Eli Lilly and Company experienced a roughly 3% decline in its share price on Monday after an Evercore ISI analyst called attention to a liver-related report in the U.S. Food and Drug Administration adverse event database that could cause market confusion around the company’s oral GLP-1 drug, Foundayo. At the same time, shares of Novo Nordisk moved about 2% higher.
The concern centers on a reported case of hepatic failure listed in the FDA Adverse Event Reporting System that appears to involve Foundayo. The entry describes a 56-year-old male; the event may have taken place on or before April 15 and the report was submitted to the FDA on April 30.
The Evercore ISI analyst provided comparative figures for hepatic failure and other serious liver events involving competitor GLP-1 medicines to offer context for the report. In prior entries, Mounjaro was associated with 30 hepatic failure reports and Zepbound with 2. Ozempic and Wegovy showed 33 and 15 hepatic failure reports, respectively.
When broader serious hepatic events are considered, the analyst noted that Mounjaro and Zepbound combined have 311 reported cases against approximately 105 million prescriptions since the third quarter of 2018. Over the same period, Ozempic and Wegovy together recorded 447 such cases versus roughly 150 million prescriptions. These comparisons were offered by the analyst to frame the single Foundayo entry within a wider dataset from other GLP-1 therapies.
The analyst emphasized that "we cannot look at this single liver case in a silo … and such cases do tend to occur on other GLPs as well because of various confounding factors." That comment underlines the point that adverse event databases can include cases with multiple contributing variables and may not demonstrate direct causation on their own.
Separately, the analyst pointed to the clinical trial record for Foundayo that bears on its hepatic safety profile. Foundayo’s liver profile has been examined across multiple studies, including the ACHIEVE-4 trial, which enrolled roughly 2,800 patients and was conducted at the request of the FDA to investigate hepatic safety. According to the analyst’s summary, that trial did not show a hepatic safety signal.
Despite the clinical-trial findings, the analyst urged that the responsibility rests with Eli Lilly to ensure rapid and thorough adjudication of liver-related reports as they arise in commercial use to prevent confusion in the market. He also referenced background concerns cited by regulators and observers about liver toxicity with other oral GLP-1 molecules developed by other manufacturers, and noted some elevations in alanine aminotransferase (ALT) in earlier Foundayo trials.
The market reaction reflected investor sensitivity to safety reports and comparative adverse event data across the GLP-1 class, with Eli Lilly shares declining while a major competitor saw gains on the same session.
Clear summary
An Evercore ISI analyst highlighted an FDA adverse event report that lists a hepatic failure case involving Foundayo, prompting about a 3% decline in Eli Lilly shares while Novo Nordisk shares rose near 2%. The reported case concerns a 56-year-old man, possibly occurring on or before April 15 and reported on April 30. The analyst placed the report in the context of similar hepatic events tied to other GLP-1 drugs and urged prompt adjudication by Eli Lilly, while reminding readers that Foundayo’s ACHIEVE-4 trial involving about 2,800 patients showed no hepatic safety signal.