Search Results

How much are orthopedic surgeons earning in 2026? Orthopedic surgeons remain among the highest-compensated physician specialties in the US, with the latest AMGA 2026 Medical Group Compensation and Productivity Survey showing that orthopedic surgery compensation has remained stable despite continued growth in clinical productivity. For orthopedic surgeons reviewing employment contracts, negotiating compensation packages or benchmarking career progression, understanding how salary compares with workload expectations is essential. The latest AMGA data shows that median compensation for orthopedic surgeons reached $751,350 in 2026, making orthopedics one of the highest-paid surgical specialties tracked in the survey. However, compensation growth was modest compared with other physician specialties, increasing by just 0.3% year-over-year, while productivity increased slightly through growth in median work relative value units (wRVUs). How Much Do Orthopedic Surgeons Earn in 2026? According to the AMGA 2026 Medical Group Compensation and Productivity Survey, median compensation for orthopedic surgeons increased from: Year Median Compensation 2025 $748,799 2026 $751,350 This represents: +$2,551 increase year-over-year 0.3% compensation growth While compensation growth was relatively flat, orthopedic surgery remains one of the most financially rewarding physician specialties in the US healthcare market. For orthopedic surgeons evaluating current contracts, this benchmark provides insight into whether their compensation remains competitive relative to national employment trends. Orthopedic Surgeon Productivity Trends: Are wRVUs Increasing? Compensation alone does not show the full picture. Many orthopedic surgeon contracts are closely linked to productivity measures, particularly work relative value units (wRVUs), which are commonly used to measure clinical output. The AMGA survey shows: Metric 2025 2026 Change Median wRVUs 9,915 10,007 +0.9% The increase suggests orthopedic surgeons continued to generate slightly higher levels of clinical productivity year-over-year. However, productivity growth outpaced compensation growth, indicating that increased clinical output was not matched by a similar increase in overall compensation. For physicians working under productivity-based contracts, this distinction is particularly important when assessing whether additional workload is translating into increased earnings. What Does Compensation Per wRVU Mean for Orthopedic Surgeons? The compensation-to-wRVU ratio helps show how much physicians are being paid for each unit of productivity generated. For orthopedic surgery: Year Compensation per wRVU 2025 $78.00 2026 $78.94 This represents: 1.2% increase year-over-year A rising compensation-to-wRVU ratio can indicate changes in market demand, adjustments in physician employment models or increased competition for specialist talent. For orthopedic surgeons negotiating contracts, this metric can provide additional context beyond headline salary figures. Why Orthopedic Surgeons Should Pay Attention to Compensation Trends Compensation benchmarks can support several important career decisions. Contract negotiations National benchmarks provide orthopedic surgeons with data when reviewing: Base salary offers Productivity incentives wRVU thresholds Bonus structures Contract renewals Understanding where compensation sits relative to national averages can help physicians assess whether their current agreement reflects market conditions. Career planning Orthopedic surgeons considering different employment models can use compensation data to understand earning potential across: Hospital employment Health system roles Private practice opportunities New physician recruitment offers Productivity expectations Changes in wRVUs highlight whether compensation increases are being driven by: Increased clinical volume Greater procedural activity Market adjustments Changes in reimbursement structures For orthopedic surgeons, productivity remains a major component of financial performance. The Bigger Picture for Orthopedic Surgery Orthopedic care continues to experience strong demand driven by an ageing population, rising rates of musculoskeletal conditions and increasing demand for joint replacement procedures. At the same time, healthcare organisations are balancing specialist recruitment needs with broader financial pressures, reimbursement changes and changing physician employment models. The latest AMGA data suggests that orthopedic surgery remains one of the most highly valued medical specialties, although compensation growth has slowed compared with previous years. For orthopedic surgeons, understanding salary benchmarks, productivity expectations and compensation-per-wRVU trends provides important insight when evaluating career opportunities and negotiating future agreements. Summary The AMGA 2026 Medical Group Compensation and Productivity Survey shows that orthopedic surgeons remain among the highest-compensated physician groups in the US. Key findings include: Median orthopedic surgeon compensation: $751,350 Year-over-year compensation growth: 0.3% Median wRVUs: 10,007 wRVU growth: 0.9% Compensation per wRVU: $78.94 For orthopedic surgeons assessing contracts, employment opportunities or long-term career positioning, these benchmarks provide valuable insight into the current physician compensation landscape. Source AMGA 2026 Medical Group Compensation and Productivity Survey. Data reflects 2025 compensation reported by participating medical groups and health systems. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

How much are nurse practitioners earning in 2026? Nurse practitioners (NPs) continue to play an increasingly important role in US healthcare, with new data from the AMGA 2026 Medical Group Compensation and Productivity Survey showing continued growth in both compensation and clinical productivity across multiple practice settings. As healthcare organisations expand their use of advanced practice clinicians (APCs) to improve patient access and address physician shortages, compensation benchmarking has become increasingly important for nurse practitioners evaluating job offers, negotiating contracts and planning their careers. The latest AMGA data shows that salary growth varied across NP specialties, with surgical specialty nurse practitioners recording the strongest year-over-year compensation increase, while primary care and medical specialty NPs also saw healthy gains. Productivity, measured by work relative value units (wRVUs), generally increased more slowly than compensation, suggesting employers continue to place a premium on attracting and retaining experienced nurse practitioners. Key Findings: Nurse Practitioner Compensation in 2026 According to the AMGA 2026 Medical Group Compensation and Productivity Survey: Specialty Median Compensation Salary Growth Primary Care NP $149,178 +4.8% Medical Specialty NP $147,269 +4.1% Surgical Specialty NP $149,614 +7.3% Additional benchmarks include: Primary Care NP wRVU growth: +2.4% Medical Specialty NP wRVU growth: +1.2% Surgical Specialty NP wRVU growth: -0.1% The survey reflects compensation data from nearly 188,000 providers across 451 medical groups and health systems, making it one of the largest physician and APC compensation benchmarking studies in the United States. Nurse Practitioner Salary by Specialty The AMGA data highlights relatively consistent salary levels across the three major NP practice settings, although salary growth differed significantly. Nurse Practitioner Specialty 2025 2026 Annual Change Medical Specialty $141,408 $147,269 +4.1% Primary Care $142,324 $149,178 +4.8% Surgical Specialty $139,411 $149,614 +7.3% The strongest increase came in surgical specialty nurse practitioners, where median compensation rose by more than $10,000 in a single year. For nurse practitioners comparing employment opportunities, these figures demonstrate how compensation can vary depending on clinical specialty rather than simply the NP role itself. Nurse Practitioner Productivity Trends: Are wRVUs Increasing? Many healthcare employers now combine guaranteed salaries with productivity-based incentives. The AMGA survey reports the following productivity changes: Specialty 2025 wRVUs 2026 wRVUs Change Medical Specialty NP 2,644 2,676 +1.2% Primary Care NP 4,539 4,647 +2.4% Surgical Specialty NP 2,179 2,177 -0.1% The data suggests compensation generally increased faster