Sun Pharma has secured rights to commercialise and manufacture LIB Therapeutics' PCSK9 inhibitor lerodalcibep across markets outside the US and China. The agreement covers the EU-approved therapy, marketed as Lyrokaul, and includes upfront and milestone payments to LIB Therapeutics as well as royalties on future sales. The partnership expands Sun Pharma's cardiovascular portfolio while providing LIB Therapeutics with a commercialisation partner across a broad international territory. Field Content Alert Type Licensing agreement Companies Sun Pharmaceutical Industries; LIB Therapeutics Deal Type Exclusive licensing, commercialisation and manufacturing agreement Asset or Company Lerodalcibep (Lyrokaul) Therapy Area(s) Cardiovascular disease; hypercholesterolaemia Technology or Modality PCSK9 inhibitor Deal Value Upfront and milestone payments plus royalties; financial amounts not disclosed Development Stage Approved in the European Union Geography Markets outside the US and China What Happened Sun Pharma entered an agreement with LIB Therapeutics for the licensing, commercialisation and manufacturing of lerodalcibep outside the US and China. Why It Matters The transaction gives Sun Pharma access to an approved PCSK9-targeted cardiovascular therapy across a broad international territory. Supporting Context Lerodalcibep, marketed as Lyrokaul, has received European Union approval for the treatment of adults with primary hypercholesterolaemia and mixed dyslipidaemia. Strategic Rationale The agreement expands Sun Pharma's specialty cardiovascular portfolio while providing LIB Therapeutics with commercial and manufacturing capabilities across international markets. Potential Impact The partnership could broaden commercial access to lerodalcibep across markets covered by the agreement. Key Takeaway Sun Pharma has secured broad ex-US and ex-China rights to LIB Therapeutics' approved PCSK9 inhibitor lerodalcibep. What to Watch Commercial rollout of lerodalcibep in markets covered by the agreement and any subsequent regulatory or reimbursement developments. Primary Source Sun Pharmaceutical Industries Relevant Date 28 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

AstraZeneca is investing $2bn in Summit Therapeutics alongside a clinical collaboration focused on combinations involving the PD-1/VEGF bispecific antibody ivonescimab. The companies plan to evaluate ivonescimab with AstraZeneca oncology medicines, beginning with the antibody-drug conjugate sonesitatug vedotin. The transaction combines a major equity investment with expanded clinical collaboration around one of the industry's closely watched PD-1/VEGF programmes. Field Content Alert Type Strategic investment and clinical collaboration Companies AstraZeneca; Summit Therapeutics Deal Type Equity investment and clinical collaboration Asset or Company Ivonescimab Therapy Area(s) Oncology Technology or Modality PD-1/VEGF bispecific antibody Deal Value $2bn equity investment Development Stage Clinical development Geography Global collaboration What Happened AstraZeneca announced a $2bn equity investment in Summit Therapeutics alongside a clinical collaboration to evaluate combinations involving ivonescimab and AstraZeneca oncology medicines. Why It Matters The agreement expands AstraZeneca's exposure to the emerging PD-1/VEGF bispecific field while creating opportunities to evaluate ivonescimab alongside assets from its established oncology portfolio. Supporting Context The collaboration is expected to begin by evaluating ivonescimab in combination with AstraZeneca's antibody-drug conjugate sonesitatug vedotin. Strategic Rationale AstraZeneca gains strategic exposure to Summit and an opportunity to explore combinations between ivonescimab and its own oncology pipeline. Potential Impact The collaboration could generate new combination regimens involving PD-1/VEGF inhibition and AstraZeneca oncology therapies if clinical studies support their use. Key Takeaway AstraZeneca is making a $2bn strategic investment in Summit while expanding clinical work around ivonescimab combination therapies. What to Watch Initiation and results of combination studies involving ivonescimab and AstraZeneca oncology assets. Primary Source AstraZeneca Relevant Date 28 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

