A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy and Safety of Petrelintide Co-Administered With RO7795068 in Adults With Obesity or Overweight

The main purpose of this study is to evaluate the safety and efficacy of the co-administration of petrelintide and enicepatide compared with placebo, petrelintide monotherapy, and enicepatide monotherapy in participants with obesity or overweight with at least one weight-related comorbidity.

Start Date30 Sep 2026

Sponsor / Collaborator

Zealand Pharma A/S

NCT07682818

/ RecruitingPhase 1

Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Hepatic Function

This clinical research trial is testing the investigational medicinal product (IMP) petrelintide that is being developed for body weight reduction in people living with obesity or overweight who have comorbidities.
The aim of this clinical research trial is to investigate whether the pharmacokinetics (PK) of petrelintide will be different in people with hepatic impairment (HI) compared to people with normal hepatic function.

Start Date18 May 2026

Sponsor / Collaborator

Zealand Pharma A/S

NCT07338214

/ CompletedPhase 1

Investigating the Pharmacokinetics of Petrelintide Using Different Drug Product Concentrations in Participants With a BMI ≥27.0 kg/m²

This clinical research study is testing the study compound petrelintide that is being developed for the weight management in people with obesity or overweight with co-morbidities or related diseases.
The goal is to learn how the same single dose of petrelintide, given using different concentrations, works in the body when given to participants with a BMI at, or above, 27kg/m2.
The main questions it aims to answer are:
1. Are there differences in how the body absorbs, distributes, metabolises and excretes petrelintide when same single dose petrelintide is given using different concentrations?
2. Are there differences in safety of petrelintide when same single dose petrelintide is given using different concentrations?
Participants will:
Visit the study center 10 times for tests and blood sampling (9 day ambulatory visits and 1 in-house visit of 4 consecutive days with sleeping 3 nights at the study center).
Petrelintide will be given once as a single injection in a skin fold of the abdomen on Day 1. The participants will be monitored until approximately Day 50.

Start Date17 Dec 2025

Sponsor / Collaborator

Zealand Pharma A/S

[+1]

100 Clinical Results associated with Petrelintide

100 Translational Medicine associated with Petrelintide

100 Patents (Medical) associated with Petrelintide

Literatures (Medical) associated with Petrelintide

01 Jul 2026·DIABETES OBESITY & METABOLISM

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Petrelintide for Weight Management: Two Randomized, Controlled Phase 1 Trials

Article

Author: Macura, Stanislava ; Brændholt Olsen, Minna ; Heise, Tim ; Griffin, Jon ; Fredsted Hagen, Berith ; Hesse, Dan ; Hövelmann, Ulrike

ABSTRACT:

Aims:

Petrelintide is a long‐acting amylin analogue in development for weight management. The safety, tolerability, pharmacokinetics, and pharmacodynamics of petrelintide were evaluated in single ascending dose (SAD) and multiple ascending dose (MAD) trials.

Materials and Methods:

Both trials were randomized, placebo‐controlled, and double‐blind. The SAD trial assessed subcutaneous (SC) petrelintide doses of 0.04–2.4 mg and a 0.35 mg intravenous dose. The MAD trial evaluated 6 once‐weekly SC doses of 0.6 and 1.2 mg (part 1), and 16 once‐weekly doses escalated every 2 weeks to target doses of 2.4, 4.8, and 9.0 mg (part 2). The SAD and MAD part 1 trials enrolled normal or overweight adults; MAD part 2 enrolled adults with overweight or obesity.

Results:

Petrelintide was well tolerated, with no serious or severe treatment‐emergent adverse events (TEAEs). In both trials, the most common TEAEs included gastrointestinal (GI) disorders, most of which were mild. One participant discontinued treatment due to GI TEAEs. Nausea, the most common GI TEAE, occurred in 16.7%–33.3% of participants receiving petrelintide versus 16.7% for placebo in MAD part 2, while diarrhoea was rare and vomiting was only experienced by the participant who discontinued. Petrelintide was slowly absorbed, had a half‐life of ~10 days, showed steady‐state dose proportionality, and reduced body weight by up to 8.6% after 16 weeks.

Conclusion:

Petrelintide appeared safe, had a low incidence of GI TEAEs, and resulted in clinically relevant weight loss. These findings support further development of petrelintide as an effective weight‐management medication, with potential for improved GI tolerability over existing therapies.

01 Mar 2026·VASCULAR PHARMACOLOGY

Amylin receptors as therapeutic targets in obesity: Emerging peptide-based strategies

Review

Author: Rejili, Mokhtar ; Sahoo, Samir ; Haouala, Faouzi ; Khan, Yumna ; Pal, Amrita ; Arora, Vimal ; Ganesan, Subbulakshmi ; Hussain, Md Sadique

Obesity is a chronic, relapsing metabolic disorder driven by complex genetic and environmental factors, leading to an imbalance in energy regulation. Despite the presence of GLP-1 receptor agonists with induced mild weight loss, there are significant unmet clinical needs with poor efficacy and tolerability problems. Amylin, a neuroendocrine hormone co-released with insulin, controls hunger, gastric motility, glucagon secretion, and energy metabolism via divergent amylin receptor (AMYR) subtypes (1-3), namely the calcitonin receptor (CTR) and the receptor activity-modifying proteins (RAMPs). Novel insight into the molecular make-up of AMYRs and central signaling reinforces its key function in modulating homeostatic and hedonic feeding mechanisms. The article is a review of the emerging preclinical and clinical data regarding the application of peptide-based amylin receptor agonists (AMYRAs), including pramlintide and cagrilintide, KBP-series DACRAs, and investigational drugs, including ZP8396 and amycretin. The agents show enhanced pharmacokinetics, synergy with GLP-1 receptor agonist, and favorable impact on weight regulation and metabolic plasticity. Genetic CALCR and RAMP mutations, new delivery approaches, and dual therapy by digital health technologies and bariatric surgery are also discussed in this review. Of particular interest, amylin-derived medications can have advantages over weight loss but definite disease-modifying action remains to be determined. Taken together, AMYRAs represent a potential category of therapeutics with promising disease-modifying effects that goes beyond weight loss, providing fresh perspectives for precision obesity management by 2030.

