In re BioAge Labs, Inc., Securities Litigation, No. 25-cv-00196, 2025 WL 3038991 (N.D. Cal. Oct. 30, 2025)~~Case Highlights~~In October 2025, a federal district court dismissed securities claims against a biopharmaceutical company, BioAge Labs, Inc., arising from disclosures in connection with its initial public offering (IPO) concerning the safety of the company’s lead drug candidate, azelaprag, which was intended to facilitate weight loss by mimicking the physiological effects of exercise. The court held that the plaintiff failed to plausibly allege that BioAge’s IPO offering documents were misleading because they omitted discussion of a potential liver-related safety risk.~~At the time of the IPO, BioAge was conducting a Phase 2 clinical trial of azelaprag. Approximately nine weeks after the IPO, BioAge discontinued the trial after 11 participants who received azelaprag developed transaminitis—elevated liver enzyme levels that can indicate injury to the liver. Following that announcement, BioAge’s stock price dropped, and investors brought a class action under Sections 11 and 15 of the Securities Act of 1933.~~The plaintiff alleged that BioAge’s IPO offering documents were misleading because they failed to disclose that transaminitis posed a serious risk to the development and commercialization of azelaprag. Specifically, the plaintiff claimed that transaminitis was “virtually certain” to occur in the Phase 2 trial because a single patient in an earlier, Phase 1 trial experienced transaminitis and, therefore, it was not possible to accurately discuss the risk that side effects of azelaprag might derail the drug’s prospects without expressly disclosing the risk posed by transaminitis.~~The court disagreed, identifying both legal and factual deficiencies in the complaint.~~First
, as a matter of law, the court emphasized that Section 11 does not impose a freestanding duty to disclose all material risks. Here, the plaintiff did not identify any statement in which BioAge affirmatively downplayed or mischaracterized the risk of transaminitis. Instead, the plaintiff argued that by discussing the general risk of adverse events, BioAge implicitly represented that no “expected” or “typical” safety risks existed. The court rejected this argument, holding that a company does not assume an obligation to disclose every conceivable safety signal merely because it elects to discuss clinical trial risks in general terms.~~Second
, the court found that the plaintiff failed to plausibly allege that transaminitis was “inevitable” at the time of the IPO. The complaint relied heavily on non-serious liver enzyme elevation in one of 265 participants across eight Phase 1 trials, which resolved without treatment and did not disrupt development. The court held that this isolated observation did not establish a trend, much less make liver toxicity “virtually certain” to derail Phase 2 testing. The complaint also pointed to the fact that BioAge tracked liver enzyme levels in mice that were dosed with azelaprag in a 27-week mouse study. But the court found that study actually showed that azelaprag lowered liver enzyme levels, and nothing in the mouse study would have indicated that transaminitis was inevitable.~~Key Takeaways~~BioAge provides helpful guidance on a pharmaceutical company’s obligation to disclose drug-safety risks, particularly when reporting clinical trial results. The decision underscores that the omission of isolated adverse events may not, standing alone, render otherwise accurate descriptions of general trial risks and outcomes misleading. At the same time, BioAge serves as a reminder that once a company elects to speak about a specific risk, it assumes a duty to disclose additional context to avoid providing investors with “half-truths.” Importantly, the more serious and prevalent the undisclosed safety risk, the more likely it is that general statements about clinical trial risks may be rendered misleading. This is particularly so under Section 11, where Items 105 and 303 of Regulation S-K impose affirmative disclosure obligations regarding known trends, uncertainties, and material risk factors. Companies should carefully calibrate their risk disclosures with these principles in mind and consult experienced counsel when drafting public statements about drug development programs and observed safety events.~~This newsletter has been prepared by the Life Sciences and Securities Litigation teams of Gibson Dunn. For further information, please contact the Gibson Dunn lawyer with whom you usually work, or any of us by email:~~Life Sciences:
Ryan Murr – Co-Chair, San Francisco (rmurr@gibsondunn.com)
Branden Berns – San Francisco (bberns@gibsondunn.com)
Melanie Neary – San Francisco (mneary@gibsondunn.com)~~Securities Litigation:
Jessica Valenzuela – Palo Alto (jvalenzuela@gibsondunn.com)
Jeff Lombard – Palo Alto (jlombard@gibsondunn.com)
Monica Loseman – Co-Chair, Denver, New York (mloseman@gibsondunn.com)
Brian Lutz – Co-Chair, San Francisco (blutz@gibsondunn.com)
Jason J. Mendro – Co-Chair, Washington, D.C. (jmendro@gibsondunn.com)
Craig Varnen – Co-Chair, Los Angeles (cvarnen@gibsondunn.com)~~Gibson Dunn associates Zaneta Kim and Celina Jackson also contributed to this update.~~© 2026 Gibson, Dunn & Crutcher LLP. All rights reserved. For contact and other information, please visit us at www.gibsondunn.com.~~Attorney Advertising: These materials were prepared for general informational purposes only based on information available at the time of publication and are not intended as, do not constitute, and should not be relied upon as, legal advice or a legal opinion on any specific facts or circumstances. Gibson Dunn (and its affiliates, attorneys, and employees) shall not have any liability in connection with any use of these materials. The sharing of these materials does not establish an attorney-client relationship with the recipient and should not be relied upon as an alternative for advice from qualified counsel. Please note that facts and circumstances may vary, and prior results do not guarantee a similar outcome.~~Download PDF~~
Mar 3
Deal Summary
