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

Boehringer Ingelheim and Envisagenics have entered a multi-year oncology collaboration worth more than $1 billion to discover therapeutic targets created by alternative RNA splicing. The partnership will use Envisagenics' AI-powered SpliceCore platform to identify tumour-specific RNA-splicing targets for potential ADCs, T-cell engagers and multispecific antibodies. Envisagenics is eligible for more than $1 billion in potential payments plus royalties, providing major validation for its precision-oncology discovery platform. Field Content Alert Type Deal Companies Boehringer Ingelheim; Envisagenics Deal Type Multi-year oncology discovery collaboration Asset or Company SpliceCore platform Therapy Area(s) Oncology; hard-to-treat cancers Technology or Modality AI-powered RNA splicing target discovery; ADCs; T-cell engagers; multispecific antibodies Deal Value More than US$1 billion in potential payments plus royalties Geography Global What Happened Boehringer Ingelheim and Envisagenics entered a multi-target collaboration to discover tumour-specific targets arising from alternative RNA splicing. Why It Matters Alternative RNA splicing can generate cancer-specific targets that are not present in healthy tissue, potentially enabling more selective precision therapies. Supporting Context Envisagenics' SpliceCore platform uses artificial intelligence to identify disease-associated RNA-splicing events and translate them into therapeutic targets. Strategic Rationale Boehringer gains access to a differentiated oncology target-discovery platform while Envisagenics receives significant milestone and royalty economics. Potential Impact The collaboration could generate new targeted therapies for cancers that remain difficult to treat with existing modalities. Key Takeaway Boehringer Ingelheim is partnering with Envisagenics in an oncology collaboration carrying more than US$1 billion in potential value. What to Watch Target selection, validation of RNA-splicing-derived targets and advancement of resulting programmes into preclinical development. Primary Source Envisagenics 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 FDA has granted final approval to Lantheus' Bravnetsa for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours. Bravnetsa, or lutetium Lu 177 dotatate, has been determined by the FDA to be bioequivalent and therapeutically equivalent to Lutathera. The approval adds another radioligand therapy option for SSTR-positive GEP-NETs and introduces further competition in the US nuclear-medicine market. Field Content Alert Type Approval Drug Name Lutetium Lu 177 dotatate Brand Name Bravnetsa Company Lantheus Regulatory Authority U.S. Food and Drug Administration Approval Type Final approval Indication Adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours Therapy Area(s) Oncology; neuroendocrine tumours Technology or Modality Radioligand therapy Reference Product Lutathera Regulatory Status FDA determined Bravnetsa to be bioequivalent and therapeutically equivalent to Lutathera Geography United States What Happened The FDA granted final approval to Bravnetsa for adults with SSTR-positive GEP-NETs. Why It Matters The approval introduces an additional therapeutically equivalent lutetium Lu 177 dotatate product and expands competition in radioligand treatment. Supporting Context Lutetium Lu 177 dotatate delivers targeted radiation to tumour cells expressing somatostatin receptors. Key Takeaway Bravnetsa is now fully FDA approved as a therapeutic equivalent to Lutathera for SSTR-positive GEP-NETs. What to Watch Commercial launch, treatment-centre adoption and the effect of additional competition on radioligand therapy access. Primary Source Lantheus 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 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

