The FDA approval adds an oral ALK2 inhibitor for patients aged 12 years and older with the ultra-rare genetic disorder fibrodysplasia ossificans progressiva. Atebrioz (zilurgisertib) has been approved by the FDA to reduce the volume of new heterotopic ossification in adults and paediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva. The approval, supported by the pivotal PROGRESS study, makes Atebrioz the third FDA-approved treatment for FOP and adds an oral therapy targeting the ALK2 pathway. Field Content Field Content Alert Type FDA Approval Company Mirum Pharmaceuticals Product Atebrioz (zilurgisertib) Indication Fibrodysplasia ossificans progressiva (FOP) Patient Population Adults and paediatric patients aged 12 years and older Technology/Modality Oral ALK2 inhibitor Regulator U.S. Food and Drug Administration Regulatory Status FDA approved What Happened FDA approved Atebrioz to reduce the volume of new heterotopic ossification in patients with FOP aged 12 years and older. Why It Matters The approval adds a new oral treatment option for an ultra-rare genetic disorder characterised by progressive formation of bone in soft tissues. Supporting Evidence The approval was supported by the pivotal PROGRESS study. Competitive Context Atebrioz becomes the third FDA-approved treatment for FOP. Potential Impact The therapy expands treatment options for eligible adolescents and adults living with FOP. Key Takeaway Atebrioz provides a new FDA-approved oral ALK2-targeted treatment for FOP. What to Watch US launch, clinical uptake and longer-term evidence on control of heterotopic ossification. Primary Source U.S. Food and Drug Administration Relevant Date 25 September 2026 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

Arcturus Therapeutics has agreed to acquire Belgian AI drug-discovery company myNEO, expanding its computational capabilities for mRNA medicine design and target identification. Arcturus has worked with myNEO since 2024 and plans to integrate the company's artificial-intelligence platform into its broader mRNA discovery and development capabilities. The acquisition is expected to close in October subject to customary conditions and adds specialised AI expertise to Arcturus' genetic-medicines platform. Field Content Alert Type Deal Companies Arcturus Therapeutics; myNEO Deal Type Acquisition Asset or Company myNEO Technology or Modality Artificial intelligence; computational drug discovery; mRNA medicines Geography United States; Belgium Transaction Status Definitive acquisition agreement; expected to close in October subject to customary conditions What Happened Arcturus Therapeutics entered a definitive agreement to acquire Belgian AI drug-discovery company myNEO. Why It Matters The acquisition adds artificial-intelligence capabilities that can support target identification and optimisation of mRNA therapeutic design. Supporting Context Arcturus and myNEO have collaborated since 2024, giving the companies an existing working relationship ahead of integration. Strategic Rationale Arcturus can bring computational target discovery and molecular design capabilities in-house to complement its mRNA technology platform. Potential Impact Integration of AI-based discovery could improve candidate selection and accelerate development of future mRNA medicines. Key Takeaway Arcturus is acquiring myNEO to strengthen AI-driven target discovery and mRNA design capabilities. What to Watch Transaction completion, integration of the myNEO platform and future pipeline programmes generated using the combined technologies. Primary Source Arcturus Therapeutics Relevant Date 23 September 2026 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

EU pharmaceutical legislation has moved closer to completion after member states backed the Council's first-reading positions on the regulation and directive forming the bloc's revised medicines framework. The texts cover centralised medicine authorisation and EMA oversight as well as a revised Union code for medicinal products for human use. The step advances the legislative package toward formal Council adoption and subsequent completion of the EU law-making process. Field Content Alert Type Industry Update Development EU pharmaceutical legislation reform Institution Council of the European Union Policy Area Medicines regulation; pharmaceutical legislation Legislative Instruments Regulation governing Union procedures for authorisation and supervision of medicinal products and EMA rules; Directive establishing the Union code for medicinal products for human use Geography European Union What Happened Member states advanced the Council's first-reading positions on the regulation and directive forming the revised