Antyder også ofte at m&a targetet er mye mindre enn den som kjøper, neppe så overraskende for NOVO 
Novo Nordisk to showcase new data across its haemophilia portfolio at the ISTH Congress 2026, featuring investigational denecimig
- FRONTIER4 data on investigational denecimig : Exploring efficacy and safety across dosing frequencies for pediatric, adolescent, and adult haemophilia A patients, with or without inhibitors
- Explorer10 data on concizumab (Alhemo®): Details presented for pediatric haemophilia A or B patients (up to 11 years old), with inhibitors
- Data underscores the breadth of Novo Nordisk’s haemophilia portfolio, building on Novo Nordisk’s legacy across rare blood disorders
Plainsboro, NJ and Bagsværd, Denmark, 26 June 2026 – Novo Nordisk today announced that new data will be presented at the upcoming International Society on Thrombosis and Haemostasis (ISTH) Congress, 11-15 July in Paris, France. The broad range of oral and poster presentations spans the Novo Nordisk haemophilia portfolio and is highlighted by multiple analyses of the phase 3 FRONTIER4 study evaluating the long-term efficacy and safety of investigational denecimig (Mim8) across a range of age groups and dosing frequencies, including once-monthly, once-every-two-weeks, and once-weekly prophylaxis. Additional insights from the portfolio will span clinical and real-world treatment data as well as patient-reported outcomes.
“Everyone’s experience with haemophilia is different, and we have a deep responsibility to meet the real-world needs of the community. For more than 45 years, we have listened to the lived experiences of patients, and we continue to advance scientific innovation to improve care,” said Martin Holst Lange, chief scientific officer and executive vice president, Research & Development at Novo Nordisk. “We are excited to share data across our portfolio, including for denecimig, as each of our studies accounts for that lived reality as we focus on advancing person-centric research that will help bring meaningful impact to the rare blood disorders community."
Additionally, data from the open-label phase 3 explorer10 study will be presented for the first time, evaluating the efficacy and safety of concizumab in children up to 11 years of age living with haemophilia A or B (HA/HB), with inhibitors. The use of concizumab in children below 12 years of age with haemophilia A or B, with or without inhibitors, is investigational and not approved by regulatory authorities or available anywhere in the world.
Summary of all presentations
Accepted data at the 34th ISTH Congress include the following poster and oral presentations. Additional information can be found on the ISTH website .Full details of Novo Nordisk abstracts to be presented:
Investigational denecimig
- Oral presentation: Mim8 (denecimig) prophylaxis in adults and adolescents with haemophilia A with or without inhibitors: Interim results from the FRONTIER4 long-term safety and efficacy study
- Oral presentation: Mim8 (denecimig) prophylaxis in children with haemophilia A with or without inhibitors: Interim safety and efficacy results from the FRONTIER4 long-term extension study
- Poster presentation: Mim8 (denecimig) prophylaxis in adults, adolescents and children with haemophilia A with or without inhibitors: Interim patient-reported outcomes from the long-term extension study (FRONTIER4)
- Poster presentation: Denecimig (Mim8) restores thrombin generation into the normal range in people with haemophilia A: Post hoc analysis of the phase 3 FRONTIER2 and FRONTIER5 studies
- Poster presentation: Thrombin generation of haemophilia B-causing factor IX variants with non-factor therapies
- Poster presentation: Denecimig (Mim8) tiered dosing achieves consistent exposure and bleed control in phase 3 FRONTIER studies
- Poster presentation: A multinational, open-label study to investigate efficacy and safety of denecimig (Mim8) in adults with acquired haemophilia A: study enrolment 2026
- Poster presentation: Denecimig (Mim8) enhances in vitro thrombin generation in von Willebrand disease type 3 plasma
- Poster presentation: Effects of denecimig (Mim8) and tranexamic acid in an in vitro clot lysis assay
- Poster presentation: FVIIIa-mimetic bispecific antibody (Mim8) enhances thrombus formation of von Willebrand disease (VWD) under high shear flow condition
- Poster presentation: The coagulation potential in the copresence of Mim8 and warfarin
Concizumab (Alhemo®) injection
- Oral presentation: Concizumab prophylaxis in paediatric participants with haemophilia A/B with inhibitors in the phase 3 explorer10 study: Efficacy, safety and PK/PD results from the 32-week cut-off
- Poster presentation: Association of Concizumab with Tissue Factor Pathway Inhibitor (TFPI) within Platelets and the Extracellular Matrix (ECM)
- Poster presentation: Mechanism-based functional monitoring of concizumab focusing on coagulation initiation: from comprehensive global assays to TFPI-oriented assessment
- Poster presentation: The effect of anti-TFPI antibodies in a novel rapid automatable clotting assay measuring the activity of TFPI and in a thrombin generation assay
Pre-clinical data & general haemophilia
- Poster presentation: Evaluation of Physical Activity and Related Bleeds in Patients with Hemophilia in the US: A Real-World Microhealth App Study
- Poster presentation: Physicians’ Preferences in the Treatment of Hemophilia: A Discrete-Choice Experiment
- Poster presentation: Real-World Indirect Cost Burden and Patient-Reported Outcomes in Adults with Hemophilia A in the United States – A CHESS-US Analysis
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Noe som komplementerer egen pipe / kan brukes i kombo med egne produkter.
