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The reverse merger will create Nasdaq-listed Cortigent Holdings, providing Vivani's brain-computer interface business with independent funding to accelerate vision restoration and neurorehabilitation technologies. Vivani Medical has agreed to spin out its brain-computer interface (BCI) business through a reverse merger with Nasdaq-listed communications technology company ClearOne, creating a new publicly traded neurotechnology company focused on restoring vision and motor function. Once the transaction closes, expected in the third quarter of 2026, ClearOne will be renamed Cortigent Holdings and will trade on the Nasdaq under the ticker CRGT. The move gives Vivani’s neurotechnology division independent access to public capital while allowing the parent company to concentrate on its long-acting drug implant portfolio. Creating a Standalone Brain-Computer Interface Company Under the agreement, Vivani will receive 12.5 million shares of ClearOne common stock and will own between 59.4% and 67.5% of the combined company, depending on the final financing structure. Existing ClearOne shareholders will retain between 12.7% and 14.4% ownership. Although ClearOne currently develops professional audio and video collaboration systems, that business will become a legacy, non-core operation following completion of the merger as the company shifts its strategic focus towards neurotechnology. Investor enthusiasm was immediate. Following the announcement, ClearOne's share price more than doubled during trading, highlighting growing interest in the brain-computer interface sector. Building a Pipeline Focused on Restoring Vision and Movement The new Cortigent Holdings will inherit a portfolio of implantable neurostimulation technologies targeting significant unmet neurological needs. Its lead programmes include: Orion, a brain-computer interface implant designed to restore functional vision in blind patients. Argus II, a retinal prosthesis intended to provide artificial vision for people living with severe retinitis pigmentosa. The company is also developing a next-generation neurostimulation device designed to help restore arm and hand movement following stroke-related paralysis, expanding its focus beyond vision restoration into neurorehabilitation. These technologies originated from Second Sight Medical before becoming part of Vivani following its merger with Nano Precision Medical in 2022. Funding Future Development Alongside the merger, ClearOne plans to raise between $10 million and $15 million through a share offering to support continued clinical and product development. For Vivani, the transaction also delivers strategic benefits beyond financing. By separating Cortigent into an independent public company, Vivani expects to reduce ongoing investment requirements while sharpening its focus on developing long-acting implantable drug delivery technologies. The structure allows both businesses to pursue distinct growth strategies while maintaining Vivani as the majority shareholder in the new neurotechnology company. Why the Deal Matters The transaction reflects several broader trends emerging across healthcare innovation: Brain-computer interface technologies are attracting increasing commercial and investor interest. Companies are using reverse mergers to access public markets more quickly than through traditional IPOs. Neurotechnology developers are expanding beyond research into commercially focused clinical pipelines. Investors are showing growing confidence in implantable devices targeting neurological disorders and rehabilitation. The market opportunity is substantial. Industry forecasts project the global neurology devices market to exceed $25 billion by 2034, while some analysts estimate the long-term addressable market for healthcare-focused brain-computer interfaces could eventually reach hundreds of billions of dollars as the technology matures. Summary Vivani Medical has agreed to merge its Cortigent neurotechnology business with ClearOne, creating a new publicly listed company dedicated to brain-computer interface technologies. The transaction provides Cortigent with independent access to public markets while enabling Vivani to focus on its core drug delivery platform. As investment and clinical development accelerate across neurotechnology, the deal highlights the growing commercial momentum behind brain-computer interfaces aimed at restoring vision, movement and neurological function. 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 decision makes Itvisma the first and only gene replacement therapy approved in the EU for older children, teenagers and adults living with 5q spinal muscular atrophy. The European Commission has approved Novartis' Itvisma (onasemnogene abeparvovec) for the treatment of older children, teenagers and adults with 5q spinal muscular atrophy (SMA) who have a bi-allelic mutation in the survival motor neuron 1 (SMN1) gene. The approval significantly expands access to gene replacement therapy within Europe, making Itvisma the only approved treatment of its kind for this broader patient population. Expanding Access Beyond Early Childhood Spinal muscular atrophy is a rare genetic neuromuscular disorder caused by mutations in the SMN1 gene, resulting in insufficient production of survival motor neuron protein and progressive muscle weakness. Until now, gene replacement therapies have largely been focused on younger patients. The European Commission's decision extends access to older children, adolescents and adults, addressing a long-standing unmet need for patients who previously had limited treatment options. Itvisma delivers a functional copy of the SMN1 gene through a single fixed-dose intrathecal injection, eliminating the need for ongoing dosing