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 approved Cordis' SELUTION SLR sirolimus drug-eluting balloon for treatment of coronary in-stent restenosis, making it the first sirolimus drug-eluting balloon available in the United States. The device delivers sustained sirolimus therapy to the vessel wall without leaving another permanent implant behind, providing a new interventional option for patients whose coronary stents have narrowed again. The approval expands the US coronary intervention toolkit and introduces a different drug-delivery approach for treating in-stent restenosis. Field Content Alert Type Approval Device Name SELUTION SLR Company Cordis Regulatory Authority U.S. Food and Drug Administration Approval Type Medical device approval Indication Treatment of coronary in-stent restenosis Therapy Area(s) Cardiology; interventional cardiology Technology or Modality Sirolimus drug-eluting balloon Geography United States What Happened The FDA approved Cordis' SELUTION SLR drug-eluting balloon for coronary in-stent restenosis. Why It Matters SELUTION SLR is the first sirolimus drug-eluting balloon approved in the US and provides drug delivery without implanting an additional permanent stent. Supporting Context In-stent restenosis occurs when treated coronary arteries narrow again after stent implantation and may require repeat intervention. Potential Impact The device could give interventional cardiologists another treatment option for restenosis while reducing the need for additional metal implants. Key Takeaway SELUTION SLR becomes the first FDA-approved sirolimus drug-eluting balloon for coronary in-stent restenosis in the US. What to Watch US commercial rollout, adoption in catheterisation laboratories and real-world outcomes compared with repeat stenting and other balloon technologies. Primary Source Cordis Relevant Date 21 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

Lexeo Therapeutics has agreed to acquire Mantle Therapeutics for up to $21.3 million, adding four Friedreich ataxia development programmes to its pipeline. Lexeo will pay $8.3 million upfront with up to $13 million in additional milestone payments for assets spanning small molecules, protein replacement and RNA-based therapeutic approaches. The transaction broadens Lexeo's rare-disease strategy beyond gene therapy and creates a multi-modality development portfolio focused on Friedreich ataxia. Field Content Alert Type Deal Companies Lexeo Therapeutics; Mantle Therapeutics Deal Type Acquisition Asset or Company Mantle Therapeutics and four Friedreich ataxia programmes Therapy Area(s) Rare disease; neurology; Friedreich ataxia Technology or Modality Small molecules; protein replacement; RNA-based therapies Deal Value US$8.3 million upfront plus up to US$13 million in milestone payments; total potential consideration US$21.3 million Geography United States What Happened Lexeo Therapeutics entered an agreement to acquire Mantle Therapeutics and its four Friedreich ataxia development programmes. Why It Matters The acquisition expands Lexeo's rare-disease pipeline across several therapeutic modalities and deepens its focus on Friedreich ataxia. Supporting Context Mantle's programmes span small-molecule, protein-replacement and RNA-based approaches rather than relying on a single therapeutic technology. Strategic Rationale Lexeo gains a broader platform of Friedreich ataxia assets that complements its existing genetic-medicine expertise. Potential Impact A diversified pipeline could increase the chances of identifying effective treatments across different biological mechanisms involved in Friedreich ataxia. Key Takeaway Lexeo is acquiring Mantle Therapeutics for up to US$21.3 million to add four Friedreich ataxia programmes. What to Watch Transaction completion, prioritisation of the acquired programmes and advancement toward clinical development. Primary Source Lexeo Therapeutics 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

