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.

Vera Therapeutics’ Trutakna becomes the first FDA-approved therapy targeting both BAFF and APRIL pathways, introducing a new immune-based approach for adults with progressive IgA nephropathy. The FDA has approved Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression, marking a significant advance in targeted immune therapy for kidney disease. The approval is supported by the Phase III NCT04716231 trial, in which Trutakna achieved a 46% reduction in proteinuria compared with placebo after nine months of treatment, although further confirmatory studies are required to establish its long-term impact on kidney function decline. Alert Type Regulatory Approval (FDA) Drug Name Trutakna (atacicept-vymj) Indication Reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression Therapy Area(s) Nephrology, Immunology, Rare Disease, Kidney Disease Geography United States (FDA approval) What Changed The FDA approved Vera Therapeutics’ Trutakna (atacicept-vymj) for adults with primary IgA nephropathy at risk of disease progression. Trutakna is the first FDA-approved therapy targeting both B cell activating factor (BAFF) and A Proliferation Inducing Ligand (APRIL), two immune pathways involved in abnormal IgA antibody production. Approval was supported by Phase III data showing a 46% reduction in proteinuria compared with placebo after nine months of treatment. Clinical Relevance The approval introduces a new targeted immune approach for IgA nephropathy, a chronic kidney disease where abnormal antibody production contributes to inflammation, proteinuria and progressive kidney damage. Trutakna offers a potential new treatment option for patients at risk of disease progression, although long-term impact on kidney function decline remains under evaluation through confirmatory studies required under accelerated approval. Source Link https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-reduce-proteinuria-adults-primary-immunoglobulin-nephropathy Date 02-Jul-2026 Status Draft Notes Trutakna was granted accelerated approval, Priority Review and Breakthrough Therapy designation for this indication. The Phase III trial (NCT04716231) was a randomised, double-blind, placebo-controlled study in adults with biopsy-confirmed IgA nephropathy. Treatment involves a once-weekly 150mg subcutaneous injection. Safety considerations include increased infection risk due to immune suppression, with monitoring recommended during treatment. Continued approval is dependent on confirmation of long-term clinical benefit in slowing kidney function decline. 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 with Sino Biopharmaceutical gives AstraZeneca ex-China rights to TQC3721, an experimental dual PDE3/4 inhibitor being developed for chronic respiratory diseases. AstraZeneca has entered into a new collaboration with China’s Sino Biopharmaceutical focused on the development of TQC3721, an experimental respiratory therapy that could be worth up to $2.1 billion in upfront, milestone and royalty payments. The agreement continues AstraZeneca’s recent run of strategic partnerships in China and highlights the growing importance of Chinese biopharma companies as sources of innovative pipeline assets for multinational drugmakers. Deal Terms and Scope Under the agreement, AstraZeneca will pay Sino Biopharmaceutical $200 million upfront for exclusive rights to develop, manufacture and commercialise TQC3721 outside China. Sino is eligible to receive up to $1.9 billion in additional development and commercial milestone payments, alongside tiered sales royalties that may reach double-digit percentages. AstraZeneca will also gain exclusive global rights to certain future development programmes related to the therapy. A Dual PDE3/4 Approach for Respiratory Disease TQC3721 is designed to inhibit both phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4), a mechanism intended to combine bronchodilatory and anti-inflammatory effects. According to Sino Biopharmaceutical, the therapy has the potential to improve lung function, reduce exacerbations and address broader disease burden in patients with chronic respiratory diseases such as chronic obstructive pulmonary disease (COPD). A nebulised formulation of TQC3721 demonstrated what the company described as a “potential best-in-class profile” in a Phase IIb study in COPD. The nebulised version is currently being evaluated in a Phase III study in China, while a dry-powder inhaler formulation is also being advanced in a Phase II clinical trial. Accelerating Global Development Sino Biopharmaceutical said the partnership with AstraZeneca is expected to accelerate the global clinical development of TQC3721 and maximise the therapy’s clinical and commercial potential. For AstraZeneca, the deal strengthens its respiratory pipeline by adding a late-stage Chinese asset with potential applications in chronic respiratory disease management. The collaboration also reflects a broader strategy of sourcing innovative medicines from China for development and commercialisation in international markets. Part of a Wider China Strategy The TQC3721 agreement is AstraZeneca’s latest collaboration with a Chinese pharmaceutical company. Just days earlier, the company expanded its relationship with CSPC Pharmaceutical through a deal focused on siRNA drug discovery for renal diseases, with potential milestone payments approaching $1.8 billion. AstraZeneca