The agreement adds a late-stage oral therapy for rare genetic photodermatoses to LEO Pharma's dermatology pipeline while expanding its focus on rare skin diseases. LEO Pharma has agreed to acquire the worldwide rights to dersimelagon from Tanabe Pharma for up to $435 million in upfront and near-term milestone payments, together with potential downstream milestones and tiered royalties. The acquisition gives LEO Pharma a Phase III-complete investigational oral therapy for erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), strengthening its rare dermatology pipeline ahead of a potential US launch, subject to regulatory approval. Field Content Alert Type Deal Companies LEO Pharma; Tanabe Pharma Corporation Deal Type Asset acquisition / global licensing rights acquisition Asset or Company Worldwide rights to dersimelagon (MT-7117) Therapy Area(s) Rare dermatology; Rare genetic skin diseases Technology or Modality Oral small-molecule melanocortin 1 receptor (MC1R) agonist Deal Value Up to $435 million in upfront and near-term milestone payments, together with potential downstream development and commercial milestones and tiered royalties on net sales. The $435 million does not represent guaranteed consideration. (LEO Pharma) Development Stage NDA under FDA review following completed Phase III development Geography Worldwide What Happened On 18 August 2026, LEO Pharma announced an agreement to acquire the worldwide rights to dersimelagon from Tanabe Pharma. Dersimelagon is a once-daily oral MC1R agonist being developed for EPP and XLP and has completed Phase III development, with a New Drug Application submitted to the FDA in June 2026. The transaction remains subject to customary closing conditions, including regulatory approvals. (LEO Pharma) Why It Matters The acquisition adds a late-stage rare disease programme to LEO Pharma's dermatology portfolio and supports its strategy of expanding through targeted acquisitions and partnerships. If approved, dersimelagon could become the first oral therapy for EPP and XLP, although regulatory approval has not yet been granted. (LEO Pharma) Supporting Context EPP and XLP are rare inherited disorders characterised by severe, painful phototoxic reactions following exposure to sunlight. Phase III data showed statistically significant improvements in sunlight tolerance, and the programme is currently under FDA review. (LEO Pharma) Strategic Rationale LEO Pharma gains a late-stage asset that complements its growing rare dermatology portfolio and leverages its established global commercial infrastructure in dermatology. Tanabe Pharma monetises the programme while remaining eligible for future milestone payments and royalties. (LEO Pharma) Potential Impact If approved, dersimelagon could broaden LEO Pharma's rare disease portfolio with a novel oral treatment option for patients with EPP and XLP. The programme's clinical and commercial impact will depend on FDA review, successful transaction completion and subsequent market uptake. (LEO Pharma) Key Takeaway LEO Pharma is investing up to $435 million to strengthen its rare dermatology pipeline with a Phase III-complete oral therapy approaching potential regulatory approval. (LEO Pharma) What to Watch Completion of the transaction, the FDA's review of the pending NDA, potential regulatory decisions in additional markets and LEO Pharma's commercial launch plans if the therapy is approved. (LEO Pharma) Primary Source https://leo-pharma.com/media-center/news/leo-pharma-further-strengthens-late-stage-pipeline-with-the-acquisition-of-dersimelagon/ Relevant Date 18 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 acquisition makes Yapan Bio a Piramal Pharma subsidiary, strengthening the company's integrated biologics development and manufacturing offering for vaccines, biologics and antibody-drug conjugates. Piramal Pharma has completed the acquisition of an additional 40.67% stake in Yapan Bio Private Limited for ₹76 crore (approximately US$7.95 million), increasing its ownership to 74% and making the biologics CDMO a subsidiary. The transaction expands Piramal Pharma Solutions' integrated large-molecule capabilities by adding Yapan Bio's expertise in biologics and vaccine development and manufacturing. Field Content Alert Type Deal Companies Piramal Pharma Limited; Yapan Bio Private Limited Deal Type Acquisition of controlling stake Asset or Company 74% controlling stake in Yapan Bio Private Limited Therapy Area(s) Multiple Technology or Modality Biologics and vaccine CDMO services; large-molecule development and manufacturing; antibody-drug conjugates (ADCs) Deal Value ₹76 crore (approximately US$7.95 million) in cash for an additional 40.67% equity stake, increasing Piramal Pharma's ownership from 33.33% to 74%. (PR Newswire) Geography India; Global What Happened On 18 August 2026, Piramal Pharma completed its acquisition of an additional 40.67% stake in Hyderabad-based Yapan Bio, increasing its