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The World Health Organization strongly recommended against obesity drugs for children under 10 because their long-term effects are unclear, prioritizing healthy food and exercise. For ages 10–19, medication is an option only after supervised lifestyle programs fail; surgery may be considered under strict conditions for severe adolescent obesity. WHO estimated 170 million children and teens had obesity in 2024. A study released last month found Novo Nordisk’s Wegovy helped two in five children aged 6–12 move out of the obesity category. Eli Lilly began testing Zepbound in that age group last month, with results due by 2029. Wegovy is approved for ages 12 and older in the US and Europe; Zepbound is not.
Eli Lilly drew attention at a diabetes conference in Milan with extensive promotion and trial results for an experimental combination of Mounjaro and eloralintide that helped patients with obesity and diabetes lose up to 23% of their weight. At the highest dose, 27% stopped treatment because of side effects. Lilly also reported that retatrutide helped patients lose about one-fifth of their body weight. Rival Novo Nordisk presented data on Ozempic, Wegovy and CagriSema, which it expects to receive regulatory clearance by year-end. Novo said real-world data showed fewer strokes and heart attacks among diabetics who increased their Ozempic dose than among those who switched to Mounjaro.
Eli Lilly said its experimental eloralintide combined with Mounjaro helped people with diabetes lose up to 23% of their weight in a 367-person study. After 48 weeks, patients on the highest-dose combination lost an average of 54 pounds, and their A1C blood-sugar measure fell 2.9% from an average baseline of 8.1%. At that dose, 27% stopped treatment because of side effects; more than four-fifths reported side effects, including nausea in about half. Lilly plans to begin late-stage studies of the combination by year-end.
Eli Lilly (LLY.N) said on Tuesday its experimental drug helped adults with type 2 diabetes and obesity lose an average of nearly 21% of their body weight in a late-stage clinical trial.
India’s weight-loss drug boom has brought counterfeit Mounjaro and listings for unapproved treatments, Bloomberg reports. In April, Haryana drug officer Amandeep Chauhan arrested Avi Sharma after finding an alleged fake-drug operation; Eli Lilly’s tests identified seized Mounjaro as counterfeit, with several doses containing 30% or less of the labeled tirzepatide concentration. Sharma’s lawyer said the case remains ongoing. India’s high branded-drug prices and extensive pharmaceutical supply chain have complicated enforcement, while cheaper generic semaglutide products have entered the market. Investigators also found retatrutide, which Eli Lilly says is unapproved anywhere. In August, authorities charged Sharma with manufacturing and distributing drugs without a valid license, among other allegations.
Eli Lilly & Co. Chief Executive Officer Dave Ricks said investors should expect more slightly larger deals, such as its $7.8 billion acquisition of Centessa Pharmaceuticals Plc, as the company seeks assets in scientific “white spaces.” Lilly is using proceeds from its weight-loss and diabetes shots to expand beyond obesity. Ricks identified infectious disease, women’s health and psychiatric conditions as opportunities. This year, Lilly acquired three vaccine-makers for up to $3.8 billion and agreed to buy AtaiBeckley Inc. for about the same amount. Ricks said Lilly has made about 40 deals this year; their combined value exceeds $20 billion, its highest annual total, according to Bloomberg data.
The US Food and Drug Administration has approved Eli Lilly's (LLY.N) once-weekly basal insulin, Onswik, for adults with type 2 diabetes, the drugmaker said on Thursday, offering patients an alternative to daily long-acting insulin injections.
Here are some details:
Onswik, chemically known as insulin efsitora alfa-gobe, is intended to be used alongside diet and exercise to control high blood sugar.
The once-weekly treatment could reduce the number of injections by more than 300 per year compared with once-daily basal insulin, Lilly said.
Lilly said Onswik would be available in the United States in the coming months as a pre-filled KwikPen in two concentrations – 500 units per milliliter and 1,000 units per milliliter.
The regulatory approval was based on a late-stage trial, which enrolled more than 3,400 adults with type 2 diabetes across four studies.
Onswik met the main goal in each study, showing reductions in A1C, a measure of blood sugar, that were not inferior to the daily basal insulins glargine.
Insulin glargine, sold under brands such as Sanofi's Lantus and Lilly's Basaglar, is a long-acting, man-made insulin used to control blood sugar in type 1 and type 2 diabetes patients.
Lilly said Onswik should not be used in patients with type 1 diabetes because of an increased risk of severe hypoglycemia, or dangerously low blood sugar.
Onswik has previously received regulatory approvals in Europe, Japan and Mexico.
In March, US FDA approved Novo Nordisk's (NOVOb.CO) insulin injection, Awiqli, to control blood sugar levels in adults living with type 2 diabetes.
European pharmaceutical companies are urging governments to increase spending on innovative medicines, warning that investment and drug launches may shift toward the US and China. Chairs of AstraZeneca, Roche, Sanofi and six other drugmakers said about 40% of newly approved therapies never reach European patients. The campaign intensified after President Donald Trump sought to prevent US drug prices from exceeding those in other wealthy countries. European governments face strained health budgets; Germany raised required rebates on most branded reimbursable medicines from 7% to 15.5%, prompting Eli Lilly and Boehringer Ingelheim to cancel some investments. Drugmakers are also seeking fiscal flexibility, faster clinical trials and stronger intellectual-property protections.
Novo Nordisk, once Europe’s most valuable company, has fallen outside the continent’s top 10 after losing dominance in GLP-1 weight-loss drugs; its shares are down 75 per cent from their 2024 peak. Shares dropped another 8 per cent after Novo outlined plans to expand weight-loss pill capacity, develop new obesity and diabetes treatments, and enter related blood, endocrine and liver diseases. It targets at least five multi-billion-dollar drugs by 2030 and oral Wegovy capacity for about 15mn patients. However, intensifying competition and lower prices have weakened obesity-drug economics. Novo expects roughly peer-level annual growth of 5 per cent through 2030, disappointing investors seeking faster expansion.
