Shares of Amgen fell more than 7% Tuesday as analysts chewed over bone density loss data from an early-stage trial on its experimental weight loss injection, MariTide.

One analyst said the additional data suggests a new potential safety risk tied to the drug. But others said the share move was 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 

The 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 from Novo Nordisk and Eli Lilly, and promotes weight loss differently.

Wall Street is waiting for crucial phase two trial results on MariTide, which are set to be released before the end of the year. 

Analysts on Tuesday cited additional publicly available data from a phase one study showing that the highest dose of MariTide – 420 milligrams – was linked to roughly 4% loss of bone mineral density over 12 weeks. A decrease in bone mineral density refers to when bones lose calcium and other minerals, making them weaker and more likely to break. 

In a research note, Cantor Fitzgerald analyst Olivia Brayer called the data a “big unknown” and suggested it could be a potential risk associated with drugs like MariTide, which work by using so-called GIPR antagonism. Amgen’s injection works by blocking a gut hormone receptor called GIP but also activates another appetite-suppressing hormone called GLP-1. 

That’s unlike Eli Lilly’s obesity drug, Zepbound, which activates GIP and GLP-1. Wegovy activates GLP-1 but does not target GIP, which may also affect how the body breaks down sugar and fat.

“On one hand, patients could naturally lose bone mineral density during weight loss treatment,” Brayer wrote. 

But Brayer said, “on the other hand, this could be a non-starter because there seems to be a dose-dependent increase” in bone mineral density loss. That means patients appear to lose more bone mineral density the higher the dose they take. 

Meanwhile, Jefferies analyst Michael Yee wrote in a note that the additional MariTide data seems to be a “non-issue.” Yee acknowledged that people on the highest dose of the drug had declines in bone density, but said “the data is all over the place.” 

For example, he pointed to data on a lower dose of the drug showing that bone density actually increased by 1% before normalizing. Yee added that bone mineral density “changes” are a known side effect of weight loss drugs in the first one to three months of use because people lose significant weight quickly. 

Amgen is also aware of the “hypothetical concern” of bone mineral density loss, Yee said, citing the firm’s discussions with management.  

“While obviously not saying there is zero effect, we are saying we don’t think there is a concern, significant [bone mineral density] drop sustained over time, or clinical risk or concern,” Jefferies said. “Overall we don’t believe there is an issue and the effect is normalized over time.”

BMO analyst Evan Seigerman wrote in a note Tuesday that “We’d be cautious about making an overarching judgment on the safety profile of MariTide with this data.” 

He added that “we’d be more comfortable judging the safety profile from a larger cohort of patients.” There may not be a clear answer until Amgen releases full phase two trial data on the drug. 

“Our view on MariTide hasn’t changed with this and if anything we see the selling as overdone,” Seigerman wrote. 

All doses of Novo Nordisk‘s highly popular weight loss injection Wegovy and diabetes drug Ozempic are now available in the U.S., according to an update on the U.S. Food and Drug Administration’s drug shortage database Wednesday. 

It is a sign that Novo Nordisk’s efforts to ramp up the supply of those weekly drugs are starting to pay off, as demand continues to skyrocket in the U.S.  

A previous update said the lowest dose of Wegovy — 25 milligrams — was still in short supply.

Several doses of semaglutide, the active ingredient in Wegovy and Ozempic, have been on the FDA’s shortage list since early 2022. 

Wednesday’s update raises the potential that the FDA might remove the blockbuster injections from its shortage list entirely, which could prevent compounding pharmacies from making customized and often cheaper versions of those branded drugs.

In a statement, Novo Nordisk said all doses of Wegovy and Ozempic are being shipped regularly to wholesalers. The Danish drugmaker said the FDA’s update is a result of the company’s significant investment in expanding manufacturing capacity and “ongoing communication” with the agency. 

Still, Novo Nordisk said patients may not always be able to immediately fill their prescriptions at a particular pharmacy, even when a medication is listed as available. 