has built a particularly active partnership network in China, including multiple agreements with CSPC Pharmaceutical since 2024, spanning renal disease, obesity, type 2 diabetes and other therapeutic areas. Sino Biopharmaceutical’s Growing Global Role The AstraZeneca agreement marks Sino Biopharmaceutical’s second major out-licensing deal with a multinational pharmaceutical company in 2026, following an earlier agreement with Sanofi involving the experimental oral JAK/ROCK inhibitor rovadicitinib. The company also announced an expansion of its collaboration with GSK to commercialise the respiratory therapies Trelegy Ellipta and Anoro Ellipta in China through its Chia Tai Tianqing Pharmaceutical unit. These parallel agreements underscore Sino Biopharmaceutical’s dual strategy of out-licensing innovative pipeline assets globally while leveraging its commercial infrastructure to expand access to established respiratory therapies within China. Strategic Implications The deal highlights several trends shaping the pharmaceutical industry: Chinese biopharma companies are becoming increasingly important sources of innovative drug candidates. Multinational pharmaceutical companies are using partnerships to access regional innovation and accelerate global development. Respiratory disease remains a significant area of unmet medical need and commercial opportunity. China is playing a growing role not only as a market for commercialised medicines but also as a contributor to global drug discovery and development. Summary AstraZeneca has secured exclusive rights outside China to develop and commercialise Sino Biopharmaceutical’s experimental respiratory therapy TQC3721 in a deal worth up to $2.1 billion. The agreement adds a dual PDE3/4 inhibitor programme to AstraZeneca’s respiratory pipeline and reinforces the company’s expanding strategy of partnering with Chinese biopharma firms to access innovative medicines for global markets. 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 clinical-stage biotech plans to use a potential public listing to accelerate development of melanocortin-based therapies targeting obesity and cancer cachexia. Kalohexis has confidentially filed for an initial public offering (IPO) in the US, positioning itself to join a growing wave of biotechnology companies seeking public investment to fund next-generation metabolic disease therapies. The company has submitted a draft registration statement to the US Securities and Exchange Commission (SEC), although details including the number of shares to be offered and the proposed valuation have yet to be disclosed. If successful, the IPO would provide fresh capital to advance Kalohexis’ clinical-stage pipeline focused on obesity and cancer cachexia. A Newly Independent Metabolic Health Company Kalohexis was launched as an independent company in March 2026 following its spin-out from peptide therapeutics specialist Endevica Bio. The biotech is developing therapies that target the melanocortin system, a biological pathway responsible for regulating appetite, energy balance, metabolism and inflammation. By selectively activating the melanocortin-3 and melanocortin-4 receptors (MC3R and MC4R), the company believes it can address a range of metabolic disorders through novel mechanisms of action. Dual Clinical Programmes Kalohexis currently has two lead clinical-stage programmes. Its most advanced candidate, mifomelatide, is a dual MC3R/MC4R agonist being evaluated in a Phase II trial for cancer cachexia, a debilitating syndrome characterised by severe weight and muscle loss in patients with advanced cancer. Despite its significant impact on quality of life and survival, there are currently no FDA-approved therapies specifically for cancer cachexia, although several late-stage candidates are in development. The company is also advancing 710GO, an oral dual MC3R/MC4R agonist currently in Phase I clinical testing for obesity. Unlike many current obesity treatments, Kalohexis is exploring whether modulation of the melanocortin pathway can deliver durable weight loss through an alternative biological mechanism. Entering a Booming Obesity Market The obesity market continues to attract significant investor attention as demand for innovative therapies accelerates worldwide. Industry forecasts estimate that obesity drug sales across the seven major pharmaceutical markets could exceed $170 billion annually by 2031, creating substantial commercial opportunities for companies developing differentiated treatments. While GLP-1 receptor agonists currently dominate the market, emerging approaches targeting complementary pathways are attracting increasing interest from investors and pharmaceutical companies alike. Riding the IPO Revival Kalohexis' confidential filing comes amid a strong resurgence in biotechnology IPO activity during 2026. Several companies have successfully raised substantial funding despite continued macroeconomic uncertainty, signalling renewed investor confidence in innovative life sciences businesses. Among the year's largest offerings, obesity-focused Kailera Therapeutics secured $625 million to support development of its late-stage obesity programme, while oncology company Parabilis Medicines followed with a $670 million IPO to advance its peptide-based cancer therapies. The improving fundraising environment suggests investors remain willing to back companies developing therapies in high-growth areas such as