ownership to 74% and converting the company from an associate into a subsidiary. Piramal has held a strategic stake in Yapan Bio since 2021, and the completed transaction brings the company's biologics development and manufacturing capabilities fully into the Piramal Pharma Solutions CDMO business. (PR Newswire) Why It Matters The acquisition expands Piramal Pharma Solutions' integrated biologics offering by adding specialist expertise in process development, characterisation and Phase I/II GMP manufacturing for vaccines and biologics. It also strengthens the company's ability to provide end-to-end large-molecule development services, including support for antibody-drug conjugate programmes. (PR Newswire) Supporting Context Yapan Bio specialises in biologics and vaccine CDMO services and already supported Piramal Pharma Solutions' biologics offering following Piramal's initial investment in 2021. Integrating Yapan Bio as a subsidiary allows Piramal to embed these capabilities more fully into its global CDMO network. (PR Newswire) Strategic Rationale Piramal gains greater operational control over a specialist biologics CDMO, enabling tighter integration of large-molecule development, manufacturing and ADC capabilities across its global service platform while supporting long-term expansion in biologics. (PR Newswire) Potential Impact The acquisition could strengthen Piramal Pharma Solutions' competitive position in the growing biologics CDMO market by broadening its integrated service offering. The long-term commercial impact will depend on successful integration and continued demand for outsourced biologics manufacturing. (PR Newswire) Key Takeaway By making Yapan Bio a subsidiary, Piramal Pharma strengthens its biologics CDMO platform and expands its ability to support customers developing complex large-molecule therapies. What to Watch Integration of Yapan Bio into Piramal Pharma Solutions, expansion of biologics manufacturing services and continued development of the company's ADCelerate™ platform. (PR Newswire) Primary Source https://www.prnewswire.com/in/news-releases/piramal-pharma-limited-completes-acquisition-of-controlling-stake-in-yapan-bio-private-limited-302854503.html Relevant Date 18 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 discussion paper launches a public consultation that could shape future regulatory expectations for AI-enabled medical devices, including premarket evaluation, risk assessment and postmarket monitoring. The US Food and Drug Administration (FDA) has published a discussion paper seeking public feedback on how generative AI-enabled medical devices should be regulated, opening a consultation covering risk assessment, premarket evaluation and postmarket monitoring. The initiative signals the FDA's intention to develop a regulatory framework tailored to generative AI while inviting input from manufacturers, clinicians, researchers and other stakeholders before any formal guidance is introduced. Field Content Alert Type Industry Update Topic Regulation of generative AI-enabled medical devices Organisation(s) US Food and Drug Administration (FDA); Digital Health Center of Excellence (DHCoE) Affected Stakeholders Medical device manufacturers, digital health developers, AI technology companies, healthcare providers, researchers and patients Therapy Area(s) Industry-wide Geography United States What Happened On 18 August 2026, the FDA's Digital Health Center of Excellence published a discussion paper requesting public feedback on considerations for regulating generative AI-enabled medical devices. The paper explores potential approaches to risk assessment, competency-based premarket evaluation, postmarket monitoring, foundation models and agentic AI systems. It is intended solely to inform future policy development and does not represent draft guidance, final guidance or a change in regulatory requirements. Stakeholder comments are invited until 19 October 2026. (U.S. Food and Drug Administration) Why It Matters The consultation provides manufacturers and healthcare stakeholders with an opportunity to influence how future FDA oversight of generative AI-enabled medical devices may evolve. Although no new regulatory requirements have been introduced, the discussion highlights the FDA's focus on ensuring that future frameworks balance innovation with patient safety and lifecycle oversight. (U.S. Food and Drug Administration) Supporting Context The FDA notes that generative AI-enabled medical devices present challenges that differ from traditional software because outputs may vary over time and models can evolve after deployment. The discussion paper therefore explores regulatory approaches that extend beyond existing AI-enabled device frameworks. (U.S. Food and Drug Administration) Who Is Most Affected Developers of AI-enabled Software as a Medical Device (SaMD) and manufacturers planning to incorporate generative AI into medical devices are likely to be most