01 Mar 2026·PEPTIDES

Long-acting amylin-related peptides as therapies for obesity and type 2 diabetes

Review

Author: Flatt, Peter R ; Bailey, Clifford J ; Conlon, J Michael

The first therapeutically useful amylin receptor (AMYR) agonist, pramlintide was based upon the structure of non-aggregating rat amylin and found limited application as an adjunct to insulin therapy. It acts centrally to induce satiety, promote weight loss, suppress prandial glucagon release and reduce prandial hyperglycaemia. Recent understanding of the heterodimeric structure of amylin-calcitonin receptor complexes and of amylin structure-function properties has assisted the design of a second generation of non-aggregating, long-acting amylin analogues. These are now advancing in clinical development and promise to provide an effective additional resource for the management of obesity and type 2 diabetes. Amongst these agents is the dual AMYR/ calcitonin-receptor (CTR) agonist, cagrilintide that has also been co-formulated into a once weekly subcutaneous injection with the long-acting glucagon-like peptide-1receptor (GLP-1R) agonist, semaglutide (CagriSema). In clinical trials, CagriSema has achieved greater effects than either component alone. A unimolecular AMYR/CTR/GLP-1R multi-agonist peptide, amycretin has been developed for weekly injection and as a once-daily tablet. Several recently developed long-acting amylin analogues have shown strong efficacy as monotherapy in clinical trials: these include eloralintide, petrelintide, Met-233 and AZD6234. Other analogues with marked efficacy in preclinical studies, including non-peptide AMYR agonists are under development. Gastrointestinal side effects, especially nausea, similar to those reported for GLP-1R agonists are commonplace during initiation and up-titration of amylin analogues but mostly resolve during continued use. Evidence is emerging that long-acting AMYR agonists may show potential therapeutic benefits in treatment of patients with fatty liver disease, diabetes-associated kidney complications and resistant hypertension.

101

News (Medical) associated with Petrelintide

23 Jul 2026

·www.biospace.com

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s strong momentum continues in the first half of 2026, delivering +6% sales growth at constant exchange rates; -2% in CHF due to the significant appreciation of the Swiss franc

