Sydney Price
December 26, 2025
Obesity Drugmaker Escapes Clinical Trial Securities Suit
2 min
AI-made summary
- U.S
- District Judge Richard Seeborg dismissed, for now, a lawsuit against BioAge Labs Inc
- alleging investors suffered losses after the company halted a clinical trial for its obesity drug azelaprag due to signs of transaminitis
- The judge found that investors failed to plausibly show BioAge inadequately disclosed trial risks, noting only one of 265 participants showed transaminitis
- Investors have three weeks to amend their complaint to address the identified deficiencies.
Biopharmaceutical company BioAge Labs Inc. has, for now, escaped a suit alleging investors were hurt by plummeting share prices after the company unexpectedly halted a clinical trial for a weight loss drug, saying that the investors failed to plausibly show the company did not properly disclose risks to the trial.
In Thursday's order, U.S. District Judge Richard Seeborg said the suit led by the Southeastern Pennsylvania Transportation Authority must do more than assert that the risk of transaminitis — a frequent indicator of liver disease — was significant and inevitable in disrupting BioAge's clinical trials for its obesity drug candidate azelaprag.
Judge Seeborg gave the investors three weeks to file an amended version of the suit addressing the deficiencies.
In the latest version of the suit filed in June, the investors claim that BioAge's shares fell from over $20 to under $5 in December 2024 after it said it would discontinue its Phase 2 clinical trial after certain study participants showed signs of transaminitis.
The investors allege that transaminitis was "virtually certain" to disrupt the trial, but Judge Seeborg did not agree. Of the clinical trials involving 265 participants, only one indicated transaminitis, the order states.
"Certainly, that isolated observation did not make it likely, much less inevitable, that the [clinical] trial would be impacted by transaminitis," Judge Seeborg determined.
Judge Seeborg also rejected the suit's argument that "once a company chooses to disclose any safety information, it must disclose all material information regarding safety."
"[SEPTA] avers that the risk disclosures were inherently misleading absent a discussion of transaminitis," the order states. "That can only be true if the risk disclosures' failure to discuss the risk of transaminitis implied that the risk did not exist."
The suit claims the December 2024 announcement particularly hurt investors who relied on company forecasts made ahead of its September initial public offering, when they predicted that it would have the topline results from the trial in the third quarter of 2025, the complaint said.
But Judge Seeborg said the investors' assertion that transaminitis had materialized in the trial's participants by the time of the IPO is "entirely conclusory."
"It is unclear, for example, how long the onset period is or how often BioAge was testing liver enzyme levels," the suit states. "Without that detail, SEPTA's claim is too speculative to survive a motion to dismiss."
Representatives of the parties did not immediately respond to requests for comment Friday.
The investors are represented by Stephen R. Basser, Samuel M. Ward, Jeffrey A. Barrack, Danielle M. Weiss and Andrew J. Heo of Barrack Rodos & Bacine.
BioAge and the individual defendants are represented by Bruce G. Vanyo, Christina L. Costley and Paul S. Yong of Katten Muchin Rosenman LLP.
The case is Soto v. BioAge Labs Inc. et al., case number 3:25-cv-00196, in the U.S. District Court for the Northern District of California.
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