adjustments based on age or body weight. Clinical Evidence Supports Approval The approval is supported by data from three clinical studies: STEER Phase IIIb STRENGTH Phase I/II STRONG The registrational STEER study demonstrated a statistically significant improvement of 2.39 points on the Hammersmith Functional Motor Scale, with benefits maintained throughout a 52-week follow-up period. Both the STEER and STRENGTH studies also showed clinically meaningful improvements in motor function across both treatment-naïve patients and those who had previously received SMA therapies. These findings helped demonstrate that gene replacement therapy may provide meaningful functional benefits beyond the early stages of the disease. A Milestone for Gene Therapy in SMA Novartis believes the expanded indication represents an important step forward in broadening access to one-time gene replacement therapy. The company said the approval has the potential to address significant unmet needs among older SMA patients who have historically had fewer therapeutic options than younger children. As with any gene therapy, treatment is associated with potential side effects. The most commonly reported adverse events include upper respiratory tract infection, fever, vomiting, headache and elevated liver enzymes. Strengthening Novartis' Rare Disease Portfolio The approval further reinforces Novartis' position in rare genetic diseases and gene therapy. The company holds exclusive global licences covering both intravenous and intrathecal delivery of AAV9-based gene therapies for spinal muscular atrophy, positioning it as one of the leading developers in this space. Gene therapies continue to reshape the treatment landscape for inherited neurological disorders by offering the potential for long-lasting therapeutic benefit following a single administration. Summary The European Commission has approved Novartis' Itvisma for older children, teenagers and adults with 5q spinal muscular atrophy, making it the first gene replacement therapy authorised for this wider patient population within the EU. Supported by positive clinical data across multiple studies, the approval expands treatment options for patients with SMA while reinforcing the growing role of one-time gene therapies in managing rare neurological diseases. 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 acquisition adds first-in-class BK polyomavirus candidate potravitug as Ipsen continues an aggressive week of dealmaking following its Kartos Therapeutics takeover. Ipsen has agreed to acquire Swiss rare disease biotech Memo Therapeutics in a deal worth more than €700 million, adding a promising late-stage rare disease programme to its pipeline and continuing its recent acquisition drive. The transaction follows just days after Ipsen announced its $1.75 billion acquisition of Kartos Therapeutics, signalling an increasingly active business development strategy focused on high-value specialist medicines. A Potential First-in-Class Therapy for Kidney Transplant Patients The centrepiece of the acquisition is potravitug, Memo's lead clinical asset targeting BK polyomavirus-associated nephropathy (BKPyVAN). BKPyVAN is a serious complication that can develop in kidney transplant recipients when the normally dormant BK virus reactivates as a result of immunosuppressive therapy. Current treatment options are limited, with clinicians often forced to reduce immunosuppressive medication to control the virus, increasing the risk of transplant rejection and long-term graft loss. Potravitug has been designed to address this unmet need by targeting the virus directly. The monoclonal antibody binds to the VP1 capsid protein, preventing the virus from attaching to and entering healthy cells, with the aim of stopping viral replication before kidney damage occurs. Late-Stage Development Underway Memo plans to launch its pivotal SAFE KIDNEY III Phase III trial later this year. The programme builds on encouraging results from the earlier SAFE Kidney II study, where potravitug enabled significantly more patients to achieve low or undetectable viral loads compared with placebo. If successful, the therapy could become the first targeted treatment approved specifically for BKPyVAN, representing a significant advance for kidney transplant care. The candidate has already received both Fast Track designation from the US Food and Drug Administration and Orphan Drug designation in both the US and Europe. Deal Structure Reflects Confidence in Future Success Under the agreement, Ipsen will pay €200 million upfront when the transaction closes, which is expected during the third quarter of 2026. Memo shareholders could receive more than €700 million in additional milestone payments linked to the programme's clinical development, regulatory approvals and future commercial performance. The heavily milestone-based structure allows Ipsen to limit upfront risk while providing substantial upside if potravitug reaches the market. Building Momentum Through Targeted Acquisitions The Memo acquisition follows Ipsen's purchase of Kartos Therapeutics, which added Phase III myelofibrosis candidate navtemadlin to its oncology pipeline. Together, the two acquisitions demonstrate Ipsen's strategy of acquiring advanced clinical-stage assets capable of delivering near- to medium-term growth across specialist therapeutic areas. Rather than pursuing broad portfolio expansion, the company continues to focus on targeted acquisitions addressing diseases with significant unmet clinical need. Summary Ipsen has agreed to acquire Memo Therapeutics in a deal worth more than €700 million, strengthening its rare disease pipeline with the addition of potravitug, a potential first-in-class therapy for BK polyomavirus-associated nephropathy. Combined with its recent acquisition of Kartos Therapeutics, the transaction highlights Ipsen's growing focus on late-stage, high-value assets that could address significant unmet medical needs while supporting the company's long-term growth strategy. 