Renalytix has signed a multi-year agreement with Quest Diagnostics to expand US access to its kidneyintelX.dkd blood test for patients with type 2 diabetes and chronic kidney disease. The collaboration is designed to make kidneyintelX.dkd accessible through Quest's national diagnostics network, broadening physician access to a test that assesses risk of progressive kidney-function decline. kidneyintelX.dkd is FDA-authorised and Medicare-reimbursed, supporting its use in identifying higher-risk patients who may benefit from earlier intervention and more intensive disease management. Field Content Alert Type Industry Update Companies Renalytix; Quest Diagnostics Agreement Type Multi-year diagnostics collaboration Product kidneyintelX.dkd Therapy Area Chronic kidney disease; type 2 diabetes Technology or Modality Blood-based prognostic diagnostic test Geography United States What Happened Renalytix signed a multi-year agreement with Quest Diagnostics to expand access to kidneyintelX.dkd through Quest's US diagnostics network. Why It Matters Quest's national reach could materially increase physician and patient access to kidneyintelX.dkd. Supporting Context The test is FDA-authorised and Medicare-reimbursed for assessing risk of progressive kidney-function decline in adults with type 2 diabetes and early-stage chronic kidney disease. Potential Impact Broader access could support earlier risk stratification and more targeted intervention for patients at increased risk of kidney disease progression. Key Takeaway Renalytix is partnering with Quest Diagnostics to expand US access to kidneyintelX.dkd. What to Watch Commercial rollout through Quest and subsequent adoption by physicians and health systems. Primary Source Renalytix Relevant Date 1 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 Enhertu plus pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer. The approval introduces a new first-line HER2-directed regimen in the European Union based on results from the Phase III DESTINY-Breast09 trial. Enhertu plus pertuzumab significantly reduced the risk of disease progression or death compared with the established taxane, trastuzumab and pertuzumab regimen, providing a new treatment option for eligible patients. Field Content Alert Type Approval Drug Name Trastuzumab deruxtecan plus pertuzumab Brand Name Enhertu plus Perjeta Company AstraZeneca; Daiichi Sankyo; Roche Regulatory Authority European Commission Approval Type Marketing authorisation / indication approval Indication First-line treatment of adults with unresectable or metastatic HER2-positive breast cancer Therapy Area(s) Oncology; breast cancer Geography European Union What Happened The European Commission approved Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. Why It Matters The approval establishes a new first-line HER2-directed treatment option in the EU and represents the first major change to the treatment approach in this setting in more than a decade. Supporting Context The approval was supported by results from the Phase III DESTINY-Breast09 trial comparing Enhertu plus pertuzumab with the established taxane, trastuzumab and pertuzumab regimen. Key Takeaway European approval of Enhertu plus pertuzumab introduces a new first-line standard option for eligible adults with unresectable or metastatic HER2-positive breast cancer. What to Watch Adoption of the combination across European markets and its impact on the sequencing of HER2-directed therapies in metastatic breast cancer. Primary Source AstraZeneca Relevant Date 1 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 Cipla exclusive rights to develop and commercialise the investigational HER2-targeted bispecific antibody-drug conjugate TQB2102 across India, South Africa and five additional emerging markets. Cipla has entered into an exclusive licensing agreement with Sino Biopharmaceutical subsidiary Chia Tai Tianqing Pharmaceutical Group for TQB2102, a bispecific antibody-drug conjugate targeting HER2. The deal expands Cipla's oncology pipeline with a late-stage asset being investigated across multiple HER2-expressing cancers, including breast and gastric cancers. Field Content Alert Type Deal Companies Cipla; Sino Biopharmaceutical; Chia Tai Tianqing Pharmaceutical Group Deal Type Exclusive licensing agreement Asset or Company TQB2102 Therapy Area(s) Oncology; HER2-expressing cancers Technology or Modality HER2-targeted bispecific antibody-drug conjugate Deal Value Financial terms were not disclosed Development Stage Late-stage