Group sales were +6% at constant exchange rates (CER) 1 , -2% when reported in CHF and +8% in USD 2 , in the first six months, driven by high demand for innovative medicines and diagnostics. Pharmaceuticals Division sales were +6% at CER, -1% when reported in CHF and +8% in USD, due to continued high growth in sales of our medicines across disease areas; Xolair (allergic asthma, chronic hives, food allergies), Hemlibra (haemophilia A), Ocrevus (multiple sclerosis), Phesgo (breast cancer) and Vabysmo (severe eye diseases) were the top growth drivers. Diagnostics Division sales were +3% at CER, -3% when reported in CHF and +6% in USD, driven by demand for immunodiagnostic and clinical chemistry products as well as pathology and molecular solutions. Core operating profit was +10% at CER, -1% when reported in CHF, driven by higher sales and other revenue; IFRS operating profit was -6% in CHF due to the appreciation of the Swiss franc. Core earnings per share were +9% at CER (-2% in CHF); IFRS diluted earnings per share were -8% in CHF due to the appreciation of the Swiss franc. Highlights: US Priority Reviews for giredestrant in an early-stage breast cancer, Enspryng in thyroid eye disease, Tecentriq in colon cancer as well as Gazyva/Gazyvaro in idiopathic nephrotic syndrome and primary membranous nephropathy, two autoimmune diseases affecting the kidneys US acceptance of a supplemental Biologics License Application for the Lunsumio and Polivy combination for blood cancer and Gazyva/Gazyvaro for systemic lupus erythematosus Positive phase III data on divarasib in lung cancer; presentation of promising data on fenebrutinib in multiple sclerosis (phase III), Gazyva/Gazyvaro in three autoimmune diseases (phase III) and enicepatide (CT-388) and petrelintide in obesity (phase II) Launch of Axelios 1 , a transformative next-generation sequencing platform based on the innovative SBX technology, enabling the fastest DNA sequencing at scale EU CE mark for two blood tests: Elecsys pTau217 to detect Alzheimer’s pathology and Elecsys IGRA TB to identify latent tuberculosis infection US approval for Ventana PTEN (SP218) RxDx Assay , the first companion diagnostic to assess the levels of a key protein in prostate cancer Global collaboration agreement with Nurix Therapeutics for the BTK degrader bexobrutideg across malignant haematology, immunology and neurology Agreement to acquire PathAI to transform AI-driven diagnostics Outlook for 2026 confirmed. Outlook for 2026 Roche (SIX: RO, ROP; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER) for 2026. Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs. Key figures CHF millions % change January–June 2026 2025 At CER 1 In CHF In USD Group sales 30,364 30,944 6 -2 8 Pharmaceuticals Division 23,629 23,985 6 -1 8 Diagnostics Division 6,735 6,959 3 -3 6 Core operating profit 11,856 12,010 10 -1 Core EPS – diluted (CHF) 10.85 11.08 9 -2 IFRS operating profit 9,671 10,330 6 -6 Roche CEO Thomas Schinecker : “Our strong momentum continued in the first half of the year, driven by a 6% sales increase at constant exchange rates and significant positive pipeline development. We reported positive phase III data for divarasib , reinforcing its potential as a best-in-class therapy in advanced lung cancer. Our regulatory momentum accelerated significantly as the US FDA granted five Priority Reviews: giredestrant in early-stage breast cancer, Enspryng in thyroid eye disease, Tecentriq in colon cancer and Gazyva/Gazyvaro in two autoimmune kidney diseases. In Diagnostics, we reached major milestones with the launch of our transformative, highly cost-effective Axelios 1 sequencing solution, alongside EU CE mark for key diagnostic tests, including the Elecsys pTau217 blood test for Alzheimer’s pathology and the Elecsys IGRA TB blood test, which delivers automated, scalable latent tuberculosis screening to laboratories worldwide. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Backed by our robust pipeline, we are well-positioned for sustained future growth. We confirm our outlook.” Group results In the first six months of 2026, Roche sales were +6% at CER, -2% when reported in CHF, to CHF 30.4 billion due to strong demand for pharmaceutical products and diagnostic solutions. The appreciation of the Swiss franc against most currencies, notably the US dollar, had a significant impact on the results reported in Swiss francs compared to constant exchange rates. Core operating profit was +10% at CER (-1% in CHF) to CHF 11.9 billion, driven by higher sales and other revenue. Core earnings per share were +9% at CER (-2% in CHF). IFRS operating profit was -6% in CHF to CHF 9.7 billion. IFRS diluted earnings per share were -8% in CHF. The IFRS results were impacted by the appreciation of the Swiss franc. Sales in the Pharmaceuticals Division were +6% at CER, -1% when reported in CHF, to CHF 23.6 billion, with our medicines across disease areas continuing their strong growth. The top five growth drivers – Xolair, Hemlibra, Ocrevus, Phesgo and Vabysmo – achieved total sales of CHF 11.0 billion, an increase of 12% at CER, or 4% in CHF, compared to the first six months of 2025. Sales of products with expired patents (Avastin, Herceptin, MabThera/Rituxan, Lucentis and Actemra/RoActemra) were CHF 2.6 billion, a decrease of 8% at CER, or 15% in CHF, compared to the first six months of 2025. In the United States , sales were +6% at CER, -3% when reported in CHF, due to continued growth of Xolair, Hemlibra, Polivy (blood cancer) and Tecentriq. This growth more than compensated for the lower sales of Perjeta (breast cancer) and Kadcyla (breast cancer) as well as the impact of biosimilar erosion on Actemra/RoActemra (rheumatoid arthritis). Sales in Europe were +1% at CER, or -1% when reported in CHF, as demand for Ocrevus, Evrysdi (spinal muscular atrophy) and Phesgo more than offset the impact of lower sales of Actemra/RoActemra due to biosimilar competition and Perjeta because of the conversion of patients to Phesgo. In Japan , sales were +11% at CER, -5% when reported in CHF, mainly due to product supply to third parties, as well as the uptake of Elevidys (Duchenne muscular dystrophy) and continued growth of Lunsumio (blood cancer), Vabysmo and Hemlibra. Sales in the International region were +10% at CER, or +4% when reported in CHF, led by Phesgo, Vabysmo, Hemlibra, Ocrevus and Polivy. In China, sales were -9% at CER, or -12% when