EU pharmaceutical framework. Why It Matters The package is intended to replace and update major parts of the EU's existing medicines legislation and will affect pharmaceutical regulation across the bloc. Supporting Context Council documents published around the 23 September Coreper meeting include first-reading positions on both the medicinal-products regulation and the new Union medicines code. Potential Impact Once the legislation completes the remaining formal steps, pharmaceutical companies will need to adapt regulatory, development and market-access strategies to the revised framework. Key Takeaway The EU pharmaceutical reform package has moved into its first-reading adoption stage at Council level. What to Watch Formal Council adoption and the remaining institutional steps before the revised pharmaceutical legislation enters into force. Primary Source Council of the European Union Relevant Date 23-24 September 2026 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 FDA has approved Lilly's Onswik as a once-weekly basal insulin for adults with type 2 diabetes, reducing the frequency of basal insulin injections from daily to weekly dosing. Onswik, or insulin efsitora alfa-gobe, was supported by the Phase III QWINT clinical programme involving more than 3,400 adults with type 2 diabetes. The approval introduces a weekly basal-insulin option that could simplify treatment schedules for adults who require insulin therapy. Field Content Alert Type Approval Drug Name Insulin efsitora alfa-gobe Brand Name Onswik Company Eli Lilly and Company Regulatory Authority U.S. Food and Drug Administration Approval Type New drug approval Indication Adults with type 2 diabetes requiring basal insulin treatment Therapy Area(s) Diabetes; endocrinology; metabolic disease Technology or Modality Once-weekly basal insulin Dosing Once weekly Clinical Programme Phase III QWINT programme Clinical Programme Population More than 3,400 adults Geography United States What Happened The FDA approved Onswik as a once-weekly basal insulin treatment for adults with type 2 diabetes. Why It Matters Weekly administration substantially reduces injection frequency compared with conventional once-daily basal insulin schedules. Supporting Context Lilly estimates that once-weekly administration can reduce basal insulin injections from approximately 365 to 52 per year. Potential Impact A simplified injection schedule could reduce treatment burden and improve convenience for adults requiring long-term basal insulin therapy. Key Takeaway Onswik introduces once-weekly basal insulin dosing for adults with type 2 diabetes in the United States. What to Watch Commercial launch, payer coverage, prescribing uptake and real-world treatment adherence. Primary Source Eli Lilly and Company Relevant Date 24 September 2026 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

Lilly and InnoCare have entered a multi-target research and licensing collaboration potentially worth $3.35 billion to discover and develop new medicines. InnoCare will identify and advance compounds against up to five targets before Lilly assumes responsibility for subsequent development and global commercialisation. InnoCare is eligible for up to $100 million in upfront and near-term payments, approximately $3.25 billion in additional milestones and tiered royalties on future sales. Field Content Alert Type Deal Companies Eli Lilly and Company; InnoCare Pharma Deal Type Strategic research collaboration and licensing agreement Asset or Company Up to five undisclosed therapeutic targets Technology or Modality Small-molecule drug discovery and development Deal Value Up to approximately US$3.35 billion, including up to US$100 million in upfront and near-term payments and approximately US$3.25 billion in development, regulatory and commercial milestones, plus tiered royalties Geography Global What Happened Lilly and InnoCare entered a research and licensing collaboration covering the discovery and development of compounds against up to five targets. Why It Matters The transaction is a major cross-border pharmaceutical discovery partnership with multi-billion-dollar potential economics. Supporting Context InnoCare will lead early discovery and advancement of compounds, after which Lilly will take responsibility for further development and commercialisation. Strategic Rationale Lilly gains access to InnoCare's discovery capabilities while InnoCare secures substantial near-term funding and downstream milestone and royalty opportunities. Potential Impact Successful programmes could generate multiple new medicines across the collaboration's undisclosed targets. Key Takeaway Lilly and InnoCare have formed a drug-discovery alliance worth