Merck has secured worldwide rights to SciBrunch Therapeutics' preclinical KRAS G12D inhibitor SPR2015 in an oncology licensing agreement worth up to $2.13bn. SciBrunch will receive $400m upfront, with additional development, regulatory and commercial milestones potentially taking aggregate consideration to $2.13bn. The agreement gives Merck responsibility for the development, manufacturing and commercialisation of SPR2015 worldwide. Field Content Alert Type Licensing agreement Companies Merck; SciBrunch Therapeutics Deal Type Exclusive global licence Asset or Company SPR2015 Therapy Area(s) Oncology Technology or Modality Oral KRAS G12D ON inhibitor Deal Value $400m upfront; aggregate potential consideration of up to $2.13bn Development Stage Preclinical Geography Worldwide What Happened Merck entered an exclusive global licence agreement with SciBrunch Therapeutics for SPR2015, an investigational oral KRAS G12D ON inhibitor. Why It Matters KRAS G12D is an important oncology target across multiple tumour types, and the agreement expands Merck's pipeline of investigational targeted cancer therapies. Supporting Context SciBrunch will receive $400m upfront and is eligible for additional development, regulatory and commercial milestone payments that could bring aggregate consideration to $2.13bn. Strategic Rationale The transaction gives Merck control of a preclinical targeted therapy designed to inhibit the active state of KRAS G12D. Potential Impact SPR2015 could add another approach to targeting KRAS-driven cancers if it progresses successfully through clinical development. Key Takeaway Merck is committing $400m upfront for worldwide rights to SPR2015, with the oncology licensing agreement potentially reaching $2.13bn. What to Watch Progression of SPR2015 from preclinical development into human clinical trials. Primary Source Merck Relevant Date 28 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

Novo Nordisk has secured rights outside Greater China to Hengrui Pharma's once-weekly oral GLP-1/GIP dual receptor agonist HRS-1596 in a deal worth up to $2.6bn. Hengrui will receive $300m upfront, with total potential consideration of up to $2.6bn plus royalties as Novo Nordisk adds the phase 1-ready candidate to its obesity and metabolic disease pipeline. The agreement gives Novo Nordisk global rights outside Greater China to develop, manufacture and commercialise HRS-1596. Field Content Alert Type Licensing agreement Companies Novo Nordisk; Hengrui Pharma Deal Type Exclusive licence Asset or Company HRS-1596 Therapy Area(s) Obesity and metabolic disease Technology or Modality Once-weekly oral GLP-1/GIP dual receptor agonist Deal Value $300m upfront; total potential consideration of up to $2.6bn plus royalties Development Stage Phase 1-ready Geography Global rights outside Greater China What Happened Novo Nordisk entered an exclusive licence agreement with Hengrui Pharma for HRS-1596, a once-weekly oral GLP-1/GIP dual receptor agonist. Why It Matters The agreement adds another oral incretin-based candidate to Novo Nordisk's metabolic disease pipeline as competition continues across next-generation obesity treatments. Supporting Context Hengrui will receive $300m upfront and is eligible for additional development, regulatory and commercial milestone payments, taking potential total consideration to up to $2.6bn, as well as royalties. Strategic Rationale Novo Nordisk gains access to a differentiated once-weekly oral GLP-1/GIP programme that complements its existing obesity and metabolic disease portfolio. Potential Impact Successful development could broaden the range of oral incretin-based treatment options available within the competitive obesity market. Key Takeaway Novo Nordisk is expanding its next-generation obesity pipeline through a potentially $2.6bn licensing agreement for Hengrui's once-weekly oral GLP-1/GIP candidate. What to Watch Clinical development of HRS-1596 and progression beyond its initial Phase I programme. Primary Source Novo Nordisk Relevant Date 29 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

Merck has secured exclusive worldwide rights to SciBrunch Therapeutics' preclinical KRAS G12D inhibitor SPR2015 in an oncology licensing transaction worth up to $2.13 billion. SciBrunch will receive $400 million upfront, with additional development, commercial and other milestone payments potentially taking the total transaction value to $2.13 billion. The agreement gives Merck a preclinical oral KRAS G12D (ON) inhibitor targeting one of the most important oncogenic mutations across multiple tumour types. Field Content Article Type Deals Companies Merck; SciBrunch Therapeutics Deal Type Exclusive global licensing agreement Asset SPR2015 Therapy Areas Oncology Technology/Modality Oral KRAS G12D (ON) inhibitor Development Stage Preclinical Upfront Payment $400 million Potential Deal Value Up to $2.13 billion Geography Worldwide What