directly affected, as any future framework could influence evidence requirements, product validation and postmarket obligations. (U.S. Food and Drug Administration) Industry Impact While no immediate regulatory changes take effect, the consultation could shape future expectations for AI governance, clinical validation, performance monitoring and regulatory submissions for generative AI-enabled medical devices. Any future obligations will depend on subsequent FDA guidance or rulemaking. (U.S. Food and Drug Administration) Key Takeaway The FDA has begun a formal consultation on how generative AI-enabled medical devices should be regulated, marking an early step towards a purpose-built regulatory framework without introducing new requirements at this stage. (U.S. Food and Drug Administration) What to Watch Publication of the final consultation outcomes, any draft FDA guidance informed by stakeholder feedback, and how future proposals align with existing AI medical device regulation. Comments are due by 19 October 2026. (Regulations.gov) Primary Source https://www.fda.gov/medical-devices/digital-health-center-excellence/considerations-regulation-generative-ai-enabled-medical-devices-discussion-paper-and-request Relevant Date 18 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 introduces the first therapy designed to address the underlying cause of glycogen storage disease type Ia, offering a one-time gene therapy option for eligible patients aged eight years and older. The US Food and Drug Administration (FDA) has granted accelerated approval to GENGLYCOS (pariglasgene brecaparvovec-opnr, also known as DTX401) for use alongside nutritional management to reduce daily cornstarch intake in adults and paediatric patients aged eight years and older with glycogen storage disease type Ia (GSDIa), making it the first approved treatment designed to address the disease's underlying cause. The approval provides a new therapeutic option for patients who currently rely on lifelong dietary management, although continued clinical follow-up is required to confirm long-term benefit under the accelerated approval pathway. Field Content Alert Type Drug Approval Drug Name GENGLYCOS (pariglasgene brecaparvovec-opnr; DTX401) Indication Adjunct to nutritional management to reduce daily cornstarch intake in adults and paediatric patients aged eight years and older with glycogen storage disease type Ia (GSDIa). (U.S. Food and Drug Administration) Therapy Area(s) Rare Diseases; Metabolic Disorders; Gene Therapy Geography United States (FDA) What Happened On 19 August 2026, the FDA granted accelerated approval to GENGLYCOS, an AAV8-based gene therapy developed by Ultragenyx, for adults and paediatric patients aged eight years and older with GSDIa. The one-time treatment delivers a functional G6PC gene to the liver to address the enzyme deficiency underlying the disease. It is the first approved therapy designed to target the root cause of GSDIa and the first gene therapy approved for this indication. The approval was supported by Phase III data demonstrating reduced reliance on dietary cornstarch and was accompanied by a post-marketing requirement to further confirm clinical benefit. (U.S. Food and Drug Administration) Why It Matters Until now, management of GSDIa has depended on strict lifelong dietary control and frequent cornstarch dosing to prevent hypoglycaemia. GENGLYCOS offers a one-time gene therapy designed to restore glucose regulation by addressing the underlying enzyme deficiency, although long-term efficacy and safety will continue to be evaluated following accelerated approval. (U.S. Food and Drug Administration) Supporting Context GSDIa is an ultra-rare inherited metabolic disorder caused by mutations affecting glucose-6-phosphatase activity, leading to impaired glucose release from the liver and severe metabolic complications. The approval was based on the Phase III GlucoGene study and the FDA also awarded Ultragenyx a Rare Pediatric Disease Priority Review Voucher. (U.S. Food and Drug Administration) Key Takeaway FDA approval establishes GENGLYCOS as the first gene therapy and first disease-modifying treatment for GSDIa, providing a new option beyond lifelong dietary management. (U.S. Food and Drug Administration) What to Watch Completion of the FDA-required post-marketing study to confirm long-term clinical benefit, commercial rollout in the US and regulatory decisions in other jurisdictions. (U.S. Food and Drug Administration) Primary Source https://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-announces-us-fda-approval-genglycostm-gene-therapy Relevant Date 19 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 provides adults with fibrodysplasia ossificans progressiva with a new treatment option designed to reduce abnormal bone formation and disease flare-ups in an ultra-rare genetic disorder. The US Food and Drug Administration (FDA) has approved Pasatru (garetosmab-grts) to