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 Approvals 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 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 Alert Type Approvals 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

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 Alert Type Approvals 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 Alert Type Deals 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 Article Type Deals Companies Sun Pharma; LIB Therapeutics 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

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 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

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 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

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

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