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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 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