reduce new heterotopic ossification lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP), making it the second approved treatment for the condition. The approval offers an additional therapeutic option for adults with this progressive rare disease, although long-term treatment outcomes and paediatric use will continue to be evaluated. Field Content Alert Type Drug Approval Drug Name Pasatru (garetosmab-grts) Indication Reduction of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). (U.S. Food and Drug Administration) Therapy Area(s) Rare Diseases; Musculoskeletal Disorders; Genetics Geography United States (FDA) What Happened On 19 August 2026, the FDA approved Pasatru (garetosmab-grts) for adults with FOP. Pasatru is a fully human monoclonal antibody that blocks Activin A, a key driver of abnormal bone formation in the disease. The approval was supported by the Phase III OPTIMA trial, in which both evaluated doses significantly reduced the formation of new HO lesions and clinician-assessed flare-ups compared with placebo. Pasatru becomes the second FDA-approved treatment for FOP and the first approved therapy shown to reduce clinician-assessed flare-ups in a placebo-controlled trial. (U.S. Food and Drug Administration) Why It Matters FOP is an ultra-rare inherited disorder in which muscle, tendons and ligaments progressively turn into bone, leading to severe disability and loss of mobility. Pasatru provides clinicians with an additional treatment option aimed at slowing new bone formation and reducing disease activity in adults, expanding therapeutic choice beyond the single previously approved medicine. (U.S. Food and Drug Administration) Supporting Context FOP is caused by mutations in the ACVR1 gene that result in inappropriate activation of bone formation pathways. In the Phase III OPTIMA study, Pasatru reduced new HO lesions by around 90% or more compared with placebo over 56 weeks. (U.S. Food and Drug Administration) Key Takeaway FDA approval gives adults with FOP a second approved treatment and introduces the first therapy demonstrated to reduce clinician-assessed disease flare-ups in a placebo-controlled study. (U.S. Food and Drug Administration) What to Watch Commercial launch in the US, initiation of Regeneron's planned paediatric clinical programme, and regulatory submissions in additional markets. (Kelo) Primary Source https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-second-treatment-fibrodysplasia-ossificans-progressiva Relevant Date 19 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 introduces the first autonomous robotic system designed to perform blood collection under phlebotomist supervision, supporting outpatient services facing workforce pressures. The US Food and Drug Administration (FDA) has granted De Novo marketing authorisation to Aletta, a standalone robotic blood draw device developed by Vitestro, for use in adults in outpatient settings under the supervision of a trained phlebotomist. The authorisation establishes a new category of AI- and imaging-enabled medical device that could help improve access to routine blood collection while maintaining human oversight. Field Content Alert Type Drug Approval Drug Name Aletta (Vitestro robotic blood draw device) Indication Standalone robotic medical device authorised to perform venous blood collection from the arm in adults in outpatient settings under the supervision of a trained phlebotomist. (U.S. Food and Drug Administration) Therapy Area(s) Diagnostics; Medical Devices; Digital Health Geography United States (FDA) What Happened On 19 August 2026, the FDA granted De Novo marketing authorisation to Vitestro's Aletta, the first standalone robotic device authorised to draw blood without hands-on operator intervention. The system uses near-infrared imaging and Doppler ultrasound to identify a suitable vein before autonomously applying a tourniquet, disinfecting the skin, inserting and removing the needle, changing collection tubes and applying a bandage. A trained phlebotomist must initiate each procedure, supervise the device and verify that samples have been collected correctly. One phlebotomist may oversee up to three Aletta devices simultaneously. (U.S. Food and Drug Administration) Why It Matters Blood collection is one of the most frequently performed medical procedures, and many healthcare providers face shortages of trained phlebotomists. Aletta introduces a regulated automation platform intended to support clinical workflows while retaining human oversight, although adoption will depend on implementation decisions by healthcare organisations rather than FDA authorisation alone. (U.S. Food and Drug Administration) Supporting Context The FDA based its decision on clinical evidence showing blood draw success rates comparable with, or better than, trained human phlebotomists when the device proceeded with venepuncture. The agency authorised the device through the De Novo pathway and