reported in CHF, due to the base effect of a severe flu season in 2025 on Xofluza sales. The Diagnostics Division’s sales were +3% at CER, -3% when reported in CHF, to CHF 6.7 billion, driven by growth in demand for immunodiagnostic and clinical chemistry products as well as pathology and molecular solutions. This growth more than offset the impact of healthcare pricing reforms in China. Sales in the Europe, Middle East and Africa (EMEA) region were +3% at CER, -1% when reported in CHF, driven by higher sales of immunodiagnostic products, the clinical chemistry portfolio and molecular solutions. In North America , sales were +8% at CER, -1% when reported in CHF, due to growth across the Core Lab and Pathology Lab customer areas. Sales in Asia-Pacific were -5% at CER, or -12% when reported in CHF, mainly due to the healthcare pricing reforms in China, partially offset by growth in demand for clinical chemistry and immunodiagnostic products across the rest of the region. In Latin America , sales were +10% at CER, or +5% when reported in CHF. Pharmaceuticals: key developments Compound Milestone Regulatory Gazyva/Gazyvaro Several autoimmune diseases FDA grants Priority Review for Roche’s Gazyva/Gazyvaro for adults with primary membranous nephropathy (pMN) The Priority Review decision is based on results from the phase III MAJESTY study, where Gazyva/Gazyvaro achieved significantly higher complete remission rates at two years compared to tacrolimus. If approved, Gazyva/Gazyvaro will be the first FDA-approved therapy for pMN, following global approvals in lupus nephritis and ongoing regulatory filings in systemic lupus erythematosus and idiopathic nephrotic syndrome. pMN is a chronic autoimmune disease with no FDA- or EMA-approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over a period of 10 years. More information: Media Release , 15 July 2026 Enspryng Thyroid eye disease FDA grants Priority Review for Enspryng, the first and only at-home subcutaneous treatment option for thyroid eye disease (TED) The filing application is based on improvements seen across key efficacy endpoints from the global phase III SatraGO-1 and SatraGO-2 studies, including proptosis (bulging eyes) and diplopia (double vision) in active TED. Enspryng has the potential to become the first at-home subcutaneous disease-modifying standard of care for TED. TED is an autoimmune disease affecting approximately 155 out of every 100,000 people that can lead to facial disfigurement and vision-threatening complications if left untreated. More information: Media Release , 30 June 2026 Lunsumio and Polivy Blood cancer FDA accepts supplemental Biologics License Application for Lunsumio and Polivy combination for relapsed or refractory large B-cell lymphoma (LBCL) Filing acceptance is based on data from the phase III SUNMO study, where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death. People with relapsed or refractory LBCL represent a population with one of the highest unmet needs in lymphoma and require timely access to effective therapies. If approved, this outpatient-ready regimen could enable access to care in the community setting, where most US patients receive treatment. More information: Media release , 18 June 2026 Tecentriq Colon cancer FDA grants Priority Review for Tecentriq for a certain type of stage III colon cancer Filing acceptance is based on data from the phase III Alliance ATOMIC study showing Tecentriq plus chemotherapy reduced recurrence or death risk by 50% versus chemotherapy alone. Nearly one in three patients with stage III colon cancer relapses within five years, highlighting a critical need for new adjuvant treatment options. If approved, Tecentriq plus chemotherapy could provide a new standard of care for the treatment of stage III dMMR/MSI-H colon cancer after surgery. More information: Media Release , 11 June 2026 Giredestrant Breast cancer FDA accepts New Drug Application for giredestrant in ER-positive early-stage breast cancer, the first and only oral selective oestrogen receptor degrader with positive phase III results in the curative setting Filing acceptance, under Priority Review, is based on phase III data showing giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy. Giredestrant represents the first significant advance in adjuvant endocrine therapy in over 20 years. Giredestrant has the potential to become a new standard-of-care in the adjuvant setting; more than 90% of ER-positive breast cancer cases are diagnosed at an early stage (I‒III). The FDA has set a Prescription Drug User Fee Act date of 30 November 2026. More information: Media Release , 2 June 2026 Phase III, pivotal and other key read-outs Divarasib Lung cancer Divarasib shows superiority in head-to-head phase III trial against approved KRAS G12C inhibitors in non-small cell lung cancer Phase III (Krascendo 1) demonstrates best-in-class potential for patients with previously treated advanced KRAS G12C non-small cell lung cancer. Divarasib showed clinically meaningful improvements in progression-free survival compared to approved KRAS G12C inhibitors; no new safety signals were observed. Statistical significance for overall survival was achieved at the interim analysis in this poor-prognosis patient population. More information: Media Release , 2 July 2026 Fenebrutinib Multiple sclerosis Fenebrutinib significantly reduces relapses versus standard of care to approximately one every 17 years in relapsing multiple sclerosis (RMS) Late-breaking phase III FENhance 1 and 2 study results showed superiority of investigational fenebrutinib compared to teriflunomide in reducing relapses and brain lesions in RMS. Both studies showed positive trends in reducing disability progression with fenebrutinib compared to teriflunomide. Fenebrutinib could become a first-in-class BTK inhibitor and the first and only high-efficacy oral medication for both RMS and primary progressive multiple sclerosis (PPMS). More information: Media Release , 22 April 2026 Other Alzheimer’s integrated portfolio presentation Roche presents new data on Alzheimer’s disease from across its integrated pharmaceuticals and diagnostics portfolio at AAIC Five oral presentations in a featured research session highlighted trontinemab, including new long-term data from the phase Ib/IIa Brainshuttle AD study and the design of phase III PrevenTRON study in preclinical Alzheimer’s disease. New data on