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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. 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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. 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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. 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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. 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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

The approval of Revtorpyk (gedatolisib) gives Celcuity a new treatment option for HR-positive, HER2-negative breast cancer patients without PIK3CA mutations, following positive Phase III VIKTORIA-1 data showing improved progression-free survival. Celcuity has received approval from the US Food and Drug Administration (FDA) for Revtorpyk (gedatolisib), a targeted therapy designed to inhibit the PI3K/AKT/mTOR (PAM) signalling pathway in certain patients with advanced breast cancer. The therapy has been approved in combination with fulvestrant, with or without Pfizer’s Ibrance (palbociclib), for adults with: Hormone receptor-positive (HR-positive) HER2-negative Locally advanced or metastatic breast cancer Second-line or later disease No PIK3CA mutation The approval represents a new treatment approach for a subset of breast cancer patients who have historically had limited targeted therapy options. Following the regulatory decision, Celcuity shares initially increased by approximately 7% before giving back most gains in after-hours trading. How Revtorpyk Works in Breast Cancer Revtorpyk is an intravenously administered comprehensive inhibitor of the PI3K/AKT/mTOR pathway, a signalling network involved in cancer cell growth, survival and treatment resistance. The PI3K pathway is one of the most frequently altered pathways in breast cancer, particularly in HR-positive, HER2-negative disease. Approximately 70% of breast cancers are HR-positive, HER2-negative, and around 40% of these tumours contain PIK3CA mutations. Unlike therapies targeting individual components of the pathway, Celcuity’s approach is designed to inhibit multiple signalling nodes within the PAM pathway. Phase III VIKTORIA-1 Trial Supports FDA Approval The FDA approval was supported by data from the Phase III VIKTORIA-1 trial, which evaluated Revtorpyk in patients with advanced HR-positive, HER2-negative breast cancer. The study enrolled 701 patients across both: PIK3CA-mutant tumours PIK3CA wild-type tumours Participants were randomised to receive: Revtorpyk plus fulvestrant and Ibrance Revtorpyk plus fulvestrant Fulvestrant alone Both patient populations met the trial’s primary endpoint of progression-free survival (PFS). The FDA submission focused initially on the PIK3CA wild-type population, which received priority review earlier this year. Revtorpyk Demonstrated Progression-Free Survival Benefit in Wild-Type Breast Cancer In the PIK3CA wild-type cohort, Celcuity reported significant improvements with Revtorpyk-based treatment combinations. The triplet combination of: Revtorpyk Fulvestrant Ibrance reduced the risk of disease progression compared with fulvestrant alone. Key results included: Treatment Median Progression-Free Survival Revtorpyk + fulvestrant + Ibrance 9.3 months Fulvestrant alone 2 months This represented a 76% improvement in progression-free survival compared with fulvestrant monotherapy. The Revtorpyk and fulvestrant combination also demonstrated statistically significant benefit, achieving a median PFS of 7.4 months. Objective response rates were: 32% for Revtorpyk + fulvestrant + Ibrance 28% for Revtorpyk + fulvestrant 1% for fulvestrant alone Additional Opportunity in PIK3CA-Mutated Breast Cancer Celcuity is also pursuing a potential expansion into PIK3CA-mutated breast cancer, where Revtorpyk demonstrated positive results in the VIKTORIA-1 trial. In this patient group, the comparator was: Novartis’ PI3Kα inhibitor Piqray (alpelisib) plus fulvestrant Presented data showed: Revtorpyk triplet therapy reduced the risk of disease progression or death by 50% Revtorpyk plus fulvestrant reduced the risk by 49% Median progression-free survival was: Treatment Median PFS Revtorpyk + fulvestrant + Ibrance 11.1 months Revtorpyk + fulvestrant 11.3 months Piqray + fulvestrant 5.6 months Celcuity announced plans to submit a supplemental regulatory application based on these findings. Challenges Remain Around Intravenous Delivery Despite positive clinical results, questions remain around how Revtorpyk will compete in a treatment landscape increasingly focused on convenience and patient quality of life. Unlike many modern targeted therapies that are administered orally, Revtorpyk requires intravenous delivery. Some clinicians have highlighted this as a potential limitation, particularly in a disease setting where patients may prefer treatments that reduce hospital visits. Denise Yardley, associate director of breast cancer research at Sarah Cannon Research Institute, noted that while Revtorpyk appeared more effective than Piqray, intravenous administration could create challenges for adoption. She also highlighted that PI3K-targeting therapies can be difficult to use due to side effects including: Rash Diarrhoea Hyperglycaemia The Future of PI3K-Targeted Breast Cancer Treatment Revtorpyk enters a competitive breast cancer market where pharmaceutical companies continue to develop increasingly targeted approaches based on tumour biology. The approval reinforces