obesity, oncology and metabolic disease. Why the IPO Matters A successful public listing would provide Kalohexis with the financial resources needed to advance both of its lead programmes while expanding its broader melanocortin platform. The filing also reflects continued investor appetite for metabolic health companies, particularly those pursuing differentiated mechanisms beyond established GLP-1 therapies. As competition intensifies across obesity and related metabolic disorders, companies developing novel biological approaches are increasingly attracting both public market investors and strategic pharmaceutical interest. Summary Kalohexis has confidentially filed for a US IPO to support the development of its pipeline of melanocortin-targeting therapies for obesity and cancer cachexia. The proposed listing comes as biotechnology IPO activity continues to rebound in 2026, with investors showing growing confidence in companies developing innovative treatments for high-value metabolic 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 collaboration will evaluate Vivani’s implantable semaglutide technology as Novo Nordisk looks to expand treatment options beyond once-weekly injections. Novo Nordisk has entered into a collaboration with California-based Vivani Medical to evaluate an investigational long-acting semaglutide implant for chronic weight management, signalling continued investment in next-generation obesity treatments. The agreement centres on NPM-139, Vivani’s miniature subdermal implant designed to deliver semaglutide continuously over extended periods using the company’s proprietary NanoPortal technology. While financial details of the partnership were not disclosed, both companies confirmed the agreement is non-exclusive. Moving Beyond Weekly GLP-1 Injections Semaglutide is the active ingredient behind Novo Nordisk’s blockbuster medicines Wegovy for obesity and Ozempic for type 2 diabetes. Although weekly injectable GLP-1 therapies have transformed obesity treatment, long-term adherence remains a challenge, with many patients discontinuing treatment or struggling to maintain regular dosing schedules. Vivani believes its implant technology could help address these issues by providing continuous drug delivery through a single implant that may only need replacing once or twice a year. The company also says the technology could improve tolerability while allowing treatment to be discontinued if required. NanoPortal Technology at the Centre of the Collaboration Vivani’s NanoPortal platform is designed to release medication steadily over prolonged periods following implantation beneath the skin. The technology aims to offer a more convenient alternative to regular injections while maintaining consistent therapeutic drug levels. According to Vivani CEO Adam Mendelsohn, the collaboration demonstrates Novo Nordisk’s interest in evaluating implantable GLP-1 therapies as demand grows for longer-acting treatment options. The company believes some patients may prefer an implant over frequent injections, particularly for long-term weight management. Clinical Development Underway Vivani plans to begin a first-in-human Phase I study of NPM-139 during mid-2026. The trial will compare the investigational implant directly with Novo Nordisk’s injectable Wegovy and will evaluate safety, pharmacokinetics and tolerability. Positive results would support progression into a Phase II dose-ranging study. Novo Responds to Intensifying Competition The partnership comes as competition in the obesity market continues to intensify. Eli Lilly has rapidly expanded its leadership position through Mounjaro and Zepbound, with both products delivering exceptional sales growth and helping drive record company revenues. Novo Nordisk has responded by broadening its obesity strategy beyond injectable medicines. Earlier this year, the company became the first to launch an oral GLP-1 treatment for weight loss, marking another significant milestone in the increasingly competitive metabolic disease market. The Vivani collaboration suggests Novo is also exploring implantable drug delivery technologies as another way to differentiate its future obesity portfolio. Why the Partnership Matters The agreement reflects a growing focus across the pharmaceutical industry on improving convenience and long-term adherence rather than relying solely on improvements in efficacy. As obesity increasingly becomes a chronic disease requiring long-term treatment, companies are investing in technologies that reduce dosing frequency while maintaining therapeutic benefit. Implantable drug delivery systems could become an important addition to the expanding range of GLP-1 treatment options if they demonstrate comparable efficacy and improved patient adherence. Summary Novo Nordisk has partnered with Vivani Medical to evaluate NPM-139, a long-acting semaglutide implant designed for chronic weight management. The collaboration highlights growing interest in implantable GLP-1 therapies that could reduce dosing frequency, improve treatment adherence and further expand options for patients living with obesity. 