Roche’s CE-marked Elecsys pTau217 blood test were presented on its use for the diagnosis of Alzheimer’s disease in both primary and secondary care. More information: Media Release , 7 July 2026 Nurix Therapeutics collaboration Roche announces global collaboration with Nurix Therapeutics to co-develop and co-commercialise potential best-in-class BTK degrader bexobrutideg across malignant haematology, immunology and neurology Agreement offers potential best-in-class targeted protein degrader therapy option for people living with B-cell malignancies. Collaboration adds to Roche’s oncology pipeline and offers potential indications in immunology (chronic spontaneous urticaria) and neurology (multiple sclerosis). Bexobrutideg utilises a novel approach to eliminate the Bruton’s tyrosine kinase (BTK) protein, potentially overcoming existing resistance mechanisms found with current standard-of-care BTK inhibitors. More information: Media Release , 8 June 2026 Obesity portfolio data presentation Roche presents new data advancing its obesity portfolio at the American Diabetes Association’s 2026 scientific sessions Late-breaking phase II data highlight enicepatide’s (CT-388) efficacy and safety, reinforcing its potential to deliver best-in-class weight loss across a broad population of people living with overweight or obesity. Late-breaking data from the phase II ZUPREME-1 trial showcase petrelintide’s efficacy, safety and compelling tolerability profile, which has the potential to redefine the weight management experience for people living with overweight or obesity. A phase II multi-arm trial evaluating enicepatide and petrelintide fixed-dose combinations will be initiated in the coming months to develop a differentiated treatment option. More information: Media Release , 1 June 2026 Oncology portfolio data presentation Roche presents new data at ASCO 2026, reinforcing giredestrant’s potential to transform the treatment paradigm in early breast cancer New data were presented from the lidERA study on giredestrant’s potential as a new standard of care for adjuvant ER-positive breast cancer across all menopausal stages. Primary results were presented from the persevERA study on the numerical improvement in progression-free survival observed with first-line giredestrant plus palbociclib in advanced, endocrine-sensitive disease. Overall, Roche highlighted data on nine approved and investigational medicines – including bispecific antibodies, antibody-drug conjugates and brain-permeable molecules – that target urgent needs in breast, blood, lung and other cancers. More information: Media Release , 19 May 2026 Ophthalmology portfolio data presentation Roche presents extensive data showcasing its industry-leading ophthalmology portfolio at ARVO 2026 New real-world data confirm the potent retinal drying of Vabysmo in neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME). Key data for Susvimo demonstrate its potential to provide lasting disease control through continuous delivery, while reducing treatment burden. Roche presented more than 45 abstracts at ARVO 2026, including 20 oral presentations across five retinal conditions. More information: Media Release , 30 April 2026 Pharmaceuticals sales Sales CHF millions As % of sales % change January–June 2026 2025 2026 2025 At CER In CHF Pharmaceuticals Division 23,629 23,985 100.0 100.0 6 -1 United States 12,229 12,670 51.8 52.8 6 -3 Europe 4,520 4,566 19.1 19.0 1 -1 Japan 1,360 1,425 5.8 5.9 11 -5 International 5,520 5,324 23.3 22.3 10 4 International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Top 20 best-selling pharmaceuticals Total United States Europe Japan International CHF m % CHF m % CHF m % CHF m % CHF m % Ocrevus Multiple sclerosis 3,470 7 2,300 2 758 10 - - 412 30 Hemlibra Haemophilia A 2,492 11 1,313 9 502 4 171 9 506 26 Vabysmo Eye diseases (nAMD, DME, RVO) 2,059 8 1,333 1 386 5 75 26 265 65 Tecentriq Cancer immunotherapy 1,704 6 815 9 410 -3 146 -2 333 17 Xolair 3 Chronic hives, food allergies 1,673 27 1,673 27 - - - - - - Perjeta 3 Breast cancer 1,389 -7 551 -11 238 -14 24 -23 576 0 Phesgo Breast cancer 1,318 18 318 0 425 9 88 15 487 47 Actemra/RoActemra 3 RA, COVID-19 1,074 -9 515 -9 238 -21 140 8 181 -3 Evrysdi Spinal muscular atrophy 968 17 323 15 335 17 39 -1 271 25 Kadcyla 3 Breast cancer 916 -6 310 -14 248 -4 39 2 319 3 Polivy Blood cancer 808 20 381 28 128 -18 98 16 201 47 Alecensa Lung cancer 795 6 261 4 126 -4 93 8 315 13 MabThera/Rituxan 3 Blood cancer, RA 609 5 402 14 62 -9 6 -11 139 -10 Activase/TNKase 3 Cardiac diseases 555 11 531 11 - - - - 24 12 Gazyva/Gazyvaro 3 Blood cancer, lupus nephritis 489 7 240 4 117 -1 17 14 115 21 Herceptin 3 Breast and gastric cancer 462 -12 94 -14 136 -7 2 -36 230 -14 Avastin 3 Various cancer types 414 -15 125 -12 35 37 36 -44 218 -13 Pulmozyme 3 Cystic fibrosis 204 -8 145 -5 29 -11 - 26 30 -18 Columvi Blood cancer 196 70 91 28 53 116 - - 52 173 Enspryng Acute inflammation of brain, spinal cord and optic nerves 195 22 50 20 23 20 79 18 43 37 DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics: key developments Product Milestone cobas HDV test Roche introduces cobas hepatitis D virus (HDV) test, the first fully automated diagnostic solution to identify the most severe form of viral hepatitis The new test enables clinicians to reliably diagnose HDV and monitor patients’ treatment response. Hepatitis D affects nearly 12 million people globally and is considered the most aggressive form of viral hepatitis, often leading to liver failure and cancer faster than other types. The cobas HDV test is the first high-throughput, fully automated HDV assay on the market, addressing the urgent need for a consistent, widely accessible solution and expanding access to critical testing just as new treatments for the disease become available. More information: Media Release , 14 July 2026 Elecsys IGRA TB test Roche receives CE mark for blood test to identify tuberculosis infection The Elecsys IGRA TB test expands global access to tuberculosis infection testing, advancing progress towards the World Health Organization’s elimination targets. Performed on Roche’s industry-leading and widely available cobas immunoassay systems, the test enables laboratories to meet growing tuberculosis infection testing needs by reducing reliance on manual workflows through automation and digital solutions. The new solution provides rapid, high-throughput and cost-effective