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 will deploy Insilico’s Pharma AI platform across Takeda’s pipeline to accelerate early-stage drug discovery and candidate selection. Insilico Medicine has entered into a strategic collaboration with Takeda to apply its AI-driven Pharma.AI platform across the discovery and development of new drug candidates, marking another major partnership in the growing field of generative AI in pharma. The deal could be worth up to $600 million in total payments, including upfront fees, development milestones, and potential commercial royalties. AI Takes a Central Role in Early Drug Discovery Under the agreement, Insilico Medicine will lead early-stage discovery efforts using its AI platform to identify and design molecules that meet predefined scientific and development criteria. The Pharma.AI system integrates generative AI models to accelerate the identification of drug candidates, with the aim of improving both the speed and precision of early-stage research. Takeda will be responsible for advancing selected candidates into clinical development, leveraging its global infrastructure for clinical validation and late-stage drug development. The collaboration focuses on identifying molecules with strong potential for differentiation across Takeda’s key therapeutic areas, including conditions with high unmet medical need. Structuring a Multi-Layered Value Agreement Insilico will receive approximately $60 million in upfront and near-term payments tied to project initiation and early milestones. Beyond this, the agreement includes a series of potential payments linked to preclinical, clinical, regulatory, and commercial achievements, which could increase the total deal value to around $600 million. The company is also eligible to receive tiered royalties on future product sales, providing additional long-term upside if any candidates reach the market. Takeda will retain exclusive global rights to develop, manufacture, and commercialise any therapeutics emerging from the collaboration. Building on a Broader AI Expansion Strategy For Insilico Medicine, the partnership adds to a growing portfolio of collaborations with major pharmaceutical companies as AI becomes increasingly embedded in drug discovery workflows. Earlier this year, the company announced multiple collaborations with China Medical System (CMS) across central nervous system and autoimmune disease programmes, further expanding its global footprint in AI-enabled drug development. Takeda, meanwhile, continues to deepen its investment in advanced computational approaches, integrating AI technologies into its broader research strategy as competition in drug discovery accelerates. Leadership Perspective Insilico Medicine founder, CEO and CBO Alex Zhavoronkov said the partnership reflects the growing integration of generative AI across the pharmaceutical value chain. He highlighted the potential for AI-driven drug discovery to improve both the quality and differentiation of future therapeutics, describing it as a step toward more advanced, data-driven pharmaceutical innovation. Summary Insilico Medicine and Takeda have formed a strategic partnership worth up to $600 million to apply AI-driven drug discovery across early-stage research programmes. The collaboration will combine Insilico’s Pharma.AI platform with Takeda’s global clinical development capabilities, reflecting the increasing role of generative AI in reshaping how new medicines are discovered and developed. 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

Funding will support the global SURPASS-IPF trial comparing deupirfenidone directly against standard-of-care pirfenidone in idiopathic pulmonary fibrosis. Celea Therapeutics has raised $180 million in new financing to support the initiation of its pivotal Phase III SURPASS-IPF clinical trial evaluating deupirfenidone (LYT-100) in idiopathic pulmonary fibrosis (IPF). The funding round brings together a consortium of investors including RA Capital Management, PureTech Health, Leaps by Bayer, a major US healthcare fund, and a sovereign wealth fund, reflecting strong confidence in the programme’s late-stage potential. Advancing a Next-Generation Antifibrotic Therapy Deupirfenidone is a deuterated form of pirfenidone, designed to improve tolerability and pharmacokinetics compared with existing antifibrotic therapies. It is being developed as a potential new standard of care for IPF, a progressive and fatal lung disease characterised by irreversible fibrosis and declining respiratory function. Currently approved treatments, including pirfenidone and nintedanib, can slow disease progression but are often limited by gastrointestinal side effects and suboptimal dosing adherence. Phase III Trial to Compare Directly Against Standard of Care The upcoming SURPASS-IPF Phase III trial is expected to begin in early Q3 2026. It will be a randomised, double-blind, head-to-head global study, comparing: Deupirfenidone 825mg three times daily (TID) vs Pirfenidone 801mg three times daily (TID) The study will enrol adults with IPF who are not receiving background antifibrotic therapy. The primary endpoint will measure change from baseline in absolute forced vital capacity (FVC) at week 52, a key indicator of lung function decline. Clinical Rationale and Early Data Deupirfenidone has already received Orphan Drug Designation from both the US Food and Drug Administration and the European Commission. Earlier data from the Phase IIb ELEVATE IPF trial suggested the therapy may stabilise lung function decline over at least 26 weeks