The designation provides regulatory development incentives for Vanda’s IL-36 receptor inhibitor in the EU and follows orphan status for the investigational therapy in the US and Japan. The European Commission has granted orphan designation to Vanda Pharmaceuticals’ imsidolimab for the treatment of generalised pustular psoriasis (GPP), following a positive opinion from the EMA’s Committee for Orphan Medicinal Products. The designation is the first EU orphan recognition for a GPP treatment and provides development incentives, but it does not constitute marketing authorisation. Field Content Alert Type Industry Update Topic Orphan designation; Regulatory development Organisation(s) Vanda Pharmaceuticals; European Commission; European Medicines Agency (EMA) Affected Stakeholders Vanda Pharmaceuticals; dermatologists; GPP researchers; patients with generalised pustular psoriasis Therapy Area(s) Dermatology; Rare disease; Generalised pustular psoriasis Geography European Union What Happened On 24 August 2026, Vanda announced that the European Commission had granted orphan designation to imsidolimab for GPP, based on a positive opinion from the EMA’s Committee for Orphan Medicinal Products. Imsidolimab is an investigational humanised IgG4 monoclonal antibody targeting the IL-36 receptor. According to Vanda, this is the first time the European Commission has granted orphan designation to a medicine for GPP. The designation recognises the programme under the EU orphan-medicines framework but does not constitute approval or marketing authorisation. (PR Newswire) Why It Matters EU orphan designation can provide incentives including protocol assistance, reduced regulatory fees and, if the medicine is subsequently approved and continues to meet the applicable criteria, market-exclusivity benefits. For Vanda, the decision adds European orphan status to designations already granted in the US and Japan as it pursues development of imsidolimab across major markets. (BioPharm International) Supporting Context GPP is a rare, potentially life-threatening inflammatory skin disease characterised by widespread pustular eruptions and systemic inflammation and associated with dysregulation of IL-36 signalling. Imsidolimab is designed to inhibit IL-36 receptor signalling and has been evaluated in the Phase III GEMINI-1 study. (PR Newswire) Who Is Most Affected Vanda is most directly affected because the designation provides regulatory incentives as it advances imsidolimab in Europe. Dermatologists and patients with GPP are the relevant clinical stakeholders, although imsidolimab remains investigational and the designation does not make it available for routine treatment. Industry Impact The decision formally recognises imsidolimab within the EU orphan-medicines framework and may support Vanda’s European development strategy. Its impact on GPP treatment will depend on subsequent regulatory submissions, assessment and any eventual marketing authorisation. Key Takeaway European orphan designation gives Vanda additional regulatory support for imsidolimab’s development in GPP but should not be confused with approval of the medicine. What to Watch Imsidolimab’s US BLA is currently under FDA review with a target action date of 12 December 2026, while further European regulatory steps will determine whether the programme progresses towards an EU marketing authorisation application. (BioPharm International) Primary Source Vanda Pharmaceuticals – European Commission orphan designation announcement Relevant Date 24 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 approval establishes Trodelvy-based treatment across PD-L1 status in first-line metastatic TNBC in Europe, following the earlier authorisation of Trodelvy monotherapy for patients not eligible for PD-1/PD-L1 inhibitors. The European Commission has approved Gilead’s Trodelvy (sacituzumab govitecan) in combination with Keytruda (pembrolizumab) for adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received no prior systemic therapy for metastatic disease and whose tumours express PD-L1 with a combined positive score (CPS) ≥10. The authorisation makes the combination the first ADC plus immunotherapy regimen approved for first-line metastatic TNBC in the EU and, together with the earlier Trodelvy monotherapy approval, provides Trodelvy-based options across PD-L1 status. Field Content Alert Type Drug Approval Drug Name Trodelvy (sacituzumab govitecan), in combination with Keytruda (pembrolizumab) Indication Treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic disease and whose tumours express PD-L1 with CPS ≥10. (Gilead Sciences Investor Relations) Therapy Area(s) Oncology; Breast cancer Geography European Union; Norway; Iceland; Liechtenstein What Happened On 24 August 2026, the European Commission granted marketing authorisation for Trodelvy in combination with Keytruda for first-line treatment of PD-L1-positive unresectable locally advanced or metastatic TNBC. The approval follows a positive CHMP opinion issued in July and is based on the Phase III ASCENT-04/KEYNOTE-D19 study. It follows a separate June 2026 European approval of Trodelvy monotherapy for first-line metastatic TNBC in adults who are not candidates for PD-1 or PD-L1 inhibitor therapy. (Gilead Sciences Investor Relations) Why It Matters The decision moves Trodelvy into first-line treatment for PD-L1-positive metastatic TNBC in combination with immunotherapy. Together with the existing monotherapy indication for patients