Happened Merck secured exclusive worldwide rights to SciBrunch Therapeutics' investigational oral KRAS G12D (ON) inhibitor SPR2015. Why It Matters The transaction adds a targeted oncology programme directed at KRAS G12D, a major oncogenic driver across several difficult-to-treat cancers. Supporting Context SPR2015 is a preclinical small-molecule programme designed to inhibit the active ON state of KRAS G12D. Strategic Rationale Merck gains a potentially differentiated KRAS-targeted asset for its oncology pipeline while SciBrunch receives substantial upfront funding and downstream milestone opportunities. Potential Impact Successful development could expand targeted treatment options for patients with KRAS G12D-mutated cancers. Key Takeaway Merck is paying $400 million upfront for SPR2015 in a licensing transaction worth up to $2.13 billion. What to Watch IND-enabling development, entry into clinical trials and initial evidence of activity across KRAS G12D-mutated tumours. Primary Source Merck Relevant Date 28 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 Emcitate as the first treatment for MCT8 deficiency, providing a therapy for the peripheral thyrotoxicosis associated with this ultra-rare genetic disorder. Emcitate (tiratricol) is approved for adults and paediatric patients with MCT8 deficiency, also known as Allan-Herndon-Dudley syndrome. The first-in-disease approval provides a treatment designed to act without relying on the defective MCT8 transporter responsible for the disorder. Field Content Article Type Approvals Drug Name Tiratricol Brand Name Emcitate Regulatory Authority U.S. Food and Drug Administration Approval Type First FDA-approved treatment for MCT8 deficiency Indication Peripheral thyrotoxicosis in adults and paediatric patients with MCT8 deficiency Therapy Areas Rare disease; endocrinology; neurology Disease MCT8 deficiency / Allan-Herndon-Dudley syndrome Technology/Modality Thyroid hormone analogue Geography United States What Happened The FDA approved Emcitate for peripheral thyrotoxicosis in adults and paediatric patients with MCT8 deficiency. Why It Matters Emcitate is the first FDA-approved treatment for MCT8 deficiency, addressing an ultra-rare genetic disorder with no previously approved therapy. Supporting Context MCT8 deficiency results from defects in the MCT8 thyroid hormone transporter and is also known as Allan-Herndon-Dudley syndrome. Potential Impact The approval establishes the first US pharmacological treatment option for patients with MCT8 deficiency. Key Takeaway Emcitate becomes the first FDA-approved treatment for MCT8 deficiency. What to Watch US launch, patient access and longer-term evidence from treatment in adults and children. Primary Source U.S. Food and Drug Administration Relevant Date 28 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

STADA and SBP Group have launched a strategic biosimilars partnership beginning with a proposed Keytruda biosimilar and providing a framework for up to three additional programmes. The initial programme covers TQB3570, a proposed pembrolizumab biosimilar, with CTTQ responsible for development, manufacturing and supply and STADA receiving exclusive commercial rights across multiple European and CIS markets. The agreement also gives the partners a framework for up to three additional oncology and immunology biosimilars, substantially broadening the potential scope of the collaboration. Field Content Article Type Deals Companies STADA; SBP Group; CTTQ Deal Type Strategic biosimilars partnership Initial Asset TQB3570 Reference Product Keytruda (pembrolizumab) Therapy Areas Oncology; immunology Technology/Modality Monoclonal antibody biosimilars Programme Scope TQB3570 plus framework for up to three additional biosimilar programmes Commercial Territories European Union; Switzerland; United Kingdom; CIS, with options covering additional territories What Happened STADA and SBP Group launched a strategic partnership initially covering TQB3570, a proposed pembrolizumab biosimilar, with a framework for up to three additional biosimilars. Why It Matters The partnership combines a major biosimilar opportunity around Keytruda with the potential creation of a broader oncology and immunology portfolio. Development Responsibilities CTTQ will develop, manufacture and supply the products while STADA receives exclusive commercial rights in agreed territories. Strategic Rationale The arrangement combines SBP Group and CTTQ's development and manufacturing capabilities with STADA's established European biosimilars commercial infrastructure. Potential Impact The collaboration