Grünenthal has agreed to acquire Bayer's established oncology medicine Stivarga in a transaction worth up to €375 million. The acquisition gives Grünenthal global rights to regorafenib, which is approved in more than 90 markets for indications including metastatic colorectal cancer, gastrointestinal stromal tumours and hepatocellular carcinoma. The transaction expands Grünenthal's portfolio of established medicines while allowing Bayer to transfer a mature oncology asset to a company focused on managing and commercialising established products. Field Content Alert Type Deal Companies Grünenthal; Bayer Deal Type Pharmaceutical asset acquisition Asset or Company Stivarga (regorafenib) Therapy Area(s) Oncology; colorectal cancer; gastrointestinal stromal tumours; hepatocellular carcinoma Technology or Modality Oral multikinase inhibitor Deal Value Up to €375 million Geography Global What Happened Grünenthal agreed to acquire Bayer's oncology medicine Stivarga and associated global rights for up to €375 million. Why It Matters The transaction transfers a globally established oncology medicine approved across multiple tumour types and significantly expands Grünenthal's mature-product portfolio. Supporting Context Stivarga is marketed in more than 90 countries and is used in metastatic colorectal cancer, gastrointestinal stromal tumours and hepatocellular carcinoma. Strategic Rationale Grünenthal gains a sizeable established oncology asset while Bayer streamlines its portfolio and transfers lifecycle management to a specialist in established medicines. Potential Impact The deal broadens Grünenthal's commercial footprint and adds a significant oncology revenue stream to its portfolio. Key Takeaway Grünenthal is acquiring Bayer's Stivarga franchise for up to €375 million. What to Watch Transaction completion, transfer of commercial operations and Grünenthal's strategy for lifecycle management of Stivarga. Primary Source Grünenthal 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 approved Aqneursa as the first treatment specifically indicated for ataxia in adults and children with ataxia-telangiectasia weighing at least 15kg. Aqneursa, or levacetylleucine, is approved to treat the neurological manifestation of ataxia in patients with the rare inherited disorder ataxia-telangiectasia. The approval introduces the first FDA-authorised therapy specifically targeting ataxia in this patient population, addressing an area that previously lacked an approved treatment. Field Content Alert Type Approval Drug Name Levacetylleucine Brand Name Aqneursa Regulatory Authority U.S. Food and Drug Administration Approval Type New drug approval Indication Treatment of ataxia in adults and paediatric patients with ataxia-telangiectasia weighing at least 15kg Therapy Area(s) Rare disease; neurology; genetic disease Technology or Modality Small-molecule therapy Geography United States What Happened The FDA approved Aqneursa (levacetylleucine) for treatment of ataxia in adults and children with ataxia-telangiectasia weighing at least 15kg. Why It Matters Aqneursa is the first FDA-approved treatment specifically addressing the neurological symptom of ataxia in patients with this rare genetic disorder. Supporting Context Ataxia-telangiectasia is an inherited multisystem disorder characterised by progressive neurological impairment, including worsening coordination and balance. Key Takeaway Aqneursa introduces the first FDA-approved therapy specifically for ataxia associated with ataxia-telangiectasia. What to Watch Clinical uptake, access for eligible paediatric and adult patients and longer-term evidence on neurological outcomes. Primary Source U.S. Food and Drug Administration 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

Sandoz and mAbxience have entered a global collaboration to develop, manufacture and commercialise a proposed biosimilar to Roche's haemophilia medicine Hemlibra. mAbxience will lead development and manufacturing of the emicizumab biosimilar, while Sandoz will hold exclusive commercialisation rights across most global markets. The agreement expands both companies' biosimilar portfolios and targets a major biologic franchise with estimated annual global sales of approximately $5.7 billion. Field Content Alert Type Deal Companies Sandoz; mAbxience Deal Type Biosimilar development, manufacturing and commercialisation agreement Asset or Company Proposed emicizumab biosimilar Reference Product Hemlibra Therapy Area(s) Haematology; haemophilia A Technology or Modality Biosimilar monoclonal antibody Reference Product Sales Approximately US$5.7 billion in annual global sales Deal Value Financial terms were not disclosed Geography Most global markets What Happened Sandoz and mAbxience entered an agreement covering development, manufacturing and commercialisation of a proposed emicizumab biosimilar referencing Hemlibra. Why It Matters The partnership targets a major haemophilia biologic and adds another high-value programme to the global biosimilar pipeline. Supporting Context mAbxience will lead development and manufacturing while Sandoz will be responsible for commercialisation across most markets. Strategic Rationale The companies combine mAbxience's development and production capabilities with Sandoz's global biosimilar commercial infrastructure. Potential Impact A successfully approved biosimilar could increase competition and expand access to emicizumab treatment for people with haemophilia A. Key Takeaway Sandoz and mAbxience are partnering globally on a proposed biosimilar to Hemlibra. What to Watch Clinical development, regulatory submissions and future market-entry timing relative to Hemlibra's exclusivity landscape. Primary Source mAbxience / Sandoz 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