when used as monotherapy. Open-label extension results further indicated that treatment effects could be sustained for at least 52 weeks, supporting progression into late-stage development. Leadership Perspective Celea Therapeutics CEO Sven Dethlefs said the funding represents a critical step in addressing a disease with significant unmet need. He noted that IPF remains a devastating condition with limited treatment options and highlighted the potential for deupirfenidone to deliver meaningful improvements in patient outcomes. Expanding Potential Beyond IPF Beyond idiopathic pulmonary fibrosis, Celea is also exploring the potential of deupirfenidone in other fibrotic conditions, including progressive fibrosing interstitial lung diseases, suggesting a broader future development strategy. Summary Celea Therapeutics has secured $180 million to advance its Phase III SURPASS-IPF trial evaluating deupirfenidone in idiopathic pulmonary fibrosis. The head-to-head study against pirfenidone will begin in early Q3 2026 and represents a key step in determining whether the next-generation antifibrotic can redefine treatment standards in a disease with limited therapeutic options. 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 collaboration will integrate manufacturing, clinical research, and commercial readiness services to support late-stage development of a next-generation mRNA therapy. Thermo Fisher Scientific has entered into a strategic collaboration with Arcturus Therapeutics to support the Phase III development and potential commercialisation of ARCT-032, an investigational messenger RNA (mRNA) therapy for cystic fibrosis. The agreement brings together clinical development, manufacturing, and commercial infrastructure under Thermo Fisher’s Accelerator Drug Development platform, aiming to streamline the transition from late-stage trials to potential market launch. Integrated Support for Late-Stage mRNA Development Under the terms of the collaboration, Thermo Fisher will provide a fully integrated set of services, including: Clinical trial execution through its PPD clinical research business Manufacturing support for investigational and potential commercial supply Commercial readiness planning to prepare for potential market entry The partnership is designed to support ARCT-032 through Phase III development, contingent on positive outcomes from ongoing Phase II studies. If the programme progresses successfully, Arcturus intends to conduct its Phase III clinical trials in collaboration with Thermo Fisher’s global clinical research infrastructure. Positioning for Potential Commercial Launch Beyond clinical development, the agreement also includes provisions for future commercial manufacturing rights. Subject to regulatory approval, Thermo Fisher could obtain exclusive manufacturing responsibilities for ARCT-032 under a separate commercial arrangement, ensuring continuity from clinical supply through to potential market production. This structure reflects a growing industry trend toward end-to-end partnerships that reduce operational fragmentation and accelerate timelines for complex modalities such as mRNA therapeutics. Advancing a Next-Generation Cystic Fibrosis Therapy ARCT-032 is an investigational mRNA-based therapy designed to address cystic fibrosis, a genetic condition characterised by progressive lung damage and chronic respiratory complications. mRNA-based approaches aim to restore or replace defective protein function at the cellular level, representing a rapidly evolving area of genetic medicine with potential applications across a range of rare diseases. Leadership Perspectives on the Collaboration Arcturus Therapeutics president and CEO Joseph Payne highlighted Thermo Fisher’s expertise in supporting complex biologic programmes from late-stage development through commercialisation. He noted that the collaboration aligns with Arcturus’ goal of advancing its cystic fibrosis programme efficiently into Phase III while preparing for potential large-scale supply requirements. Thermo Fisher Biopharma Services executive vice-president Mike Shafer said biopharma companies are increasingly seeking integrated partners capable of managing both clinical and commercial complexities. He emphasised that the Accelerator Drug Development model brings together manufacturing and clinical expertise to simplify development pathways and accelerate delivery of innovative therapies to patients. Expanding Role of Integrated Development Platforms The collaboration reflects a broader shift in how advanced therapies are developed, with companies increasingly relying on integrated service providers to reduce operational complexity. Thermo Fisher’s approach combines contract development and manufacturing organisation (CDMO) capabilities with global clinical trial infrastructure, positioning it as a single partner across multiple stages of drug development. Summary Thermo Fisher and Arcturus Therapeutics have formed a strategic collaboration to support the Phase III development of ARCT-032, an mRNA therapy for cystic fibrosis. The partnership integrates clinical research, manufacturing, and commercial readiness services, reflecting a growing industry trend toward end-to-end development models for complex genetic medicines. 