
(1) that approximately 20% of the patients enrolled in Akero's 96-week SYMMETRY study had cryptogenic cirrhosis and did not have definitive NASH at baseline (a nonalcoholic fatty liver disease activity score of greater than or equal to 3, with a score of at least 1 in each of the components of steatosis, ballooning, and inflammation);
(2) that the cryptogenic cirrhotic patients included in the SYMMETRY study did not have biopsy-proven compensated cirrhosis due to definitive NASH;
(3) that the results from the cryptogenic cirrhosis patients - i.e., those who did not have definitive NASH - were to be excluded from the calculation of the NASH resolution secondary endpoints;
(4) that, 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;
(5) that 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; and
(6) that, as a result of (1)-(5) above, defendants had materially misrepresented the nature of the SYMMETRY trial, 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, according to the Complaint, Akero announced the results of the Phase 2b SYMMETRY trial for EFX and disclosed that the trial had failed to meet its primary endpoint. On a subsequent call with investors to discuss the SYMMETRY trial's results, Akero's Chief Development Officer acknowledged that patients with cryptogenic cirrhosis had been included in the study's patient population, a fact that Akero had previously failed to disclose to investors. Analysts reacted negatively to this disclosure including one research report averring that "this feature of the study needlessly introduces confounding risk, and may have played a part in missing the primary endpoint[.]"
On this news, according to the Complaint, Akero's stock price fell $30.39 per share, or 62.61%, to close at $18.15 per share on October 10, 2023.
What's Next?
A class action lawsuit has already been filed. If you wish to review a copy of the Complaint, you can visit the firm's site: bgandg.com/AKRO or you may contact Peretz Bronstein, Esq. or his Client Relations Manager, Nathan Miller, of Bronstein, Gewirtz & Grossman, LLC at 332-239-2660. If you suffered a loss in Akero you have until June 25, 2024, to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as lead plaintiff.
There is No Cost to You
We represent investors in class actions on a contingency fee basis. That means we will ask the court to reimburse us for out-of-pocket expenses and attorneys' fees, usually a percentage of the total recovery, only if we are successful.
Why Bronstein, Gewirtz & Grossman:
Bronstein, Gewirtz & Grossman, LLC is a nationally recognized firm that represents investors in securities fraud class actions and shareholder derivative suits. Our firm has recovered hundreds of millions of dollars for investors nationwide.
Attorney advertising. Prior results do not guarantee similar outcomes.
Contact:
Bronstein, Gewirtz & Grossman, LLC
Peretz Bronstein or Nathan Miller,
332-239-2660 | info@bgandg.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/207688
