1. When will the decision on the trial or lawsuit be made?
2. What will be the result if Novo wins or loses?

Thank you for the help guys and can’t wait for earnings!

"The company said major cardiovascular events occurred less frequently ​than expected in both the treatment and placebo groups. But when measuring just the three most severe events - ​heart attack, stroke and death - patients on retatrutide had a 12% higher risk than the placebo group."

The article also states:

"Lilly said it plans ⁠to ​submit a biologics license application for retatrutide to the FDA in the ​first quarter of next year. The company also said full results of the latest trials will be published in medical journals at a ​later date."

Some information about biologics and the Biologics License Application (BLA):

"Expensive biologic medications make up only 5% of prescriptions in the U.S. but account for 51% of total drug spending as of 2024." (source)

Biologics are not allowed to be compounded. (source) However, they are in fact much more expensive to produce than small molecule class drugs or peptides. The advantage for a pharma producer when a product in the BLA procedure is a 12 year market exclusivity period, where biosimilars as reference products will not be approved by the FDA to enter the market. (source, p. 32)

Edit:

Some more background about the question on biologics approval:

In 2023, the FDA already denied the approval of another drug as a biologic (Alzheimer's disease) by Eli Lilly before. (source)

In 2024, Eli Lilly sued the FDA for its terms on biologics classification. (source)

Currently, Eli Lilly is suing the FDA again to reclassify retatrutide as a biologic rather than a traditional drug. (source)

Does anybody have the pill numbers for Wegovy vs Foundayo?

Novo Nordisk’s sales of the weight-loss pill Wegovy (semaglutide) grew by double digits in week 29, as evident from prescription data collected by the analytics firm Iqvia.

The number of prescriptions written increased by 13% during the week to approximately 111,000. Meanwhile, the number of prescriptions for the starting dose of the Wegovy pill increased by 14% on a weekly basis. This may be a sign that the expanded coverage under the US public health insurance program Medicare has led more people to start weight-loss treatment.

Medicare’s Bridge Program covers seniors who can receive weight-loss medications for USD 50 per month.

However, Barclays notes that the growth was also significantly boosted by the fact that the previous week was shortened due to the US Independence Day holiday.

Citi notes that prescriptions for the weight-loss pill now account for 34% of total Wegovy prescriptions. This represents a one percentage point increase and indicates that users are increasingly preferring the pill over injections.

However, Barclays also notes that the vast majority of new prescriptions for the tablet are being written for people who have not previously been on GLP-1 treatments.

“Over 80 percent of new prescriptions for the Wegovy tablet are for people who are new to GLP-1 treatments, indicating that the oral formulation is expanding the obesity treatment market rather than replacing existing injection-based treatments,” analysts from the major British bank write.

Meanwhile, growth for Wegovy as an injection remained largely flat on a weekly basis. In total, Wegovy in injectable form was prescribed 49,642 times. The high-dose version accounted for approximately 4% of these prescriptions.

Competitor Eli Lilly also saw strong growth with its weight-loss pill, Foundayo, in week 29. The number of prescriptions grew by 32% to 6,640 compared to the previous week.

Several major banks rely on data from Iqvia, as it is said to provide a more accurate picture of market trends, although even Iqvia does not have a complete overview.

Iqvia captures about 60% of prescriptions, Novo stated in its first-quarter financial report, according to Barclays.

Novo Nordisk is employing somewhat drastic measures by suing its US competitor Eli Lilly for misleading marketing, and that makes perfect sense.

That’s the view of several Novo Nordisk investors whom Danish business daily Børsen has spoken with.

“It underscores that the obesity market has evolved into a ‘marketing battleground.’ Whereas two years ago we were discussing which drug could deliver the greatest weight loss, today we’re focusing more on factors like ease of use and brand recognition. That’s why I think it makes perfect sense for Novo to sue Lilly in this case,” Lars Söderfjell, head of equities at the Swedish bank Ålandsbanken, tells the publication.