clinical development Geography India, South Africa and five additional emerging markets What Happened Cipla entered into an exclusive licensing agreement with Chia Tai Tianqing Pharmaceutical Group, part of Sino Biopharmaceutical, covering the development and commercialisation of TQB2102 in India, South Africa and five additional emerging markets. Why It Matters The agreement gives Cipla access to a differentiated late-stage HER2-targeted oncology asset and strengthens its speciality oncology pipeline across important emerging markets. Supporting Context TQB2102 is a bispecific antibody-drug conjugate being evaluated for the treatment of multiple HER2-expressing cancers. Strategic Rationale The licence supports Cipla's strategy of expanding access to innovative oncology medicines while adding an advanced targeted therapy to its portfolio. Potential Impact If successfully developed and approved, TQB2102 could expand treatment options for patients with HER2-expressing tumours across Cipla's licensed territories. Key Takeaway Cipla has secured exclusive rights to a late-stage HER2 bispecific ADC across seven emerging markets, strengthening its targeted oncology portfolio. What to Watch Clinical development of TQB2102, subsequent regulatory filings and the programme's progression towards commercialisation in the licensed territories. Primary Source Cipla Relevant Date 1 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 Roche exclusive global rights to develop, manufacture and commercialise Simcere Zaiming's investigational trispecific antibody SIM0660 outside Greater China. Roche has entered into a global licensing agreement for SIM0660, an investigational CD79a/CD19/CD3 trispecific antibody being developed by Simcere Zaiming for B-cell malignancies and autoimmune diseases. Simcere is eligible to receive up to $1.53 billion under the agreement, including a $75 million upfront payment, development and commercial milestone payments and tiered royalties on future sales. Field Content Alert Type Deal Companies Roche; Simcere Zaiming Deal Type Exclusive licensing agreement Asset or Company SIM0660 Therapy Area(s) B-cell malignancies; autoimmune diseases Technology or Modality CD79a/CD19/CD3 trispecific antibody Deal Value Up to $1.53 billion, including $75 million upfront plus potential development and commercial milestone payments; Simcere is also eligible for tiered royalties on future sales Development Stage Clinical-stage Geography Global rights outside Greater China What Happened Roche secured exclusive rights outside Greater China to develop, manufacture and commercialise SIM0660, Simcere Zaiming's investigational CD79a/CD19/CD3 trispecific antibody. Why It Matters The agreement adds a differentiated B-cell-targeting programme to Roche's pipeline with potential applications across both haematological malignancies and autoimmune diseases. Supporting Context SIM0660 is designed to engage CD3-positive T cells while targeting CD79a and CD19 on B cells, providing a dual B-cell-targeting approach. Strategic Rationale The licence gives Roche access to a potentially differentiated B-cell-directed therapy while allowing Simcere to retain rights in Greater China. Potential Impact Successful development could broaden therapeutic options for diseases driven by pathogenic or malignant B cells. Key Takeaway Roche is committing up to $1.53 billion to secure global rights outside Greater China to Simcere's trispecific B-cell antibody SIM0660. What to Watch Further clinical development of SIM0660 and progress across its oncology and autoimmune indications. Primary Source Simcere Pharmaceutical Group Relevant Date 1 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 Besremi for adults with essential thrombocythemia, extending ropeginterferon alfa-2b-njft into a second myeloproliferative neoplasm indication in the United States. Besremi is administered by subcutaneous injection and was evaluated in the randomised SURPASS ET study against anagrelide in adults with essential thrombocythemia. The approval provides a new treatment option for a rare blood disorder characterised by excessive platelet production and associated risks of thrombosis and bleeding. Field Content Alert Type Approval Regulatory Authority U.S. Food and Drug Administration (FDA) Product Besremi (ropeginterferon alfa-2b-njft) Company PharmaEssentia Indication Treatment of adults with essential thrombocythemia Therapy Area Hematology / myeloproliferative neoplasms Technology or Modality Long-acting monopegylated