“Our intentional approach to gradually increase supply into the U.S. market is working,” Novo Nordisk said. “We will continue to prioritize continuity of care for patients, closely monitoring market dynamics and prescribing trends along the way.”

It comes a week after Novo Nordisk asked the FDA to prevent compounding pharmacies from making unapproved versions of Wegovy and Ozempic, arguing that the medications are too complex for those manufacturers to make safely. 

Earlier this month, the FDA removed tirzepatide, the active ingredient in Eli Lilly‘s weight loss drug Zepbound and diabetes treatment Mounjaro, from its shortage list. But a trade group representing some compounders sued the FDA, which led the agency to say it will reconsider its decision to remove tirzepatide from its shortage list.

Eli Lilly on Wednesday fell short of profit and revenue expectations for the third quarter, weighed down by disappointing sales of its blockbuster weight loss drug Zepbound and diabetes treatment Mounjaro, and slashed its full-year adjusted profit guidance.

The company’s stock tumbled more than 8% on Wednesday.

Eli Lilly now expects full-year adjusted earnings of between $13.02 and $13.52 per share, down from previous guidance of $16.10 to $16.60 per share. The drugmaker cited a $2.8 billion charge recorded during the third quarter and related to its acquisition of bowel disease drugmaker Morphic Holding as denting its results.

Eli Lilly also lowered the high end of its revenue outlook for the year and now expects sales of between $45.4 billion and $46 billion. The company’s previous guidance called for revenue of as much as $46.6 billion.

Here’s what Eli Lilly reported for the period ended Sept. 30 compared with what Wall Street was expecting, based on a survey of analysts by LSEG: 

• Earnings per share: $1.18 adjusted vs. $1.47 expected
• Revenue: $11.44 billion vs. $12.11 billion expected

The September period was Zepbound’s third full quarter on the U.S. market after winning approval from regulators nearly a year ago. The weekly injection raked in $1.26 billion in sales for the period, below the $1.76 billion that analysts expected, according to StreetAccount.

Meanwhile, Mounjaro posted $3.11 billion in revenue for the third quarter, more than double what it booked in the same period a year ago. But analysts expected $3.77 billion in sales for the diabetes treatment, according to StreetAccount.

In an interview with CNBC, Eli Lilly CEO David Ricks said the third-quarter performance of Zepbound and Mounjaro “is not a function of supply.” The company said third-quarter sales of the drugs were negatively impacted by inventory decreases among wholesalers.

Supply increases allowed Eli Lilly to fulfill back orders for wholesalers in the second quarter, which led to increased inventory of Zepbound and Mounjaro during the period. Those wholesalers tapped into some of that existing stock in the third quarter instead of buying more from the company, which dampened revenue from both treatments. 

“We did have a lot of inventory going into the quarter. We had a lot less going out in the channel,” Ricks said. He also said underlying demand for Mounjaro and Zepbound remains strong.

Demand in the U.S. has far outpaced supply for Lilly’s incretin drugs, such as Zepbound and Mounjaro, over the last year. Both treatments mimic certain gut hormones to tamp down a person’s appetite and regulate their blood sugar.

The popularity of those injectable drugs has forced both Eli Lilly and Novo Nordisk to invest billions to increase manufacturing capacity for the treatments.

Eli Lilly’s supply woes began to ease earlier this year. As of Wednesday, the Food and Drug Administration’s drug database said all doses of Zepbound and Mounjaro are available in the U.S. after extended shortages. Still, the agency warns that patients may not always be able to immediately fill their prescription for those drugs at a particular pharmacy.

Ricks said the company pushed back plans to advertise and promote Zepbound due to customer service levels. He sad the drugmaker will begin those efforts, which are expected to help drive demand, in November.

“When people go and they can’t get their medicine, they’re very frustrated. They tell us that. So we didn’t want to send more people to do that necessarily,” Ricks said.

Eli Lilly has said it expects incretin drug production in the second half of 2024 to be 50% higher than it was during the same period last year. And Ricks said Wednesday the company expects “even greater” expansions in manufacturing capacity at the end of the year and 2025.