could create multiple new biosimilar competitors across major oncology and immunology biologic markets. Key Takeaway STADA and SBP Group are building a multi-product biosimilars partnership starting with a proposed Keytruda biosimilar. What to Watch Development progress for TQB3570, regulatory filings and selection of the additional biosimilar programmes. Primary Source STADA Relevant Date 28 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 Council has formally adopted its position on the EU pharmaceutical package, moving the bloc's largest overhaul of medicines legislation in decades toward its final legislative stages. The reform covers medicine authorisation, regulatory data and market protection, supply obligations, orphan-drug incentives, antimicrobial resistance and changes to the Bolar exemption. The regulation and directive still require adoption by the European Parliament before the new pharmaceutical framework can enter into force. Field Content Article Type Industry Updates Development EU pharmaceutical legislation reform Institution Council of the European Union Policy Area Pharmaceutical and medicines regulation Legislative Instruments EU pharmaceutical package regulation and directive Geography European Union What Happened The Council formally adopted its first-reading position on the regulation and directive forming the EU pharmaceutical package. Why It Matters The package represents the most extensive reform of EU pharmaceutical legislation in decades and will reshape important rules governing medicines development, authorisation, incentives and supply. Key Measures Changes cover regulatory and market-protection rules, medicine-supply obligations, orphan-drug incentives, the Bolar exemption and incentives addressing antimicrobial resistance. Legislative Status Council first-reading position formally adopted; European Parliament adoption remains required. Potential Impact Pharmaceutical and biotechnology companies operating in Europe will need to adapt regulatory, intellectual-property and market-access strategies to the revised framework. Key Takeaway The EU pharmaceutical reform has passed a major Council milestone and is moving toward completion of the legislative process. What to Watch European Parliament adoption, publication of the final legislation and implementation timelines for the new rules. Primary Source Council of the European Union Relevant Date 28 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 expanded indication extends Lilly's JAK inhibitor to adolescents aged 12 years and older with severe alopecia areata. The FDA has expanded the approval of Olumiant (baricitinib) to include patients aged 12 years and older with severe alopecia areata. The decision was supported by the Phase III BRAVE-AA-PEDS study, extending a treatment previously available in the US for adults with severe alopecia areata to eligible adolescents. Field Content Alert Type Approval Company Eli Lilly and Company Product Olumiant (baricitinib) Indication Severe alopecia areata Patient Population Patients aged 12 years and older Technology/Modality JAK inhibitor Regulator U.S. Food and Drug Administration Regulatory Status Expanded FDA approval Clinical Study Phase III BRAVE-AA-PEDS What Happened FDA expanded Olumiant's approval to include adolescents aged 12 years and older with severe alopecia areata. Why It Matters The decision extends an established systemic treatment for severe alopecia areata to a younger patient population. Supporting Evidence The approval was supported by the Phase III BRAVE-AA-PEDS study. Previous Population Olumiant was previously approved in the US for adults with severe alopecia areata. Potential Impact Eligible adolescents with severe alopecia areata gain access to an FDA-approved systemic treatment already used in adults. Key Takeaway Olumiant's US alopecia areata indication now covers patients from age 12. What to Watch Adolescent uptake, treatment guidelines and post-approval safety and effectiveness data. Primary Source Eli Lilly and Company 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