who are not candidates for PD-1/PD-L1 inhibitors, the approvals establish Trodelvy-based first-line options across PD-L1 status in Europe and move the ADC substantially earlier in the metastatic treatment pathway. (Gilead Sciences Investor Relations) Supporting Context The approval is supported by ASCENT-04/KEYNOTE-D19, which compared Trodelvy plus Keytruda with standard-of-care chemotherapy plus Keytruda in first-line PD-L1-positive metastatic TNBC. The Trodelvy combination produced a statistically significant improvement in progression-free survival, reducing the risk of disease progression or death by 35% versus the comparator regimen. (Gilead Sciences Investor Relations) Key Takeaway The European approval establishes Trodelvy plus Keytruda as a new first-line option for PD-L1-positive metastatic TNBC and completes Trodelvy’s expansion across PD-L1 status in the European first-line setting. What to Watch Adoption of Trodelvy-based regimens in European first-line metastatic TNBC and how clinicians position the ADC plus Keytruda against existing chemotherapy-immunotherapy approaches for PD-L1-positive disease. Primary Source Gilead Sciences – European Commission marketing authorisation announcement (Gilead Sciences Investor Relations) Relevant Date 24 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 authorisation gives patients aged five years and older the first treatment specifically approved for Rett syndrome across the European Union, with Acadia preparing for an initial German launch in the fourth quarter of 2026. The European Commission has granted marketing authorisation to Daybue (trofinetide) for the treatment of neurobehavioural symptoms associated with Rett syndrome in patients aged five years and older, making it the first and only authorised treatment for the condition in the EU. The decision extends trofinetide’s regulatory reach beyond existing approvals in the US, Canada and Israel and follows a regulatory process in which Acadia Pharmaceuticals pursued re-examination after an earlier negative CHMP assessment. Field Content Alert Type Drug Approval Drug Name Daybue (trofinetide) Indication Treatment of neurobehavioural symptoms associated with Rett syndrome in patients aged five years and older. (BiotechDispatch) Therapy Area(s) Neurology; Rare disease; Neurodevelopmental disorders Geography European Union; Iceland; Liechtenstein; Norway What Happened On 25 August 2026, the European Commission granted marketing authorisation for Daybue (trofinetide) to treat neurobehavioural symptoms associated with Rett syndrome in patients aged five years and older. The authorisation applies across all 27 EU member states and extends to Iceland, Liechtenstein and Norway. Acadia Pharmaceuticals holds the exclusive worldwide licence to develop and commercialise trofinetide from Neuren Pharmaceuticals. Daybue becomes the first and only authorised treatment specifically for Rett syndrome in the EU. (BiotechDispatch) Why It Matters Until this authorisation, there was no treatment specifically approved for Rett syndrome in the EU. Daybue therefore introduces a disease-specific pharmacological treatment option for eligible European patients and extends access to a therapy already commercialised in other markets, including the US and Canada. (BiotechDispatch) Supporting Context The European approval follows an extended regulatory process. Acadia originally submitted the MAA in January 2025, but in February 2026 the CHMP communicated a negative trend vote, prompting plans for re-examination. The subsequent European Commission authorisation therefore represents a reversal of the programme's earlier regulatory trajectory. (Neuren Pharmaceuticals) Key Takeaway European approval makes Daybue the first authorised treatment specifically for Rett syndrome in the EU and expands trofinetide into another major commercial market. What to Watch Acadia expects to launch Daybue in Germany early in the fourth quarter of 2026. Under its licensing agreement, Neuren is due $35 million following the first commercial sale in Europe and is eligible for up to $170 million in European sales milestones plus tiered royalties ranging from the mid-teens to low twenties per cent. (BiotechDispatch) Primary Source Acadia Pharmaceuticals / Neuren Pharmaceuticals Relevant Date 25 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 MHLW marketing approval adds a Neulasta biosimilar to Biocon’s Japanese portfolio, with Sandoz K.K. responsible for its exclusive promotion, sale and distribution in the country. Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted marketing approval to Biocon Biologics’ pegfilgrastim biosimilar to Neulasta, expanding the company’s biosimilar portfolio in the Japanese market. The product was developed and manufactured by Biocon Biologics, with Global Regulatory Partners Japan serving as marketing authorisation holder and Sandoz K.K. exclusively responsible for promotion, sales and distribution in Japan. Field Content Alert Type Drug Approval Drug Name Pegfilgrastim biosimilar to Neulasta Indication Pegfilgrastim is used as supportive treatment to reduce the risk of infection associated with chemotherapy-induced neutropenia. (Business Standard) Therapy Area(s) Oncology; Haematology; Cancer supportive care Geography Japan What Happened On 25 August 2026, Biocon announced that wholly owned subsidiary Biocon Biologics had received marketing approval from Japan’s MHLW for its pegfilgrastim biosimilar to Amgen’s Neulasta. The