tuberculosis testing, delivers reliable results in under 24 hours and cuts standard processing times in half to just 19 minutes per patient. More information: Media Release , 9 July 2026 Axelios 1 sequencing platform Roche announces the launch of Axelios 1, a transformative next-generation sequencing platform Axelios 1 delivers a unique combination of accuracy, speed, scalability and cost efficiency, giving laboratories of all sizes the freedom to customise their workflows and explore a wider array of applications. Powered by innovative SBX technology, the platform is capable of end-to-end, same-day whole-genome sequencing in research workflows, with accurate results within hours. The Axelios 1 platform holds promise for research laboratories today, and potentially for a broad range of clinical settings in the future. More information: Media Release , 29 June 2026 Ventana PTEN (SP218) RxDx Assay Roche receives FDA approval for the first companion diagnostic to assess PTEN protein in people living with prostate cancer The new Ventana PTEN (SP218) RxDx Assay fulfills an unmet medical need by helping clinicians identify patients with PTEN protein loss who may benefit from combination treatment with Truqap. In prostate cancer, PTEN protein loss is associated with faster disease progression and reduced benefit from current standard-of-care treatments. The FDA approval reinforces Roche’s leadership in companion diagnostics and its ongoing commitment to expanding personalised healthcare to improve patient outcomes. More information: Media Release , 12 June 2026 Liver Disease Panel Roche launches the Liver Disease Panel, the first suite of certified algorithms to support chronic liver disease (CLD) management Roche introduces the first comprehensive library of certified healthcare algorithms to support CLD management. The Liver Disease Panel includes LiverPRO — a certified algorithm developed by the health tech company Evido — requiring only age and routine blood markers for the timely detection of liver fibrosis. With CLD affecting 1.5 billion people worldwide, the non-invasive panel solution covers care along the patient pathway from fibrosis risk identification to the surveillance of liver cancer. More information: Media Release , 27 May 2026 Elecsys pTau217 test Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys plasma phosphorylated-tau 217 (pTau217) Elecsys pTau217 is the first blood test for Alzheimer’s disease pathology with a single‑assay design, intended to rule in and rule out amyloid pathology across primary and secondary care, offering faster diagnosis for millions of patients around the world. While maintaining accuracy comparable to spinal fluid diagnostics against the gold standard PET-CT scans, the Elecsys pTau217 test offers a more convenient, minimally invasive alternative via a routine blood draw. Diagnosing dementia currently takes 3.5 years on average, and an estimated 75% of people living with dementia remain undiagnosed. Elecsys pTau217 offers a simple blood test to aid in earlier, more accessible Alzheimer’s disease diagnosis for millions of patients around the world. More information: Media Release , 12 May 2026 PathAI agreement Roche enters into a definitive merger agreement to acquire PathAI to transform AI-driven diagnostics PathAI’s best-in-class Image Management System (IMS) with advanced AI analysis and workflow capabilities will complement Roche’s digital pathology portfolio to drive laboratory efficiency. Combining Roche’s strong position in companion diagnostics and PathAI’s advanced AI platform helps accelerate clinical therapy development, foster the discovery of new biomarkers and create novel diagnostic tools. These integrated capabilities will accelerate the shift from broad intervention towards personalised healthcare for patients. More information: Media Release , 7 May 2026 Diagnostics sales Sales CHF millions As % of sales % change January–June 2026 2025 2026 2025 At CER In CHF Diagnostics Division 6,735 6,959 100.0 100.0 3 -3 Customer areas Core Lab 3,756 3,839 55.8 55.2 4 -2 Molecular Lab 1,196 1,250 17.7 18.0 3 -4 Near Patient Care 909 1,018 13.5 14.6 -5 -11 Pathology Lab 874 852 13.0 12.2 11 3 Regions Europe, Middle East, Africa 2,466 2,485 36.6 35.7 3 -1 North America 2,211 2,235 32.8 32.1 8 -1 Asia-Pacific 1,522 1,729 22.6 24.9 -5 -12 Latin America 536 510 8.0 7.3 10 5 More information on Roche’s performance in the first six months of 2026: Half-Year 2026 Presentation Half-Year 2026 Presentation with appendix Half-Year 2026 Finance Report Appendix with tables About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceuticals Divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit . All trademarks used or mentioned in this release are protected by law. References [1] CER (Constant Exchange Rates). The percentage changes at constant exchange rates are calculated using simulations by reconsolidating both the 2026 and 2025 results at constant exchange rates (the average rates for the year ended 31 December 2025). For the definition of CER, see page 178 of the Roche Finance Report 2025. [2] USD (US dollars). The percentage changes for selected sales figures in US dollars are calculated by translating both the 2026 and 2025 sales figures at the respective average US dollar exchange rate for the period in question. This supplementary information is provided to assist readers when assessing comparability with other companies. [3] Products launched before 2015. Cautionary statement regarding forward-looking statements This document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. Roche Global Media Relations Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com Hans Trees, PhD Phone: +41 79 407 72 58 Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915 Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53 Yvette Petillon Phone: +41 79 961 92 50 Dr Rebekka Schnell Phone: +41 79 205 27 03 Irène Stephan Phone: +41 79 377 83 75 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 687 52 84 E-mail: bruno.eschli@roche.com Dr Sabine Borngräber Phone: +41 61 688 80 27 E-mail: sabine.borngraeber@roche.com Dr Birgit Masjost Phone: +41 61 688 48 14 E-mail: birgit.masjost@roche.com Investor Relations North America Loren Kalm Phone: +1 650 225 32 17 E-mail: kalm.loren@gene.com Attachments Media & Investor Release Roche HY 2026 EN Communications appendix tables_HY_Results_13072026