than productivity. For surgical specialty nurse practitioners in particular, salaries increased substantially despite productivity remaining virtually unchanged. This may reflect: Growing demand for experienced nurse practitioners Workforce shortages across specialist services Increased reliance on APC-led care models Competition between healthcare organisations to recruit experienced clinicians What Does Compensation Per wRVU Mean for Nurse Practitioners? Compensation per wRVU measures how much clinicians are paid for each unit of clinical productivity. The AMGA data shows: Specialty 2025 2026 Change Medical Specialty NP $53.09 $54.82 +3.3% Primary Care NP $32.19 $33.83 +5.1% Surgical Specialty NP $64.16 $67.17 +4.7% A higher compensation-per-wRVU ratio may indicate stronger market demand or improved compensation structures rather than simply increased workloads. For nurse practitioners reviewing employment agreements, this metric can help evaluate: Productivity bonus formulas Incentive thresholds Fair market compensation Expected clinical workload Why Nurse Practitioners Should Pay Attention to Compensation Benchmarks Compensation benchmarking is becoming increasingly valuable as nurse practitioner roles continue to evolve across the healthcare system. Contract negotiations Current market data provides valuable context when reviewing: Base salary Productivity incentives Annual pay reviews Bonus opportunities Employment offers Having access to national benchmarks can strengthen negotiations and help identify whether compensation is competitive within a particular specialty. Career planning Salary growth varies across NP specialties. Understanding market trends can help nurse practitioners evaluate opportunities in: Primary care Medical specialties Surgical services Hospital employment Large health systems Specialty choice may have a significant impact on long-term earning potential. Understanding productivity expectations Many healthcare organisations increasingly measure APC performance using productivity metrics. Monitoring changes in: Salary growth wRVUs Compensation per wRVU can help nurse practitioners determine whether increasing clinical expectations are being matched by appropriate financial rewards. The Outlook for Nurse Practitioner Compensation Demand for nurse practitioners continues to grow as healthcare systems seek to expand access to care while managing physician workforce shortages. Advanced practice clinicians are becoming an increasingly important component of care delivery across primary care, specialty medicine and surgical services. The latest AMGA data suggests employers continue to invest in attracting and retaining experienced nurse practitioners, with compensation growth generally exceeding productivity growth across most NP specialties. Summary The AMGA 2026 Medical Group Compensation and Productivity Survey shows continued growth in nurse practitioner compensation across the United States. Key findings include: Primary Care NP median salary: $149,178 (+4.8%) Medical Specialty NP median salary: $147,269 (+4.1%) Surgical Specialty NP median salary: $149,614 (+7.3%) While productivity increased modestly across most specialties, compensation generally rose at a faster pace, reflecting continued demand for nurse practitioners across the US healthcare system. For nurse practitioners evaluating employment opportunities, negotiating compensation or benchmarking career progression, these figures provide an important snapshot of the current APC employment market. Source AMGA 2026 Medical Group Compensation and Productivity Survey. Data reflects 2025 compensation reported by participating medical groups and health systems. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

How much are physician assistants earning in 2026? Physician assistants (PAs) continue to play an expanding role across the US healthcare system, with new data from the AMGA 2026 Medical Group Compensation and Productivity Survey highlighting how compensation varies by specialty while demand for experienced advanced practice clinicians (APCs) remains strong. As hospitals, physician groups and health systems increasingly rely on physician assistants to improve patient access and support multidisciplinary care, understanding salary benchmarks has become increasingly valuable for professionals reviewing employment contracts, negotiating compensation or planning their next career move. The latest AMGA data shows that surgical physician assistants remain the highest-paid PA specialty, while compensation growth differs considerably between primary care, medical specialties and surgical practice. Key Findings: Physician Assistant Compensation in 2026 According to the AMGA 2026 Medical Group Compensation and Productivity Survey: Specialty Median Compensation Salary Growth Physician Assistant – Primary Care $156,894 +1.3% Physician Assistant – Medical Specialty $146,873 -1.0% Physician Assistant – Surgical $159,659 +6.2% Additional benchmarks include: Primary Care PA wRVU change: -1.8% Medical Specialty PA wRVU growth: +2.6% Surgical PA wRVU growth: +3.8% The AMGA survey includes compensation data from 451 medical groups and health systems representing nearly 188,000 providers, making it one of the largest compensation benchmarking resources for physicians and APCs in the United States. Physician Assistant Salary by Specialty Compensation differs noticeably depending on clinical setting. Physician Assistant Specialty 2025 2026 Annual Change Medical Specialty $148,429 $146,873 -1.0% Primary Care $154,818 $156,894 +1.3% Surgical $150,326 $159,659 +6.2% The strongest salary growth occurred among surgical physician assistants, whose median compensation increased by more than $9,300 over the previous year. Meanwhile, physician assistants working in medical specialties experienced a modest decline in median compensation despite increases in productivity, highlighting how compensation trends can differ significantly across specialties. For physician assistants evaluating new opportunities, this reinforces the importance of comparing salaries within their own specialty rather than relying on overall APC averages. Physician Assistant Productivity Trends: Are wRVUs Increasing? Many physician assistant compensation models now include productivity incentives linked to work relative value units (wRVUs). The AMGA survey reports the following productivity changes: Specialty 2025 wRVUs 2026 wRVUs Change Medical Specialty PA 2,808 2,881 +2.6% Primary Care PA 4,959 4,868 -1.8% Surgical PA 1,760 1,827 +3.8% The data highlights several different trends across specialties. Medical specialty physician assistants generated higher productivity despite a slight reduction in compensation. Primary care physician assistants experienced declines in measured productivity while compensation still increased modestly. Surgical physician assistants saw both compensation and productivity increase, reflecting continued demand within surgical services. These differences demonstrate that salary growth is influenced by more than productivity alone, with recruitment pressures, workforce shortages and regional demand all likely contributing factors. What Does Compensation Per wRVU Mean for Physician Assistants? Compensation per wRVU measures how much clinicians are paid for each unit of productivity generated. The AMGA data shows: Specialty 2025 2026 Change Medical Specialty PA $52.54 $53.06 +1.0% Primary Care PA $31.83 $34.00 +6.8% Surgical PA $85.65 $85.35 -0.4% The compensation-per-wRVU ratio can provide valuable insight when reviewing productivity-based employment contracts. For example: Primary care physician assistants saw the largest increase in compensation per wRVU despite lower productivity. Surgical physician assistants maintained the highest compensation per wRVU overall, although the ratio declined slightly year-over-year. Medical specialty physician assistants recorded modest growth in compensation per unit of productivity. Understanding this metric can help physician assistants assess whether productivity expectations are appropriately rewarded. Why Physician Assistants Should Pay Attention to Compensation Benchmarks Compensation benchmarking is increasingly important as physician assistant roles continue to expand across healthcare. Contract negotiations National salary data can support discussions around: Base salary Productivity incentives Annual pay reviews Bonus opportunities Employment offers Benchmarking