Kjøpet at Akero er f.eks et slikt. Novo fikk seg en langtidsvirkende FGF21-analog med tilsynelatende svært god effekt i leverfibrose. De tenker seff ikke å selge dette alene, men i kombo med en glp1, ev. en glp1/amylin-drug.
Akero-kjøpet er basicly bare Novo som sørger for at de har en FGF21-analog (efruxifermin) som er tilsynelatende er top of the class (Roche gjorde akkurat det samme da de kjøpte 89bio). For dem som husker skrota Novo også sitt eget FGF21-program (zalfermin) rett før kjøpet.
Men altså, efruxifermin er en laksetrapp. Fancy det, men Novo trenger en ny bil. Foreløbig er det en slags first mover, “alle er trygge på wegovy”-effekt, men før eller senere må Novo stikke fingeren i jorda og innse at basisdrugen som skal ligge under alle “bolt on”-produktene de ønsker å selge må være noe annet enn wegovy. Jeg fatter fortsatt ikke at Novo valgte å skrinlegge sitt eget glp1/gip (once weekly)-program, men det kan jo tenkes at Novos kandidat ikke matcha tirzepatide, eller noen av de andre kandidatene der ute (Vikings vk2735, eller Roches CT-388), hvem vet.
Så skal man finne ut hva Novo potensielt kan finne på å kjøpe, så er det jo bare å se hva de shelver selv. Eller hva hullene i pipen deres er. Spørsmålet er kanskje mest når ledelsen i Novo selv finner ut hva hullene er. Før eller senere blir walkman utdatert.
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Er ikke UBT251 og Amycretin neste generasjon som skal ta over da?
Joda. Men altså, for fem år siden var Novo foran LLY i dette racet. Og på et eller annet magisk (les: tragisk) vis, har de klart å havne totalt bakpå (i store deler av racet, ikke alt).
LLYs trippelagonist reta er på markedet seint 2027, tidlig 2028.
Amycretin / Zenagamtide er fort seint 2029, tidlig 2030.
UBT251 også rundt 2030.
Hva skjedde med forspranget? Og hvorfor gjorde ikke Novo det “logiske” her, som var å lage en drug som lignet på tirzepatide, just in case.? Vi snakker tross alt om et selskap som finner på å kjøre fase III trials i ganske mye rart her. Så å kjøre på med en GLP-1/GIP kombo, bare for å ha en sikring, en baselinedrug som ca. matcher tirzepatide i efficacy / toleranse hadde vært en ganske smart move. Men Novo ville mer. De ville toppe det hele, de trodde ikke det var nødvendig med noe sånt. Og derfor står vi her med et “gapende hull” midt i pipen deres. I stedet for en GLP-1/GIP, så fikk vi en GLIPP. Men altså, jeg tror ikke løpet er kjørt for CagriSema. Sema har et så godt navn i seg selv. Og når bare Novo skjønner det alle andre har skjønt, nemlig at Cagri-delen er den du skal stå på resten av livet når du har oppnådd vekttapet, og klarer å pitche det, så kan det være vi ihvertfall ikke ser på en total failure. Oral Wegovy har overrasket svært positivt så langt, mulig pga at LLY priser Foundayo for høyt, mulig fordi det er en bedre drug, mulig fordi folk – når alt kommer til alt – er skeptiske til ikke-peptid small molecules, ev. så har bare rollouten til LLY vært treg. Jeg tror oral w har en fordel mange ikke snakker om ennå, og det er at det er lite kryss-drug problematikk, dvs. at man kan ta den sammen med veldig mange andre drugs, noe som visstnok skal være litt mer problematisk med fondue-drugen til LLY. Og LLY har ikke noe annet oralt i pipe som dukker opp rundt neste sving. Så det er bra for Novo. Men jeg vil se Novo med en ikke-peptid pille i pipe som ikke kommer i 2050, og en glp-1/gip som ny baseline drug, la oss kalle den “enhanced semaglutide” eller noe slikt.