product was developed and manufactured by Biocon Biologics. Global Regulatory Partners Japan serves as the marketing authorisation holder on Biocon’s behalf, while Sandoz K.K. will exclusively promote, sell and distribute the product in Japan. (Business Standard) Why It Matters The approval expands the availability of biosimilar pegfilgrastim within Japan and strengthens Biocon’s presence in the country’s biosimilars market. For Biocon, it adds another approved oncology-supportive-care biosimilar to a global portfolio in which pegfilgrastim is already established; its Fulphila pegfilgrastim biosimilar had reached a 30% US market share by the end of FY2025. (Biocon Biologics) Supporting Context Pegfilgrastim is a long-acting granulocyte colony-stimulating factor used to reduce the incidence of infection associated with chemotherapy-induced neutropenia. Biocon Biologics has an established global pegfilgrastim franchise and was the first company globally to receive US FDA approval for a biosimilar pegfilgrastim in 2018. (Biocon Biologics) Key Takeaway Japanese marketing approval expands Biocon Biologics’ biosimilar footprint while giving Sandoz K.K. an additional oncology supportive-care product to commercialise in the country. What to Watch Commercial launch timing and how Sandoz positions the product within Japan’s existing pegfilgrastim market will determine the near-term commercial impact of the approval. Primary Source Biocon / Biocon Biologics regulatory announcement Relevant Date 25 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 technology-transfer collaboration will use Serum Institute’s manufacturing capabilities to develop and produce KM Biologics’ Japanese encephalitis vaccine in India, with a regulatory application targeted as early as 2027. Meiji Seika Pharma group company KM Biologics and Serum Institute of India (SII) are collaborating to transfer technology for the development and manufacture in India of the Japanese encephalitis vaccine currently produced and marketed by KM Biologics in Japan. SII is expected to seek Indian regulatory approval as early as 2027, with the partnership intended to establish local manufacturing and supply of the vaccine for children in India. Field Content Alert Type Deal Companies KM Biologics; Meiji Seika Pharma; Serum Institute of India Deal Type Technology transfer and development/manufacturing collaboration Asset or Company Japanese encephalitis vaccine currently manufactured and marketed in Japan by KM Biologics Therapy Area(s) Infectious diseases; Vaccines; Japanese encephalitis Technology or Modality Cell-culture Japanese encephalitis vaccine Deal Value Financial terms have not been disclosed. Meiji Seika Pharma has also said that it cannot yet provide an investment figure for its wider plans in India because its strategy remains under development. (Devdiscourse) Development Stage Technology transfer and Indian development activities ahead of planned regulatory submission Geography India; Japan What Happened KM Biologics, a Meiji Seika Pharma group company, has entered a technology collaboration with Serum Institute of India covering development and manufacturing of a Japanese encephalitis vaccine in India. The collaboration is based on a technology-transfer agreement, and SII has begun development activities using the vaccine technology currently employed by KM Biologics in Japan. Meiji Seika Pharma president Toshiaki Nagasato said SII is expected to apply for Indian regulatory approval as early as 2027, after which the vaccine could be made available to children in India if approved. SII technical personnel have already visited Japan to study the vaccine technology. Why It Matters The agreement combines an established Japanese vaccine technology with SII’s large-scale vaccine development and manufacturing infrastructure in India. Local development and manufacturing could support a more stable and potentially more affordable supply of Japanese encephalitis vaccine for the Indian market, although regulatory approval, pricing and commercial availability have not yet been established. (Devdiscourse) Supporting Context The underlying technology collaboration was announced in April 2026, when KM Biologics reported achievement of the first milestone under its agreement with SII. The vaccine marketed in Japan is ENCEVAC, a cell-culture Japanese encephalitis vaccine manufactured by KM Biologics and sold by Meiji Seika Pharma. Strategic Rationale KM Biologics and Meiji Seika Pharma gain access to SII’s development and large-scale manufacturing capabilities in India, providing a route to extend an established Japanese vaccine technology into another major market. SII gains access to the vaccine technology and would be responsible for progressing the programme towards Indian regulatory approval and local supply. (Devdiscourse) Potential Impact If successfully developed and approved, the partnership could establish an additional locally manufactured Japanese encephalitis vaccine for India. Its eventual impact on vaccine access and supply will depend on regulatory approval, manufacturing scale, pricing and inclusion within relevant vaccination channels. Key Takeaway The partnership transfers KM Biologics’ established Japanese encephalitis vaccine technology to Serum Institute with the aim of developing a locally manufactured vaccine for India. What to Watch Completion of technology transfer and development work, followed by SII’s planned Indian regulatory application