against national compensation figures provides useful context when reviewing contracts. Career planning Compensation varies considerably depending on specialty. Understanding current market trends can help physician assistants compare opportunities across: Primary care Medical specialties Surgical practice Hospital systems Multi-specialty physician groups Specialty selection may have a significant influence on long-term earning potential. Understanding productivity expectations As more employers incorporate productivity-based compensation models, physician assistants should monitor trends in: Salary growth wRVUs Compensation per wRVU These benchmarks help determine whether increasing workloads are translating into higher earnings. The Outlook for Physician Assistant Compensation Healthcare organisations continue to expand the use of physician assistants to improve access to care and support growing patient demand. As workforce shortages affect many physician specialties, experienced physician assistants are becoming increasingly valuable across primary care, specialist medicine and surgical services. The latest AMGA data shows that while compensation trends vary by specialty, physician assistants continue to see competitive salaries, particularly within surgical practice. Summary The AMGA 2026 Medical Group Compensation and Productivity Survey highlights continued demand for physician assistants across the US healthcare system. Key findings include: Primary Care PA median salary: $156,894 (+1.3%) Medical Specialty PA median salary: $146,873 (-1.0%) Surgical PA median salary: $159,659 (+6.2%) While productivity trends differed across specialties, compensation remained strongest in surgical practice, reinforcing the importance of specialty-specific benchmarking. For physician assistants reviewing contracts, negotiating salaries or planning career progression, these benchmarks provide a valuable snapshot of today's APC employment market. Source AMGA 2026 Medical Group Compensation and Productivity Survey. Data reflects 2025 compensation reported by participating medical groups and health systems. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

Zeta Surgical’s robotic navigation platform uses AI and computer vision to improve precision and repeatability during transcranial magnetic stimulation procedures. Zeta Surgical has received US Food and Drug Administration (FDA) clearance for its robotic transcranial magnetic stimulation (TMS) navigation system, a technology designed to improve the accuracy and consistency of TMS treatment delivery for patients with treatment-resistant depression (TRD). The FDA has classified the system as a Class II stereotaxic instrument, allowing it to support clinicians in delivering targeted TMS therapy by automatically tracking patient movement and maintaining accurate positioning of the treatment coil. The clearance represents another step forward in the use of artificial intelligence (AI), robotics and navigation technologies within neuromodulation, an area of healthcare focused on modifying neural activity to treat neurological and psychiatric conditions. How Zeta Surgical’s TMS Navigation System Works Transcranial magnetic stimulation is a non-invasive therapy that uses electromagnetic coils positioned against the scalp to stimulate specific regions of the brain. The treatment is primarily used for patients with treatment-resistant depression, a severe form of major depressive disorder (MDD) where symptoms do not improve adequately following treatment with at least two antidepressant medications at appropriate doses and durations. Because TMS relies on stimulating targeted brain regions and neural circuits, accurate positioning of the magnetic coil is an important factor in delivering consistent treatment. Zeta Surgical’s system uses AI and computer vision technology to monitor patient movement throughout the procedure. If a patient changes position during treatment, the robotic navigation platform can automatically adjust the coil location to maintain accurate targeting of the intended brain region. The company said the technology is designed to make TMS delivery more reproducible and easier to integrate into routine clinical workflows. Improving Precision in Depression Treatment Historically, one of the challenges associated with TMS has been ensuring consistent targeting between treatment sessions and across different patients. Zeta Surgical said its platform aims to address this challenge by improving treatment precision and reducing dependence on manual repositioning. Dr William Gormley, co-founder of Zeta Surgical, said the technology could help expand access to targeted brain therapies by making precise TMS delivery easier to incorporate into clinical practice. Before receiving FDA clearance, the system’s accuracy and usability were evaluated through collaborations involving Harvard Medical School and the University of Cambridge. The companies did not disclose specific clinical performance data from these evaluations. Expanding Role of TMS in Mental Health Care TMS has become an established treatment option within the mental health sector, particularly for patients with depression who do not respond to conventional therapies. The first TMS device for major depressive disorder received FDA clearance in 2008, when Neuronetics launched its NeuroStar TMS Therapy System. Since then, the use of neuromodulation technologies has expanded beyond depression. TMS is also used in behavioural health conditions including obsessive-compulsive disorder (OCD), while researchers continue to investigate applications in conditions such as post-traumatic stress disorder (PTSD). Zeta Surgical Expands Medical Navigation Portfolio The latest FDA clearance follows an earlier regulatory milestone for Zeta Surgical. In May 2026, the company received FDA clearance for navigation technology used alongside its Bolt and Stylet instruments to support neurosurgical procedures, including external ventricular drain placement and cerebral shunt catheter placement. The company’s wider technology platform is focused on improving navigation accuracy across neurological procedures. Growing Market for Neuromodulation Devices The approval comes as the global neuromodulation market continues to expand. Neuromodulation technologies are increasingly being applied across neurological and psychiatric disorders, including: Deep brain stimulation (DBS) for conditions such as Parkinson’s disease Transcranial magnetic stimulation (TMS) for depression and other behavioural health disorders Non-invasive stimulation technologies targeting symptoms such as tremors According to GlobalData analysis, the global neuromodulation device market is projected to grow from approximately $6.8bn in 2025 to more than $13bn by 2035. Increasing demand for personalised therapies, advances in AI-driven medical devices and the need for alternatives to pharmaceutical treatments are expected to support continued innovation in the sector. What Zeta Surgical’s FDA Clearance Means for the TMS Market Zeta Surgical’s FDA clearance highlights the growing role of robotics and artificial intelligence in improving the delivery of brain stimulation therapies. By combining robotic positioning, computer vision and automated movement tracking, the company aims to make TMS treatment more consistent and scalable. As neuromodulation adoption expands, technologies that improve accuracy, workflow efficiency and patient outcomes are likely to become increasingly important across mental health and neurological care. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The approvals expand the use of Keytruda and Keytruda Qlex alongside Padcev into the perioperative treatment setting for adults with muscle-invasive bladder cancer, regardless of cisplatin eligibility. The US Food and Drug Administration (FDA) has approved two new combinations from Merck & Co. (MSD) for the treatment of adults with muscle-invasive bladder cancer (MIBC), expanding the role of its immunotherapy platform Keytruda (pembrolizumab). The approvals cover: Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) plus Padcev Both combinations are approved for use in the neoadjuvant setting before surgery and adjuvant setting after surgery for patients with MIBC, including those who are not eligible for cisplatin-based chemotherapy. The FDA decision was supported by results from the Phase III KEYNOTE-B15 trial, also known as EV-304, which evaluated pembrolizumab and enfortumab vedotin-ejfv compared with standard neoadjuvant chemotherapy followed by surgery. The approval further strengthens MSD’s oncology portfolio, with Keytruda already one of the most widely used cancer immunotherapies globally. Phase III KEYNOTE-B15 Trial Shows Reduced Risk of Disease Events The KEYNOTE-B15 study enrolled 808 patients with muscle-invasive bladder cancer and assessed whether the combination of pembrolizumab and enfortumab vedotin-ejfv could improve outcomes compared with chemotherapy followed by surgery. In patients eligible for cisplatin-based chemotherapy, the Keytruda and Padcev combination demonstrated a: 47% reduction in the risk of event-free survival (EFS) events 35% reduction in the risk of death Median event-free survival was not reached among patients receiving pembrolizumab plus enfortumab vedotin-ejfv. The combination also improved pathological complete response rates, meaning no detectable cancer remained in tissue samples following treatment. Patients receiving the MSD combination achieved: 55.8% pathological complete response rate compared with: 32.5% for chemotherapy plus surgery These results suggest that combining immune checkpoint inhibition with antibody-drug conjugate therapy could provide a more effective treatment approach for some patients with MIBC. Expanding Treatment Options Before and After Surgery Muscle-invasive bladder cancer represents an aggressive form of bladder cancer where tumours have grown into the muscle layer of the bladder wall. Standard treatment has traditionally involved chemotherapy followed by radical cystectomy, a surgical procedure to remove the bladder. However, a significant proportion of patients are unable to receive cisplatin-based chemotherapy due to factors including kidney function, age or other health conditions. The latest FDA approvals expand treatment options by providing a perioperative approach that can be used regardless of cisplatin eligibility. MSD Research Laboratories senior vice-president and global clinical development oncology head Dr Marjorie Green said the approvals represent progress for patients with MIBC. “The results from KEYNOTE-B15, together with KEYNOTE-905, highlight the potential of these new treatment options for patients regardless of cisplatin eligibility in the perioperative setting and mark a promising step forward in the treatment of muscle-invasive bladder cancer,” Green said. Safety Profile of Keytruda and Padcev Combination The FDA approval included safety data from patients treated in the neoadjuvant setting. Permanent discontinuation of pembrolizumab due to adverse reactions occurred in: 17% of patients during the neoadjuvant phase Reported serious adverse reactions included: Rash Pneumonitis or interstitial lung disease Diarrhoea Fatal adverse reactions occurred in: 1.7% of patients during the neoadjuvant phase 3.2% of patients during the adjuvant phase Healthcare providers will continue to monitor patients receiving the combination for immune-related adverse events and complications associated with treatment. Keytruda and Padcev Continue to Expand Across Bladder Cancer The latest approval builds on previous regulatory decisions supporting the use of Keytruda-based combinations in bladder cancer. The FDA decision follows earlier approval activity linked to the Phase III KEYNOTE-905 (EV-303) trial, which also evaluated pembrolizumab and enfortumab vedotin-ejfv in patients with MIBC. Outside the US, the European Commission recently approved MSD’s Keytruda combination with Padcev as a neoadjuvant treatment option for MIBC. The continued expansion of the Keytruda platform highlights the growing importance of combination approaches in oncology, particularly therapies that pair immune checkpoint inhibitors with targeted cancer treatments such as antibody-drug conjugates. What This Means for the Muscle-Invasive Bladder Cancer Market The FDA approvals mark a significant development in the treatment landscape for muscle-invasive bladder cancer by introducing a new perioperative option that could reduce reliance on traditional chemotherapy pathways. For oncologists, the decision provides another treatment strategy for managing MIBC patients before and after surgery. For the pharmaceutical market, the approval reinforces MSD’s position in immuno-oncology while highlighting the increasing role of combination therapies in improving cancer outcomes. As clinical data continues to mature, the long-term impact of Keytruda and Padcev combinations will depend on durability of response, overall survival benefits and adoption across treatment centres. Summary The FDA has approved MSD’s Keytruda and Keytruda Qlex combinations with Padcev for adults with muscle-invasive bladder cancer. The approvals are based on Phase III KEYNOTE-B15 data showing: A 47% reduction in event-free survival risk A 35% reduction in risk of death Higher pathological complete response rates compared with chemotherapy The decision expands treatment options for patients with MIBC regardless of cisplatin eligibility and represents another step forward for combination immunotherapy approaches in oncology. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

iPredict-DR uses artificial intelligence to analyse retinal images and support earlier detection of diabetic eye disease. iHealthScreen has received US Food and Drug Administration (FDA) clearance for iPredict-DR, an artificial intelligence (AI)-powered screening software designed to detect diabetic retinopathy in adults with diabetes. The software, developed by New York-based Software as a Medical Device (SaMD) company iHealthScreen, analyses retinal fundus images captured by the iCare DRSplus camera to identify cases of more than mild diabetic retinopathy (mtmDR). The FDA clearance marks another milestone in the adoption of AI-based medical imaging technologies, with companies increasingly using artificial intelligence to support earlier diagnosis, improve screening capacity and help address healthcare workforce pressures. How iPredict-DR Detects Diabetic Retinopathy Diabetic retinopathy is one of the most common complications associated with diabetes and occurs when prolonged high blood sugar levels damage blood vessels in the retina. The condition can affect people with: Type 1 diabetes Type 2 diabetes Gestational diabetes In its early stages, diabetic retinopathy can be difficult to identify without regular eye examinations. iPredict-DR uses AI algorithms to assess colour retinal fundus images and detect signs of disease progression. The software is designed to work with the iCare DRSplus camera, which is already widely used in ophthalmology clinics and optician practices across the US. By analysing retinal images automatically, the technology aims to support healthcare providers in identifying patients who may require further assessment or referral. FDA Clearance Based on Clinical Validation iHealthScreen said the FDA clearance was supported by a clinical validation trial assessing the software’s diagnostic performance, safety and usability. The company said the approval supports its wider ambition to expand AI-powered retinal screening into primary care and community healthcare settings. Dr Alauddin Bhuiyan, CEO of iHealthScreen, said the clearance reinforces the company’s goal of improving access to retinal screening and enabling earlier detection of vision-threatening disease. Following the approval, iHealthScreen is continuing development work on additional AI-based diagnostic applications. The company is seeking future FDA clearances for technologies focused on detecting: Age-related macular degeneration (AMD) Glaucoma Hypertensive retinopathy Cardiovascular disease risk The Growing Need for Diabetic Eye Screening Diabetic retinopathy remains a significant global healthcare challenge. The condition is a leading cause of preventable blindness worldwide, but early detection and treatment can help reduce the risk of severe vision loss. The International Diabetes Federation (IDF) estimates that the global number of people living with diabetes could reach 700 million by 2045. Despite the importance of regular eye screening, many patients do not complete recommended examinations. Research from the American Academy of Ophthalmology (AAO) estimates that around six in 10 people with diabetes miss annual screenings that could identify early signs of diabetic retinopathy. AI-powered screening tools are increasingly being viewed