BioAge Labs, Inc. (NASDAQ: BIOA) is facing scrutiny and legal challenges after halting its Phase 2 clinical trial of azelaprag, a drug candidate aimed at treating obesity. The decision, announced on December 6, 2024, cited safety concerns related to elevated liver transaminase levels observed in trial participants.
The discontinuation of the STRIDES trial, which investigated azelaprag both as a monotherapy and in combination with tirzepatide, triggered a sharp decline in BioAge's stock price. Shares plummeted over 76%, falling from $20.09 on December 6 to $4.65 by December 9, 2024.
Legal Investigations and Class Action Lawsuits
Several law firms, including Bleichmar Fonti & Auld LLP, Pomerantz LLP, Faruqi & Faruqi LLP, and Kirby McInerney LLP, have announced investigations into BioAge for potential violations of federal securities laws. These firms are representing investors who incurred substantial losses as a result of the stock drop following the trial discontinuation.
A class action lawsuit, Soto v. BioAge Labs, Inc., et al., No. 25-cv-196, has been filed in the U.S. District Court for the Northern District of California. The lawsuit alleges that BioAge made false and/or misleading statements regarding the STRIDES Phase 2 clinical trial in its IPO documents and throughout the Class Period, which runs from September 22, 2024, through January 7, 2025.
The complaint asserts claims under Sections 11 and 15 of the Securities Act of 1933, targeting investors who purchased stock pursuant and/or traceable to BioAge's registration statement for its initial public offering (IPO) held on or about September 26, 2024.
Azelaprag's Development and Trial Details
Azelaprag is an orally available small-molecule agonist of the apelin receptor (APJ), designed to enhance weight loss. BioAge had previously stated that azelaprag was well-tolerated in 265 individuals across eight Phase 1 clinical trials.
The STRIDES trial was designed to evaluate azelaprag in combination with GLP-1R agonists for enhanced weight loss. BioAge had collaborated with Eli Lilly and Company on the trial, with Lilly advising and assisting on all aspects of the trial's design and execution. The company had anticipated topline results in Q3 2025.
Allegations of Misleading Information
The lawsuits allege that BioAge's IPO documents conveyed to investors that there were no safety concerns regarding azelaprag and that the company expected topline results to meet its primary endpoint goals. However, the subsequent discontinuation of the trial due to liver transaminitis contradicted these statements.
Investor Options and Deadline
Investors who purchased BioAge securities during the specified period have until March 10, 2025, to apply to the Court to be appointed as lead plaintiff in the class action. Lead plaintiffs direct and oversee the litigation on behalf of the class.