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 in vivo gene editing biotech has announced IPO plans as it pushes its lead PCSK9 programme into first-in-human trials. Scribe Therapeutics has announced plans for an initial public offering on the Nasdaq, marking a significant step for the CRISPR-focused biotech as it transitions from platform development into early clinical execution. The company did not disclose pricing terms for the proposed share sale, which will serve as an early test of investor appetite for pre-commercial gene editing platforms. A More Crowded IPO Window in 2026 The announcement comes during a resurgence in biotech IPO activity in 2026, with several high-profile listings from companies such as Parabilis Medicines, Kailera Therapeutics, Generate:Biomedicines, and Kardigan. However, most of those entrants are backed by later-stage clinical assets. Scribe’s IPO is notable for arriving at a comparatively earlier stage of development, with its lead programme only recently cleared to enter human trials. Building In Vivo CRISPR Therapies Founded in 2017, Scribe Therapeutics is focused on developing engineered in vivo CRISPR-based genetic medicines designed for durable therapeutic effects without permanent DNA alteration. Its lead programme, STX-1150, is being developed for hypercholesterolaemia and targets the PCSK9 gene, a key regulator of LDL cholesterol levels. The therapy combines: mRNA encoding a highly engineered epigenetic long-term X-repressor (ELXR) A single guide RNA targeting PCSK9 A liver-targeted lipid nanoparticle delivery system The goal is a single-dose treatment that epigenetically silences PCSK9 in liver cells, potentially delivering long-term LDL-C reduction without permanent genome modification. First-in-Human Trials Underway In May 2026, Scribe received clearance from the Australian Therapeutic Goods Administration to begin a Phase I clinical trial of STX-1150. The study will evaluate up to 64 adults with elevated LDL cholesterol and increased cardiovascular risk, with trial sites across Australia and New Zealand. The company’s broader pipeline includes: STX-1200 for elevated lipoprotein(a) STX-1400 for severe hypertriglyceridaemia and familial chylomicronaemia syndrome IPO Funding to Expand Pipeline Proceeds from the planned IPO are expected to support advancement of STX-1150 into later-stage development, as well as continued investment in earlier pipeline assets and CRISPR platform expansion. The funding will also help accelerate Scribe’s broader ambition to build a diversified portfolio of in vivo gene editing therapies targeting cardiometabolic disease. Strategic Partnerships Strengthen Platform Reach Alongside internal development, Scribe has established multiple partnerships with major pharmaceutical companies. These include collaborations with Eli Lilly, focused on applying its CRISPR X-Editing (XE) technologies to neurological and neuromuscular disorders, as well as two separate agreements with Sanofi, the most recent of which explores in vivo genetic medicines including potential applications in sickle cell disease. Summary Scribe Therapeutics has announced plans to list on the Nasdaq as it advances its CRISPR-based gene editing pipeline into clinical development. With its lead PCSK9-targeting programme now in Phase I trials and multiple cardiometabolic and genetic disease assets in development, the IPO will test investor confidence in early-stage in vivo gene editing platforms amid a renewed wave of biotech public offerings. 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 acquisition adds a novel antibody-drug conjugate payload platform and two preclinical oncology programmes targeting hard-to-treat solid tumours. Novartis has agreed to acquire UK-based biotechnology company Myricx Bio in a deal worth up to $1.5 billion, further expanding its oncology portfolio and strengthening its position in the rapidly growing antibody-drug conjugate (ADC) market. The acquisition includes Myricx’s proprietary N-myristoyltransferase inhibitor (NMTi) payload platform, alongside two lead preclinical ADC programmes targeting B7-H3 and HER2 for the treatment of solid tumours. The transaction is expected to complete later this year. Expanding the Next Generation of ADC Payloads Rather than focusing solely on new tumour targets, the acquisition centres on payload innovation—the cancer-killing component carried by an antibody-drug conjugate. Myricx has developed a new class of N-myristoyltransferase inhibitor (NMTi) payloads, designed to block an enzyme that plays a critical role in protein function and cancer cell survival. By inhibiting NMT, the payload disrupts multiple biological processes required for tumour growth, offering a differentiated mechanism compared with traditional ADC payloads. Preclinical studies have demonstrated promising activity across solid tumours, including models resistant to topoisomerase I (TOPO-1) inhibitors, one of the most widely used ADC payload classes today. Strengthening Novartis' Oncology Strategy The acquisition reflects Novartis' continued investment in oncology and its ambition to expand beyond established ADC technologies. The deal brings two lead preclinical candidates into the company's pipeline: A B7-H3-targeted ADC A HER2-targeted ADC Both programmes are designed to exploit Myricx's proprietary NMTi payload technology, potentially broadening treatment options for patients with difficult-to-treat solid tumours. Novartis believes novel payload mechanisms will be essential for overcoming resistance and extending the effectiveness of ADC therapies into new cancer settings. Deal Structure Under the terms of the agreement: $1.1 billion will be paid upfront. Myricx shareholders are eligible for up to $400 million in additional development and commercial milestone payments. The transaction represents another significant investment in oncology innovation, with total deal value reaching $1.5 billion. From Academic Spin-Out to Billion-Dollar Acquisition Founded in 2020, Myricx Bio emerged as a spin-out from Imperial College London and the Francis Crick Institute. The company secured a £90 million ($114 million) Series A financing in 2024, attracting backing from leading healthcare investors including Novo Holdings, Eli Lilly, and Sofinnova Partners. The biotech appointed Mohit Rawat as CEO