as a potential solution to improve access, particularly in primary care and community settings where specialist ophthalmology resources may be limited. AI Transforming Medical Imaging The FDA clearance for iPredict-DR highlights the expanding role of artificial intelligence in healthcare imaging. AI technologies are being developed across multiple areas of diagnosis, including: Eye disease detection Cancer imaging Cardiovascular risk assessment Neurological disease identification Medical imaging has become one of the fastest-growing applications for healthcare AI, with algorithms capable of analysing large volumes of clinical images and identifying patterns that may be difficult to detect through traditional approaches. According to GlobalData analysis, the healthcare AI market is forecast to reach a valuation of $57.4bn by 2029. The Future of AI-Powered Eye Diagnostics The use of AI in ophthalmology continues to expand beyond diabetic retinopathy. Researchers and healthcare companies are exploring whether retinal imaging can provide insights into a wider range of conditions. For example, a research team at the University of Edinburgh is developing AI software designed to help optometrists identify potential dementia risk through routine eye examinations. As healthcare systems look for scalable approaches to early disease detection, AI-powered retinal screening could become an increasingly important tool in expanding access to preventative care. What iHealthScreen’s FDA Clearance Means for Digital Health The approval of iPredict-DR represents another step towards integrating AI-powered diagnostics into everyday healthcare environments. By combining retinal imaging hardware with automated analysis software, iHealthScreen aims to make diabetic retinopathy screening faster, more accessible and easier to deploy outside specialist settings. As diabetes rates continue to rise globally, technologies that support earlier detection and intervention could play an increasingly important role in preventing avoidable vision loss. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The deal gives Bayer additional financial flexibility while allowing the company to retain operational control of its long-acting reversible contraceptives portfolio. Bayer has agreed a €3bn ($3.4bn) investment deal with global asset management firm Apollo, selling a minority stake in its newly established long-acting reversible contraceptives (LARC) business. The transaction allows Bayer to unlock capital from a mature pharmaceutical asset while maintaining control over the strategic direction and operations of the business. The agreement comes as Bayer continues to reshape its long-term pharmaceutical strategy, strengthen its balance sheet and increase investment focus on growth opportunities in specialised medicines. Apollo Takes Minority Stake in Bayer’s Contraceptives Division Under the agreement, Apollo will acquire a minority, non-controlling stake in Bayer’s LARC business. The portfolio includes several of Bayer’s established contraceptive products, including: Mirena hormonal intrauterine system (IUD) Kyleena hormonal intrauterine system Jaydess hormonal intrauterine system Jadelle contraceptive implant These products form part of Bayer’s wider women’s health portfolio and provide long-term pregnancy prevention options through devices designed to provide contraception over extended periods. The transaction is expected to close in the third quarter of 2026, subject to customary closing conditions. Despite Apollo’s investment, Bayer will retain complete operational control of the business. The company confirmed that there will be no changes to the strategy, activities or management of the contraceptives division, which will remain part of Bayer Pharmaceuticals’ core operations. Bayer Uses Deal to Improve Financial Flexibility Bayer CFO Dr Judith Hartmann said the agreement will strengthen the company’s capital structure while allowing Bayer to maintain ownership and control of an important pharmaceutical business area. The investment provides additional liquidity at a time when Bayer is managing increased financial pressures, including upcoming bond maturities and ongoing litigation costs. The company has faced significant financial challenges following its acquisition of Monsanto in 2018, including extensive legal disputes surrounding glyphosate-based weed killer Roundup and allegations linking the product to cancer. Bayer acquired Monsanto in a $63bn transaction, but subsequent litigation has created a long-term financial burden for the German healthcare and agriculture group. The Apollo transaction provides Bayer with additional resources without requiring a full divestment of a profitable pharmaceutical asset. Bayer Returns to Pharmaceutical Dealmaking The contraceptives investment follows a renewed period of pharmaceutical deal activity for Bayer. After a period of limited dealmaking, the company recently agreed to acquire ophthalmology specialist Perfuse Therapeutics for $2.45bn. The acquisition gives Bayer access to a drug candidate that could potentially strengthen its ophthalmology pipeline and complement its existing position in eye care through Eylea (aflibercept), the blockbuster therapy developed with Regeneron. Bayer has increasingly focused its pharmaceutical strategy on moving beyond older established products and expanding into specialised medicines with longer-term growth potential. The company is targeting innovation-led growth areas while seeking to reduce reliance on legacy products. Pharma Industry Sees Surge in High-Value Deal Activity Bayer’s latest transaction reflects a wider trend across the pharmaceutical sector, with companies increasingly using acquisitions, licensing agreements and strategic investments to strengthen pipelines. Pharmaceutical companies are turning to external innovation to: Add new medicines to development pipelines Access emerging technologies Expand into high-growth therapeutic areas Reduce reliance on ageing blockbuster products According to GlobalData’s Pharmaceutical Intelligence Center, the total value of licensing agreements increased by 40% in the first quarter of 2026 compared with the same period in 2025. The value of pharmaceutical acquisitions increased by 260% over the same period, highlighting a significant acceleration in healthcare dealmaking activity. What the Apollo Deal Means for Bayer’s Future Strategy The investment in Bayer’s contraceptives business demonstrates a growing trend among pharmaceutical companies: unlocking value from established assets while retaining strategic control. Rather than selling the division outright, Bayer has chosen a partnership model that provides immediate capital while preserving long-term ownership of a core healthcare business. As Bayer continues to prioritise specialised medicines and rebuild financial flexibility, further portfolio optimisation and strategic deals are likely to remain central to the company’s future growth plans. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The latest agreement strengthens the companies’ collaboration as they target a major central nervous system indication using AI-powered drug discovery. Insilico Medicine and China Medical System (CMS) have expanded their strategic partnership through a new artificial intelligence (AI) drug discovery agreement worth approximately RMB1.2bn ($177m), focused on developing therapies for a large-scale central nervous system (CNS) indication. The agreement builds on the companies’ existing multi-project collaboration and further demonstrates the growing role of AI in pharmaceutical research and development. While neither company disclosed the specific disease target, the programme will utilise a novel mechanism of action identified using Insilico Medicine’s proprietary PandaOmics AI platform. AI Drug Discovery Platform to Identify New CNS Therapies The new collaboration will centre on Insilico’s PandaOmics platform, an AI-powered discovery engine designed to identify novel therapeutic targets and accelerate early-stage drug development. According to Insilico, the platform helps prioritise high-potential biological targets by analysing vast biomedical datasets, with the aim of improving translational success and reducing development timelines. Insilico Chief Scientific Officer Dr Feng Ren said the technology is designed to streamline the discovery of promising medicines and accelerate the progression of candidates from