as early as 2027 and subsequent decisions on manufacturing scale, pricing and vaccine availability. (The Tribune) Primary Source Serum Institute of India / KM Biologics technology collaboration announcement Relevant Date 24 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 agreement gives Genentech ex-South Korea rights to a Phase I non-incretin UCN2 analogue designed to reduce weight while preserving lean body mass, adding a differentiated mechanism to Roche’s growing cardiometabolic pipeline. Hanmi Pharm has granted Roche subsidiary Genentech exclusive rights to develop, manufacture and commercialise HM17321 outside South Korea for $190 million upfront, with the total deal value potentially reaching approximately $2.3 billion through development, regulatory and commercial milestones. The Phase I UCN2 analogue provides Roche with a non-incretin obesity programme designed to promote weight loss while preserving lean body mass, potentially complementing incretin-based approaches already being developed across the obesity market. Field Content Alert Type Deal Companies Hanmi Pharm; Genentech, a member of the Roche Group Deal Type Exclusive licensing agreement Asset or Company HM17321 Therapy Area(s) Obesity; Metabolic disease; Type 2 diabetes; Cardiovascular disease Technology or Modality Long-acting UCN2 (urocortin-2) analogue; non-incretin peptide therapeutic Deal Value $190 million upfront. Hanmi is eligible for additional development, regulatory and commercial milestone payments that could bring the total deal value to approximately $2.3 billion, plus separate tiered royalties on future net sales. The amount above the upfront payment is contingent and should not be treated as guaranteed consideration. (Hanmi Pharmaceutical) Development Stage Phase I (Hanmipharm) Geography Worldwide excluding South Korea What Happened On 24 August 2026, Hanmi Pharm entered an exclusive licensing agreement with Genentech covering HM17321, its investigational UCN2 analogue for obesity and associated metabolic conditions. Genentech receives exclusive development, manufacturing and commercialisation rights worldwide excluding South Korea. Hanmi will receive $190 million upfront, with development, regulatory and commercial milestones potentially taking the transaction to approximately $2.3 billion, plus tiered royalties on future sales. HM17321 is currently in Phase I development; Hanmi will complete the ongoing Phase I study before Genentech assumes development from Phase II. (Hanmi Pharmaceutical) Why It Matters HM17321 gives Roche access to an obesity mechanism distinct from the incretin pathways underlying established GLP-1-based therapies. The candidate is designed to selectively reduce fat mass while preserving or improving muscle mass and function, potentially addressing concerns around loss of lean body mass during weight reduction. These potential advantages are not yet clinically established, however, and HM17321 remains in early-stage development. (Hanmi Pharmaceutical) Supporting Context HM17321 is a long-acting, CRF2 receptor-selective UCN2 analogue developed by Hanmi. The company has reported preclinical evidence of weight reduction and body-composition effects both as monotherapy and in combination with GLP-1-based treatment, but these findings require confirmation in clinical development. (PR Newswire) Strategic Rationale Genentech gains worldwide ex-South Korea rights to a differentiated obesity candidate that can broaden Roche’s cardiometabolic pipeline beyond conventional incretin mechanisms. Hanmi receives substantial upfront consideration while retaining South Korean rights and an economic interest in the programme through milestones and tiered royalties. (Hanmi Pharmaceutical) Potential Impact If HM17321 demonstrates clinically meaningful weight reduction while preserving lean mass, the programme could provide Roche with a differentiated standalone or combination approach within obesity and related metabolic diseases. That potential remains dependent on successful clinical development and regulatory approval. Key Takeaway Roche is committing $190 million upfront for access to a non-incretin obesity programme designed around weight loss and lean-mass preservation, with milestones potentially taking Hanmi’s deal to approximately $2.3 billion. What to Watch Completion of HM17321’s Phase I programme, Genentech’s transition into Phase II development and the first clinical evidence showing whether the body-composition effects reported preclinically translate into people with obesity. (M2 Pharma) Primary Source Hanmi Pharm official licensing announcement (Hanmi Pharmaceutical) Relevant Date 24 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 approval extends Johnson & Johnson’s FcRn-blocking therapy into wAIHA, providing a new targeted treatment for adults with a rare autoimmune blood disorder that can cause severe and persistent haemolytic anaemia. The US Food and Drug Administration (FDA) has approved Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune haemolytic anaemia (wAIHA) in adults, making it the first FDA-approved therapy specifically indicated for the condition. The approval is supported by the Phase III ENERGY study, in which Imaavy plus standard of care produced a higher rate of durable haemoglobin response than placebo plus standard of care. Field Content Alert Type Drug Approval Drug Name Imaavy (nipocalimab-aahu) Indication Treatment of warm autoimmune haemolytic anaemia (wAIHA) in adults. Therapy