in September 2025 as it advanced its ADC platform towards clinical development. Why the Deal Matters The acquisition reflects several wider trends across oncology drug development: Pharmaceutical companies are investing heavily in next-generation ADC technologies. Innovation is increasingly shifting beyond antibody targets to include novel payload mechanisms. Companies are seeking new approaches to overcome treatment resistance in solid tumours. Platform acquisitions continue to attract significant premiums as competition for differentiated oncology technologies intensifies. Summary Novartis has agreed to acquire Myricx Bio in a deal worth up to $1.5 billion, adding a novel ADC payload platform and two preclinical cancer programmes to its oncology pipeline. By investing in differentiated payload technology rather than traditional ADC approaches alone, Novartis is positioning itself to address treatment resistance and broaden the future application of antibody-drug conjugates across multiple solid tumour indications. 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

Genentech has secured global rights to a fragment-based drug discovery programme targeting a key regulator of breast cancer cell growth. Roche has expanded its oncology pipeline through a new research collaboration and licensing agreement with Astex Pharmaceuticals, a wholly owned subsidiary of Otsuka Pharmaceutical, in a deal worth more than $490 million. The partnership gives Roche's Genentech division exclusive worldwide rights to a preclinical small-molecule programme targeting a key cell-cycle regulator implicated in breast cancer, reinforcing the company's continued investment in precision oncology. Targeting a Critical Driver of Breast Cancer The collaboration centres on Astex's fragment-based drug discovery platform, which has been used to identify highly selective small molecules designed to inhibit a protein involved in regulating cancer cell division. Disruption of cell-cycle regulators has become an increasingly important strategy in breast cancer, particularly as researchers look to improve outcomes beyond existing targeted therapies. The programme originated through a long-running collaboration between Astex, Newcastle University, and Cancer Research Horizons, combining academic research with industry-led drug discovery. Shared Discovery, Roche-Led Development Under the agreement, Astex and Genentech will work together to optimise lead compounds into candidates ready for preclinical development. Once selected, Genentech will assume sole responsibility for: Preclinical development Clinical trials Global regulatory activities Worldwide commercialisation The structure allows Roche to leverage Astex's discovery expertise while utilising its own global oncology development infrastructure to advance potential therapies. Deal Structure Financially, the collaboration follows a milestone-driven model common across early-stage biotech partnerships. The agreement includes: $25 million upfront payment to Astex Potential development, regulatory and commercial milestone payments Tiered royalties on future global sales Combined, the deal could exceed $490 million if all milestones are achieved. Building on Astex's Oncology Partnerships The Genentech agreement adds another major pharmaceutical partner to Astex's growing list of oncology collaborations. The company already maintains a long-standing alliance with Merck & Co., first established in 2020 and expanded in 2023 to include additional cancer programmes. In 2025, Astex also outlicensed two clinical-stage oncology assets — ASTX029 and ASTX295 — to Mosaic Therapeutics, highlighting the breadth of its cancer drug discovery portfolio. Why the Deal Matters The collaboration reflects several broader trends shaping oncology research: Precision oncology continues to drive investment in highly selective targeted therapies. Fragment-based drug discovery is gaining traction as a tool for identifying novel small-molecule candidates. Large pharmaceutical companies are increasingly partnering with specialist biotech firms at the discovery stage rather than acquiring later-stage assets. Cell-cycle regulation remains one of the most active areas of breast cancer drug development beyond established CDK-targeting therapies. Summary Roche has signed a collaboration worth more than $490 million with Astex Pharmaceuticals to develop precision small-molecule therapies for breast cancer. The agreement combines Astex's fragment-based drug discovery platform with Genentech's global development capabilities, further strengthening Roche's oncology pipeline while highlighting continued industry investment in next-generation targeted cancer therapies. 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 adds advanced imaging capabilities to the xvision Spine System platform, supporting broader adoption of augmented reality navigation in spinal procedures. US-based medical technology company VB Spine has signed an agreement with Augmedics to acquire exclusive rights to its computed tomography-to-fluoroscopy (CT-Fluoro) technology for spinal applications. The transaction builds on VB Spine’s earlier acquisition of exclusive rights to the Augmedics xvision Spine System, further expanding its portfolio of image-guided surgical technologies. Financial terms of the agreement were not disclosed, with completion subject to customary closing conditions and regulatory approvals. Reducing Barriers to Spine Navigation Augmedics’ CT-Fluoro technology is designed to allow surgeons to register a patient’s preoperative CT scan using standard fluoroscopic imaging during spinal procedures. By reducing dependence on intraoperative CT or advanced 3D imaging systems, the technology could provide hospitals and surgical centres with greater flexibility when