proof-of-concept into clinical development. The financial terms of the agreement include milestone payments alongside future royalty opportunities for Insilico should the programme progress successfully. Collaboration Covers Discovery Through Commercialisation Unlike many early-stage research partnerships, the new agreement spans the full pharmaceutical development process. Insilico Medicine and CMS will jointly oversee: AI-driven target discovery Drug research and development Clinical development Future commercialisation activities The companies said each partner will contribute complementary expertise throughout the programme, although specific responsibilities have not been publicly disclosed. Further details, including the therapeutic target, clinical development plans and expected timelines, have not yet been announced. Growing Interest in AI for CNS Drug Development Central nervous system diseases remain one of the most challenging therapeutic areas for pharmaceutical companies. Conditions such as Alzheimer's disease, Parkinson's disease, depression and schizophrenia have historically experienced lower clinical success rates than many other therapeutic categories. Artificial intelligence is increasingly being used to improve target identification and candidate selection in an effort to reduce the high failure rates associated with CNS drug development. Companies are investing heavily in AI platforms capable of analysing genetic, molecular and clinical data to uncover previously unrecognised disease mechanisms. Insilico Continues Active Business Development Strategy The latest CMS collaboration continues a period of significant deal activity for Insilico Medicine. Since the beginning of 2026, the AI drug discovery company has announced partnerships with several major pharmaceutical organisations, including: Servier Qilu Pharmaceutical Eli Lilly SK Biopharmaceuticals Takeda These collaborations span multiple therapeutic areas and reflect growing industry interest in integrating AI technologies into traditional pharmaceutical research pipelines. As competition intensifies among AI-enabled biotechnology companies, strategic licensing and co-development agreements have become an increasingly important route to commercialising discovery platforms. What the Deal Means for AI Drug Discovery The expanded partnership between Insilico Medicine and China Medical System highlights the continued momentum behind AI-powered pharmaceutical research. Rather than focusing solely on target discovery, the collaboration extends across the entire drug development lifecycle, from early research through to potential commercialisation. With pharmaceutical companies increasingly seeking faster and more efficient ways to identify new medicines, partnerships combining artificial intelligence with clinical development expertise are becoming an increasingly prominent feature of the global life sciences industry. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The Claria System is designed to improve safety and efficiency during minimally invasive hysterectomy procedures by providing a controlled tissue extraction approach. Claria Medical has received FDA De Novo classification and marketing authorisation for its Claria System, a medical device designed to support tissue extraction during minimally invasive hysterectomy procedures. The approval allows Claria Medical to introduce a new device category for its uterine containment and extraction technology, which aims to improve procedural safety while reducing challenges associated with current approaches to tissue removal. The FDA reviewed the device through its Safer Technologies Program (STeP), an initiative designed to accelerate regulatory review for medical technologies that demonstrate potential safety improvements compared with existing treatment options. Claria System Designed to Improve Hysterectomy Safety Hysterectomy is one of the most commonly performed gynaecological surgical procedures, with minimally invasive approaches increasingly used to reduce recovery times and improve patient outcomes. However, tissue extraction during these procedures remains a key technical challenge, particularly when removing larger uteri. The Claria System has been developed as a uterine containment and extraction solution designed to support surgeons during minimally invasive hysterectomy procedures. The device uses SafeStop technology, which combines electronic communication between a tri-layer tissue container and handpiece to help monitor the system and reduce the risk of unintended breaches of the containment barrier. According to Claria Medical, the system enables a transvaginal tissue extraction approach, potentially avoiding the need for mini-laparotomy procedures. The company said the device also features an ergonomic design intended to improve usability for surgeons during procedures. Clinical Study Supported FDA Submission The FDA authorisation was supported by data from a multinational, prospective, controlled clinical study evaluating the safety and performance of the Claria System. The study reported positive outcomes, including a median extraction time of four minutes for large uteri. Claria Medical said surgeons participating in the trial achieved these results following minimal device training, with all participating surgeons providing favourable feedback on the technology. The company is expected to present more detailed clinical findings later this year. FDA Clearance Through Safer Technologies Program The Claria System was reviewed through the FDA’s Safer Technologies Program, which provides an alternative regulatory pathway for devices that may offer significant improvements in safety compared with existing technologies. The De Novo pathway is used for novel medical devices where no existing classification applies but where the FDA determines the technology presents low to moderate risk. Following authorisation, Claria Medical plans to establish commercial pilot sites with leading US healthcare systems. The company said the next phase will focus on introducing the technology to hospitals, surgeons and patients across the country. Addressing an Unmet Need in Minimally Invasive Surgery Claria Medical CEO Alexey Salamini said current approaches to tissue extraction present safety challenges and that the company’s goal is to provide surgeons with a safer alternative. The company believes the Claria System could help improve procedural workflows while addressing concerns associated with tissue containment during minimally invasive hysterectomy. The technology is backed by private and strategic investors and has also received grant support from the National Institutes of Health (NIH) and the National Science Foundation (NSF). The Future of Surgical Technology Innovation The FDA clearance highlights continued innovation in minimally invasive surgical technologies, with companies increasingly focused on improving safety, reducing procedural complexity and supporting better patient outcomes. As healthcare systems continue to prioritise less invasive procedures, technologies that improve surgical efficiency while addressing safety concerns are becoming an important area of medical device development. The Claria System’s entry into the US market represents another example of how targeted device innovation is reshaping established surgical workflows. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