the importance of pathway-based therapies in HR-positive, HER2-negative breast cancer, particularly for patients whose tumours do not contain traditional actionable mutations. For Celcuity, future success will depend on balancing clinical benefit with practical considerations such as administration burden, tolerability and positioning against established targeted therapies. Summary The FDA has approved Celcuity’s Revtorpyk (gedatolisib) for adults with HR-positive, HER2-negative advanced breast cancer without PIK3CA mutations. Supported by Phase III VIKTORIA-1 data, the therapy demonstrated improved progression-free survival when combined with fulvestrant, with or without Ibrance. While the approval expands treatment options for patients with limited alternatives, Celcuity will need to overcome challenges around intravenous delivery and the broader tolerability concerns associated with PI3K-targeting therapies as it seeks commercial adoption. 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Sacituzumab tirumotecan plus Keytruda improves progression-free survival in advanced NSCLC, expanding potential role of ADC-immunotherapy combinations. Kelun-Biotech’s antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT), in combination with Merck & Co.’s Keytruda (pembrolizumab), has achieved a late-stage clinical success in first-line non-small-cell lung cancer (NSCLC), strengthening the potential of ADC-immunotherapy combinations across a broader patient population. The Phase III OptiTROP-Lung06 trial met its primary endpoint, demonstrating that sac-TMT plus Keytruda delivered a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with Keytruda combined with standard chemotherapy in patients with locally advanced or metastatic NSCLC. The positive results focus specifically on patients with PD-L1 tumour proportion scores below 1% — a population with limited response to existing immunotherapy approaches. Expanding Treatment Options in PD-L1-Negative NSCLC The OptiTROP-Lung06 study enrolled 432 patients with previously untreated locally advanced or metastatic NSCLC whose tumours had PD-L1 expression levels below 1%. Patients were randomised to receive either: Sacituzumab tirumotecan plus Keytruda Keytruda plus pemetrexed and platinum-based chemotherapy The study’s primary endpoint was progression-free survival assessed by blinded independent central review (BICR). Top-line results showed the ADC combination achieved a significant improvement in PFS compared with the chemotherapy-based regimen. The combination also demonstrated a positive trend in overall survival, although further follow-up will be required to determine the full impact. Kelun reported that the safety profile remained consistent with previous studies, with no new safety concerns identified. The company plans to discuss the results with Chinese regulatory authorities. Merck’s Strategic Bet on Sac-TMT The latest results reinforce Merck’s growing investment in sac-TMT, following its agreement with Kelun-Biotech in 2022 for exclusive rights outside China. Under the partnership, Merck gained global development and commercialisation rights for the TROP2-targeting ADC, while Kelun continues to develop the asset in China. Sac-TMT, marketed as Jia Tai Lai in China, has already received approval in four indications, including: Triple-negative breast cancer EGFR mutation-positive NSCLC HR-positive/HER2-negative breast cancer The ADC is now being evaluated across multiple tumour types as Merck looks to expand its oncology pipeline ahead of future market challenges. Building Momentum Across Lung Cancer Studies The OptiTROP-Lung06 success follows another Phase III win for the combination in first-line NSCLC. In the OptiTROP-Lung05 trial, sac-TMT plus Keytruda demonstrated improved PFS compared with Keytruda alone in treatment-naïve patients with PD-L1-positive NSCLC. Additional data presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting showed the combination reduced the risk of disease progression or death by 65% compared with Keytruda monotherapy after a median follow-up of 10.5 months. Together, the results suggest sac-TMT could have potential across a wide range of NSCLC patients, regardless of PD-L1 status. Kelun CEO Michael GE said the combined findings from OptiTROP-Lung05 and OptiTROP-Lung06 highlight the “strong synergetic effect” of sac-TMT combined with Keytruda and support its potential to benefit the broader first-line NSCLC population. The Growing Role of ADCs in Oncology ADC technology has become one of the most competitive areas in oncology development, combining the targeting ability of antibodies with the cancer-killing effects of cytotoxic payloads. By selectively delivering therapy to tumour cells, ADCs aim to improve efficacy while reducing systemic toxicity compared with traditional chemotherapy. Sac-TMT is currently being investigated in 10 registrational lung cancer studies, including five trials in China and five global studies. Beyond lung cancer, the ADC has also achieved a late-stage success in endometrial cancer and forms part of Merck’s wider TroFuse Phase III programme evaluating ADC-based combinations across multiple tumour types. What This Means for the NSCLC Market The latest Phase III success adds further momentum to the shift towards combination approaches in lung cancer treatment. While PD-1 inhibitors such as Keytruda have transformed NSCLC care, many patients — particularly those with low or absent PD-L1 expression — continue to require more effective treatment options. If future regulatory submissions are successful, sac-TMT plus Keytruda could strengthen Merck’s position in a highly competitive lung cancer market while demonstrating the expanding role of ADCs beyond traditional chemotherapy-based treatment pathways. For pharmaceutical companies, the result also highlights the growing importance of strategic partnerships with biotech innovators as major players look to build next-generation oncology portfolios. 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