Clinical ResultPhase 2Phase 3Drug Approval

23 Jul 2026

·www.biospace.com

Roche’s late stage pipeline ‘so full,’ CEO Schinecker not feeling pressure to add on

iStock, Nuthawut Somsuk Roche has 19 investigational medicines that could launch by 2030—and even if not all of them make it to market, the company is “well set-up for growth into the next decade,” CEO Thomas Schinecker said on the pharma’s Q2 earnings call. Unlike its Big Pharma peers, Roche doesn’t have its “back against the wall” to make a major acquisition any time soon, according to CEO Thomas Schinecker. “I think we’re well set up for growth into the next decade,” Schinecker told reporters during a press event Thursday to present the company’s second quarter earnings . “In fact, our late-stage pipeline is so full that adding something late stage—we would then have to see how to reallocate more money” into these programs. Currently, Roche is pushing several medicines through the pipeline, with up to 19 potentially launching by 2030. These include the obesity therapies petrelintide, being developed in partnership with Zealand Pharma , and enicepatide, which Roche picked up in its $2.7 billion acquisition of Carmot Therapeutics in December 2023. ezstandalone.cmd.push(function () { ezstandalone.showAds(129); }); Weight loss Roche Makes Another Obesity Play With Potential $5.3B Amylin Pact With Zealand Roche and Zealand plan to study petrelintide as a monotherapy and in combination with CT-388, a dual agonist of the GLP-1 and GIP receptors that Roche picked up in its recent acquisition of Carmot Therapeutics. March 12, 2025 · 2 min read · Tristan Manalac Read more Also nearing the market is the Alzheimer’s disease therapy trontinemab and the SERD drug giredestrant, which is currently under FDA review for ER-positive, HER2-negative breast cancer with a decision date of Nov. 30. Roche forecasts over $3 billion in peak sales for each of these assets, according to a company presentation on Thursday. “Even if not all make it,” Schinecker said of these 19 molecules, Roche will still be well-positioned for growth in the coming years. M&A has been a central theme for biopharma this year so far. There were more than 50 acquisitions in the first half of 2026, up from around 30 during the same period last year. Eli Lilly, for instance, pledged over $25 billion to absorb smaller players, including Centessa Pharmaceuticals in March and Kelonia Therapeutics in April. Far behind the Indianapolis giant is Gilead Sciences, which in total announced up to $14.8 billion in acquisition spend, and GSK, which has so far committed $13.5 billion, according to a BioSpace analysis. Mergers & acquisitions Biopharma strikes 50+ M&As deals in H1, led by Lilly’s $25B spend The total of 52 mergers and acquisitions for the first half of 2026 reflects what analysts, industry watchers and executives are saying over and over: M&A is back. July 1, 2026 · 1 min read · Annalee Armstrong Read more Roche, notably, has been missing out on most of the action. The company last month put up to $2.3 billion on the line to advance a protein degrader with Nurix Therapeutics for B cell malignancies, and the pharma has enriched its diagnostics business by swallowing PathAI and SAGA Diagnostics . But Roche hasn’t made a hefty, late-stage acquisition this year. According to Schinecker on Thursday morning, there’s no real impetus for a big buy. “We are not maybe under the same pressure as some of the other companies,” given that Roche isn’t facing any real patent cliff, he said. “We feel very good where we are at the moment with the pipeline.” In the first half of the year, Roche reported nearly CHF 30.4 billion ($37.3 billion) in sales, a 6% year-on-year increase at constant currencies. Much of the group’s revenue came from its pharmaceuticals unit, which brought in over CHF 23.6 billion ($29 billion), while its diagnostics division made CHF 6.7 billion ($8.2 billion). Roche’s top-performing product was Ocrevus, indicated for multiple sclerosis, hitting almost CHF 3.5 billion ($4.3 billion). Close behind were the hemophilia A therapy Hemlibra with CHF 2.5 billion ($3.1 billion) and the eye injection Vabysmo with almost CHF 2.1 billion ($2.6 billion). Key growth drivers, on the other hand, include the allergy medicine Xolair, which surged 27% year-on-year to CHF 1.67 billion ($2.1 billion) and the lymphoma therapy Polivy, which logged 20% growth to bring in nearly CHF 808 million ($992 million).

Acquisition

06 Jul 2026

·www.prnewswire.com

Ascletis Submits Two IND Applications to the U.S. FDA for the Treatment of Obesity: ASC36 Once-Monthly Injection, a Peptide Amylin Receptor Agonist, and ASC36_35 FDC Once-Monthly Injection, a Co-Formulation of ASC36 Plus Peptide GLP-1R/GIPR Agonist ASC35

