Får dra fram denne klassiske kommentaren (fra et amerikansk forum) igjen:
Posta i november i fjor her også:
Håpet mitt nå er Cagrisema kan gjøre det bedre enn markedet forventer. ResearchPulse1 postet denne på twitter i nå
Hentet herfra: Effects of CagriSema on appetite, eating behaviour and food cue reactivity using functional MRI in adults with overweight or obesity
Så satser jeg på at prognosene om fremtiden som ble presentert på CMD virkelig var på en underpromise linje + at det gjøres gode oppkjøp som kan styrke og komplimentere deres pipe
“What we have learned the last couple of years is overpromising and underdelivering loses trust very quickly ,” Doustdar said in a Bloomberg TV
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Her lurer jeg på hvor lave forventningene egentlig er.
Jeg tror de er ganske lave.
Og jeg tror CagriSema kan overraske positivt.
Kanskje bare litt, kanskje en del.
Begynner å mistenke at på et eller annet tidspunkt så snur det for Novo. Spørsmålet er om det gjør det til jul nå i 2026, eller om vi må godt ut i 2028 før NVO kommer seg out of the woods.
Novo provides update on the denecimig Biologics License Application (BLA) in the US
2026-10-02 22:53:57
- The US Food and Drug Administration (FDA) has informed Novo that the BLA review of denecimig for the treatment of haemophilia A is still ongoing. The FDA has not communicated a new timeline for regulatory action on the BLA
- The FDA has informed Novo that the ongoing facility remediation activities are the cause for extension of the Agency’s review. The FDA has not identified any deficiencies related to the clinical efficacy or safety data submitted in the denecimig BLA
- Novo is actively working with the FDA, addressing the Agency’s requests for remediations related to the manufacturing facility. The extended FDA review time for the denecimig BLA has no impact on Novo’s financial outlook for 2026 and pending regulatory decision, Novo aims to launch denecimig in the US in the first half of 2027
Bagsværd, Denmark, 02 October 2026 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has informed Novo that the BLA review of denecimig for the treatment of haemophilia A, with or without inhibitors in adults and children, is still ongoing. The FDA has not communicated a new timeline for expected regulatory action on the BLA.
Novo submitted a BLA for denecimig for the treatment of haemophilia A in adult and paediatric patients to the US FDA for review in September 2025, with an anticipated regulatory decision in the third quarter of 2026. Following this submission, the FDA performed a pre-license inspection of the manufacturing site and provided feedback. Today, the FDA has informed Novo that the ongoing facility remediation activities are the cause for extension of the Agency’s review.
“Haemophilia A patients should expect more from their standard of care,” said Mike Doustdar, president and CEO of Novo. “As Novo prepares to bring denecimig to market, our ambition is to help make better care something they can count on. Novo is already in the process of addressing the FDA’s requests as efficiently as possible and continuing to work closely with the Agency toward bringing denecimig to patients in the US.”
The Agency has not identified deficiencies related to the clinical efficacy or safety data of denecimig demonstrated in the FRONTIER clinical trial programme. Novo is continuing implementation of the facility remediation activities in response to the FDA’s feedback and is working closely with the Agency to address the outstanding requirements. The feedback on the manufacturing site does not impact other marketed Novo products.
The additional FDA review time does not have an impact on Novo’s financial outlook for 2026. Pending regulatory decision, Novo aims to launch denecimig in the US in the first half of 2027.