established new special controls for future devices of this type. (U.S. Food and Drug Administration) Key Takeaway FDA authorisation establishes Aletta as the first standalone autonomous robotic blood draw device, creating a new regulated category for automated venepuncture technology. (U.S. Food and Drug Administration) What to Watch Clinical adoption across outpatient services, real-world operational performance, and whether additional autonomous blood collection systems follow through the FDA's newly established regulatory pathway. (U.S. Food and Drug Administration) Primary Source https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-its-kind-robotic-blood-draw-device Relevant Date 19 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

We’re proud to share that our Net Promoter Score (NPS) has increased to 79 for the first half of 2026. Building on an already world-class score of 73 in 2025, this improvement reflects our continued commitment to delivering scientific engagement that is relevant, practical and valuable for healthcare professionals. More importantly, it’s the feedback behind the score that matters. Recent HCP comments include: “The current standard of the actions is very high. Continuing at this high level of quality would be ideal.” “Excellent study, I would gladly conduct further studies.” “Excellent information that I will reconsider current treatment protocols.” These comments reinforce what we strive for every day: creating educational experiences that are clear, clinically meaningful and capable of influencing real-world practice. We’re incredibly grateful to all the healthcare professionals who continue to engage with us, share their feedback and help us improve every interaction. While we’re delighted to see our NPS continue to rise, our goal remains unchanged: to keep raising the standard of every HCP engagement. You can read more H1 2026 testimonials on our updated page 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 designation broadens regulatory support for the CLDN18.2 × CD47 bispecific antibody as Phanes advances its chemotherapy combination through Phase II development in metastatic pancreatic ductal adenocarcinoma. The US Food and Drug Administration (FDA) has granted Fast Track designation to Phanes Therapeutics’ spevatamig (PT886) in combination with chemotherapy for first-line metastatic pancreatic ductal adenocarcinoma (PDAC). The designation provides opportunities for increased FDA interaction as Phanes advances the Phase II TWINPEAK programme, but does not constitute approval or establish clinical benefit. Field Content Alert Type Industry Update Topic FDA Fast Track designation; clinical development Organisation(s) Phanes Therapeutics; US Food and Drug Administration (FDA) Affected Stakeholders Pancreatic cancer researchers; oncologists; clinical investigators; patients with metastatic pancreatic ductal adenocarcinoma Therapy Area(s) Oncology; Pancreatic cancer Geography United States What Happened The FDA has granted Fast Track designation to spevatamig (PT886) in combination with chemotherapy for first-line treatment of metastatic pancreatic ductal adenocarcinoma. Spevatamig is Phanes Therapeutics’ investigational bispecific antibody targeting CLDN18.2 and CD47 and is being evaluated in the Phase I/II TWINPEAK study. The new designation follows an earlier Fast Track designation covering metastatic CLDN18.2-positive pancreatic adenocarcinoma and supports increased regulatory interaction as the broader first-line programme progresses. Fast Track designation does not represent FDA approval. Why It Matters Metastatic PDAC remains associated with limited treatment options and poor outcomes, creating a need for additional first-line approaches. The designation is relevant because Phanes is evaluating spevatamig with chemotherapy across a broader metastatic PDAC population, rather than limiting development to patients selected as CLDN18.2-positive, although efficacy and safety still require confirmation in prospective trials. Supporting Context Spevatamig is a native IgG-like bispecific antibody designed to target CLDN18.2 and CD47 simultaneously. Phanes has reported early Phase II findings from the first-line metastatic PDAC programme, but these results come from relatively small patient cohorts and require confirmation in the larger study population. Who Is Most Affected Phanes and investigators developing spevatamig are most directly affected because Fast Track status provides opportunities for more frequent FDA interaction as the programme advances. Patients with metastatic PDAC are the relevant clinical population, although spevatamig remains investigational and is not currently an approved treatment. Industry Impact The designation supports continued development of a bispecific immunotherapy approach combining CLDN18.2 tumour targeting with CD47 blockade in pancreatic cancer. Its significance for the treatment landscape will depend on