ASC36_35 FDC, a once-monthly subcutaneous (SQ) injection co-formulation of ASC36 and ASC35, is a potentially first-in-class drug candidate targeting three validated targets of amylin receptor, GLP-1R and GIPR. ASC36_35 FDC demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide in a head-to-head diet-induced obese (DIO) rat study. ASC36 is a potentially first-in-class once-monthly to once-quarterly SQ injection targeting amylin receptor. ASC36 monotherapy demonstrated approximately 91% and 32% greater relative body weight reduction compared to petrelintide and eloralintide monotherapies, respectively, in head-to-head DIO rat studies. HONG KONG, July 5, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today recent submissions of two Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA) for ASC36, a once-monthly to once-quarterly next-generation peptide amylin receptor agonist and ASC36_35 FDC, a once-monthly injection co-formulation of ASC36 plus peptide GLP-1R/GIPR agonist ASC35, for the treatment of obesity. "Eloralintide in combination with tirzepatide recently demonstrated 29.0% weight loss at week 32[1]. However, two separate weekly injections are required; one for eloralintide and one for tirzepatide. In contrast, ASC36_35 FDC, a potentially first-in-class subcutaneous (SQ) injection co-formulation targeting amylin receptor, GLP-1R and GIPR, requires only one monthly injection," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, "Equally exciting, ASC36_35 FDC demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide in a head-to-head diet-induced obese (DIO) rat study. These animal models are highly predictive of human efficacy." Both ASC36 and ASC35 were discovered in-house utilizing Ascletis' Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD). Both ASC36 once-monthly to once-quarterly formulation and ASC36_35 FDC once-monthly co-formulation are Self-Assembling Lipid Depot (SALD) formulations, developed in-house utilizing Ascletis' Ultra-Long-Acting Platform (ULAP) technology. In head-to-head non-human primate (NHP) studies, ASC36 SALD formulation demonstrated approximately 6-fold longer observed half-life than eloralintide, supporting once-monthly to once-quarterly SQ administration in humans. In NHP studies, ASC36_35 FDC SALD co-formulation demonstrated long observed half-lives for both ASC36 and ASC35, supporting once-monthly SQ administration in humans. Preclinical studies have established the superior efficacy of ASC36 injection and ASC36_35 FDC injection co-formulation. In head-to-head DIO rat studies, which are highly predictive of human efficacy, ASC36 monotherapy, targeting amylin receptor, demonstrated approximately 91% and 32% greater relative body weight reduction compared to petrelintide and eloralintide monotherapies, respectively. In head-to-head DIO rat studies, the ASC36_35 co-formulation, targeting three targets of amylin receptor, GLP-1R and GIPR, demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide. Both ASC36 injection formulation and ASC36_35 FDC injection co-formulation exhibit excellent chemical and physical stability with no aggregation or precipitation caused by fibrillation at neutral pH. Two IND submissions for ASC36 once-monthly injection and ASC36_35 once-monthly injection co-formulation build upon the recent milestone achieved by ASC35 once-monthly SALD formulation. In June 2026, Ascletis announced U.S. FDA IND clearance to initiate a Phase I clinical trial for ASC35 as a once-monthly SQ treatment for obesity (Press Release), highlighting the Company's robust clinical execution and the potential of its ULAP technology. About Ascletis Pharma Inc. Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead program, ASC30, a small molecule GLP-1R agonist designed to be administered once daily orally and once monthly to once quarterly subcutaneously as a treatment therapy and a maintenance therapy for chronic weight management; ASC36, an amylin receptor peptide agonist, ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist and ASC37, a GLP-1R/GIPR/GCGR triple peptide agonist, ASC39, an eloralintide-like potent and amylin-selective oral small molecule amylin receptor agonist, and ASC30_39 FDC, a fixed-dose combination (FDC) of ASC30 (GLP-1RA) and ASC39 (amylin RA), for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK). For more information, please visit . Contact： Peter Vozzo ICR Healthcare 443-231-0505 (U.S.) [email protected] Ascletis Pharma Inc. PR and IR Teams +86-181-0650-9129 (China) [email protected] [email protected] SOURCE Ascletis Pharma Inc. 21% more press release views with Request a Demo

Phase 1Clinical Result

100 Deals associated with Petrelintide

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 2	United States	Roche Holding AG	22 Apr 2025
Diabetes Mellitus, Type 2	Phase 2	United States	Zealand Pharma A/S	22 Apr 2025
Obesity	Phase 2	United States	Zealand Pharma A/S	09 Dec 2024
Obesity	Phase 2	Poland	Zealand Pharma A/S	09 Dec 2024
Obesity	Phase 2	Romania	Zealand Pharma A/S	09 Dec 2024
Overweight	Phase 1	Germany	Zealand Pharma A/S	17 Dec 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ZUPREME 1 (ADA2026)	Phase 2	Obesity	485	Petrelintide	svrmcjzsny(habadqesrz) = nqtuquypdv oaaoxsuuka (yrmgbxhffp ) View more	Positive	20 Jun 2026
				Placebo	xtecyrtzlp(egogjnuwbz) = qqgklhjasy cwejqpbsvd (ezbqgwigyw )
NCT05096598 (ADA2026)	Phase 1	Weight Loss	72	Petrelintide	jtaforfyog(tzvhzfdeyv) = The incidence of gastrointestinal (GI) AEs was low with OW doses; vomiting occurred in one participant, who was also the only participant to discontinue due to GI AE ixrasosvqk (adppyytbqk )	Positive	20 Jun 2026
				Placebo
NCT06662539 (ZUPREME-1, Company pipeline) Manual	Phase 2	Overweight \| Obesity	493	petrelintide	ooiheonuzd(qwmvkexlll) = resulted in statistically significant and clinically meaningful weight loss. xkumlgnogg (xjrsaslrzs ) Met View more	Positive	05 Mar 2026
				Placebo
NCT05613387 (MAD, Biospace) Manual	Phase 1	Overweight	48	Petrelintide	arhhdbyhrs(doziohxetg) = Petrelintide was assessed to be well tolerated in the trial, with no serious or severe adverse events (AEs). All gastrointestinal (GI) AEs were mild except for two moderate events (nausea and vomiting) reported by one participant who discontinued treatment after the third dose. hljreuyebh (bjewggpcwv ) View more	Positive	20 Jun 2024
				Placebo
NCT05613387 (MAD , GlobeNewswire) Manual	Phase 1	Obesity	-	ZP8396 0.6mg (administered once-weekly)	svifpgmclq(hvrbhrvmyr) = gbiagdovdb sbriukwcvb (fhhrozpcxl )	Positive	03 Jul 2023
				ZP8396 1.2mg (administered once-weekly)	svifpgmclq(hvrbhrvmyr) = jyddquevul sbriukwcvb (fhhrozpcxl )
NCT05096598 (ADA2023)	Not Applicable	Overweight	56	ZP8396	luemlhzbhc(spqoyvgbeq) = most events were mild and transient oafcbhcgkp (psbrbqeyep ) View more	Positive	20 Jun 2023
				Placebo

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