Her er grunnen til at Novo nå ligger rundt 250,- 
Dette intervjuet med Jim Cramer ble gjort i August når kursen var rundt 300
“You have a really good runway, which is what makes me intrigued by the stock. Because I think that you may be able to have better numbers than you think…”
“…this stock is too cheap, from today I just don’t see anymore downside…”
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Du vet det er Kina-trial når:
Resten av AEs:
Shiten funker som f på efficacy, ikke noe å si på det. Men bivirkningene? Hmmmm 
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Novo’s CagriSema was associated with 25% weight loss on average for women in a post hoc analysis of REDEFINE 1 presented at The Menopause Society Annual Meeting
• Investigational CagriSema 2.4 mg / 2.4 mg showed significant weight loss among women
overall and across pre-, peri- and postmenopausal stages in two post hoc analyses from
REDEFINE 1, a phase 3 trial in adults with obesity or overweight¹,²
• Across the two analyses, CagriSema use was associated with reductions in abdominal fat,
as measured by waist circumference, among women overall and across menopause
stages¹,²
• CagriSema is an investigational once-weekly combination of semaglutide, a GLP-1 receptor
agonist (RA), and cagrilintide, a long-acting amylin analogPLAINSBORO, N.J. and BAGSVÆRD, Denmark, Oct. 20, 2026 /PRNewswire/ – Today, Novo announced results from two post hoc analyses of the REDEFINE 1 trial presented at The Menopause Society 2026 Annual Meeting in San Diego. In an analysis of 2,309 women with obesity or overweight, CagriSema 2.4 mg / 2.4 mg (cagrilintide 2.4 mg and semaglutide 2.4 mg) was associated with an average weight loss of 25.0% at week 68, compared with 3.0% with placebo, if all patients adhered to treatment (efficacy estimand*).1 In a second analysis of 1,902 women with overweight or obesity assigned post hoc by menopausal status, average weight loss at week 68 was 26.7%, 24.8% and 23.1% in premenopausal, perimenopausal and postmenopausal women, compared with 2.1%, 1.7% and 2.6% with placebo, respectively (efficacy estimand*).2
“Many women with obesity or overweight experience weight gain as they move through menopause, and it is important to explore investigational products such as CagriSema across the reproductive lifespan,” said Michelle Skinner Moore, PharmD, MBA, interim head of clinical development, medical and regulatory affairs and vice president, medical affairs at Novo. “CagriSema has the potential to be the first amylin analog and GLP-1 RA combination therapy for weight management, and these REDEFINE 1 data show it was associated with significant weight loss for women with obesity or overweight. These findings add to the body of evidence from the REDEFINE clinical program.”
Women experience major hormonal shifts throughout the different stages of menopause, which can increase abdominal fat accumulation and impact body composition, weight and cardiometabolic risk.2,3 More than 86 million women in the U.S. are aged 40 and older, the years in which perimenopause, menopause and postmenopause occur,4 yet reproductive stage is rarely evaluated as a factor in obesity research.5
In the post hoc analysis of all 2,309 women enrolled in the REDEFINE 1 trial, treatment with CagriSema 2.4 mg / 2.4 mg was associated with an average weight loss of 25.0% at week 68, compared with 3.0% with placebo, as well as meaningful improvements in waist circumference – a secondary endpoint of the REDEFINE 1 trial and a measure associated with abdominal fat.1
Change in bodyweight and waist circumference, and achievement of weight-loss targets, among women in REDEFINE 1 at week 68, efficacy estimand results* 1
a Statistically significant compared with placebo, estimated mean, p<0.0001; p values were not adjusted for multiplicity and formal treatment-by-sex interaction testing was not performedIn a separate post hoc analysis, 1,902 women with overweight or obesity in REDEFINE 1 who received CagriSema 2.4 mg / 2.4 mg or placebo were evaluated by menopausal stage. Menopause status was derived post hoc using age, medical history, and recorded symptoms and was not based on prospectively collected reproductive staging or biochemical confirmation. CagriSema was associated with clinically meaningful weight loss across all menopause stages, with an average weight loss at week 68 of 26.7% in premenopausal women, 24.8% in perimenopausal women and 23.1% in postmenopausal women.2
Change in bodyweight from baseline to week 68, efficacy estimand results* 2
a Statistically significant compared with placebo, estimated mean, p<0.0001; p values were not adjusted for multiplicity and formal treatment-by-subgroup interaction testing was not performed“This post hoc analysis from REDEFINE 1 offers new insight into weight loss with investigational CagriSema in women grouped by reproductive life stage,” said Maria D. Hurtado Andrade, M.D., Ph.D., Assistant Professor, Mayo Clinic Alix School of Medicine, and lead author of the analyses. “The weight loss observed in each group is encouraging, and the numerical differences among the groups highlight the need for further research to better understand how reproductive aging may influence weight loss outcomes in women.”