interferon alfa Geography United States What Happened The FDA approved Besremi (ropeginterferon alfa-2b-njft) injection for the treatment of adults with essential thrombocythemia. Dosing The recommended starting dosage is 250 mcg by subcutaneous injection, increasing to 350 mcg at two weeks and a maintenance dosage of 500 mcg at four weeks, with maintenance dosing every two weeks unless modification is required for tolerability. Supporting Evidence The effectiveness of Besremi was evaluated in SURPASS ET, an open-label, multicentre, randomised study comparing Besremi with anagrelide in adults with essential thrombocythemia. Why It Matters Essential thrombocythemia can increase the risk of blood clots and bleeding because of excessive platelet production, and the approval provides another treatment option for affected adults. Supporting Context Besremi was already approved in the United States for polycythemia vera, another myeloproliferative neoplasm. Potential Impact The expanded indication could broaden use of ropeginterferon alfa-2b-njft across myeloproliferative neoplasms and provide physicians with an additional disease-directed treatment option. Key Takeaway FDA approval extends Besremi into essential thrombocythemia, giving adults with the rare blood disorder a newly authorised interferon-based treatment option. What to Watch Clinical adoption of Besremi in essential thrombocythemia and its positioning relative to established cytoreductive therapies. Primary Source U.S. Food and Drug Administration Relevant Date 31 August 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

Mimrylo is the first FDA-approved polycythemia vera treatment designed to mimic hepcidin, targeting the iron availability that drives excessive red blood cell production. The FDA approved Mimrylo (rusfertide) for treatment of erythrocytosis in adults with polycythemia vera whose disease has not been adequately controlled with existing therapies. By limiting the iron available for red blood cell production, the first-in-class therapy offers a new mechanism for controlling hematocrit and reducing the burden associated with excessive erythrocyte production. Field Content Alert Type Approval Regulatory Authority U.S. Food and Drug Administration (FDA) Product Mimrylo (rusfertide) Indication Treatment of erythrocytosis in adults with polycythemia vera Therapy Area Hematology / myeloproliferative neoplasms Technology or Modality Hepcidin mimetic Geography United States What Happened On 28 August 2026, the FDA approved Mimrylo (rusfertide) for adults with polycythemia vera, a rare blood disorder characterised by excessive red blood cell production. Mechanism Rusfertide mimics hepcidin, a hormone that regulates iron availability. By limiting the iron available for production of new red blood cells, the therapy helps reduce erythrocytosis. Why It Matters Mimrylo is the first approved treatment for polycythemia vera that mimics hepcidin, introducing a new mechanism of action for patients whose disease is not adequately controlled with existing therapies. Supporting Context Excess red blood cells can thicken the blood and increase the risk of complications including blood clots, stroke and heart attack. Potential Impact The approval provides clinicians with a new disease-control strategy that directly targets the biology supporting excessive red blood cell production. Key Takeaway FDA approval establishes Mimrylo as the first-in-class hepcidin-mimetic treatment for erythrocytosis in adults with polycythemia vera. What to Watch Uptake in patients requiring better hematocrit control and the therapy's positioning alongside existing cytoreductive and phlebotomy-based management strategies. Primary Source U.S. Food and Drug Administration Relevant Date 28 August 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’s planned acquisition of Merida Biosciences adds an antibody-engineering platform designed to selectively remove disease-causing antibodies while preserving normal immune function. Eli Lilly has entered into a definitive agreement to acquire Merida Biosciences for up to $2.875 billion in cash, including an upfront payment and contingent milestone payments. The transaction strengthens Lilly’s immunology portfolio and brings in Merida’s lead programme MER511, which has shown early Phase 1 reductions in pathogenic thyroid-stimulating antibodies. Field Content Alert Type Deal Companies Eli Lilly and Company; Merida Biosciences Deal Type Acquisition Asset or Company Merida Biosciences