For the third quarter, Ely Lilly recorded net income of $970.3 million, or $1.07 per share, compared with a net loss of $57.4 million, or 6 cents per share, during the third quarter of 2023.

Excluding one-time items associated with the value of intangible assets and other adjustments, Eli Lilly posted earnings of $1.18 per share for the most recent quarter.

Revenue was up 20% year over year to $11.44 billion.

The FDA’s decision to remove tirzepatide, the active ingredient in Zepbound and Mounjaro, from its shortage list has drawn fierce opposition from compounding pharmacies that make customized and sometimes cheaper alternatives to Eli Lilly’s branded drugs. Compounding pharmacies are calling for the FDA to reconsider its decision, as both Eli Lilly and Novo Nordisk attempt to crack down on unapproved versions of their top-selling drugs.

Ricks told CNBC the company agrees with the FDA that Zepbound and Mounjaro are no longer in shortage, adding, “We have stock.” He said that compounded versions of Eli Lilly’s branded drugs are not regulated by the FDA, raising questions about their safety and efficacy. 

Novo Nordisk‘s blockbuster diabetes drug Ozempic may reduce the risk of developing Alzheimer’s disease, suggesting its potential to delay or prevent the memory-robbing condition, according to a study released Thursday. 

Semaglutide, the active ingredient in Ozempic, was associated with a 40% to 70% lower risk of a first-time Alzheimer’s diagnosis in patients with Type 2 diabetes compared with seven other diabetes medications. That includes insulin and older so-called GLP-1 drugs similar to Ozempic, the research said. 

Alzheimer’s disease is often diagnosed in the mild dementia stage, when a person has significant trouble with memory and thinking. Almost 7 million Americans have the condition, the fifth-leading cause of death for adults over 65, according to the Alzheimer’s Association. But the number of Alzheimer’s patients is projected to rise to almost 13 million in the U.S. by 2050. 

There are no cures for Alzheimer’s, only drugs that treat the symptoms of the disease or slow the progression of the condition in people at the early stages of it. But a potential preventive treatment such as semaglutide may prove even more useful, said lead study co-author Dr. Rong Xu, a biomedical informatics professor at Case Western Reserve University. 

That’s because by the time many patients are diagnosed with the disease, “it’s often too late for treatment,” Xu told CNBC. She added that many of the risk factors of Alzheimer’s, such as obesity, diabetes and smoking, are preventable and “modifiable.” 

The results add to mounting evidence that GLP-1s, a popular class of obesity and diabetes medications, may offer health benefits beyond promoting weight loss and regulating blood sugar. That includes Ozempic, Novo Nordisk’s weight loss injection Wegovy, and drugs from Eli Lilly that work slightly differently. 

Novo Nordisk and rival Eli Lilly have been studying their drugs as potential treatments for chronic conditions such as sleep apnea and fatty liver disease. Novo Nordisk, which did not fund the new Case Western study, is also examining semaglutide in a late-stage study on Alzheimer’s patients. 

The new Case Western study released Thursday builds on other research released in July on a once-daily drug for diabetes and obesity called liraglutide, which Novo Nordisk sells under the brand names Saxenda and Victoza. In the liraglutide research, data from a midstage trial found that the drug may slow the progression of Alzheimer’s disease by protecting patients’ brains. 

In the study released Thursday, researchers from Case Western analyzed three years of electronic records of nearly 1 million U.S. patients with diabetes who did not have a prior Alzheimer’s diagnosis. The study was partly funded by the National Institutes of Health. 

The study compared semaglutide with seven different diabetes medications, including insulin and a drug called metformin. It also includes other GLP-1s, such as liraglutide and a medication from Eli Lilly called dulaglutide. 

Semaglutide was associated with a roughly 70% lower risk of first-time Alzheimer’s diagnosis compared with insulin, a nearly 60% lower risk compared with metformin and a 40% lower risk compared with other GLP-1s, according to the study. Semaglutide was also associated with significantly lower prescriptions for Alzheimer’s disease-related medications, the study said. 