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 combines Biocytogen’s fully human antibody discovery platform with Whitehawk’s ADC expertise to develop novel cancer therapies with enhanced targeting potential. Biocytogen and Whitehawk Therapeutics have entered into a global partnership to develop bispecific antibody-drug conjugates (BsADCs), combining antibody engineering and targeted cancer drug delivery technologies. The collaboration aims to identify new ADC candidates by pairing Biocytogen’s bispecific antibody capabilities with Whitehawk’s proprietary antibody-drug conjugate (ADC) linker-payload platform. Combining Antibody Engineering with ADC Innovation Under the agreement, Biocytogen will provide access to up to five bispecific antibodies generated through its RenLite platform. Whitehawk will evaluate these antibody candidates alongside its own ADC technologies to identify potential BsADC programmes with differentiated therapeutic profiles. Following evaluation, Whitehawk will have the option to advance selected candidates into its development pipeline. If Whitehawk chooses to proceed with any resulting BsADC programmes, it will retain global rights and full control over further development activities. Targeting the Next Generation of Cancer Therapies Bispecific ADCs represent an emerging approach in oncology by combining two targeted antibody binding sites with the cancer-killing capabilities of ADC technology. Traditional ADCs use antibodies to deliver cytotoxic payloads directly to tumour cells, while bispecific antibodies are designed to recognise multiple targets or improve tumour selectivity. By combining these approaches, companies hope to improve precision, overcome treatment resistance and expand the number of cancers that can be effectively targeted. RenLite Platform Supports Bispecific Antibody Development Biocytogen’s RenLite platform uses a common light-chain antibody design to support the discovery and optimisation of fully human bispecific antibodies. The approach is intended to reduce the risk of light-chain mispairing, a technical challenge that can affect the development and manufacturing of bispecific antibody therapies. Through the partnership, Biocytogen will contribute its antibody discovery capabilities, while Whitehawk will apply its expertise in ADC development and oncology drug discovery. Deal Structure and Commercial Terms Financial terms include an upfront payment to Biocytogen, with the company also eligible for additional payments linked to development, regulatory and commercial milestones. Biocytogen will additionally receive low single-digit royalties on net sales of any commercial products resulting from the collaboration. Further financial details were not disclosed. Expanding Interest in ADC Platforms The partnership reflects continued industry investment in ADC technologies, which have become one of the fastest-growing areas of oncology drug development. Pharmaceutical companies are increasingly pursuing next-generation ADC approaches designed to improve tumour targeting, increase efficacy and address resistance to existing therapies. For Biocytogen, the collaboration expands the potential applications of its bispecific antibody platform beyond standalone antibody therapeutics. For Whitehawk, the partnership provides access to additional antibody candidates that could strengthen its ADC pipeline. Why the Partnership Matters The collaboration highlights several important trends in oncology innovation: Bispecific antibodies and ADCs are increasingly being combined to create more targeted cancer therapies. Biotech partnerships are accelerating access to specialised discovery platforms. Companies are seeking differentiated approaches to overcome limitations of existing oncology treatments. ADC technology remains a major focus for investment across the pharmaceutical industry. Summary Biocytogen and Whitehawk Therapeutics have partnered to develop bispecific antibody-drug conjugates by combining Biocytogen’s RenLite antibody platform with Whitehawk’s ADC expertise. The collaboration aims to generate differentiated cancer therapies with improved targeting capabilities, adding to the growing momentum behind next-generation oncology platforms. 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 non-binding recommendation could create a regulated US compounding route for BPC-157, KPV, TB-500 and MOTS-c, but it does not approve the substances as drugs or establish their safety or effectiveness. The FDA’s Pharmacy Compounding Advisory Committee has recommended that BPC-157-, KPV-, TB-500- and MOTS-c-related bulk substances be added to the Section 503A Bulks List after reviewing proposed uses including ulcerative colitis, wound healing, inflammatory conditions, obesity and osteoporosis. The recommendation concerns compounding eligibility only and remains subject to an FDA decision; none of the peptides has received FDA marketing approval through this process. Field Content Alert Type Regulatory Recommendation – Compounding Drug Name BPC-157, KPV, TB-500 and MOTS-c, including the free-base and acetate forms considered by the committee Indication Uses evaluated by the FDA included ulcerative colitis for BPC-157; wound healing and inflammatory conditions for KPV; wound healing for TB-500; and obesity and osteoporosis for MOTS-c. Therapy Area(s) Gastroenterology; inflammation and wound care; metabolic disease; bone health Geography US (FDA) What Happened On 23 July 2026, the FDA’s Pharmacy Compounding Advisory Committee recommended adding four groups of peptide-related bulk substances to the Section 503A Bulks List. The recommendation is advisory and non-binding: the FDA retains responsibility for the final decision, and the vote did not approve the peptides as medicines. Why It