On April 14, 2025, Barrack, Rodos & Bacine was appointed lead counsel in Soto v. BioAge Labs, Inc., et al., Case No. 3:25-cv-00196-RS, where it represents the Court-appointed lead plaintiff the Southeastern Pennsylvania Transportation Authority and a putative class of investors that purchased shares of BioAge Labs, Inc. pursuant and/or traceable to the company’s registration statement for its initial public offering held in September 2024. The action is pending in the United States District Court for the Northern District of California before the Honorable Richard Seeborg.
BioAge describes itself as a “clinical-stage biopharmaceutical company” that develops therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging. BioAge’s lead development candidate is azelaprag, a small molecule agonist of the apelin receptor APJ, designed to be taken orally. In documents issued by the company in relation to the IPO, BioAge discussed its collaboration with Eli Lilly and Company (“Lilly”) in connection with its ongoing STRIDES clinical trial of azelaprag in combination with GLP-1R agonists (such as Lilly’s product tirzepatide) to establish proof of concept for enhanced weight loss. Under the terms of this collaboration, Lilly agreed to supply tirzepatide and clinical trial design and execution advice.
Specifically, the STRIDES trial involved giving azelaprag in combination with tirzepatide to approximately 220 obese individuals aged 55 and over, an age group that represents 35-40% of the adult obese population in the U.S. According to the offering documents, defendants focused on this age group because the muscle and metabolic benefits of azelaprag observed in BioAge’s Phase 1b clinical trial had been achieved in older patients. The goal of the STRIDES clinical trial was to establish proof of concept for enhanced weight loss with its primary endpoint of weight loss at 24 weeks. According to the offering materials, defendants anticipated topline results for the trial in the third quarter of 2025. It is alleged that defendants’ statements in the registration statement for BioAge’s IPO were false and/or materially misleading at the time of the IPO as a result of their failure to disclose the potential for liver transaminitis in any of BioAge’s previous clinical Phase 1 trials and various preclinical tox studies.
After the market closed on December 6, 2024 – less than three months after the completion of the IPO – BioAge announced that it was discontinuing the STRIDES Phase 2 study of azelaprag after liver transaminitis was observed in several subjects who received azelaprag in the study. Liver transaminitis results in elevated levels of liver enzymes in the blood, specifically alanine aminotransferase and aspartate aminotransferase and can lead to liver failure. Following this disclosure, the trading price of BioAge stock fell sharply, from $20.09 per share on December 6, 2024 to close at $4.65 per share on December 9, 2024. BioAge common stock continued to trade well below the IPO price of $18 per share thereafter, trading at approximately $5.82 per share as of the filing of the initial complaint in this action.
An amended complaint in the action is currently scheduled to be filed by June 2, 2025.
If you have information that you believe is pertinent to the action, we encourage you to reach out to us – by contacting Mark R. Stein or Linda Border at Barrack, Rodos & Bacine, at the toll-free number 877-386-3304, or via email at investoralert@barrack.com.