whether the Phase II programme confirms the efficacy and safety signals observed in earlier cohorts. Key Takeaway Fast Track designation gives Phanes additional regulatory interaction as it evaluates whether spevatamig plus chemotherapy can progress towards pivotal development in first-line metastatic PDAC. What to Watch Phanes expects topline Phase II results by the end of 2026, which will be important in determining whether the programme can progress towards Phase III development. Primary Source Phanes Therapeutics Relevant Date 17 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 new device provides adults with hypercholesterolaemia with an additional self-administration option for once-monthly Lerochol alongside the existing pre-filled syringe. The US Food and Drug Administration (FDA) has approved a single-use autoinjector for Lerochol (lerodalcibep-liga) 300 mg/1.2 mL and updated the indication statement for the PCSK9 inhibitor, which is used alongside diet and exercise to reduce LDL-C in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia (HeFH). The approval adds a new administration option for patients prescribed the once-monthly therapy, with US availability of the autoinjector expected by January 2027. Field Content Alert Type Drug Approval Drug Name Lerochol (lerodalcibep-liga) Indication As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia (HeFH). Therapy Area(s) Cardiovascular disease; Lipid management Geography United States (FDA) What Happened On 17 August 2026, the FDA approved a single-use autoinjector for Lerochol (lerodalcibep-liga) 300 mg/1.2 mL, providing an additional administration option alongside the existing pre-filled syringe. Lerochol is administered subcutaneously once monthly. The FDA also approved updated indication wording stating that cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk of major adverse cardiovascular events in adults at increased risk when treated with statins or monoclonal antibody PCSK9 inhibitors added to statin therapy. Lerochol itself was originally FDA approved in December 2025. Why It Matters Long-term lipid-lowering treatment can make administration method a practical consideration for patients and clinicians. The pressure-activated autoinjector provides another way for eligible patients to self-administer their monthly Lerochol dose while retaining the pre-filled syringe as an alternative; however, the effect of the new device on adherence or clinical outcomes has not been established. Supporting Context Lerochol is a third-generation PCSK9 inhibitor comprising an engineered PCSK9-binding adnectin fused to human serum albumin to extend its plasma half-life. The once-monthly treatment can be stored at room temperature for up to 90 days, providing additional flexibility around storage and administration. Key Takeaway FDA approval of the Lerochol autoinjector gives eligible patients an additional self-administration option for once-monthly PCSK9-directed LDL-C lowering. What to Watch LIB Therapeutics expects the autoinjector to become available in the US by January 2027. Commercial availability, insurance coverage and reimbursement are separate from FDA approval, with the company expecting coverage to expand during 2027. Primary Source https://www.businesswire.com/news/home/20260817106971/en/U.S.-Food-and-Drug-Administration-Approves-an-Autoinjector-Version-of-LEROCHOL-lerodalcibep-liga-and-Updated-Indication Relevant Date 17 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 completed acquisition adds MediSix’s PEBL T-cell engineering technology, clinical pipeline and Singapore-based R&D team to IASO Bio’s existing cell therapy development, manufacturing and commercial capabilities. IASO Biotechnology has completed the acquisition of Singapore-based MediSix Therapeutics, adding its proprietary T-cell engineering platform, development pipeline and international research team to IASO Bio’s cell therapy organisation; financial terms were not disclosed. The transaction broadens IASO Bio’s technology and pipeline capabilities in T-cell malignancies and other diseases while establishing Singapore as an additional component of its international cell therapy development network. Field Content Alert Type Deal Companies IASO Biotechnology (IASO Bio); MediSix Therapeutics Deal Type Acquisition Asset or Company MediSix Therapeutics, including its PEBL (Protein Expression Blocker) platform, pipeline and R&D capabilities Therapy Area(s) Haematological malignancies; Oncology; Autoimmune diseases Technology or Modality CAR-T cell therapy; T-cell engineering; PEBL technology; ex vivo and in vivo CAR-T approaches Deal Value Financial terms were not disclosed. Development Stage Clinical and research stage; lead programme IASO107 (formerly PCART7) is undergoing clinical evaluation. (PR Newswire) Geography Singapore; China; global What Happened On 13 August 2026, IASO Bio announced that it had completed its acquisition of MediSix