Area(s) Haematology; Autoimmune disease; Rare disease Geography United States (FDA) What Happened On 24 August 2026, the FDA approved Johnson & Johnson’s Imaavy (nipocalimab-aahu) for adults with wAIHA. Imaavy is a neonatal Fc receptor (FcRn)-blocking monoclonal antibody designed to reduce circulating IgG antibodies, including the pathogenic IgG autoantibodies responsible for red blood cell destruction in wAIHA. The approval makes Imaavy the first treatment specifically approved by the FDA for wAIHA and expands the drug’s US label beyond its existing indication in generalised myasthenia gravis. Why It Matters wAIHA is a rare autoimmune disorder in which IgG autoantibodies target and destroy red blood cells, potentially resulting in severe anaemia, fatigue, breathlessness and other complications. Treatment has historically relied on approaches including corticosteroids and other immunosuppressive therapies rather than an FDA-approved medicine specifically indicated for wAIHA, so Imaavy introduces a targeted FcRn-directed treatment into the US pathway. Supporting Context Approval was supported by the Phase III ENERGY study, which compared Imaavy plus standard of care with placebo plus standard of care in adults with wAIHA. The study met its primary endpoint, demonstrating a statistically significant improvement in durable haemoglobin response with Imaavy; the regulatory decision therefore establishes a new approved use for nipocalimab rather than a designation or preliminary recommendation. Key Takeaway FDA approval of Imaavy introduces the first therapy specifically indicated for adults with wAIHA and establishes FcRn blockade as a new targeted treatment approach for the rare autoimmune blood disorder. What to Watch Uptake of Imaavy within the wAIHA treatment pathway, particularly how clinicians position FcRn blockade relative to corticosteroids and other existing treatment approaches, as well as subsequent regulatory decisions for nipocalimab in additional autoimmune indications. Primary Source https://www.jnj.com/media-center/press-releases/fda-approves-imaavy-nipocalimab-aahu-as-first-ever-treatment-for-warm-autoimmune-hemolytic-anemia-waiha-representing-a-landmark-advancement-for-patients Relevant Date 24 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 technology-transfer collaboration will use Serum Institute’s manufacturing capabilities to develop and produce KM Biologics’ Japanese encephalitis vaccine in India, with a regulatory application targeted as early as 2027. Meiji Seika Pharma group company KM Biologics and Serum Institute of India (SII) are collaborating to transfer technology for the development and manufacture in India of the Japanese encephalitis vaccine currently produced and marketed by KM Biologics in Japan. SII is expected to seek Indian regulatory approval as early as 2027, with the partnership intended to establish local manufacturing and supply of the vaccine for children in India. Field Content Alert Type Deal Companies KM Biologics; Meiji Seika Pharma; Serum Institute of India Deal Type Technology transfer and development/manufacturing collaboration Asset or Company Japanese encephalitis vaccine currently manufactured and marketed in Japan by KM Biologics Therapy Area(s) Infectious diseases; Vaccines; Japanese encephalitis Technology or Modality Cell-culture Japanese encephalitis vaccine Deal Value Financial terms have not been disclosed. Meiji Seika Pharma has also said that it cannot yet provide an investment figure for its wider plans in India because its strategy remains under development. (Devdiscourse) Development Stage Technology transfer and Indian development activities ahead of planned regulatory submission Geography India; Japan What Happened KM Biologics, a Meiji Seika Pharma group company, has entered a technology collaboration with Serum Institute of India covering development and manufacturing of a Japanese encephalitis vaccine in India. The collaboration is based on a technology-transfer agreement, and SII has begun development activities using the vaccine technology currently employed by KM Biologics in Japan. Meiji Seika Pharma president Toshiaki Nagasato said SII is expected to apply for Indian regulatory approval as early as 2027, after which the vaccine could be made available to children in India if approved. SII technical personnel have already visited Japan to study the vaccine technology. Why It Matters The agreement combines an established Japanese vaccine technology with SII’s large-scale vaccine development and manufacturing infrastructure in India. Local development and manufacturing could support a more stable and potentially more affordable supply of Japanese encephalitis vaccine for the Indian market, although regulatory approval, pricing and commercial availability have not yet been established. (Devdiscourse) Supporting Context The underlying technology collaboration was announced in April 2026, when KM Biologics reported achievement of the first milestone under its agreement with SII. The vaccine marketed in Japan is ENCEVAC, a cell-culture Japanese encephalitis vaccine manufactured by KM Biologics and sold by Meiji Seika Pharma. Strategic Rationale KM Biologics and Meiji Seika Pharma gain access to SII’s development and large-scale manufacturing capabilities in India, providing a route to extend an established Japanese vaccine technology into another major market. SII gains access to the vaccine technology and would be responsible for progressing