Neuropsychiatric drug developer Draig Therapeutics has raised $65 million in an oversubscribed Series B financing round to accelerate development of its pipeline, led by its investigational depression therapy DT-101. The funding comes as pharmaceutical companies continue to explore new approaches to treating major depressive disorder (MDD), with growing interest in therapies that target alternative biological pathways beyond traditional antidepressants. DT-101 is a positive allosteric modulator of the AMPA receptor and is currently being evaluated in two Phase II clinical trials, including a global monotherapy study and a US trial assessing its use alongside existing antidepressant treatments. Draig said the financing will support ongoing clinical development of DT-101, while advancing additional neuropsychiatric programmes targeting GABAA receptor pathways. Draig Therapeutics Raises $65M to Advance Depression Drug Pipeline The Series B financing was led by Deep Track Capital, with participation from new and existing investors including Janus Henderson Investors, Marshall Wace, British Business Bank and Jefferson Life Sciences. The latest funding brings Draig Therapeutics’ total disclosed financing to approximately $205 million since the company launched in June 2025 with a $140 million Series A round. The company said the capital will be used to accelerate clinical development of DT-101, alongside advancing its broader pipeline of neuroscience programmes. Draig CEO Ivana Magovčević-Liebisch said early clinical findings have supported continued investment in the company’s AMPA receptor approach. DT-101 Targets AMPA Receptor Pathway in Major Depressive Disorder DT-101 is designed as a positive allosteric modulator of the AMPA receptor, a target involved in mood regulation, synaptic plasticity and cognitive function. The therapy is currently being studied in two Phase II trials: A global study evaluating DT-101 as a monotherapy treatment for major depressive disorder A US study assessing DT-101 as an adjunctive therapy alongside existing antidepressant treatment Draig believes the approach could address limitations associated with previous AMPA receptor programmes by improving precision and maintaining a wider therapeutic margin. According to the company, DT-101 has been designed to provide transient receptor engagement through differentiated pharmacokinetic properties, supporting mechanisms involved in restoring synaptic connectivity. Growing Interest in AMPA Receptor Modulators The AMPA receptor pathway has attracted increasing attention from pharmaceutical developers searching for alternatives to conventional antidepressant treatments. Neurocrine Biosciences’ osavampator (TAK-653/NBI-1065845) is currently among the most advanced AMPA receptor modulators in development. Licensed from Takeda in 2020, osavampator entered Phase III development following positive Phase II results from the SAVITRI trial, where the therapy demonstrated improvements in depressive symptoms among patients with MDD. The growing investment in AMPA receptor research reflects wider industry efforts to develop treatments that can improve efficacy, speed of response and durability of benefit compared with existing antidepressants. Expanding Neuroscience Pipeline Beyond Depression Alongside DT-101, Draig Therapeutics is developing additional programmes targeting GABAA receptors. The company’s preclinical pipeline includes: DT-201 A negative allosteric modulator targeting the α5 GABAA receptor subtype. Draig believes this mechanism could have potential applications across multiple neuropsychiatric disorders. DT-301 A positive allosteric modulator targeting α2/α3 GABAA receptor subtypes while avoiding α1 and α5 receptors. The company believes this selectivity could help minimise unwanted effects associated with sedation and cognitive impairment. One of these programmes is expected to enter clinical development during 2026. Investment Highlights Growing Interest in Neuropsychiatric Innovation Deep Track Capital, which led the Series B financing, highlighted Draig’s rapid progress since launch. Managing director Rebecca Luse said the company had built an international organisation, initiated two Phase II trials in MDD and advanced additional pipeline assets towards clinical development in less than two years. The investment reflects broader industry interest in next-generation neuroscience therapies, as pharmaceutical companies continue searching for new approaches to conditions including depression and other neuropsychiatric disorders. What This Means for the Depression Treatment Market Depression remains one of the largest areas of unmet need in healthcare, with many patients experiencing inadequate responses to existing therapies. While traditional antidepressants remain widely used, pharmaceutical companies are increasingly exploring novel mechanisms that could offer improved outcomes through alternative biological pathways. Draig’s focus on AMPA receptor modulation places the company within a growing field of neuroscience innovation targeting synaptic function and neural connectivity. The success of DT-101 will depend on whether it can demonstrate meaningful clinical benefits while avoiding the safety and tolerability challenges that have affected previous AMPA receptor programmes. Summary Draig Therapeutics has raised $65 million in Series B financing to advance its neuropsychiatric pipeline, led by Phase II depression therapy DT-101. The AMPA receptor modulator is being evaluated in major depressive disorder, with the company aiming to develop a next-generation approach to improving mood regulation and synaptic connectivity. The funding will also support Draig’s broader neuroscience pipeline, including preclinical GABAA receptor programmes targeting additional neuropsychiatric conditions. As pharmaceutical developers continue searching for alternatives to traditional antidepressants, AMPA receptor modulation remains an area of significant industry interest. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The agreement expands AstraZeneca’s oncology portfolio with an oral EGFR inhibitor for non-small-cell lung cancer, as Dizal seeks to broaden Zegfrovy’s use into earlier lines of treatment. AstraZeneca has strengthened its oncology pipeline through a licensing agreement worth up to $1.5 billion for global development and commercialisation rights to Dizal Pharmaceutical’s Zegfrovy (sunvozertinib), an oral targeted therapy for non-small-cell lung cancer (NSCLC). The agreement includes a $600 million upfront payment, with Dizal eligible for a further $900 million in development and commercial milestones, alongside tiered royalties on future sales. The deal gives AstraZeneca exclusive rights to develop and commercialise Zegfrovy outside existing arrangements, adding a potential new growth driver to its lung cancer portfolio. Following the announcement, Dizal’s shares increased by nearly 20%. What is Zegfrovy and How Does It Work? Zegfrovy is an oral irreversible epidermal growth factor receptor (EGFR) inhibitor designed to target specific mutations found in NSCLC. The therapy is currently approved in: China The United States for adults with locally advanced or metastatic NSCLC harbouring EGFR exon 20 insertion mutations whose disease has progressed following platinum-based chemotherapy. EGFR exon 20 insertion mutations represent a challenging subset of lung cancer, with historically limited targeted treatment options compared with other EGFR-driven tumours. AstraZeneca said the agreement will allow the companies to expand access to a targeted oral therapy for patients with significant unmet medical need. Dave Fredrickson, executive vice-president of AstraZeneca’s oncology haematology business unit, said the deal would help bring a differentiated treatment option to patients with limited therapeutic choices worldwide. Clinical Data Supporting Zegfrovy Approval Zegfrovy’s existing approvals were supported by clinical data from multiple studies. In China, approval was based on findings from the pivotal WU-KONG6 study, while the US approval was supported by data from the Phase I/II WU-KONG1 Part B trial. The programme demonstrated activity in patients with EGFR exon 20 insertion-positive NSCLC following platinum-based chemotherapy, a population where treatment options remain limited. The drug’s oral administration also differentiates it from some existing targeted approaches, potentially offering greater convenience for patients and healthcare providers. AstraZeneca and Dizal Target Earlier-Line Lung Cancer Treatment The latest deal comes as Dizal continues to evaluate Zegfrovy in earlier stages of NSCLC treatment. The company has submitted regulatory applications in both China and the US seeking approval for first-line treatment in patients with EGFR exon 20 insertion mutations. These applications are supported by data from the Phase III WU-KONG28 study. If approved, Zegfrovy would enter a more competitive treatment setting, including against Johnson & Johnson’s Rybrevant (amivantamab-vmjw), a bispecific antibody already approved by the FDA for first-line treatment of EGFR exon 20 insertion-positive NSCLC in combination with chemotherapy. The move into earlier treatment lines could significantly expand the commercial opportunity for Zegfrovy. Why AstraZeneca Is Investing in Lung Cancer Innovation Lung cancer remains one of the largest areas of focus within oncology, with targeted therapies becoming increasingly important as researchers