The European Commission has authorised Icotyde for adults and adolescents with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Icotyde, or icotrokinra, is an oral peptide designed to selectively target the IL-23 receptor and is approved for patients aged 12 years and older weighing at least 40kg. The approval introduces a targeted oral systemic treatment option for plaque psoriasis and expands the range of non-injectable therapies available to eligible patients in Europe. Field Content Alert Type Approval Drug Name Icotrokinra Brand Name Icotyde Regulatory Authority European Commission Approval Type EU marketing authorisation Indication Moderate-to-severe plaque psoriasis in adults and adolescents aged 12 years and older weighing at least 40kg who are candidates for systemic therapy Therapy Area(s) Dermatology; immunology Technology or Modality Oral targeted peptide; IL-23 receptor antagonist Target IL-23 receptor Geography European Union What Happened The European Commission granted marketing authorisation for Icotyde for moderate-to-severe plaque psoriasis. Why It Matters Icotyde adds an oral targeted systemic therapy to a treatment landscape dominated by injectable biologics and conventional oral immunomodulators. Supporting Context Icotrokinra is designed to selectively inhibit IL-23 receptor signalling, a pathway involved in the inflammatory biology of psoriasis. Key Takeaway Icotyde is now authorised across the EU for eligible adults and adolescents with moderate-to-severe plaque psoriasis. What to Watch European launch timing, reimbursement decisions and adoption relative to biologic and other oral systemic therapies. Primary Source European Medicines Agency Relevant Date 18 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 UK government and CSL Seqirus have expanded their vaccine partnership, including plans for the UK to become the first country to introduce AUJEMFLU from the 2027/28 influenza season. The agreement also extends the companies' pandemic-preparedness Advance Purchase Agreement and supports continued vaccine manufacturing capability at CSL Seqirus' Liverpool site. The partnership strengthens UK influenza and pandemic-response preparedness while creating a pathway for wider use of an adjuvanted cell-based flu vaccine. Field Content Alert Type Deal Parties UK Government; CSL Seqirus Deal Type Strategic vaccine partnership and Advance Purchase Agreement extension Asset or Company AUJEMFLU and UK pandemic influenza vaccine supply Therapy Area(s) Vaccines; infectious disease; public health Technology or Modality Adjuvanted cell-based influenza vaccine Planned Rollout AUJEMFLU from the 2027/28 influenza season Manufacturing Site Liverpool, United Kingdom Geography United Kingdom What Happened The UK government and CSL Seqirus expanded their vaccine partnership, including plans for the UK to become the first country to introduce AUJEMFLU and an extension of their pandemic-preparedness supply agreement. Why It Matters The agreement strengthens domestic vaccine manufacturing and pandemic-response capability while introducing a new influenza vaccine platform into the UK programme. Supporting Context The extended Advance Purchase Agreement supports ongoing readiness for rapid vaccine supply during future influenza pandemics. Strategic Rationale The UK reinforces health-security capacity while CSL Seqirus secures continued strategic support for its Liverpool manufacturing operations. Potential Impact The partnership could improve seasonal influenza protection and preserve rapid-response manufacturing capacity for future pandemics. Key Takeaway The UK and CSL Seqirus are expanding a long-term vaccine partnership combining future AUJEMFLU rollout with strengthened pandemic preparedness. What to Watch Implementation ahead of the 2027/28 flu season, procurement details and future use of the Liverpool site in pandemic planning. Primary Source CSL Seqirus / UK Government 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

The European Commission has approved Ubeslo and Evlarco for treatment of primary hypercholesterolaemia or mixed dyslipidaemia, marking the first regulatory approval worldwide for obicetrapib. Ubeslo contains obicetrapib as monotherapy, while Evlarco combines obicetrapib with ezetimibe to provide an additional LDL-cholesterol-lowering option for eligible patients. The decision introduces a new oral lipid-lowering therapy in Europe and broadens treatment options for patients who require further reduction in LDL cholesterol. Field Content Alert Type Approval Drug Name Obicetrapib Brand Names Ubeslo; Evlarco Companies NewAmsterdam Pharma; Menarini Group Regulatory Authority European Commission Approval Type EU marketing authorisation Indication Primary hypercholesterolaemia or mixed dyslipidaemia Therapy Area(s) Cardiology; lipid management; cardiometabolic disease Technology or Modality Oral lipid-lowering therapy Products Ubeslo: obicetrapib monotherapy; Evlarco: obicetrapib plus ezetimibe fixed-dose combination Geography European Union What Happened The European Commission approved Ubeslo and Evlarco for treatment of primary hypercholesterolaemia or mixed dyslipidaemia. Why It Matters The decision represents the first regulatory approval worldwide for obicetrapib and introduces another oral option for patients requiring additional LDL-cholesterol reduction. Supporting Context Evlarco combines obicetrapib with ezetimibe, while Ubeslo provides obicetrapib as a single-agent treatment. Key Takeaway Obicetrapib has received its first global regulatory approval through EU authorisation of Ubeslo and Evlarco. What to Watch European pricing and reimbursement, launch timing and positioning alongside existing lipid-lowering therapies. Primary Source Menarini Group Relevant Date 21 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