Therapy Area(s) Autoimmune and allergic diseases Technology or Modality Antibody-engineering platform designed to selectively degrade pathogenic autoantibodies Lead Programme MER511 Deal Value Up to $2.875 billion in cash, including an upfront payment and contingent milestone payments Geography United States What Happened On 31 August 2026, Eli Lilly and Merida Biosciences announced a definitive agreement under which Lilly will acquire Merida for up to $2.875 billion in cash. Why It Matters The acquisition expands Lilly's immunology capabilities with a platform designed to target and remove disease-causing antibodies while preserving normal immune function. Supporting Evidence Initial Phase 1 data for MER511 showed robust reductions in pathogenic thyroid-stimulating antibodies with a favourable initial safety profile. Supporting Context Merida is developing biologics engineered to selectively degrade pathogenic autoantibodies implicated in a range of immune-mediated diseases. Strategic Rationale Lilly gains a precision immunology platform and pipeline that could complement its existing presence in autoimmune and allergic diseases. Potential Impact If successfully developed, Merida's programmes could provide new therapeutic approaches for immune-mediated conditions driven by pathogenic antibodies. Key Takeaway Lilly is investing up to $2.875 billion to acquire Merida and add a differentiated antibody-degradation platform to its immunology portfolio. What to Watch Regulatory approvals, expected transaction completion in the fourth quarter of 2026 and further clinical development of MER511. Primary Source Eli Lilly and Company Relevant Date 31 August 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 binding term sheet resolves litigation between Ascendis Pharma and BioMarin while granting Ascendis a worldwide licence covering YUVIWEL and other navepegritide-related products. BioMarin has agreed to grant Ascendis a non-exclusive, worldwide, royalty-bearing licence allowing it to continue researching, developing, manufacturing and commercialising navepegritide-related products without restriction. Ascendis will pay BioMarin royalties equal to 20% of US net sales and 18% of net sales in the European Union, South Korea and Brazil from first commercial sale through 20 May 2030, while the companies will dismiss their respective proceedings. Field Content Alert Type Industry Update Companies Ascendis Pharma; BioMarin Pharmaceutical Agreement Type Global settlement and licence agreement Product YUVIWEL (navepegritide) Therapy Area Achondroplasia and skeletal dysplasias Technology or Modality C-type natriuretic peptide prodrug Geography Global What Happened On 31 August 2026, Ascendis Pharma and BioMarin entered into a binding term sheet setting out the terms of a global settlement and licence agreement related to YUVIWEL and other navepegritide-related products. The agreement is intended to resolve litigation and disputes between the companies. Licence Terms BioMarin will grant Ascendis a non-exclusive, worldwide, royalty-bearing licence allowing Ascendis to continue researching, developing, manufacturing and commercialising navepegritide-related products without restriction. Royalty Terms Ascendis will pay BioMarin royalties equal to 20% of US net sales and 18% of net sales in the European Union, South Korea and Brazil from first commercial sale in each territory through 20 May 2030. Why It Matters The settlement removes a material intellectual-property dispute surrounding Ascendis' navepegritide franchise and provides a defined framework for continued global development and commercialisation. Supporting Context BioMarin has also agreed to waive certain regulatory rights and exclusivities, dismiss proceedings and provide a covenant not to sue relating to the covered intellectual property. Potential Impact Resolution of the dispute could reduce legal uncertainty around YUVIWEL and allow Ascendis to focus on commercial expansion and further development of navepegritide-related products. Key Takeaway Ascendis has secured a worldwide licence and global settlement with BioMarin covering YUVIWEL and navepegritide-related products in exchange for defined royalty payments through May 2030. What to Watch Execution of the definitive settlement agreement and the commercial trajectory of YUVIWEL across the covered markets. Primary Source Ascendis Pharma Relevant Date 31 August 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 latest regulatory package is intended to reduce