Similar reductions in risks were seen across patients in the trial, regardless of their gender, age group and whether they had obesity. 

But the study has limitations since it relies on data from electronic health records. Xu called for more research, specifically clinical trials that randomly assign patients to receive semaglutide or other treatments, to confirm how much Ozempic and other GLP-1s can help prevent or delay Alzheimer’s disease. 

Xu and the team of researchers also plan to study whether GLP-1s can prevent Alzheimer’s in patients with obesity, but they want to wait one or two years for GLP-1s approved for weight loss to be on the market longer so there is more patient data for them to analyze. Wegovy won approval in the U.S. in 2021, while Eli Lilly’s weight loss injection Zepbound only entered the market last fall.

A version of this article first appeared in CNBC’s Healthy Returns newsletter, which brings the latest health-care news straight to your inbox. Subscribe here to receive future editions.

Good afternoon and happy Tuesday! To no surprise, expanding Medicare coverage of costly weight loss drugs could come at a steep cost for the federal government. 

Allowing Medicare to cover obesity medications would increase federal spending by about $35 billion from 2026 to 2034, according to an analysis released by the U.S. Congressional Budget Office last week. 

The federal costs for covering those drugs would grow from $1.6 billion in 2026 to $7.1 billion in 2034, the CBO said. 

The analysis is all hypothetical, and comes as drugmakers and advocacy groups push for the government to expand coverage of – and give more seniors access to – the highly popular treatments. Those include GLP-1s for obesity such as Novo Nordisk‘s Wegovy and Eli Lilly’s Zepbound, which both carry hefty price tags of roughly $1,000 per month before insurance and other rebates. 

Right now, Medicare doesn’t cover weight loss treatments unless they are approved and prescribed for another health condition. For example, Medicare covers Wegovy for reducing the risk of serious cardiovascular complications in those with heart disease and obesity, but doesn’t cover the drug for weight loss.  

The CBO expects that savings from improved health among patients – mainly by reducing the incidence of obesity-related conditions – 

will grow over time. Still, it says those savings could be relatively small, totaling less than $50 million in 2026 and about $1 billion in 2034.

“Even though net federal savings per user are projected to be larger over the longer term, they would still be less than the cost of the medications,” the CBO said in the report.

The cost of drugs could also fall over time, according to the CBO.  

Here’s why: It expects generic versions of popular weight loss injections to enter the market and reduce prices. The CBO also anticipates average net prices for obesity medications will fall in 2027 due to Medicare drug price negotiations with manufacturers.

Semaglutide, the active ingredient in Wegovy and Novo Nordisk’s diabetes drug Ozempic, could be among the 15 prescription drugs selected for the next round of price talks, which will begin in 2025 and go into effect in 2027. 

But how could Medicare coverage of those treatments impact access? 

If Medicare covers those medications, more than 12.5 million beneficiaries would newly qualify for weight loss drugs beginning in 2026, according to the CBO. The analysis said around 2% of those patients are expected to use the treatments in the first year. 

More than two-thirds of Medicare beneficiaries are

classified as either obese or overweight, according to their

body mass index, the CBO said. 

Notably, spending could look slightly different beyond 2034. 

The CBO said Medicare spending on weight loss drugs would probably be lower on a per-user basis due to lower costs tied to the drugs and increasing savings. But Medicare coverage of those treatments would still increase net federal costs from 2034 to 2044, the CBO noted. 

A Novo Nordisk spokesperson said in a statement Tuesday that the medical and societal costs of obesity are “significant,” with some estimates exceeding $1.7 trillion annually in the U.S. 

“We know treatment of obesity is linked to better medical outcomes, even if bureaucrats haven’t figured out how to account for these savings,” the spokesperson said, adding that the company hopes Medicare will start to offer coverage for weight loss drugs. 

Eli Lilly did not immediately respond to CNBC’s request for comment. 

Feel free to send any tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.