In the REDEFINE 1 trial, discontinuation due to adverse events occurred in 5.9% of participants receiving CagriSema versus 3.5% with placebo.6 Adverse events were mainly gastrointestinal (79.6% in the CagriSema group vs 39.9% with placebo) including nausea (55% vs 12.6%), constipation (30.7% vs 11.6%), vomiting (26.1% vs 4.1%) and were mostly transient and mild-to-moderate in severity.6
Exploratory post hoc analyses are hypothesis generating, and further work investigating the clinical validity of these results would be of value.
Novo filed a New Drug Application with the U.S. Food and Drug Administration in December 2025 for CagriSema for weight management. A decision is expected in Q4 2026. CagriSema is not approved for use in the United States. Safety and efficacy are not established.
*Based on the efficacy estimand: estimated efficacy in an idealized scenario in which all patients stayed on treatment and took no other weight loss therapies.
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Novo to present new liver data across Wegovy 2.4 mg and investigational efruxifermin at The Liver Meeting® (AASLD) 2026
- The PLATINUM-Truveta retrospective cohort analysis compared the effectiveness of semaglutide 2.4 mg and resmetirom on liver enzymes and cardiometabolic markers in people with MASH
- New post-hoc data from ESSENCE examines changes in liver-related parameters with semaglutide 2.4 mg vs placebo in people with MASH and a BMI below 27 kg/m²
- Four posters, including one oral presentation, on investigational efruxifermin research and new analyses from the phase 2b SYMMETRY trial in compensated MASH cirrhosis
Plainsboro, New Jersey, US and Bagsværd, Denmark, 28 October 2026 - Novo Nordisk today announced that 12 new abstracts on semaglutide real-world and clinical data will be presented at the American Association for the Study of Liver Diseases congress, The Liver Meeting® 2026, from November 5-9 in Denver, Colorado.
“MASH often goes unrecognized and undiagnosed, allowing liver damage to progress over time. Earlier diagnosis and treatment are needed,” said Martin Holst Lange, chief scientific officer and executive vice president, Research & Development at Novo. “The data we are presenting at AASLD include results from real-world studies of semaglutide 2.4 mg and post-hoc analyses of people with MASH without obesity as well as studies investigating efruxifermin, which all deepen our understanding of MASH within our portfolio.”
Key Presentations:
PLATINUM-Truveta study was a retrospective cohort analysis using de-identified electronic health records that compared the effectiveness of semaglutide 2.4 mg and resmetirom on liver enzymes and cardiometabolic markers in patients with MASH treated in routine clinical practice. This study assessed changes in liver enzymes, body weight, HbA1c, and other cardiometabolic measures at three and six-month timepoints. Full findings will be presented during a poster session on Friday, November 6, from 13:00–14:00. The study was selected as a Poster of Distinction, a designation given to the top 10% of submitted posters.1
Additional presentations include a real-world retrospective analysis from the RHODIUM-2 study , examining changes in liver enzymes and cardiometabolic markers among patients with MASH who initiated semaglutide 2.4 mg compared with those who did not.2 Other research will explore healthcare resource use in MASLD and ALD, and awareness and perceptions of MASLD and MASH among healthcare professionals and people at risk for or living with these conditions.3–6
Real-world study data can provide valuable insights into how treatments work outside of controlled clinical trial settings. Real-world data analyses also have several limitations; while associations can be demonstrated, causal relationships cannot be definitively established. Results may reflect potential unmeasured confounding, the relatively recent approval of both treatments limited follow-up duration, and electronic medical record data may be subject to coding inaccuracies.