Acquisition adds FDA-authorised fibromyalgia therapy and strengthens smartphone-based digital health offering XRHealth has acquired Swing Therapeutics, expanding its digital therapeutics portfolio beyond virtual reality and into smartphone-based care for chronic pain and fibromyalgia. The acquisition brings together XRHealth's extended reality (XR) therapies with Swing's FDA-authorised digital therapeutic, Stanza, and its virtual chronic pain management platform, creating a broader digital care ecosystem for patients living with long-term pain conditions. The deal also reflects a wider trend across digital health, where companies are combining software, connected devices and virtual clinical services to deliver more scalable healthcare outside traditional clinical settings. XRHealth broadens digital therapeutics portfolio XRHealth has built its business around immersive therapeutic technologies, including virtual reality (VR) programmes used to support pain management, mental health and cognitive rehabilitation. Its flagship FDA-registered VR platform is prescribed as Durable Medical Equipment (DME), allowing patients to receive clinician-guided therapy remotely. With the acquisition of Swing Therapeutics, XRHealth is expanding beyond immersive technologies into smartphone applications, wearable devices and connected digital care. The combined platform now supports patients through multiple digital treatment modalities depending on clinical need. Stanza becomes part of XRHealth's chronic pain offering A key asset in the acquisition is Stanza, the first FDA-authorised digital behavioural therapy specifically indicated for fibromyalgia symptoms. Delivered through a smartphone application, Stanza is designed to help patients manage chronic pain using evidence-based behavioural interventions without requiring medication or invasive procedures. The therapy was evaluated in a Phase III randomised controlled trial published in The Lancet, where patients demonstrated significant improvements across multiple clinical outcomes, including: Fibromyalgia symptom severity Pain intensity Fatigue Sleep quality Depression The programme is delivered through Swing Care, a virtual clinic that combines digital therapy with clinician oversight, medication management, mental health support and personalised coaching. According to the company, thousands of patients have already received treatment through the platform. Virtual care model delivers long-term support Swing Care extends beyond digital therapy by integrating licensed clinicians into the treatment pathway. Reported one-year outcomes showed: 88% of patients experienced improvements in overall wellbeing 50.2% reported feeling "much improved" or better after treatment Following the acquisition, XRHealth plans to incorporate these services into its existing network of virtual clinics using its established reimbursement model. The combined platform aims to offer patients a more comprehensive approach to chronic pain management while improving access to specialist care. Digital health consolidation continues The Swing acquisition continues XRHealth's strategy of building an integrated digital healthcare platform through targeted acquisitions. Recent deals include: RealizedCare (2025) – adding chronic pain and behavioural health programmes alongside AI-supported patient triage. Innerworld – bringing avatar-based virtual mental health communities. NeuroReality (2024) – expanding neurological rehabilitation capabilities. Amelia Virtual Care (2023) – strengthening immersive therapeutic technologies. Each acquisition has expanded XRHealth's ability to deliver remote care across physical, cognitive and behavioural health conditions. Meeting growing demand for scalable chronic pain care Chronic pain remains one of healthcare's largest unmet needs, placing significant pressure on healthcare systems facing clinician shortages and rising patient demand. Digital therapeutics are increasingly viewed as one solution to improving access while reducing the reliance on in-person appointments. By combining virtual reality therapy, smartphone-based digital therapeutics, wearable technologies and clinician-led virtual care, XRHealth is positioning itself as a broader digital health platform capable of supporting patients across multiple treatment settings. What the acquisition means The acquisition demonstrates how the digital therapeutics market is evolving beyond single technologies towards integrated care platforms. Rather than focusing solely on virtual reality, XRHealth now combines immersive therapies, mobile applications and virtual clinical services under one ecosystem. As healthcare providers continue to adopt remote care models, platforms capable of delivering evidence-based treatment across multiple digital channels are expected to play an increasingly important role in chronic disease management, particularly in areas such as chronic pain, behavioural health and 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