Eli Lilly will spend $4.5 billion to build a center aimed at finding better ways to manufacture its medicines. 

The facility, called the Lilly Medicine Foundry, will house development of new manufacturing methods with an eye toward efficiency. It’s a strategy that’s already paying off with Lilly’s obesity and weight loss drugs Mounjaro and Zepbound, and Lilly wants it to propel the rest of its pipeline.

The foundry serves a dual purpose: researching new manufacturing procedures, then putting them into practice with production of drugs for clinical trials. Lilly says the facility will be the first of its kind to combine research and production in a single location. 

“The idea is to take molecules from a bench in a lab to scaled for medicines in a pharmacy, and this research and development site will do that work,” Eli Lilly Chief Executive Officer David Ricks said in an interview from the company’s headquarters in Indianapolis. 

The center, which is slated to open in late 2027, will be equipped to make small molecules, biologics and genetic medicines. It will be near a $9 billion manufacturing complex Lilly is building in Lebanon, Indiana, to produce pharmaceutical ingredients like tirzepatide, the active ingredient in Mounjaro and Zepbound.

The cranes and steel frames of the active construction site stick out amid the flat farmland, about a 40-minute drive from Lilly’s Indianapolis headquarters. 

The investments are part of Lilly’s plan to build upon its success with Mounjaro and Zepbound, which are riding a wave of popularity in so-called GLP-1 drugs with Novo Nordisk’s Ozempic and Wegovy.

Mounjaro and Zepbound are expected to bring in $50 billion alone by 2028 – almost twice the company’s entire full-year revenue in 2022. That gives Lilly more freedom to invest, but it also puts pressure on the company to find and develop more new medicines to keep growing in the years to come. 

Lilly is already charting its future beyond tirzepatide. The company also wants to develop more drugs for Alzheimer’s disease and other neurodegenerative conditions like amyotrophic lateral sclerosis, or ALS.

“There are all of these huge opportunities to improve human health that are hiding in plain sight,” said Dr. Dan Skovronsky, Lilly’s chief scientific officer. “In our industry, people usually like to see what’s popular and then follow the leader. So a lot of the other companies are now stopping their different research projects so they can try and figure out how to catch up to us in obesity and Alzheimer’s disease. OK, we’re working on the next thing. Sorry.” 

Lilly wants to look for “breakthrough ideas” in areas where the company already has a foothold such as oncology and immunology, as well as newer areas like cardiovascular disease, chronic pain and hearing loss, Skovronsky said.

Neuroscience is one area where he and Ricks want to put particular focus. Lilly has a long history in the space between its antidepressant Prozac and its newly approved Alzheimer’s drug Kisunla, but they see more work to do. 

“Neuropsych is a huge unmet need,” Ricks said. “Addiction and mental health, but also neurodegenerative conditions, so we’re investing heavily there. And perhaps the gains we’ve made in obesity can help fund the research in new areas.”

That’s not to say Lilly is done with obesity.

Ricks acknowledged that one drug won’t meet all needs and that Lilly needs to keep moving the science forward. The company has 11 obesity drugs in its pipeline with different mechanisms of action and modes of delivery, he said. That includes two closely watched drugs in Phase 3 trials: an experimental pill called orforglipron and another injectable medicine called retatrutide. 

Lilly is investing everywhere it thinks makes sense in obesity, Ricks said, but he recognizes other companies might explore new mechanisms that it’s possible Lilly hasn’t. He wants to see more pills, especially ones that can go after multiple targets. He’s also interested in technologies that mean giving injections less frequently, such as short interfering RNA. 

Any new advances could help Lilly become the first trillion-dollar health-care company. The company’s stock has soared nearly 65% over the past year, giving Lilly a market capitalization of about $840 billion.

Ricks downplays the importance of hitting the trillion-dollar mark, saying it would be an outcome, not a goal, for Lilly. 

“We want to do valuable things, and if we’re successful, we create value,” Ricks said. “That’s how we’ll get to a bigger number.”