up to approximately US$3.35 billion. What to Watch Disclosure of therapeutic targets, candidate selection and progression of the first programmes into development. Primary Source InnoCare Pharma Relevant Date 24 September 2026 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 FDA has approved Welireg in combination with Lenvima for adults with advanced clear-cell renal cell carcinoma following prior PD-1 or PD-L1 immunotherapy. The combination of belzutifan and lenvatinib achieved median progression-free survival of 14.6 months in the Phase III LITESPARK-011 study, compared with 10.6 months for cabozantinib. The approval adds a new post-immunotherapy treatment option for patients with advanced kidney cancer and combines HIF-2α inhibition with VEGF-targeted therapy. Field Content Alert Type Approval Drug Names Belzutifan; lenvatinib Brand Names Welireg; Lenvima Companies Merck; Eisai Regulatory Authority U.S. Food and Drug Administration Approval Type Combination therapy approval Indication Adults with advanced renal cell carcinoma with a clear-cell component following prior PD-1 or PD-L1 therapy Therapy Area(s) Oncology; kidney cancer; renal cell carcinoma Technology or Modality HIF-2α inhibitor plus multikinase inhibitor Clinical Study LITESPARK-011 Median Progression-Free Survival 14.6 months with belzutifan plus lenvatinib versus 10.6 months with cabozantinib Geography United States What Happened The FDA approved Welireg in combination with Lenvima for advanced clear-cell renal cell carcinoma after prior immunotherapy. Why It Matters The approval provides another treatment option after PD-1 or PD-L1 therapy in a setting where patients may require additional targeted approaches. Supporting Context Belzutifan inhibits HIF-2α while lenvatinib targets multiple receptor tyrosine kinases involved in tumour angiogenesis and growth. Key Takeaway Welireg plus Lenvima is now FDA approved for advanced clear-cell renal cell carcinoma following prior immune-checkpoint therapy. What to Watch Clinical uptake, treatment sequencing and longer-term survival results from LITESPARK-011. Primary Source U.S. Food and Drug Administration Relevant Date 24 September 2026 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

SK Biopharmaceuticals has secured exclusive global rights to 1ST Biotherapeutics' preclinical Parkinson's disease candidate 1ST-104 in a deal worth up to $314.8 million. 1ST-104 is an oral dual inhibitor of LRRK2 and c-Abl designed to target disease biology associated with Parkinson's progression rather than only managing symptoms. The agreement also includes a $2.2 million strategic investment in 1ST Biotherapeutics and gives the developer potential milestone payments and royalties as the programme advances. Field Content Alert Type Deal Companies SK Biopharmaceuticals; 1ST Biotherapeutics Deal Type Exclusive global licensing agreement Asset or Company 1ST-104 Therapy Area(s) Neurology; Parkinson's disease Technology or Modality Oral dual LRRK2/c-Abl inhibitor Development Stage Preclinical Deal Value Up to US$314.8 million under the licence, plus a separate US$2.2 million strategic equity investment and royalties Geography Worldwide What Happened SK Biopharmaceuticals secured exclusive global rights to 1ST-104 from 1ST Biotherapeutics. Why It Matters The programme targets two disease-associated signalling pathways and is intended as a potentially disease-modifying approach to Parkinson's disease. Supporting Context LRRK2 and c-Abl have both been implicated in molecular processes associated with Parkinson's disease pathology and neurodegeneration. Strategic Rationale SK Biopharmaceuticals expands its neuroscience pipeline while 1ST Biotherapeutics gains funding and access to a global development and commercialisation partner. Potential Impact Successful development could introduce a new oral treatment designed to affect Parkinson's disease biology rather than symptoms alone. Key Takeaway SK Biopharmaceuticals has licensed 1ST-104 globally in a transaction worth up to US$314.8 million. What to Watch IND-enabling work, first-in-human development and early evidence of target engagement. Primary Source 1ST Biotherapeutics / SK Biopharmaceuticals Relevant Date 17 September 2026 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 FDA has expanded approval of two Roche HER2 companion diagnostics to identify patients with metastatic gastroesophageal adenocarcinoma who may be eligible for ZIIHERA treatment. The PATHWAY HER2 4B5 assay and VENTANA HER2 Dual ISH DNA Probe Cocktail can now be used to assess HER2 status in metastatic gastric, gastroesophageal-junction and oesophageal adenocarcinoma. The approvals strengthen the diagnostic infrastructure