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Ingen sommerferie i EU
Novo Nordisk receives European Commission approval of Wegovy® pill as first oral GLP-1 for weight management in the EU; single, ready-to-use pen for higher dose 7.2 mg also approved
2026-07-15 17:51:00
- First GLP-1 pill approved in the European Union for the treatment of obesity and overweight
- Only Wegovy® pill demonstrates 17%* mean weight loss1 and cardiovascular benefits
- Wegovy® 7.2 mg injection in a single-dose pen, delivering 21%* weight loss, has now been approved in EU
Bagsværd, Denmark, 15 July 2026 – Novo Nordisk today announced that the European Commission (EC) has granted marketing authorisation for Wegovy® pill (once-daily oral semaglutide 25 mg) for the treatment of adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity, as an adjunct to a reduced-calorie diet and increased physical activity. This follows the positive opinion issued by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in May 2026.
The Wegovy® pill approval is a landmark moment in the treatment of obesity in Europe, making it the first GLP-1 receptor agonist available in tablet form for weight management across all European Union member states. It marks the fifth regulatory approval of Wegovy® pill, after the US, UK, UAE and Bahrain.
“Today’s European Commission approval of Wegovy® as a once-daily pill brings another important treatment option to people living with obesity,” said Mike Doustdar, president and CEO of Novo Nordisk. “Obesity is a serious chronic disease, and choice can make a real difference. For many people, a tablet may be a simpler and more acceptable way to start and continue treatment. This is more than a regulatory milestone - it is a step toward better and lasting health for people with obesity and a strong societal response to one of Europe’s most significant health challenges.”
The Wegovy® pill approval is based on the extensive OASIS clinical trial programme, including OASIS 4, which evaluated once-daily oral semaglutide 25 mg in adults with obesity or overweight with at least one weight-related comorbidity. In the trial, oral semaglutide 25 mg demonstrated clinically meaningful and statistically significant weight loss of approximately 17% compared with 3% with placebo when used alongside lifestyle intervention. Around one in three individuals achieved 20% weight loss or more1*.
The safety and tolerability profile of oral semaglutide is consistent with the established injectable semaglutide profile, which is based on many years of patient experience, with adverse-event–related discontinuations nearly comparable to placebo at 6.9% vs 5.9%1*.
The European Commission (EC) also granted approval for Wegovy® 7.2 mg injection in a single-dose pen for people living with obesity.
Wegovy® pill is currently available in the US, UK and UAE, and Novo Nordisk is committed to launching Wegovy® pill in more countries in the second half of 2026.
Tydligvis også godkjent i Bahrain, men ikke lansert
3 Likes
Greit at Novo fikk seg en head start på Lilly, men det begynner å bli ganske klart hva kundene foretrekker.
Har sett noen analytikere si at det egentlig ikke er noe uvanlig / tregt med Foundayos rollout, det er bare at Oral W har hatt en kanon-rollout.
Så langt ser det ut til at Novo klarer å møte etterspørselenen, at det produseres peptider over en lav sko i Novo-fabrikkene. Det er en achievement i seg selv når vi tenker på mengden virkestoff som går med.
Tror Lilly blir nødt til å sette ned prisen om de skal konkurrere. Eneste de har gående (bortsett fra t2d blodsukkeret, da) er at de kan produsere mye billigere. Så kan man spørre seg om når det ev. skjer?
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Er det dette som du har nevnt tidligere @WernerVonHaussenberg? At det er uforståelig at de stoppet programmet
I wish, men det jeg har påpekt / klaga på, er at NVO shelva once weekly GLP1/GIP-en sin (altså samme kombo som tirzepatide, vk2735, Roches CT-388). Det kan seff være issues med akkurat det produktet NVO utviklet, men når dette ser ut til å bli selve ryggraden / kjernen i diverse selskaps obesity franchiser, så hadde det jo vært lurt å ha for Novo også, imho.
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Litt andre regler for markedsføring utenfor USA 
Ang det å saksøke Eli Lilly så kan det gi litt nyttig PR for nylig lanserte Wegovy HD, uansett hvordan saken ender
Tror du det også er en faktor med i søksmålet? At Novo også snik-markedsfører 7,2mg med dette?