The approval introduces a selective dopamine D1/D5 receptor partial agonist as a new oral treatment option for adults with Parkinson's disease. Juvmo (tavapadon) has been approved by the FDA for the treatment of Parkinson's disease in adults. The approval follows the Phase III TEMPO clinical programme and brings a selective dopamine D1/D5 receptor partial agonist into the US Parkinson's treatment landscape. Field Content Field Content Alert Type FDA Approval Product Juvmo (tavapadon) Indication Parkinson's disease Patient Population Adults Technology/Modality Oral selective dopamine D1/D5 receptor partial agonist Regulator U.S. Food and Drug Administration Regulatory Status FDA approved Clinical Programme Phase III TEMPO programme What Happened FDA approved Juvmo for the treatment of Parkinson's disease in adults. Why It Matters The approval introduces a new oral treatment using selective partial agonism of dopamine D1 and D5 receptors. Supporting Evidence The regulatory programme was supported by the Phase III TEMPO studies. Therapeutic Area Neurology Potential Impact Juvmo adds another pharmacological option for the management of Parkinson's disease in adults. Key Takeaway Juvmo brings a selective D1/D5 receptor partial agonist to the US Parkinson's disease market. What to Watch Commercial launch, prescribing uptake and positioning within existing Parkinson's treatment pathways. 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

The collaboration gives Roche access to Atavistik Bio's AMPS platform to discover allosteric small molecules across cardiovascular, renal and metabolic disease targets. Roche and Atavistik Bio have entered a multi-target research collaboration using Atavistik's AMPS platform to identify and develop allosteric small-molecule therapies. Atavistik will receive $70 million upfront and could earn up to $1.9 billion in milestone payments, as well as tiered royalties on resulting products. Field Content Field Content Alert Type Research Collaboration Companies Atavistik Bio; Roche Deal Type Multi-target research collaboration Technology/Platform AMPS allosteric drug discovery platform Therapy Areas Cardiovascular, renal and metabolic diseases Technology/Modality Allosteric small molecules Upfront Payment $70 million Potential Milestones Up to $1.9 billion Additional Economics Tiered royalties What Happened Roche entered a collaboration with Atavistik Bio to discover and develop allosteric small-molecule therapies against multiple targets. Why It Matters The agreement pairs Roche's drug-development capabilities with Atavistik's platform for identifying allosteric binding opportunities. Strategic Rationale The collaboration is designed to generate new medicines against cardiovascular, renal and metabolic disease targets. Potential Impact Successful programmes could broaden Roche's pipeline while validating Atavistik's AMPS platform across multiple targets. Key Takeaway The collaboration carries potential economics of nearly $2 billion in upfront and milestone payments before royalties. What to Watch Target progression, candidate nominations and movement of programmes into clinical development. Primary Source Atavistik Bio 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 agreement gives Sun Pharma rights to the once-monthly PCSK9 inhibitor lerodalcibep across global markets excluding the US and China. Sun Pharma has secured exclusive licensing, commercialisation and manufacturing rights to LIB Therapeutics' lerodalcibep worldwide outside the US and China. The deal adds an EU-approved once-monthly PCSK9 inhibitor, marketed as Lyrokaul in Europe, to Sun Pharma's portfolio in exchange for undisclosed upfront and milestone payments plus royalties. Field Content Field Content Alert Type Licensing Agreement Companies Sun Pharma; LIB Therapeutics Deal Type Exclusive licensing, commercialisation and manufacturing agreement Asset Lerodalcibep Brand Lyrokaul in the European Union Therapy Area Cardiovascular disease / lipid management Target PCSK9 Technology/Modality Once-monthly injectable PCSK9 inhibitor Geography Worldwide excluding the US and China Deal Value Financial amounts not disclosed Deal Economics Upfront payment, milestone payments and royalties What Happened Sun Pharma secured exclusive rights to lerodalcibep in markets worldwide excluding the US and China. Why It Matters The transaction gives Sun Pharma access to a differentiated once-monthly cholesterol-lowering therapy with an existing European regulatory approval. Strategic Rationale The agreement expands Sun Pharma's cardiovascular portfolio and provides a platform for commercialising lerodalcibep across multiple international markets. Potential Impact The partnership could broaden global access to lerodalcibep while strengthening Sun Pharma's position in lipid management. Key Takeaway Sun Pharma gains broad international rights to LIB Therapeutics' once-monthly PCSK9 inhibitor. What to Watch Market launches, reimbursement decisions and commercial uptake outside the US and China. Primary Source Sun Pharma Relevant Date 28 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