identify more specific genetic drivers of disease. AstraZeneca has built a strong position in lung cancer through medicines targeting different molecular pathways, including EGFR mutations. The company’s oncology strategy has increasingly focused on precision medicine approaches that match treatments to specific patient characteristics. Adding Zegfrovy could strengthen AstraZeneca’s ability to compete across different EGFR-mutated lung cancer populations while expanding its pipeline of oral targeted therapies. The Growing Competition in EGFR-Driven NSCLC The EGFR landscape continues to evolve as pharmaceutical companies develop therapies aimed at increasingly specific mutations. While traditional EGFR inhibitors have transformed treatment for some NSCLC patients, exon 20 insertion mutations have remained more difficult to treat due to differences in receptor structure and drug response. New therapies targeting these mutations are attempting to address this gap by offering more precise inhibition. The success of Zegfrovy will depend on its ability to demonstrate durable clinical benefit, secure broader regulatory approvals and compete within an increasingly crowded precision oncology market. Summary AstraZeneca has secured global development and commercialisation rights to Dizal Pharmaceutical’s Zegfrovy in a deal potentially worth $1.5 billion. The oral EGFR inhibitor is currently approved for previously treated patients with EGFR exon 20 insertion-positive NSCLC in China and the US. With regulatory submissions underway for first-line treatment, Zegfrovy could become an important addition to AstraZeneca’s oncology portfolio as competition intensifies in targeted lung cancer therapies. The agreement highlights the continued value of precision oncology assets as pharmaceutical companies look to strengthen their pipelines through strategic licensing deals. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

Detailed CELIA trial results show Biogen and Ionis’ diranersen slowed cognitive decline in early Alzheimer’s disease, but questions remain over why the lowest dose delivered the strongest clinical benefit. Biogen is moving ahead with plans to advance its investigational Alzheimer’s disease therapy diranersen (BIIB080) into Phase III development, despite new data from a Phase II study raising questions around the optimal dose and the scale of potential clinical benefit. Detailed results from the CELIA study presented at the Alzheimer’s Association International Conference (AAIC) showed that diranersen slowed cognitive decline in patients with early Alzheimer’s disease, but the strongest effect was observed at the lowest dose tested. The findings have prompted renewed debate around the programme’s future, with analysts questioning why higher doses did not translate into greater clinical improvement despite producing similar or greater reductions in tau protein levels. Following the presentation, Biogen’s shares fell approximately 8%. CELIA Trial Evaluated Diranersen in Early Alzheimer’s Disease The Phase II CELIA trial enrolled 416 patients with: Mild cognitive impairment due to Alzheimer’s disease Mild Alzheimer’s dementia The study evaluated diranersen, an antisense oligonucleotide (ASO) developed in partnership with Ionis Pharmaceuticals, designed to reduce production of tau protein. Tau accumulation is considered one of the key pathological features of Alzheimer’s disease, alongside amyloid-beta plaque formation. Unlike currently approved anti-amyloid therapies, diranersen targets tau pathology, representing a different approach to slowing disease progression. The trial aimed to determine whether higher doses of diranersen would deliver greater clinical benefit over an 18-month treatment period. However, the results did not demonstrate a clear dose-response relationship. Lowest Diranersen Dose Showed Greatest Cognitive Benefit The strongest clinical results came from the lowest dose tested. Patients receiving 60mg of diranersen administered intrathecally every 24 weeks experienced: A 26% slowing of cognitive decline compared with placebo based on the Clinical Dementia Rating–Sum of Boxes (CDR-SB) A 0.54-point improvement difference versus placebo The magnitude of benefit was comparable with results reported for existing Alzheimer’s disease therapies. For comparison: Biogen and Eisai’s Leqembi (lecanemab) demonstrated approximately a 27% reduction in decline in its pivotal trial Eli Lilly’s Kisunla (donanemab) reported a 35% reduction Additional cognitive measures also showed positive trends with the 60mg dose, including: 42% slowing on Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog13) 50% slowing on Mini-Mental State Examination (MMSE) 30% slowing on modified Integrated Alzheimer’s Disease Rating Scale (iADRS) 23% slowing on Alzheimer’s Disease Composite Score (ADCOMS) Biogen noted that statistical significance for many of these secondary measures was nominal compared with placebo. Higher Doses Raise Questions Around Treatment Strategy The CELIA study also evaluated higher doses of diranersen: 115mg every 24 weeks 115mg every three weeks However, neither produced stronger clinical outcomes than the lower dose. The higher-dose groups showed: 14% slowing of decline on CDR-SB for the every-24-week regimen 9% slowing for the every-three-week regimen The lack of a traditional dose-response pattern has become one of the main questions surrounding the programme. RBC Capital Markets analyst Brian Abrahams said the results "leave more questions than answers", noting that tau reduction appeared greater at higher doses despite weaker clinical outcomes. The analyst questioned whether the observed treatment effect would be considered sufficiently meaningful if larger Phase III studies produce more moderate results across different dosing groups. Diranersen Successfully Reduced Tau Biomarkers Despite uncertainty around dosing, Biogen highlighted evidence that diranersen successfully achieved its intended biological effect. Across all treatment groups, the therapy reduced tau levels in cerebrospinal fluid by approximately 50% to 65% from baseline. The company said these findings provide proof-of-concept that tau reduction can translate into clinical benefit. Biogen’s head of development, Priya Singhal, said the CELIA results demonstrated that diranersen’s tau-reduction mechanism could represent an important new therapeutic approach if confirmed in Phase III trials. Safety Profile Differs From Anti-Amyloid Alzheimer’s Therapies The safety profile of diranersen was generally consistent with previous studies. The most common adverse events reported in the CELIA trial included: Procedural pain Post-lumbar puncture syndrome Confusional state Biogen said confusion-related events occurred shortly after dosing and resolved within approximately one week. The company also highlighted that amyloid-related imaging abnormalities (ARIA), a key safety concern associated with anti-amyloid Alzheimer’s therapies, are not expected with diranersen because of its different mechanism targeting tau rather than amyloid. What Diranersen Means for the Future of Alzheimer’s Treatment The Alzheimer’s treatment landscape is rapidly evolving, with the first generation of disease-modifying therapies focused primarily on targeting amyloid plaques. However, many researchers believe future treatment approaches may require addressing multiple disease pathways, including tau accumulation. A successful tau-targeting therapy could potentially complement existing anti-amyloid medicines or provide an alternative treatment approach for patients where amyloid therapies are unsuitable. The challenge for Biogen and Ionis will be demonstrating that diranersen’s cognitive benefits are consistent, clinically meaningful and scalable in Phase III development. Summary Biogen’s diranersen programme remains one of the most closely watched tau-targeting approaches in Alzheimer’s disease. Phase II CELIA data showed the therapy slowed cognitive decline, with the strongest results observed at the lowest dose tested. However, the unexpected dose-response pattern has raised questions about the optimal treatment strategy and whether the level of benefit can be replicated in larger trials. As Biogen prepares for Phase III development, diranersen could become an important test of whether targeting tau can deliver the next major advance in Alzheimer’s disease treatment. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com