The US FDA has approved Eli Lilly's (LLY.N) drug combination to treat adults with a type of advanced breast cancer that has spread to other parts of the body, the drugmaker said on Friday.
Here are some details:
The combination, Inluriyo-Verzenio, is meant for patients whose tumors are estrogen receptor-positive, HER2-negative and carry an ESR1 mutation, and whose cancer has worsened after at least one hormone treatment.
About half of the patients with ER-positive, HER2-negative metastatic breast cancer develop an ESR1 mutation during or after treatment with a widely used class of hormone-blocking therapies, Lilly said.
The US Food and Drug Administration had approved Inluriyo in September last year to treat metastatic breast cancer, also called Stage IV breast cancer with ESR1 mutations.
The approval was based on a late-stage study of 159 patients with this type of advanced breast cancer. Patients who took both drugs went a median of 11.1 months before their cancer worsened, compared with 5.5 months for those who took Inluriyo alone.
HR+/HER2- is the most common subtype of breast cancer — the second leading cause of cancer death in women.
Inluriyo is a daily pill that blocks and breaks down estrogen receptors that can help some breast cancers grow, while Verzenio is a twice-daily pill that slows cancer-cell division.
The combination also carries risks, Lilly said, including severe diarrhea, low white blood cell counts, lung inflammation, liver problems and blood clots.
Inluriyo's label includes a warning for embryo-fetal toxicity, which refers to potential risk of harm to a developing embryo and fetus if exposure occurs during pregnancy.
Lilly said Inluriyo plus Verzenio is available immediately in the United States.
Berenberg analyst Kerry Holford upgraded Eli Lilly to buy from hold and set a $1,400 price target, implying 21% upside from Thursday’s close. Lilly shares have risen about 300% since Mounjaro’s 2022 approval, pushing its market value above $1 trillion. Holford expects sales growth through 2030 to outpace peers, supported by GLP-1 drugs, strong research productivity and the pending approval of diabetes pill Foundayo. She also said investors underappreciate Lilly’s non-obesity pipeline. According to her calculations, Lilly has committed roughly $60 billion to more than 25 business-development deals year-to-date, including acquisitions of Centessa Pharmaceuticals, Kelonia Therapeutics and AtaiBeckley.
S&P 500 Index futures fall 0.2% as of 7:42 a.m. in New York. Stocks are heading for more declines as oil prices and Treasury yields climb.
- Nasdaq 100 futures fall 0.2%
- Dow Jones Industrial Average futures are down 0.3%
- The MSCI World Index is little changed
Here are some of the biggest US movers before the bell:
- Magnificent Seven stocks:
- Nvidia (NVDA) +0.5%, Tesla (TSLA) -0.1%, Amazon (AMZN) -0.2%, Meta Platforms (META) -0.5%, Apple (AAPL) -0.6%, Alphabet (GOOGL) -0.9%, Microsoft (MSFT) -0.9%
- Cryptocurrency-linked stocks fall on waning optimism that a comprehensive US crypto regulatory bill will progress this week.
- Dave & Buster’s (PLAY) drops 13% after the restaurant and arcade chain operator reported revenue for the second quarter that missed the average analyst estimate.
- Eli Lilly (LLY) is up 1.3% after Berenberg upgraded the pharmaceutical giant, with analysts arguing it’s worthy of a more significant valuation premium due to its superior growth profile and the breadth of its pipeline.
- Enova International (ENVA) falls 18% after the financial services company withdrew its applications with the Office of the Comptroller of the Currency and the Federal Reserve for the acquisition of Grasshopper Bancorp.
- Etsy (ETSY) rises 3% after Oppenheimer upgraded the online retailer to outperform, citing improvements the company is making to its platform.
- Forgent Power Solutions (FPS) gains 9% after the power equipment company reported fourth-quarter revenue and adjusted Ebitda above a guidance range given in May. The company’s backlog grew 256% year-over-year.
- Vera Therapeutics (VERA) jumps 12% after the drugmaker gave updated results from a late-stage trial of its recently approved drug for a kidney disorder.
- Waystar (WAY), which provides payment-related software to health-care organizations, rises 12% after a Reuters report that said the company is exploring options that include a sale. The report cited sources familiar with the matter.
Eli Lilly is preparing a broader women’s health push, using proceeds from its weight-loss and diabetes drugs to explore treatments in osteoporosis, preeclampsia, endometriosis and other pregnancy-related disorders, according to people familiar with the matter and job postings. The company hired reproductive medicine expert Kelle Moley in May to lead women’s health and early clinical development. Lilly is also studying women’s health uses for obesity medicines and invested $40 million in Absci, which is developing an early-stage endometriosis treatment. The effort builds on Lilly’s breast cancer and osteoporosis businesses. Women’s health has received only 6% of private healthcare investment, according to the World Economic Forum.
Novartis’s experimental heart drug pelacarsen lowered inherited lipoprotein(a), or Lp(a), but failed to produce meaningful cardiovascular benefits in a major trial, surprising researchers and raising doubts about rival treatments from Amgen and Eli Lilly. Jefferies cut its peak-sales forecast for Amgen’s olpasiran from about $4 billion to $1.3 billion, while Amgen lost roughly $24 billion in market value. Novartis disclosed few trial details. Possible explanations include pelacarsen’s roughly 80% reduction in Lp(a), versus more than 90% for newer rivals; enrollment of patients with established disease; and inclusion of strokes in the main endpoint. Experts remain divided over whether Lp(a) is a causal therapeutic target or primarily a risk marker.