Shares of Amgen fell greater than 7% Tuesday as analysts chewed over bone density loss knowledge from an early-stage trial on its experimental weight reduction injection, MariTide.
One analyst mentioned the extra knowledge suggests a brand new potential security threat tied to the drug. However others mentioned the share transfer was an overreaction, and that extra knowledge on a bigger group of sufferers is required.
Amgen didn’t instantly reply to a request for touch upon the info
The drug is a promising potential competitor within the weight reduction drug market. It’s designed to be taken month-to-month, relatively than as soon as every week like current injections from Novo Nordisk and Eli Lilly, and promotes weight reduction otherwise.
Wall Avenue is ready for essential section two trial outcomes on MariTide, that are set to be launched earlier than the top of the yr.
Analysts on Tuesday cited further publicly out there knowledge from a section one research displaying that the very best dose of MariTide – 420 milligrams – was linked to roughly 4% lack of bone mineral density over 12 weeks. A lower in bone mineral density refers to when bones lose calcium and different minerals, making them weaker and extra prone to break.
In a analysis word, Cantor Fitzgerald analyst Olivia Brayer referred to as the info a “huge unknown” and steered it may very well be a possible threat related to medicine like MariTide, which work by utilizing so-called GIPR antagonism. Amgen’s injection works by blocking a intestine hormone receptor referred to as GIP but in addition prompts one other appetite-suppressing hormone referred to as GLP-1.
That is in contrast to Eli Lilly’s weight problems drug, Zepbound, which prompts GIP and GLP-1. Wegovy prompts GLP-1 however doesn’t goal GIP, which can additionally have an effect on how the physique breaks down sugar and fats.
“On one hand, sufferers might naturally lose bone mineral density throughout weight reduction therapy,” Brayer wrote.
However Brayer mentioned, “alternatively, this may very well be a non-starter as a result of there appears to be a dose-dependent enhance” in bone mineral density loss. Which means sufferers seem to lose extra bone mineral density the upper the dose they take.
In the meantime, Jefferies analyst Michael Yee wrote in a word that the extra MariTide knowledge appears to be a “non-issue.” Yee acknowledged that individuals on the very best dose of the drug had declines in bone density, however mentioned “the info is everywhere.”
For instance, he pointed to knowledge on a decrease dose of the drug displaying that bone density really elevated by 1% earlier than normalizing. Yee added that bone mineral density “modifications” are a recognized aspect impact of weight reduction medicine within the first one to 3 months of use as a result of individuals lose vital weight rapidly.
Amgen can be conscious of the “hypothetical concern” of bone mineral density loss, Yee mentioned, citing the agency’s discussions with administration.
“Whereas clearly not saying there’s zero impact, we’re saying we do not suppose there’s a concern, vital [bone mineral density] drop sustained over time, or medical threat or concern,” Jefferies mentioned. “Total we do not imagine there is a matter and the impact is normalized over time.”
BMO analyst Evan Seigerman wrote in a word Tuesday that “We might be cautious about making an overarching judgment on the security profile of MariTide with this knowledge.”
He added that “we might be extra comfy judging the security profile from a bigger cohort of sufferers.” There might not be a transparent reply till Amgen releases full section two trial knowledge on the drug.
“Our view on MariTide hasn’t modified with this and if something we see the promoting as overdone,” Seigerman wrote.