implementing navigation workflows. VB Spine believes the platform could help make augmented reality (AR)-based spine navigation more accessible across a wider range of healthcare settings. Building on the xvision Spine System The acquisition complements VB Spine’s existing focus on the xvision Spine System, an augmented reality navigation platform designed to provide surgeons with real-time guidance during spinal procedures. The system uses AR technology to display surgical navigation information directly within the surgeon’s field of view, helping support implant placement and procedural accuracy. VB Spine said integrating CT-Fluoro capabilities into its portfolio will provide surgeons with additional options for how navigation technology is used during operations. Supporting Technology-Enabled Spine Care VB Spine co-CEO Marc Viscogliosi said the company’s goal is to remove barriers that limit access to technologies designed to improve surgical efficiency and patient care. The addition of CT-Fluoro technology is expected to strengthen the xvision platform by expanding workflow flexibility for surgeons and healthcare facilities. Following completion of the deal, VB Spine plans to make the technology available as part of its broader spine procedure portfolio. Expanding Medical Technology Footprint The agreement represents another step in VB Spine’s strategy to develop a broader ecosystem of digital and image-guided solutions for spinal surgery. Earlier in 2026, the company agreed to acquire the SpineHawk intraoperative spinal visualisation platform from Robotron Surgical Technologies. That acquisition was aimed at expanding VB Spine’s capabilities in intraoperative imaging and advancing a software-focused roadmap for technology-enabled spine care. Why the Deal Matters The partnership reflects several wider trends in surgical technology: Augmented reality navigation is becoming increasingly important in complex procedures. Medical device companies are combining imaging, software and navigation technologies to improve surgical workflows. Reducing reliance on expensive imaging infrastructure could increase access to advanced surgical tools. Spine surgery continues to be a major focus area for digital health and medtech innovation. Summary VB Spine has agreed to acquire exclusive rights to Augmedics’ CT-Fluoro technology for spine applications, expanding its augmented reality navigation capabilities. The deal strengthens the xvision Spine System platform and supports VB Spine’s broader ambition to improve access to advanced image-guided technologies across spinal surgery. 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 MHRA has conditionally approved Novo Nordisk’s GLP-1 therapy for adults with metabolic-associated steatohepatitis, marking another milestone in the evolution of obesity medicines. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has expanded the approved use of Novo Nordisk's Wegovy (semaglutide) to include the treatment of metabolic-associated steatohepatitis (MASH). The conditional approval covers adults with MASH and moderate-to-advanced liver fibrosis, adding a third major indication for the GLP-1 therapy alongside obesity management and cardiovascular risk reduction. The decision further strengthens Wegovy's position as one of the most versatile GLP-1 medicines currently on the market. Conditional Approval for Patients with Liver Fibrosis The MHRA has granted a conditional marketing authorisation, meaning Novo Nordisk must continue generating evidence from ongoing clinical studies before full approval is confirmed. The regulator will review updated safety and efficacy data annually as additional evidence becomes available. According to the MHRA, current clinical data indicate that semaglutide represents a safe and effective treatment option for eligible MASH patients. Building on Positive Phase III Data The approval follows encouraging results from the Phase III ESSENCE trial, which previously supported Wegovy's approval in the United States. After 72 weeks of treatment: 37% of patients experienced improved liver fibrosis without worsening steatohepatitis, compared with 22.5% receiving placebo. 62.9% achieved resolution of steatohepatitis without additional liver scarring, versus 34.1% in the placebo group. These findings positioned Wegovy as the first GLP-1 receptor agonist approved for MASH, expanding the therapeutic potential of a drug class originally developed for diabetes and obesity. Expanding Global Momentum The UK joins a growing list of markets approving semaglutide for MASH. Wegovy received US approval for the indication last year and has also secured approval in Japan. Within the European Union, the therapy is authorised for MASH under the brand name Kayshild. The expanding regulatory footprint reflects growing confidence in GLP-1 therapies beyond weight management and diabetes. Competition in the MASH Market Despite Wegovy's momentum, competition within the MASH landscape continues to intensify. Madrigal Pharmaceuticals' Rezdiffra (resmetirom) remains the first therapy specifically developed for MASH and is expected to continue playing a significant role, particularly among patients without obesity who may not require the weight-loss benefits associated with GLP-1 medicines. However, Wegovy enters the market with considerable advantages, including widespread physician familiarity, an established safety profile, and the commercial reach of Novo Nordisk. As additional therapies progress through development, clinicians are likely to have an increasingly diverse range of treatment options tailored to different patient populations. Why the Approval Matters The expanded indication highlights several broader trends across healthcare: GLP-1 medicines continue to expand beyond their original metabolic indications. MASH is rapidly becoming one of the most active areas of pharmaceutical innovation. Regulators are increasingly using conditional approvals to accelerate access while longer-term evidence is collected. The future MASH treatment landscape is expected to include multiple therapeutic classes addressing different aspects of disease progression. Summary The MHRA has conditionally approved Novo Nordisk's Wegovy for adults with metabolic-associated steatohepatitis (MASH) and moderate-to-advanced liver fibrosis. The decision marks another significant expansion for semaglutide, reinforcing the growing role of GLP-1 therapies beyond obesity and diabetes while intensifying competition in the emerging MASH treatment market. 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