Also being presented are clinical trial data from a post-hoc analysis of the phase 3 ESSENCE trial in people with a BMI below 27 and research examining the burden of MASH.7 An oral presentation will take place on Sunday, November 8, from 11:45–12:00.
Exploratory post-hoc analyses are hypothesis generating, and further work investigating the clinical validity of these results would be of value.
The research to be presented at The Liver Meeting® 2026 reflects Novo’s leadership in advancing the understanding of optimal screening, diagnosis, and management of MASH and other serious chronic conditions.
Summary of presentations
Accepted data at The Liver Meeting® 2026 include the following poster and oral presentations. Accepted abstracts include preliminary data that may be subject to change in the final published manuscripts. Dates and times of the presentations can be found on the AASLD website.AASLD poster and oral sessions
Semaglutide 2.4 mg
- Real-world comparative effectiveness of semaglutide versus resmetirom on liver enzymes and cardiometabolic markers in patients with MASH. Poster presentation 2461, Friday, November 6, 13:00–14:00
- Semaglutide 2.4 mg and the changes in liver enzymes and cardiometabolic markers in patients with MASH: a descriptive real-world data study. Poster presentation 2473, Friday, November 6, 13:00–14:00
- Semaglutide improves liver health in non-obese participants with MASH: a post hoc analysis from the phase 3 ESSENCE trial. Oral presentation 0072, Sunday, November 8, 11:45–12:00
Cross-product (investigational)
- Effects of zalfermin, cagrilintide, and semaglutide on non-invasive fibrosis biomarkers in alcohol-related liver disease: a phase 2 randomized trial. Oral presentation 0087, Sunday, November 8, 11:00–11:15
MASH disease-area sessions
- ACT on MASH – US Data: a survey of awareness, understanding, and perceptions of MASLD and MASH among healthcare professionals. Poster presentation 2526, Friday, November 6, 13:00–14:00
- ACT on MASH – US Data: a survey of awareness, understanding, and perceptions of MASLD and MASH among people living with MASLD/MASH or at risk for MASH. Poster presentation 2556, Friday, November 6, 13:00–14:00
- The economic burden of patients with metabolic dysfunction-associated steatohepatitis stratified by baseline and changes in FIB-4 index. Poster presentation 2631, Friday, November 6, 13:00–14:00
- The impact of cardiometabolic risk factors on health care resource use in adult patients living with steatotic liver disease. Poster presentation 2163, Friday, November 6, 13:00–14:00
Efruxifermin (investigational)
- The FGF21 analog EFX regulates intercellular fibrogenic signaling by disrupting hepatocyte to stellate cell transfer of dysfunctional mitochondria. Poster presentation 3360, Saturday, November 7, 13:00–14:00
- Efruxifermin improved fibrosis in participants with MASH cirrhosis and multiple cardiometabolic comorbidities: a post hoc analysis of the SYMMETRY Phase 2b trial. Poster presentation 3548, Saturday, November 7, 13:00–14:00
- Efruxifermin drives multidimensional histologic improvement in compensated cirrhosis: an AI-based analysis from the SYMMETRY randomized controlled trial. Oral presentation 0066, Sunday, November 8, 14:30–14:45
- Multi-omic dissection of the direct mechanism of action of efruxifermin-mediated reversal of lipotoxicity in primary human hepatocyte. Poster presentation 3544, Saturday, November 7, 13:00–14:00
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Novo raises full-year outlook on continued GLP-1 momentum, with third-quarter adjusted operating profit increasing 27% at CER to DKK 31,720 million
2026-11-04 07:30:47
4 November - Financial report for the period 1 January 2026 to 30 September 2026
Financial performance
- Q3 2026 adjusted and reported sales increased by 4% at CER, driven by continued GLP-1 volume growth across the US and International operations, primarily in obesity.
- Q3 2026 adjusted operating profit increased by 27% at CER, driven by GLP-1 sales growth and a favourable comparison base following DKK 9 billion of company-wide transformation costs recognised in Q3 2025.