supporting biomarker-driven use of zanidatamab-hrii and reinforce the role of HER2 testing in gastrointestinal oncology. Field Content Alert Type Approval Products PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody; VENTANA HER2 Dual ISH DNA Probe Cocktail Company Roche Diagnostics Regulatory Authority U.S. Food and Drug Administration Approval Type Expanded companion diagnostic approval Indication Identification of HER2-positive metastatic gastric, gastroesophageal-junction and oesophageal adenocarcinoma patients who may be eligible for ZIIHERA Associated Therapy ZIIHERA (zanidatamab-hrii) Therapy Area(s) Oncology; gastrointestinal cancer; precision diagnostics Biomarker HER2 Technology or Modality Immunohistochemistry and in-situ hybridisation companion diagnostics Geography United States What Happened The FDA expanded approval of two Roche HER2 diagnostic assays for use in metastatic gastroesophageal adenocarcinoma. Why It Matters The approvals provide validated diagnostic tools for identifying patients whose tumours may respond to HER2-targeted treatment with ZIIHERA. Supporting Context Accurate HER2 assessment is essential for selecting patients for HER2-directed therapies in gastric and gastroesophageal cancers. Key Takeaway Roche's HER2 companion diagnostics now support patient selection for ZIIHERA in metastatic gastroesophageal adenocarcinoma. What to Watch Testing uptake, integration into pathology workflows and broader use of HER2-targeted treatment in gastrointestinal cancers. Primary Source Roche Diagnostics Relevant Date 23 September 2026 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

Zealand Pharma and Roche have started the global Phase 3 ZUPREME programme evaluating once-weekly petrelintide as a treatment for people with overweight or obesity. The registrational programme includes three Phase 3a studies expected to enrol around 7,000 participants across populations with obesity, type 2 diabetes and cardiovascular disease. The move into Phase 3 represents a major development milestone for the amylin analogue and positions petrelintide as a potential future competitor in the rapidly expanding obesity-treatment market. Field Content Alert Type Industry Update Companies Zealand Pharma; Roche Development Type Phase 3 programme initiation Drug Candidate Petrelintide Programme ZUPREME Therapy Area(s) Obesity; metabolic disease; type 2 diabetes; cardiovascular disease Technology or Modality Long-acting amylin analogue Development Stage Registrational Phase 3a Planned Enrollment Approximately 7,000 participants across three trials Geography Global What Happened Zealand Pharma and Roche initiated the global registrational Phase 3 ZUPREME programme for once-weekly petrelintide in chronic weight management. Why It Matters Progression into Phase 3 moves petrelintide substantially closer to potential regulatory submission and commercial competition in obesity treatment. Supporting Context The programme is designed to evaluate petrelintide across obesity populations both with and without type 2 diabetes and cardiovascular disease. Potential Impact If successful, petrelintide could add a new amylin-based therapeutic option to a market currently dominated by incretin-based medicines. Key Takeaway Petrelintide has entered a large global Phase 3 programme involving around 7,000 participants. What to Watch Weight-loss efficacy, tolerability, cardiovascular outcomes and timing of regulatory submissions. Primary Source Zealand Pharma Relevant Date 22 September 2026 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

AVS Bio has acquired Biorbyt, expanding its global life-sciences platform with a catalogue of more than one million antibodies, proteins and other research reagents. The acquisition adds Biorbyt's ecommerce, distribution and biomaterials portfolio to AVS Bio's existing capabilities serving pharmaceutical, biotechnology and academic research customers. The deal strengthens AVS Bio's position as a broader supplier of biological research products and supporting infrastructure across drug discovery and life-science development. Field Content Alert Type Deal Companies AVS Bio; Biorbyt Deal Type Acquisition Asset or Company Biorbyt Ltd Sector Life-sciences research products; biomaterials Technology or Modality Antibodies; proteins; bio-reagents; research materials Product Catalogue More than one million research products Deal Value Financial terms were not disclosed Geography Global What Happened AVS Bio acquired Biorbyt, adding its extensive research-product catalogue and global ecommerce capabilities. Why It Matters The transaction broadens AVS Bio's offering across the research supply chain and expands its reach with pharmaceutical, biotechnology