Matters Inclusion on the Section 503A Bulks List could allow qualifying licensed pharmacists and physicians to use these bulk substances in individually compounded prescriptions, subject to statutory compounding requirements. It would not provide the safety, efficacy, manufacturing or labelling findings associated with FDA approval of a new drug. Supporting Context FDA briefing materials had proposed that the free-base and acetate forms of all four peptides should not be included on the Section 503A Bulks List. The committee therefore reached a different recommendation after reviewing the available characterisation, safety, effectiveness and historical-use evidence. Key Takeaway The recommendation moves the four peptides closer to possible eligibility for pharmacy compounding but does not make them FDA-approved treatments. What to Watch The FDA’s final decision, any formal rulemaking required to amend the Section 503A Bulks List and any conditions or limitations placed on future inclusion. Primary Source FDA Pharmacy Compounding Advisory Committee meeting materials Relevant Date 23 July 2026 — advisory committee recommendation date 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 functional electrical stimulation technology to Ottobock’s neuro-orthotics offering, strengthening its position in the growing neurological devices market. German medical device company Ottobock has agreed to acquire Spanish medtech firm Fesia Technology, expanding its neuro-orthotics portfolio with a range of functional electrical stimulation (FES) products designed to support mobility and rehabilitation. The transaction, which is expected to close within six months, will see Ottobock take ownership of Fesia’s portfolio of wearable FES devices used to support patients recovering from neurological conditions including stroke, multiple sclerosis (MS) and cerebral palsy. Financial terms of the acquisition were not disclosed. Expanding Access to Functional Electrical Stimulation Fesia Technology develops wearable FES orthoses that use electrical pulses to stimulate weakened muscles, helping patients restore movement by encouraging the formation of new neural pathways. The company’s technology is designed to support people living with movement impairments caused by neurological disorders and injuries. Fesia’s product portfolio includes: Fesia Walk – a device designed to address foot drop by stimulating muscles involved in walking. Fesia Grasp – an upper limb orthosis designed to support hand function by targeting multiple muscle groups. The systems are controlled through the Fesia Pro smartphone application, allowing clinicians to customise stimulation parameters based on individual patient requirements. Strengthening Ottobock’s Neuro-Orthotics Strategy The acquisition complements Ottobock’s existing neurorehabilitation portfolio, which includes the Exopulse Mollii Suit, a full-body neuromodulation system designed to reduce muscle spasticity and pain through electrical stimulation. By integrating Fesia’s FES platform, Ottobock aims to broaden its ability to support patients across different stages of neurological rehabilitation. Fesia CEO Haritz Zabaleta said the partnership would allow the company to scale its technology globally and accelerate innovation in neurorehabilitation and human mobility. Growing Demand for Neurological Technologies The acquisition comes as demand for neurological devices continues to increase worldwide. Neurological disorders are currently the leading cause of disability globally and represent one of the largest healthcare challenges facing health systems. Industry analysis projects that the global neurology devices market will exceed $25 billion by 2034, driven by rising disease prevalence and increasing demand for advanced rehabilitation technologies. A 2024 World Health Organization report found that the overall health burden associated with neurological conditions has increased significantly since 1990, with access to specialist care remaining a challenge in many regions. Supporting Future Mobility Solutions Ottobock CEO Oliver Jakobi highlighted the growing number of people affected by neurological conditions and said improving care pathways for these patients remains a core focus for the company. The acquisition provides Ottobock with an established FES technology platform that can be integrated into its wider mobility ecosystem. By combining assistive devices, rehabilitation technologies and digital tools, Ottobock is positioning itself to play a larger role in the evolving neurological care market. Why the Acquisition Matters The deal reflects several broader trends shaping medical device innovation: Neurorehabilitation technologies are becoming increasingly important as neurological disease burden rises. Functional electrical stimulation is gaining traction as a non-invasive approach to restoring mobility. Medtech companies are expanding beyond traditional devices into integrated rehabilitation platforms. Demand is increasing for personalised solutions that support long-term patient recovery. Summary Ottobock has agreed to acquire Fesia Technology, adding wearable functional electrical stimulation devices to its neuro-orthotics portfolio. The acquisition strengthens Ottobock’s position in neurological rehabilitation and supports its broader strategy of developing technologies aimed at improving mobility and independence for patients living with neurological conditions.