New funding will support a pivotal Phase III trial comparing deupirfenidone head-to-head with Roche’s Esbriet as competition intensifies in idiopathic pulmonary fibrosis. Celea Therapeutics has secured $180 million in financing to advance its lead investigational therapy for idiopathic pulmonary fibrosis (IPF), less than a year after being spun out by PureTech Health. The funding round was backed by PureTech Health, which retains a 35.4% stake in the company, alongside RA Capital Management and Leaps by Bayer. The capital will primarily support the global Phase III SURPASS-IPF trial, which will directly compare Celea's lead candidate, deupirfenidone (LYT-100), against Roche's established IPF therapy Esbriet (pirfenidone). Taking Aim at the Limitations of Current IPF Therapies Idiopathic pulmonary fibrosis is a progressive and ultimately fatal lung disease characterised by irreversible scarring of lung tissue and a steady decline in respiratory function. While current antifibrotic therapies, including Roche's Esbriet and Boehringer Ingelheim's Ofev (nintedanib), can slow disease progression, their widespread use has been limited by gastrointestinal side effects that often prevent patients from remaining on optimal doses. According to PureTech, only around a quarter of eligible IPF patients in the United States currently receive either therapy, despite the treatments collectively generating peak global sales exceeding $5 billion. Celea believes its investigational therapy could address this gap. Deuterium Technology Could Improve Tolerability Deupirfenidone is a deuterated version of pirfenidone, meaning selected hydrogen atoms have been replaced with the heavier isotope deuterium. This subtle chemical modification can alter how the drug is metabolised by the body, potentially increasing drug exposure while reducing side effects without changing its underlying mechanism of action. The company hopes these pharmacological advantages will allow patients to remain on effective treatment for longer while improving overall tolerability. Phase II Results Build Confidence Ahead of Pivotal Study Encouraging mid-stage clinical data has strengthened confidence in the programme. In the Phase IIb ELEVATE IPF study, deupirfenidone demonstrated lower rates of common gastrointestinal adverse events than Esbriet while meeting its primary endpoint. Patients receiving the therapy experienced a statistically significant reduction in the decline of forced vital capacity (FVC) over 26 weeks, representing an 80.9% treatment effect compared with placebo. The results prompted former PureTech CEO Bharatt Chowrira to describe the findings as "remarkable" if replicated in a larger Phase III programme. That validation effort is now set to begin. SURPASS-IPF Trial Set to Launch Celea plans to initiate the global SURPASS-IPF study during the third quarter of 2026. The randomised Phase III trial will compare deupirfenidone administered three times daily against Esbriet in adults with idiopathic pulmonary fibrosis who are not receiving background therapy. The primary endpoint will assess change from baseline in forced vital capacity at 52 weeks, a widely accepted measure of lung function decline in IPF studies. A positive outcome could position deupirfenidone as a potential next-generation antifibrotic therapy capable of improving both efficacy and patient adherence. Competition in IPF Continues to Intensify Celea enters a rapidly evolving treatment landscape. Last year, Boehringer Ingelheim's Jascayd (nerandomilast) became the third FDA-approved therapy for IPF, offering a twice-daily oral treatment with an improved tolerability profile and no routine liver function monitoring requirements. Meanwhile, United Therapeutics is preparing regulatory submissions for an inhaled formulation of Tyvaso (treprostinil) after positive Phase III results, while Avalyn Pharma is advancing inhaled versions of both pirfenidone and nintedanib in mid-stage clinical development following its recent IPO. As multiple companies pursue differentiated approaches, the next generation of IPF therapies is increasingly focused on improving tolerability, convenience and long-term adherence rather than simply slowing disease progression. Why the Funding Matters Celea's financing reflects continued investor confidence in pulmonary medicine despite growing competition. The funding will allow the company to generate the pivotal data needed to determine whether deupirfenidone can improve upon one of the current standards of care while addressing one of IPF's biggest treatment challenges: keeping patients on therapy. Summary Celea Therapeutics has raised $180 million to fund the pivotal Phase III SURPASS-IPF trial of deupirfenidone, a next-generation version of Roche's Esbriet designed to improve tolerability without compromising efficacy. Supported by strong Phase II data, the programme will now enter head-to-head testing against one of the leading IPF therapies as competition intensifies across the pulmonary fibrosis market.