the programme towards Indian regulatory approval and local supply. (Devdiscourse) Potential Impact If successfully developed and approved, the partnership could establish an additional locally manufactured Japanese encephalitis vaccine for India. Its eventual impact on vaccine access and supply will depend on regulatory approval, manufacturing scale, pricing and inclusion within relevant vaccination channels. Key Takeaway The partnership transfers KM Biologics’ established Japanese encephalitis vaccine technology to Serum Institute with the aim of developing a locally manufactured vaccine for India. What to Watch Completion of technology transfer and development work, followed by SII’s planned Indian regulatory application as early as 2027 and subsequent decisions on manufacturing scale, pricing and vaccine availability. (The Tribune) Primary Source Serum Institute of India / KM Biologics technology collaboration announcement Relevant Date 24 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 agreement gives Genentech ex-South Korea rights to a Phase I non-incretin UCN2 analogue designed to reduce weight while preserving lean body mass, adding a differentiated mechanism to Roche’s growing cardiometabolic pipeline. Hanmi Pharm has granted Roche subsidiary Genentech exclusive rights to develop, manufacture and commercialise HM17321 outside South Korea for $190 million upfront, with the total deal value potentially reaching approximately $2.3 billion through development, regulatory and commercial milestones. The Phase I UCN2 analogue provides Roche with a non-incretin obesity programme designed to promote weight loss while preserving lean body mass, potentially complementing incretin-based approaches already being developed across the obesity market. Field Content Alert Type Deal Companies Hanmi Pharm; Genentech, a member of the Roche Group Deal Type Exclusive licensing agreement Asset or Company HM17321 Therapy Area(s) Obesity; Metabolic disease; Type 2 diabetes; Cardiovascular disease Technology or Modality Long-acting UCN2 (urocortin-2) analogue; non-incretin peptide therapeutic Deal Value $190 million upfront. Hanmi is eligible for additional development, regulatory and commercial milestone payments that could bring the total deal value to approximately $2.3 billion, plus separate tiered royalties on future net sales. The amount above the upfront payment is contingent and should not be treated as guaranteed consideration. (Hanmi Pharmaceutical) Development Stage Phase I (Hanmipharm) Geography Worldwide excluding South Korea What Happened On 24 August 2026, Hanmi Pharm entered an exclusive licensing agreement with Genentech covering HM17321, its investigational UCN2 analogue for obesity and associated metabolic conditions. Genentech receives exclusive development, manufacturing and commercialisation rights worldwide excluding South Korea. Hanmi will receive $190 million upfront, with development, regulatory and commercial milestones potentially taking the transaction to approximately $2.3 billion, plus tiered royalties on future sales. HM17321 is currently in Phase I development; Hanmi will complete the ongoing Phase I study before Genentech assumes development from Phase II. (Hanmi Pharmaceutical) Why It Matters HM17321 gives Roche access to an obesity mechanism distinct from the incretin pathways underlying established GLP-1-based therapies. The candidate is designed to selectively reduce fat mass while preserving or improving muscle mass and function, potentially addressing concerns around loss of lean body mass during weight reduction. These potential advantages are not yet clinically established, however, and HM17321 remains in early-stage development. (Hanmi Pharmaceutical) Supporting Context HM17321 is a long-acting, CRF2 receptor-selective UCN2 analogue developed by Hanmi. The company has reported preclinical evidence of weight reduction and body-composition effects both as monotherapy and in combination with GLP-1-based treatment, but these findings require confirmation in clinical development. (PR Newswire) Strategic Rationale Genentech gains worldwide ex-South Korea rights to a differentiated obesity candidate that can broaden Roche’s cardiometabolic pipeline beyond conventional incretin mechanisms. Hanmi receives substantial upfront consideration while retaining South Korean rights and an economic interest in the programme through milestones and tiered royalties. (Hanmi Pharmaceutical) Potential Impact If HM17321 demonstrates clinically meaningful weight reduction while preserving lean mass, the programme could provide Roche with a differentiated standalone or combination approach within obesity and related metabolic diseases. That potential remains dependent on successful clinical development and regulatory approval. Key Takeaway Roche is committing $190 million upfront for access to a non-incretin obesity programme designed around weight loss and lean-mass preservation, with milestones potentially taking Hanmi’s deal to approximately $2.3 billion. What to Watch Completion of HM17321’s Phase I programme, Genentech’s transition into Phase II development and the first clinical evidence showing whether the body-composition effects reported preclinically translate into people with obesity. (M2 Pharma) Primary Source Hanmi Pharm official licensing announcement (Hanmi Pharmaceutical) Relevant Date 24 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 clearance extends FDA-authorised blood-based assessment