All PR er god PR? I det lange løp har nok søksmålet lite å si. Men uansett om det er faktor eller ikke så har nå alle verdens nettaviser skrevet om dette i dag og satt økt søkelys på Wegovy HD. Noe som kan være viktig i USA hvor direct to consumer nå har blitt ett ganske stort marked
Google trends (dog fra ett veldig lavt nivå)
Ser ut som diabetes trialen blir presentert på EASD i slutten av September
https://www.abstractsonline.com/pp8/index.html#!/21509/presentation/1997
Novo også i gang med div trials i diabetes og safety med UBT251 (de startet en i overvekt tidligere i år):
https://clinicaltrials.gov/study/NCT07668388
https://clinicaltrials.gov/study/NCT07710729
https://clinicaltrials.gov/study/NCT07710768
Tidlige tegn på at flere Medicare pasienter velger å gå for injeksjoner pga større dokumentert vektnedgang;
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Novo Nordisk provides update on the ZEUS phase 3 trial in people with ASCVD, CKD and inflammation
Bagsværd, Denmark, 31 July 2026 – Novo Nordisk today announced headline results from the ZEUS cardiovascular outcomes phase 3 trial.
While ziltivekimab demonstrated target engagement and inhibition of the IL-6 pathway, as reflected by expected reductions in free IL-6 and high-sensitivity C-reactive protein (hsCRP) respectively, this did not translate into major adverse cardiovascular events (MACE) risk reduction versus placebo in people with atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD) and inflammation (hazard ratio, 0.99; 95% confidence interval, 0.88 to 1.11)1.
ZEUS was a double-blind, placebo-controlled trial enrolling over 6,300 people with ASCVD, CKD, and inflammation, as measured by hsCRP levels ≥2 mg/L. The trial evaluated once-monthly ziltivekimab 15 mg versus placebo for reducing the risk of MACE, defined as cardiovascular (CV) death, non-fatal heart attack or non-fatal stroke.
“ZEUS was designed to test whether inhibition of the IL-6 pathway could translate reductions in cardiovascular inflammation into fewer major cardiovascular events. Although ziltivekimab produced the expected biological effect, this did not result in MACE benefits in this population,” said Martin Holst Lange, executive vice president, chief scientific officer and head of Research and Development at Novo Nordisk. “While ziltivekimab did not achieve the MACE benefit we had hoped for, this does not change our strategic commitment to cardiovascular disease. The study provides important scientific evidence that will inform our ongoing cardiovascular research and the development of treatments for patients who continue to face substantial unmet need.”
Overall rates of adverse events (AEs) and serious AEs in people treated with ziltivekimab were similar to those observed with placebo. Consistent with targeting IL-6 inhibition, a higher proportion of people treated with ziltivekimab had serious infections compared to placebo. No difference in all-cause mortality was observed.
The two additional ongoing cardiovascular outcomes trials investigating ziltivekimab in people with heart failure (HERMES) and in people following an acute heart attack (ARTEMIS) are planned to continue and are anticipated to read out in the first half of 2027.
The outcome of ZEUS will not impact Novo Nordisk’s previously communicated adjusted operating profit outlook for 2026 but will result in a non-cash impairment charge in Q3 2026.
Full results of the ZEUS trial will be presented at an upcoming scientific meeting in 2026.
Fair å prøve en inngang på 296 igjen eller var dette verre nyheter enn 10 % ned?
Entrance på 299, satser på klassisk overreaksjon
Novos hjertemedicin fejler i stort forsøg
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i dag kl. 13:45 ∙ MarketWire
Novo Nordisks eksperimentelle hjertemedicin ziltivekimab er dumpet i det store fase 3-studie ZEUS, hvor midlet ikke formåede at nedbringe risikoen for alvorlige hjerte-kar-hændelser sammenlignet med placebo.
Det skriver Novo Nordisk i en meddelelse.
I alt 6300 mennesker med forskellige hjerte-, nyre- eller inflammationslidelser medvirkede i studiet, hvor en månedlig dosis på 15 milligram med ziltivekimab blev afprøvet.
- ZEUS var designet til at teste, hvorvidt en begrænsning af IL-6-banen kunne omsætte en reduktion af kardiovaskulær inflammation til færre alvorlige hjerte-kar-hændelser. Selv om ziltivekimab skabte den ønskede biologiske effekt, resulterede det ikke i forbedring af alvorlige hjerte-kar-hændelser i befolkningsgruppen, siger Novos forskningsdirektør Martin Holst Lange i meddelelsen.
Omfanget af bivirkninger og alvorlige negative reaktioner på ziltivekimab var på niveau med det, som personer på placebo oplevede. Novo bemærker dog også, at folk på ziltivekimab “konsistent med behandling målrettet IL-6” havde flere alvorlige infektioner.
Resultatet ventes at føre til en nedskrivning af værdien af midlet, men det rører ikke ved Novos forventninger til det justerede driftsoverskud for 2026.
Novo agter også fortsat at gennemføre to øvrige studier med ziltivekimab mod slagtilfælde og blodpropper. Data fra begge studier ventes offentliggjort i første halvår af 2027.
Kjøpte litt for tidlig, men trailer for en kort trade