- Q3 2026 reported operating profit decreased by 9% at CER, reflecting DKK 8.7 billion of non-cash impairment charges in the quarter, related to ziltivekimab (DKK 4.6 billion) and right-sizing of manufacturing network (DKK 4.1 billion).
Commercial highlights
- By the end of Q3, Wegovy® pill had been launched in the US, UAE, UK and Germany, with uptake driving Q3 2026 sales of DKK 5,394 million. More recently, launches in four additional countries increased the total number of launched markets to eight.
- The Wegovy® franchise maintains its US leadership in new patient starts, with more than 50% share in the branded obesity market.
- Ozempic® pill was launched in the US in May, with encouraging early momentum. Weekly new-to-brand prescriptions (NBRx) are currently up around 100% compared with pre-launch levels under the Rybelsus® brand.
- The global roll-out of Ozempic® 2.0 mg and the Wegovy® 7.2 mg single-dose pen across International Operations is progressing.
Pipeline progress
- Within obesity, CagriSema (1.0/1.0 mg) delivered encouraging weight loss of 21% at week 68 in the REDEFINE 9 trial.
- Also in obesity, the AMAZE 9 phase 3 trial with oral zenagamtide has been initiated in September.
- Within diabetes, CagriSema (1.0/1.0 mg) achieved superior weight loss of 12.4% compared with 9.1% for tirzepatide 5 mg, while demonstrating non-inferior HbA1c reduction at week 60 in adults with type 2 diabetes and obesity in the REIMAGINE 5 trial.
- Within blood & endocrine disorders, Frehemgo® (denecimig) received positive CHMP opinion on 17 September and pending full EU approval, the first launches are planned in Europe around the turn of the year. In the US, the regulatory review of denecimig is still ongoing, and pending regulatory decision, a US launch is expected in H1 2027.
Outlook
- Adjusted sales growth for 2026 is now expected to be -2% to +2% at CER and adjusted operating profit growth is now expected to be -2% to +2% at CER. The improved outlook is driven by increased expectations for GLP-1 product sales.
PROFIT AND LOSS DKK million Q3 2026 Growth in DKK Growth at CER 9M 2026 Growth in DKK Growth at CER Net sales 79,195 6% 4% 254,506 11% 13% Operating profit 23,011 (3%) (9%) 109,690 14% 18% Adjusted net sales1 79,195 6% 4% 227,746 0% 2% Adjusted operating profit1 31,720 34% 27% 97,967 5% 8% CER: Constant exchange rates; 1Adjusted sales and adjusted operating profit exclude certain exceptional and non-recurring items not reflective of the Group’s normal course of operating activities, as defined in Appendix 7. “We delivered a stronger-than-expected third quarter and are raising our full-year outlook for adjusted sales and adjusted operating profit. We are particularly pleased to see both US Operations and International Operations deliver sales growth this quarter. Growth was led by our obesity portfolio, with continued uptake of Wegovy® pill in the US and encouraging early launches internationally. Our focus is on sustaining this progress through disciplined execution and broader access to our medicines. We are also advancing our pipeline and preparing for the US launch of CagriSema in early 2027, subject to regulatory approval,” said Mike Doustdar, president and CEO of Novo.
On 4 November 2026 at 13.00 CET, corresponding to 07.00 am EST, an earnings call will be held. Investors will be able to listen in via a link on novonordisk.com, which can be found under ‘Investors’ (the contents of the company’s website do not form a part of this Form 6-K).
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Payback time for Novo - det var på tide.
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Det er Novo vi snakker om…
Man vil så gjerne ha troa, men det er litt som med familiemedlemmet som kommer ut av rehab for 17. gang 
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Novo sårer deg ikke med vilje altså, han gjør så godt han kan
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Økte på dippen i dag, tror faktisk aksjen kan være verdt å eie en stund. Burde ikke være rare reisen opp til 330 - 340 etter oppjustering av guiding.
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Er ting i ferd med å snu? Novo snakker og kursen stiger? 
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