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

EndoSure and Ziwig Endotest will be introduced as complementary diagnostic options, aiming to reduce delays in diagnosis for millions of women affected by endometriosis. The UK’s National Institute for Health and Care Excellence (NICE) has recommended the use of two non-invasive diagnostic technologies for endometriosis within the National Health Service (NHS), marking a significant step towards improving diagnosis of the condition. The draft early use healthtech guidance recommends EndoSure and Ziwig Endotest as complementary tools alongside existing clinical practice for an initial three-year period, during which further evidence will be collected to assess their long-term effectiveness. The move comes as patients in the UK continue to face lengthy delays before receiving an endometriosis diagnosis, with average waiting times exceeding nine years. New Approaches to Endometriosis Diagnosis Endometriosis occurs when tissue similar to the lining of the uterus grows outside its normal location, leading to inflammation, pain and, in some cases, infertility. The condition affects around 10% of women of reproductive age, but diagnosis can often be challenging and historically has relied on invasive procedures such as keyhole surgery. NICE said the introduction of new diagnostic approaches could provide a faster and less invasive pathway for patients while reducing reliance on specialist imaging expertise. How the New Tests Work The two recommended technologies use different approaches to identify biological signals associated with endometriosis. EndoSure Developed by EndoSure, the diagnostic uses abdominal sensor pads to detect electrical signals in the gut during a 45-minute procedure. The company says the test identifies patterns associated with the release of pro-inflammatory prostaglandins from endometriosis tissue, with results available immediately after testing. Ziwig Endotest Ziwig Endotest uses next-generation sequencing (NGS) technology to analyse saliva samples for 109 microRNAs (miRNAs) linked to endometriosis. Samples are analysed in a laboratory, with results typically returned within two to three weeks. Both tests are intended to support clinical decision-making rather than replace existing diagnostic assessments. Addressing Delays in Diagnosis The recommendation follows growing concerns over the time required for many patients to receive confirmation of endometriosis. A survey of more than 10,000 women found that half had visited their GP more than 10 times before receiving a diagnosis. NICE said the introduction of non-invasive diagnostics could support earlier identification of the condition, enabling patients to access appropriate treatment sooner. Dr Anastasia Chalkidou, healthtech programme director at NICE, highlighted the potential impact of faster diagnosis on patient outcomes and treatment decisions. A Step Forward for Women’s Health Innovation The NHS adoption of EndoSure and Ziwig Endotest reflects broader efforts to improve access to faster, less invasive diagnostic technologies. While NICE has not recommended either test as a standalone diagnostic solution, the guidance represents a move towards integrating emerging technologies into routine care pathways. The three-year evidence collection period will allow researchers and healthcare providers to assess how effectively the tools perform in real-world NHS settings. Why the Recommendation Matters The introduction of these technologies highlights several wider trends in healthcare innovation: Non-invasive diagnostics are increasingly being developed to replace or reduce reliance on invasive procedures. Earlier diagnosis is becoming a priority in conditions historically associated with long delays. Digital and molecular technologies are expanding diagnostic options across women’s health. Real-world evidence generation is becoming central to NHS adoption decisions. Summary NICE has recommended the NHS introduce EndoSure and Ziwig Endotest as complementary tools for diagnosing endometriosis. The technologies aim to reduce diagnostic delays by offering faster, less invasive alternatives to traditional pathways, potentially improving access to care for millions of women affected by the condition. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The deal gives Vertex access to a commercial acromegaly therapy and a late-stage rare disease pipeline as the company diversifies beyond cystic fibrosis. Vertex Pharmaceuticals has agreed to acquire Crinetics Pharmaceuticals in a transaction valued at approximately $10 billion, marking the company’s largest acquisition to date. Under the terms of the agreement, Vertex will acquire Crinetics for $85 per share, with the transaction expected to close in the third quarter of 2026. The acquisition strengthens Vertex’s position in rare diseases by adding an established endocrinology portfolio, including Palsonify (paltusotine), an oral therapy approved in the US and EU for adults with acromegaly. Expanding Beyond Cystic Fibrosis Vertex built its commercial success around cystic fibrosis, with its franchise generating more than $11 billion in revenue in 2025. The company has used that financial strength to expand into additional therapeutic areas, including gene therapy, pain management and kidney disease. However, some newer growth areas have faced challenges. The company’s non-opioid pain medicine Journavx (suzetrigine) gained approval as the first new non-opioid pain treatment in more than two decades. Still, expectations for broader chronic pain adoption have remained limited. Meanwhile, uptake of Vertex’s gene therapy, Casgevy (exagamglogene autotemcel), has been affected by challenges common to cell and gene therapies, including high costs, reimbursement barriers, and complex treatment pathways. The Crinetics acquisition provides Vertex with a commercial product and a pipeline focused on rare endocrine disorders. Palsonify Provides Immediate Commercial Opportunity The centrepiece of the deal is Palsonify (paltusotine), an oral non-peptide somatostatin receptor type 2 (SST2) agonist designed to treat acromegaly. The therapy was approved in the US and EU as a first-line treatment for adults with acromegaly, a rare hormonal disorder caused by excess growth hormone production. Since launching in the US in late 2025, Palsonify has generated approximately $15.7 million in net product revenue. Vertex said early performance reflects strong demand, expanding prescribing activity and increasing reimbursement coverage. Vertex CEO Reshma Kewalramani said the company’s experience commercialising rare disease medicines would help accelerate the drug’s growth following the acquisition. Building a Rare Endocrinology Pipeline Beyond Palsonify, the acquisition adds Crinetics’ clinical pipeline, led by atumelnant, an oral adrenocorticotropic hormone (ACTH) receptor antagonist currently being studied in Phase III trials for congenital adrenal hyperplasia (CAH). CAH is a rare genetic disorder characterised by impaired cortisol production and excess androgen levels. In Phase II studies, atumelnant demonstrated reductions in androgen biomarkers, including androstenedione and 17-hydroxyprogesterone, while allowing patients to maintain physiologic glucocorticoid replacement therapy. The candidate is also being evaluated in Cushing’s syndrome, another rare endocrine condition. Crinetics’ wider pipeline includes: CRN09682, a Phase I/II programme for neuroendocrine tumours Preclinical programmes targeting Graves’ disease Thyroid eye disease Polycystic kidney disease Obesity Diabetes Vertex expects Palsonify and atumelnant together could generate peak annual revenue exceeding $5 billion. Strengthening Vertex’s M&A Strategy The Crinetics acquisition follows Vertex’s previous major acquisition of Alpine Immune Sciences for $4.9 billion in 2024, which provided the company with povetacicept. Povetacicept, a dual APRIL/BAFF inhibitor, is currently under FDA review for immunoglobulin A nephropathy (IgAN). Vertex has previously highlighted renal disease as a potential future growth driver, with the company suggesting its kidney portfolio could eventually surpass its cystic fibrosis business. Why the Deal Matters The acquisition highlights several important trends across the biopharmaceutical sector: Large pharmaceutical companies continue to use M&A to secure late-stage and commercial assets. Rare diseases remain a major focus for pipeline diversification. Oral therapies are attracting interest as alternatives to injectable treatments. Endocrinology is becoming an increasingly attractive market due to significant unmet medical needs. Summary Vertex Pharmaceuticals has agreed to acquire Crinetics Pharmaceuticals for approximately $10 billion, gaining access to Palsonify and a broader endocrinology pipeline. The deal strengthens Vertex’s strategy of expanding beyond cystic fibrosis while adding commercial and late-stage rare disease assets across acromegaly, congenital adrenal hyperplasia and other endocrine disorders. 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