of Alzheimer’s-associated amyloid pathology to younger symptomatic adults, providing clinicians with a less invasive alternative to PET imaging and cerebrospinal fluid testing. The US Food and Drug Administration (FDA) has cleared C2N Diagnostics’ PrecivityAD2® blood test to aid identification of amyloid pathology associated with Alzheimer’s disease in adults aged 40 years and older who have signs or symptoms of cognitive impairment and are undergoing evaluation for Alzheimer’s disease or other causes of cognitive decline. The clearance provides clinicians with a blood-based tool for assessing brain amyloid pathology in a younger symptomatic population, although PrecivityAD2 is not intended for screening or as a standalone diagnostic test. Field Content Alert Type Drug Approval Drug Name PrecivityAD2® Indication Blood-based in vitro diagnostic intended to aid healthcare professionals experienced in evaluating cognitive impairment in identifying amyloid pathology associated with Alzheimer’s disease in adults aged 40 years and older who present with signs or symptoms of cognitive impairment and are undergoing evaluation for Alzheimer’s disease or other forms of cognitive decline. It is not intended for screening or use as a standalone diagnostic test. (C2N Diagnostics) Therapy Area(s) Neurology; Alzheimer’s disease; Diagnostics Geography United States (FDA) What Happened On 20 August 2026, the FDA cleared C2N Diagnostics’ PrecivityAD2 blood test for symptomatic adults aged 40 years and older. The test uses high-resolution mass spectrometry to measure plasma Aβ42/40 and p-tau217/np-tau217, combining the results in an algorithm to assess the likelihood of brain amyloid pathology associated with Alzheimer’s disease. It is the first FDA-cleared Alzheimer’s blood test indicated for symptomatic patients from age 40, expanding blood-based assessment to a younger population than previously cleared tests. (C2N Diagnostics) Why It Matters Confirming Alzheimer’s-associated amyloid pathology has traditionally relied on approaches including PET imaging and cerebrospinal fluid testing. PrecivityAD2 provides clinicians evaluating cognitive symptoms with a less invasive blood-based option and extends FDA-cleared testing to adults from age 40, which is particularly relevant when investigating possible younger-onset disease. Results must still be interpreted alongside the patient’s clinical assessment and other diagnostic information. (C2N Diagnostics) Supporting Context In a clinical validation study involving 1,142 symptomatic adults, a positive PrecivityAD2 result had a 97.6% positive predictive value for amyloid pathology, while a negative result had a 93.1% negative predictive value, using amyloid PET or cerebrospinal fluid biomarker testing as reference methods. A “Likely Positive” result occurred in 17.3% of participants and had a 77.3% positive predictive value. (C2N Diagnostics) Key Takeaway FDA clearance of PrecivityAD2 gives clinicians a blood-based method for assessing Alzheimer’s-associated amyloid pathology in symptomatic adults from age 40, broadening the population that can access an FDA-cleared blood test during diagnostic evaluation. (C2N Diagnostics) What to Watch C2N expects the FDA-cleared version of PrecivityAD2 to become available later in 2026; its current CLIA-validated laboratory-developed version remains available in the meantime. (C2N Diagnostics) Primary Source C2N Diagnostics FDA clearance announcement Relevant Date 20 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 Lumipulse plasma test provides clinicians with a less invasive way to assess amyloid pathology in cognitively impaired adults aged 55 years and older, potentially reducing reliance on PET imaging and cerebrospinal fluid testing. The US Food and Drug Administration (FDA) has cleared Fujirebio's Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio for the early detection of amyloid plaques associated with Alzheimer's disease in adults aged 55 years and older who show signs and symptoms of cognitive decline, making it the first blood-based in vitro diagnostic cleared by the FDA to aid Alzheimer's diagnosis. The test measures plasma pTau217 and β-amyloid 1-42 and could provide a more accessible assessment of amyloid pathology than PET imaging or cerebrospinal fluid testing, although it is not intended for screening or use as a standalone diagnostic. Field Content Alert Type Drug Approval Drug Name Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio Indication Blood-based in vitro diagnostic for the early detection of amyloid plaques associated with Alzheimer's disease in adults aged 55 years and older who exhibit signs and symptoms of the disease. Results must be interpreted alongside other clinical information and the test is not intended as a screening or standalone diagnostic. (U.S. Food and Drug Administration) Therapy Area(s) Neurology; Alzheimer's disease; Diagnostics Geography United States (FDA) What Happened On 16 May 2025, the FDA granted 510(k) clearance to Fujirebio Diagnostics' Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, making it the first blood test cleared to aid in diagnosing Alzheimer's disease. The assay measures plasma pTau217 and β-amyloid 1-42 and calculates their ratio to assess the likelihood of amyloid plaque pathology. The FDA determined the test was substantially equivalent to Fujirebio's previously authorised cerebrospinal-fluid-based Lumipulse G β-amyloid Ratio test. (U.S. Food and Drug Administration) Why