Anders Schelde, Chief Investment Officer at Akademikerpension, echoes this sentiment. He elaborates that the pension firm does not view this as either a desperate move or a result of extraordinary pressure but rather as an attempt to protect and grow the business.

Johnny Madsen, Chief Investment Officer and Partner at Formue- og investeringspleje, also views Novo Nordisk’s more aggressive approach in the race for the weight-loss market as a step in the right direction. At the same time, he emphasizes that a combination of various factors could change the outlook.

“The strongest statement”

US attorney Jonathan Rubin, who specializes in antitrust law, previously told MedWatch on Thursday that Novo Nordisk’s lawsuit against Eli Lilly is primarily about changing the public’s perception of the company’s best-selling weight-loss drugs.

“A lawsuit is the strongest statement Novo Nordisk can make to the public to show that they believe the allegations are false and that they are being unfairly portrayed in the market,” Rubin told MedWatch from his office in Washington DC.

At its core, this contentious case revolves around Novo Nordisk’s belief that Eli Lilly has misled US consumers in its marketing of the companies’ best-selling obesity and diabetes drugs.

Specifically, the allegations state that Eli Lilly has downplayed the effectiveness of Wegovy (semaglutide) and Ozempic (semaglutide) in two advertising campaigns that have been running on US television and social media since April.

According to Novo Nordisk, Eli Lilly portrays Zepbound (tirzepatide) and Mounjaro (tirzepatide) as superior to Wegovy and Ozempic by using “outdated” studies in its marketing.

In one of the ads, Eli Lilly compares the highest dose of the weight-loss drug Zepbound (10/15 mg) with a lower dose of Wegovy (1.7/2.4 mg) .

The ad shows how Zepbound leads to an average weight loss of 50 pounds (20.2%) compared to an average weight loss of 33 pounds (13.7%) with Wegovy.

However, Novo has received approval for a higher dose of Wegovy (7.2 mg). Therefore, the company believes the advertisements are misleading because Eli Lilly does not compare its product to Novo’s highest approved dose.

This is a new Italian guideline recommendation, not a new drug approval or a separate semaglutide update.

Italy has published its first national guideline focused specifically on adolescents aged 12–18 whose overweight or obesity has not responded adequately to structured behavioural treatment.

The underlying guideline conditionally recommends semaglutide, alongside continued lifestyle intervention, for adolescents with obesity who have not achieved a clinically meaningful response after at least six months of supervised treatment. The recommendation is supported by moderate-quality evidence.

Tirzepatide is not included as a recommended adolescent treatment, reflecting its current regulatory status for this age group in Italy.

For Novo Nordisk investors, this is not a new approval, reimbursement decision or immediate sales catalyst. However, it is another sign that semaglutide is becoming embedded in national obesity-treatment pathways beyond the adult market.

The broader investment relevance is the gradual normalization of pharmacological obesity treatment across Europe, particularly for younger patients who do not respond sufficiently to lifestyle intervention alone.

The European Wegovy indication had already included adolescents aged 12 and older with obesity and body weight above 60 kg since 2023. What is new is its incorporation into this particular Italian national clinical guideline.

Germany’s draft recommends authorised incretin-based medicines as a class, which currently favours semaglutide for adolescent obesity; it does not specifically recommend tirzepatide.

As suggested by other reddit users yesterday, I'm starting a daily NVO stock sentiment post. Feel free to discuss the stock sentiment here today.

Looking at pre-market we are in freefall again (-1.6%), dropping from 51,50 down to 47,50 in barely a week (-8%) seems very much overdone to me on basically no news except the lawsuit. If you ask me we are still in limbo until any clarity comes at the next quarterlies.

Annoying but it seems this is just the way it is.

July 23

MCLEAN, Va.--(BUSINESS WIRE)--Crux, a benefits operating system that connects employers, pharmaceutical manufacturers, and benefit solution providers, today announced a collaboration with global healthcare company Novo Nordisk to expand affordable and simplified access to authentic anti-obesity medications (AOMs) like Wegovy® for employer health plans across the United States.

