shares of amgen Shares fell more than 7% on Tuesday as analysts scrutinized bone density loss data from early-stage trials of the experimental weight-loss injection Maritide.
One analyst said the additional data suggested new potential safety risks associated with the drug. But some say the move to share is an overreaction and that more data on a larger group of patients is needed.
Amgen did not immediately respond to a request for comment on the data.
This drug is a promising potential competitor in the weight loss drug market. It is designed to be taken monthly rather than once a week like existing injections. novo nordisk and Eli Lillypromotes weight loss in different ways.
Wall Street is awaiting key Phase 2 trial results for MariTide, which are expected to be released by the end of the year.
Analysts on Tuesday cited additional published data from a phase 1 trial showing that the highest dose of Maritide (420 milligrams) was associated with a decrease in bone density of about 4% over 12 weeks. Reduced bone mineral density refers to the loss of calcium and other minerals in the bones, making them weaker and more susceptible to fractures.
In a research note, Cantor Fitzgerald analyst Olivia Breyer called the data a “big unknown” and the potential associated with drugs like maritide, which work through so-called GIPR antagonism. He suggested that there may be a significant risk. Amgen’s injection works by blocking a gut hormone receptor called GIP, but it also activates another appetite-suppressing hormone called GLP-1.
This is different from Eli Lilly’s obesity drug Zepbound, which activates GIP and GLP-1. Wegovy activates GLP-1 but does not target GIP. This can also affect how your body breaks down sugars and fats.
“On the other hand, patients may naturally lose bone density during weight loss treatment,” Dr. Breyer wrote.
But Professor Breyer said: “On the other hand, there is a dose-dependent increase in bone density loss, so this may not be a starter.” This means that the higher the dose a patient takes, the more bone density they appear to lose.
Meanwhile, Jefferies analyst Michael Yee wrote in a note that Maritide’s additional data doesn’t seem to matter. Yee acknowledged that people who took the highest doses of the drug had lower bone density, but said “the data is all over the place.”
For example, he pointed to data with lower doses of the drug showing bone density increased by 1% before actually normalizing. Yee added that “changes” in bone density are a known side effect that occurs in the first one to three months after using weight loss drugs, as people lose weight rapidly.
Amgen is also aware of “hypothetical concerns” about bone density loss, Yee said, citing discussions with the company and management.
“We’re obviously not saying there’s going to be zero impact, but we think there’s no significant long-term (bone mineral density) loss or clinical risk or concern,” Jeffries said. said. “Overall, we do not believe there is a problem and the effects will normalize over time.”
“We would be cautious about using this data to make blanket judgments about Maritide’s safety profile,” BMO analyst Evan Sagerman wrote in a note Tuesday.
He added: “It would be more reassuring to determine the safety profile from a larger patient population.” There may not be a clear answer until Amgen releases complete Phase 2 trial data on the drug.
“Our view of Maritide remains unchanged with this incident, and if anything, we believe the sell-off has gone too far,” Zeigerman wrote.