uncertainty, development costs and delays for generic manufacturers as the US government increases pressure to bring lower-cost medicines to patients more quickly. The US Food and Drug Administration (FDA) has published 55 new and revised product-specific guidances (PSGs) designed to accelerate generic drug development and streamline abbreviated new drug application (ANDA) assessment. The initiative forms part of the FDA’s wider Drug Competition Action Plan and the US administration’s efforts to increase pharmaceutical competition and reduce prescription drug costs. Field Content Alert Type Industry Update Topic Generic drug regulation; Drug pricing; Regulatory guidance Organisation(s) US Food and Drug Administration (FDA); Center for Drug Evaluation and Research (CDER) Affected Stakeholders Generic drug manufacturers; branded pharmaceutical companies; ANDA applicants; patients; payers Therapy Area(s) Multiple therapy areas Geography United States What Happened On 21 August 2026, the FDA published a batch of 55 draft product-specific guidances covering the development of generic medicines and the evidence expected to support ANDAs. The package includes 23 new guidances and 32 revisions, with the agency aiming to give developers clearer routes for demonstrating that proposed generics meet FDA requirements. (Life Sciences IP Review) Why It Matters Product-specific guidance can allow generic manufacturers to design development programmes around the FDA’s expectations earlier, potentially avoiding unnecessary studies, deficiencies and repeated review cycles. The intended result is a faster and less costly route to market, particularly for products where technical complexity has historically made generic competition more difficult. (U.S. Food and Drug Administration) Supporting Context The action is part of the FDA’s Drug Competition Action Plan and supports the objectives of Executive Order 14273, Lowering Drug Prices by Once Again Putting Americans First. FDA says it is simultaneously clarifying expectations for generic developers and improving the efficiency and predictability of its own ANDA review processes while maintaining scientific standards. (U.S. Food and Drug Administration) Who Is Most Affected Generic manufacturers stand to benefit directly from greater regulatory clarity and potentially more efficient development programmes. Originator pharmaceutical companies could face earlier or increased competition once patent and exclusivity barriers expire, while patients and payers could benefit if additional generic entrants translate into lower medicine prices. Industry Impact Faster generic development could have significant economic consequences. FDA research estimated that 773 generic drug applications approved during 2023 generated $18.6 billion in savings during the 12 months following approval, including $2.4 billion associated with first-generic entrants. (U.S. Food and Drug Administration) Key Takeaway The FDA is using more detailed product-specific guidance as one of its tools to remove regulatory bottlenecks from generic development, with the broader objective of getting competing medicines to the US market sooner and increasing downward pressure on drug prices. What to Watch Whether the new guidances translate into shorter development and review timelines, particularly for complex generics, and whether the FDA introduces further measures under its Drug Competition Action Plan as the US administration continues its push to reduce prescription drug costs. Primary Source US Food and Drug Administration Relevant Date 21 August 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 updated Comirnaty formulation targets the XFG variant and will begin shipping immediately for eligible older adults and people aged five to 64 at increased risk of severe COVID-19. The US Food and Drug Administration (FDA) has approved Pfizer and BioNTech’s XFG-adapted Comirnaty COVID-19 vaccine for the 2026–2027 season in adults aged 65 and older and people aged five to 64 with at least one underlying condition that increases their risk of severe COVID-19. The updated mRNA vaccine targets the XFG variant in line with FDA guidance and is expected to become available through US pharmacies, hospitals and clinics within days. Field Content Alert Type Vaccine Approval Product Name Comirnaty XFG (COVID-19 Vaccine, mRNA) Indication Prevention of COVID-19 in adults aged 65 years and older, and individuals aged 5–64 years with at least one underlying condition that puts them at high