and academic customers. Supporting Context Biorbyt supplies antibodies, proteins and other biological research reagents through a global ecommerce and distribution platform. Strategic Rationale AVS Bio gains additional catalogue depth, digital distribution capability and access to a wider international customer base. Potential Impact The acquisition could strengthen procurement options for researchers and create a larger integrated platform for biological research materials. Key Takeaway AVS Bio has acquired Biorbyt to expand its global biomaterials and research-reagent platform. What to Watch Integration of product catalogues, international distribution expansion and further acquisitions by AVS Bio. Primary Source AVS Bio / Biorbyt Relevant Date 23 September 2026 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 FDA has approved Lyrfigtu for adults with previously treated FGFR2-altered cholangiocarcinoma, adding a new targeted therapy for this molecularly defined group of bile duct cancers. Lyrfigtu, or lirafugratinib, is approved for unresectable, locally advanced or metastatic cholangiocarcinoma harbouring an FGFR2 fusion or other rearrangement after prior treatment. The approval was supported by the REFOCUS study and expands the range of precision medicines available for patients whose tumours are driven by FGFR2 alterations. Field Content Alert Type Approval Drug Name Lirafugratinib Brand Name Lyrfigtu Regulatory Authority U.S. Food and Drug Administration Approval Type New drug approval Indication Previously treated unresectable, locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement Therapy Area(s) Oncology; cholangiocarcinoma; biliary tract cancer Biomarker FGFR2 fusion or rearrangement Technology or Modality Targeted small-molecule FGFR inhibitor Clinical Study REFOCUS Geography United States What Happened The FDA approved Lyrfigtu for adults with previously treated FGFR2-altered cholangiocarcinoma. Why It Matters The approval provides another biomarker-directed treatment option for a difficult-to-treat cancer in which FGFR2 alterations define an actionable molecular subgroup. Supporting Context FGFR2 fusions and rearrangements occur in a subset of intrahepatic cholangiocarcinomas and can drive tumour growth. Key Takeaway Lyrfigtu adds a new FDA-approved targeted therapy for previously treated FGFR2-altered cholangiocarcinoma. What to Watch Clinical uptake, molecular testing rates and positioning against other FGFR-targeted therapies in cholangiocarcinoma. Primary Source U.S. Food and Drug Administration Relevant Date 23 September 2026 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

Novartis has secured exclusive worldwide rights to an undisclosed preclinical radioligand therapy from BoomRay Pharma in a licensing agreement worth up to $900 million. BoomRay is eligible for upfront, development, regulatory and sales milestone payments as well as royalties, while Novartis gains global development and commercialisation rights to the radiopharmaceutical asset. The agreement adds another early-stage radioligand programme to Novartis' oncology pipeline and highlights continued investment in targeted nuclear medicine. Field Content Alert Type Deal Companies Novartis; BoomRay Pharma Deal Type Exclusive global licensing agreement Asset or Company Undisclosed preclinical radioligand therapy Therapy Area(s) Oncology; nuclear medicine Technology or Modality Radioligand therapy Development Stage Preclinical Deal Value Up to US$900 million including upfront, development, regulatory and sales milestone payments, plus royalties Geography Worldwide What Happened Novartis secured exclusive worldwide rights to a preclinical radioligand therapy from BoomRay Pharma. Why It Matters The transaction adds another radiopharmaceutical programme to Novartis' oncology portfolio and reflects continued strategic investment in targeted radioligand therapy. Supporting Context BoomRay is eligible for milestone-based payments across development, regulatory and commercial stages as well as royalties on future sales. Strategic Rationale Novartis expands its radioligand pipeline while BoomRay gains the resources and global development capabilities of a major pharmaceutical partner. Potential Impact Successful development could add another targeted radiopharmaceutical treatment to the oncology market. Key Takeaway Novartis has licensed a BoomRay radioligand therapy globally in a deal worth up to US$900 million. What to Watch Disclosure of the target, progression into clinical development and achievement of early development milestones. Primary Source BoomRay Pharma Relevant Date 22 September 2026 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