It Matters Assessing Alzheimer's-related amyloid pathology has traditionally relied on tools including PET imaging and cerebrospinal fluid testing, which can be costly, time-consuming or invasive. A blood-based test provides clinicians with a less invasive option that could make amyloid assessment more accessible for symptomatic patients, while still requiring interpretation alongside the wider clinical evaluation. (U.S. Food and Drug Administration) Supporting Context In a multicentre study of 499 cognitively impaired adults, 91.7% of people with positive Lumipulse results were confirmed as amyloid-positive by PET or cerebrospinal fluid testing, while 97.3% of those with negative results were amyloid-negative by these reference methods. Fewer than 20% received an indeterminate result. (U.S. Food and Drug Administration) Key Takeaway FDA clearance establishes the Lumipulse assay as the first blood-based test authorised in the US to aid Alzheimer's diagnosis, providing a less invasive route to assessing amyloid pathology in symptomatic adults aged 55 years and older. (U.S. Food and Drug Administration) Primary Source FDA clearance announcement Relevant Date 16 May 2025 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 combination will create a Nasdaq-listed Ambros Therapeutics focused on neridronate, backed by a concurrent $150 million private placement expected to fund the programme through Phase III results and a planned FDA submission. Werewolf Therapeutics and Ambros Therapeutics have entered a definitive all-stock merger agreement based on implied pre-financing equity values of $500 million for Ambros and $47.5 million for Werewolf, alongside a $150 million concurrent private placement. The combined company will operate as Ambros Therapeutics and focus on the Phase III development of neridronate for complex regional pain syndrome type 1 (CRPS-1), with the financing expected to provide cash runway into the first half of 2029. Field Content Alert Type Deal Companies Werewolf Therapeutics; Ambros Therapeutics Deal Type All-stock merger and concurrent private placement Asset or Company Ambros Therapeutics, principally neridronate Therapy Area(s) Neurology; Pain; Rare diseases Technology or Modality Bisphosphonate Deal Value The merger exchange ratio is based on an implied $500 million value for Ambros Therapeutics and $47.5 million for Werewolf Therapeutics, before giving effect to a concurrent $150 million private placement. The financing is separate from the merger consideration. (GlobeNewswire) Development Stage Phase III – neridronate is being evaluated in the pivotal CRPS-RISE trial for CRPS-1. (Werewolf Therapeutics, Inc.) Geography United States; combined company to be Nasdaq-listed What Happened On 21 August 2026, Werewolf Therapeutics and Ambros Therapeutics entered into a definitive agreement to combine in an all-stock transaction. Ambros will become a wholly owned subsidiary of Werewolf, with the combined business operating as Ambros Therapeutics and expected to trade on Nasdaq under the ticker AMBX. Pre-merger Ambros shareholders are expected to own approximately 71.7%, existing Werewolf shareholders approximately 6.8%, and investors in the concurrent financing approximately 21.5% of the combined company. The companies have also secured commitments for a $150 million private placement expected to close concurrently with the merger. (Werewolf TX Investors) Why It Matters The transaction provides Ambros with a public-market vehicle and additional capital to advance neridronate through its pivotal Phase III programme and towards a potential FDA submission. Neridronate is being developed for CRPS-1, for which there is currently no FDA-approved therapy, giving the combined company a late-stage programme addressing a defined treatment gap. (Ambros Therapeutics, Inc.) Supporting Context Neridronate has received FDA Breakthrough Therapy, Fast Track and Orphan Drug designations for CRPS-1. The companies state that the FDA has agreed that a single successful pivotal trial could potentially support an application for approval, while Phase III CRPS-RISE topline results are expected in 2028. (Ambros Therapeutics, Inc.) Strategic Rationale Ambros gains access to the public markets and financing intended to fund neridronate through Phase III results and a planned NDA submission, while Werewolf shareholders retain an interest in the combined company. Eligible pre-merger Werewolf shareholders will also receive a contingent value right linked to potential proceeds from dispositions of Werewolf's legacy assets. (GlobeNewswire) Potential Impact If the CRPS-RISE trial is successful and neridronate subsequently secures FDA approval, the combined company could bring forward the first FDA-approved treatment for CRPS-1. This remains dependent on successful Phase III development and regulatory review. (Werewolf Therapeutics, Inc.) Key Takeaway The merger shifts the combined company's focus to Ambros' late-stage neridronate programme, with $150 million in new financing providing funding towards its pivotal CRPS-1 readout and planned FDA submission. (Werewolf Therapeutics, Inc.) What to Watch Completion of the merger and private placement, CRPS-RISE Phase III topline results expected in 2028, and a potential subsequent NDA submission for neridronate in CRPS-1. (Ambros Therapeutics, Inc.) Primary Source Werewolf Therapeutics and Ambros Therapeutics merger announcement 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