risk for severe COVID-19 outcomes Therapy Area(s) Infectious disease; Vaccines; COVID-19 Geography United States (FDA) What Happened On 27 August 2026, the FDA approved the supplemental Biologics License Application for Pfizer and BioNTech’s 2026–2027 XFG-adapted Comirnaty vaccine. The monovalent formulation targets the XFG variant and replaces the previous season’s LP.8.1-adapted formulation. Pfizer and BioNTech said shipments would begin immediately, with the vaccine expected in pharmacies, hospitals and clinics across the US within days. (Pfizer) Why It Matters COVID-19 vaccines are periodically adapted as the virus evolves. The FDA selected XFG as its preferred vaccine composition for the 2026–2027 US season, meaning this approval aligns Comirnaty more closely with contemporary circulating SARS-CoV-2 variants ahead of the autumn respiratory-virus season. (Pfizer) Supporting Context The approval draws on the cumulative clinical, non-clinical and real-world evidence supporting Comirnaty, together with manufacturing, quality and non-clinical data for the updated formulation. Pfizer and BioNTech reported that the XFG-adapted vaccine generated strong immune responses against circulating variants including XFG, XFG.1.1, NB.1.8.1, PQ.17 and PQ.2.8.1. More than five billion doses of Pfizer-BioNTech COVID-19 vaccines have been distributed globally. (Pfizer) Key Takeaway FDA approval establishes Pfizer and BioNTech’s XFG-adapted Comirnaty as their US COVID-19 vaccine for the 2026–2027 season, with eligibility focused on people aged 65 and over and younger individuals at increased risk of severe disease. What to Watch The immediate rollout of the XFG-adapted vaccine, US vaccination recommendations and coverage for the 2026–2027 season, and whether future SARS-CoV-2 evolution requires another change in vaccine composition. The same XFG-adapted formulation received European Commission marketing authorisation in July 2026, although the EU authorisation covers individuals from six months of age. (Pfizer) Primary Source Pfizer and BioNTech Relevant Date 27 August 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 once-daily combination of bictegravir and lenacapavir offers virologically suppressed adults a new route to simplify treatment, including patients previously requiring complex multi-tablet regimens. The US Food and Drug Administration (FDA) has approved Gilead Sciences’ Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg) as a complete regimen for adults with HIV-1 who are virologically suppressed on stable antiretroviral therapy and have no known or suspected resistance to its individual components. Bixlenvo becomes the first and only single-tablet regimen for most virologically suppressed patients on complex HIV treatment regimens who cannot use currently available single-tablet options, combining bictegravir with the first-in-class capsid inhibitor lenacapavir. Field Content Alert Type Drug Approval Drug Name Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg) Indication Complete regimen to replace current antiretroviral therapy in adults with HIV-1 who are virologically suppressed, with HIV-1 RNA below 50 copies/mL, on a stable regimen and with no known or suspected resistance to Bixlenvo’s individual components Therapy Area(s) Infectious disease; HIV Geography United States (FDA) What Happened On 27 August 2026, the FDA approved Gilead’s Bixlenvo, a once-daily single-tablet combination of bictegravir and lenacapavir. The treatment pairs bictegravir, an integrase strand transfer inhibitor (INSTI), with lenacapavir, a first-in-class capsid inhibitor with no cross-resistance to existing antiretroviral classes. Bixlenvo requires a two-day initiation regimen involving oral Sunlenca (lenacapavir), followed by one Bixlenvo tablet daily from day three onwards. (Gilead Sciences Investor Relations) Why It Matters Single-tablet HIV regimens have simplified treatment for many patients, but some people with resistance, tolerability issues, contraindications or drug interactions still require complex combinations. Bixlenvo provides a new simplification option for virologically suppressed adults, including treatment-experienced patients who previously required multiple tablets or more than once-daily dosing. (Gilead Sciences Investor Relations) Supporting Context Approval was supported by the Phase III ARTISTRY-1 and ARTISTRY-2 trials. Both showed Bixlenvo was comparable to the control regimens in maintaining virologic suppression through week 48. ARTISTRY-1 