Akums has received Indian marketing approval for a fixed treatment kit combining vonoprazan, clarithromycin and amoxicillin for adults with Helicobacter pylori infection. The 14-day regimen combines a potassium-competitive acid blocker with two antibiotics to support eradication of H. pylori, a major cause of peptic ulcer disease and an established gastric cancer risk factor. The approval adds a new packaged treatment option in India for H. pylori eradication and may simplify delivery of guideline-based combination therapy. Field Content Alert Type Approval Product Vonoprazan, clarithromycin and amoxicillin combination kit Company Akums Drugs & Pharmaceuticals Regulatory Authority Indian regulatory authorities Approval Type Marketing approval Indication Treatment of Helicobacter pylori infection in adults Treatment Duration 14 days Therapy Area(s) Gastroenterology; infectious disease Technology or Modality Fixed treatment kit combining potassium-competitive acid suppression and dual antibiotic therapy Active Ingredients Vonoprazan; clarithromycin; amoxicillin Geography India What Happened Akums received marketing approval in India for a combination treatment kit containing vonoprazan, clarithromycin and amoxicillin for H. pylori infection. Why It Matters The kit packages acid suppression and dual antibiotic therapy into a single treatment regimen, potentially simplifying H. pylori eradication therapy. Supporting Context H. pylori infection is associated with peptic ulcer disease and increased risk of gastric malignancy, making effective eradication an important clinical objective. Key Takeaway Akums has secured Indian marketing approval for a 14-day vonoprazan-based H. pylori eradication regimen. What to Watch Commercial launch, pricing, prescribing uptake and comparative eradication rates versus proton-pump-inhibitor-based regimens. Primary Source ETPharma.com 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

AbbVie and Iambic have entered a multi-year collaboration to use artificial intelligence and computational drug discovery across immunology, neuroscience and oncology. The partnership will combine AbbVie's therapeutic expertise with Iambic's Enchant v3 and broader molecular-superintelligence platform to identify and optimise new small-molecule drug candidates. Iambic will receive an upfront payment and is eligible for development and commercial milestones plus tiered royalties, although detailed financial terms were not disclosed. Field Content Alert Type Deal Companies AbbVie; Iambic Therapeutics Deal Type Multi-year drug discovery collaboration Asset or Company Enchant v3 and Iambic molecular-superintelligence platform Therapy Area(s) Immunology; neuroscience; oncology Technology or Modality Artificial intelligence; computational drug discovery; small molecules Deal Value Upfront payment plus development and commercial milestones and tiered royalties; financial amounts not disclosed Geography Global What Happened AbbVie and Iambic entered a multi-year collaboration to apply Iambic's AI-driven discovery platform to selected targets across immunology, neuroscience and oncology. Why It Matters The agreement adds another major pharmaceutical partner to Iambic's platform and reflects growing use of AI to accelerate small-molecule discovery and optimisation. Supporting Context Iambic's Enchant platform is designed to integrate molecular structure, chemistry and biological data to predict properties and guide drug design. Strategic Rationale AbbVie gains access to specialised AI discovery capabilities while Iambic receives funding and potential downstream economics tied to successful programmes. Potential Impact The collaboration could shorten discovery cycles and expand the number of tractable targets across several high-value therapeutic areas. Key Takeaway AbbVie is partnering with Iambic to apply AI-driven drug discovery across immunology, neuroscience and oncology. What to Watch Selection of programme targets, candidate nominations and progression of AI-designed molecules into preclinical development. Primary Source AbbVie 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