Through an alternative pharmacy benefit structure, the agreement will allow Crux to deliver a dedicated carve-out solution that provides employers and their employees with predictable, transparent pricing for Novo Nordisk AOMs obtained from a licensed NovoCare Network Pharmacy.

“Employers are looking for clear, responsible, and affordable ways to support obesity care and eligible employees deserve access to that care without unnecessary hurdles. Our collaboration with Novo Nordisk allows us to deliver both,” said Crux Co-Founder Chip Nash. “By pairing transparent pricing with straightforward access, we’re helping companies offer a benefit that delivers greater choice, is easier to administer, and is simple to navigate.”

This collaboration marks a significant expansion of the Crux platform, where employers and their employees receive upfront pricing for FDA-approved Wegovy®, with no markups, rebate requirements, or hidden fees. Through Crux, employers will be able to help further lower medication costs for employees by making tax-advantaged contributions via a health reimbursement arrangement (HRA), which are then applied at point of sale so there are no reimbursements or claims to process. Crux supports HRA plan design and contribution application, and helps employers meet compliance requirements, including high-deductible health plan monitoring and deductible tracking.

Another attempt to discuss what's going on with the stocks sentiment after several deleted posts.

It seemed sentiment was going up but it has proven fragile, now going down quick. What do you think? Does this have anything to do with the lawsuit? Am I missing something?

​

Novo Nordisk has accused arch-rival Eli Lilly of peddling false claims about its weight-loss products in advertising campaigns, marking the latest salvo in the battle for supremacy between the world’s biggest makers of obesity drugs.

Novo alleged in a lawsuit to be filed on Tuesday in a New Jersey court that Lilly was running an advertising campaign that was “deliberately false” and designed to mislead consumers over the “comparative efficacy” of the diabetes and weight-loss drugs sold by both companies.

The Danish drugmaker’s claim argues that Lilly has been citing outdated clinical trial data to support claims that its obesity drug, Zepbound, delivered higher average weight loss than Novo’s competing product, Wegovy.

Novo further alleges that Lilly’s ad campaign has falsely told patients that its diabetes medication, Mounjaro, was more effective than Novo’s Ozempic in lowering blood sugar levels.

The claim comes as the two big pharma groups are rolling out oral weight-loss pills that could increase take-up of the treatments significantly.

Novo’s filing said Lilly’s ads for injectable products Zepbound and Mounjaro were “maliciously and deceptively false”, and they created the impression that the company had more effective diabetes and weight-loss treatments than its rival.

Novo is seeking a permanent injunction barring Lilly from continuing to run the advertisements and a correction. Its filing also calls for “any and all of defendants’ profits” collected as a result of the advertising to be paid as damages.

Lilly is yet to file a defence.

The GLP-1 weight-loss drug market is one of the most talked-about investment themes of the past two years. Eli Lilly (LLY) and Novo Nordisk (NVO) have become the face of this boom, turning obesity and diabetes treatments into a projected $137 billion market by 2030. The narrative is compelling: aging populations, rising obesity rates, and a seemingly insatiable demand for effective weight-loss solutions. But for investors, the key question is not whether the market is growing—it is—but whether the growth is durable, differentiated, and already reflected in valuations.

The GLP-1 Market: A Duopoly with Pricing Power

Eli Lilly and Novo Nordisk control the lion’s share of the GLP-1 market, and their dominance is not accidental. Both companies have spent decades building manufacturing capacity, distribution networks, and regulatory relationships that competitors cannot easily replicate. The recent FDA approval of Lilly’s oral GLP-1 pill in April 2026—eliminating the need for injections—further solidified its lead. This is not just a convenience upgrade; it’s a moat. Oral administration removes a major adoption barrier for patients and prescribers, expanding the addressable market beyond those willing to self-inject.

Read the full article here.