specifically studied highly treatment-experienced patients: participants had been treated for a median 28 years, 67% had historical NRTI resistance and some were taking as many as 11 pills per day before switching. (Gilead) Safety Bixlenvo was generally well tolerated in the ARTISTRY programme, with no significant or new safety concerns identified. The most commonly reported adverse reactions were headache, nausea and diarrhoea. (Gilead Sciences Investor Relations) Key Takeaway Bixlenvo extends the benefits of once-daily single-tablet HIV therapy to a broader group of virologically suppressed adults, particularly treatment-experienced patients whose resistance or treatment history has previously required more complicated antiretroviral regimens. What to Watch Uptake among treatment-experienced patients and further expansion of Gilead’s lenacapavir-based HIV portfolio. Gilead and Merck are separately developing islatravir/lenacapavir as a once-weekly oral HIV regimen, with Phase III studies having maintained virologic suppression through week 48 and regulatory submissions planned. (Gilead Sciences Investor Relations) Primary Source Gilead Sciences Relevant Date 27 August 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

Priovant’s once-daily JAK/TYK2 inhibitor introduces a new FDA-approved treatment option for the rare autoimmune disease, supported by Phase III evidence of improvements across muscle, skin and physical-function measures. The US Food and Drug Administration (FDA) has approved Lisraya (brepocitinib) 30 mg tablets for the treatment of dermatomyositis in adults, making it the first FDA-approved oral therapy specifically indicated for the disease. The approval is supported by a 241-patient Phase III trial in which once-daily Lisraya produced greater improvement in the study’s composite Total Improvement Score at week 52 than placebo and also improved physical function and skin disease activity. Field Content Alert Type Drug Approval Drug Name Lisraya (brepocitinib) Indication Treatment of dermatomyositis in adults Therapy Area(s) Immunology; Rheumatology; Dermatology; Rare disease Geography United States (FDA) What Happened On 27 August 2026, the FDA approved Lisraya (brepocitinib) for adults with dermatomyositis. Lisraya is a once-daily oral JAK/TYK2 inhibitor designed to block signalling pathways involved in immune and inflammatory responses. The approval was granted to Priovant Therapeutics and follows FDA Orphan Drug and Priority Review designations. (U.S. Food and Drug Administration) Why It Matters Dermatomyositis is a rare autoimmune disease characterised by chronic inflammation, progressive muscle weakness and distinctive skin manifestations. Patients have historically relied substantially on corticosteroids, immunosuppressants and other therapies not specifically approved for the disease. Lisraya therefore provides a specifically approved oral treatment and introduces JAK/TYK2 inhibition as a new therapeutic approach for adult dermatomyositis. (U.S. Food and Drug Administration) Supporting Context Approval was supported by a Phase III randomised, double-blind, placebo-controlled study involving 241 adults. Patients received brepocitinib 30 mg, 15 mg or placebo for 52 weeks. The approved 30 mg dose achieved a higher average Total Improvement Score (TIS) at week 52 than placebo, with improvements also observed in physical function and skin disease activity. Patients receiving the 30 mg dose were also more likely to reduce corticosteroid use by week 48. (U.S. Food and Drug Administration) Safety Common adverse reactions included upper respiratory tract infection, headache, fatigue, urinary tract infection and nausea. Lisraya carries a boxed warning covering serious infections, increased all-cause mortality, malignancies, major adverse cardiovascular events and thrombosis. (U.S. Food and Drug Administration) Key Takeaway Lisraya becomes the first FDA-approved oral therapy specifically for adult dermatomyositis, adding a targeted JAK/TYK2 inhibitor to a treatment landscape that has historically depended heavily on corticosteroids and other immunosuppressive approaches. What to Watch Uptake of Lisraya in clinical practice, particularly its positioning relative to existing immunosuppressive treatment strategies and whether its ability to reduce corticosteroid use translates into a meaningful longer-term treatment advantage. Primary Source US Food and Drug Administration Relevant Date 27 August 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