Therapeutics, a Singapore-based immune cell engineering and cell therapy company. IASO gains MediSix’s proprietary PEBL platform, R&D pipeline and international team. MediSix’s lead programme, IASO107, formerly PCART7, is undergoing clinical evaluation. MediSix will continue developing follow-on products from its platform while using IASO Bio’s CMC, clinical-development, manufacturing and commercial capabilities. Financial terms were not disclosed. (PR Newswire) Why It Matters The acquisition adds a differentiated T-cell engineering technology to IASO Bio’s existing cell therapy platform. MediSix’s PEBL approach is designed to suppress selected target proteins on T-cell surfaces, reducing CAR-T cell fratricide and enabling development against antigens shared by therapeutic T cells and malignant T cells — a significant technical challenge in developing cell therapies for T-cell malignancies. (PR Newswire) Supporting Context MediSix was founded in Singapore in 2016 based on research by CAR-T pioneer Professor Dario Campana. Its PEBL platform has been applied to programmes including IASO107/PCART7, a CD7-directed approach developed for T-cell malignancies, while IASO Bio already operates an integrated cell therapy business spanning discovery, development, manufacturing and commercialisation. (PR Newswire) Strategic Rationale IASO Bio gains MediSix’s technology, clinical programmes and Singapore-based talent and research infrastructure, complementing its existing CMC and cell therapy development capabilities. MediSix’s programmes gain access to IASO Bio’s established manufacturing, clinical-development and commercial infrastructure, which the companies intend to use to support international development. (PR Newswire) Potential Impact Integration of the PEBL platform could broaden IASO Bio’s pipeline into additional T-cell malignancies and other diseases where conventional CAR-T engineering faces target-related challenges. Any clinical impact will depend on the performance of IASO107 and subsequent programmes in prospective clinical development. Key Takeaway The completed MediSix acquisition gives IASO Bio a specialist T-cell engineering platform and Singapore R&D presence as it expands its cell therapy pipeline internationally. What to Watch Clinical progress for IASO107, development of follow-on programmes using the PEBL platform and how IASO Bio integrates MediSix’s Singapore operations into its broader international R&D and manufacturing network. Primary Source https://www.prnewswire.com/news-releases/iaso-biotechnology-announces-acquisition-of-singapore-based-cell-therapy-company-medisix-therapeutics-302850787.html Relevant Date 13 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 portfolio collaboration combines Henlius’ biologics development and manufacturing capabilities with Sandoz’s ex-China commercial infrastructure, initially covering three biosimilars and an option on a recombinant human hyaluronidase programme. Shanghai Henlius Biotech and Sandoz have expanded their existing partnership through a strategic collaboration potentially covering up to 10 monoclonal antibody and/or antibody-drug conjugate biosimilar products or components, with initial agreements covering three products and an option on a fourth asset. For these initial programmes, Sandoz will pay Henlius upfront and milestone payments plus an option fee totalling up to $322 million, while Henlius expects up to $100.5 million to be invoiced during 2026. Field Content Alert Type Deal Companies Shanghai Henlius Biotech; Sandoz Deal Type Strategic collaboration and licensing agreement Asset or Company Up to 10 proposed mAb and/or ADC biosimilar products or components; initial programmes comprise HLX05-N (cetuximab biosimilar), HLX16 (evolocumab biosimilar), a proposed belimumab biosimilar and an option for HLXTE-HAase1001 recombinant human hyaluronidase Therapy Area(s) Oncology; Cardiovascular disease; Immunology Technology or Modality Biosimilar monoclonal antibodies; potential ADC biosimilar programmes; recombinant human hyaluronidase Deal Value For the three initially agreed products and option on HLXTE-HAase1001, Sandoz will pay Henlius upfront and milestone payments plus a non-refundable option fee totalling up to $322 million. Henlius expects up to $100.5 million to be invoiced in 2026. The $322 million includes contingent payments and should not be treated as guaranteed consideration. (Henlius) Development Stage Predominantly early stage. HLX05-N entered Phase I in July 2026; HLX16 and the proposed belimumab biosimilar are preclinical; HLXTE-HAase1001 is in process development. (Henlius) Geography Primarily global markets outside China. HLX05-N rights include the US, Canada, EU, UK, Switzerland, Japan, Australia and New Zealand, with semi-exclusive rights in certain additional markets; HLX16 and the proposed belimumab biosimilar cover all markets outside China. (Henlius) What Happened On 17 August 2026, Henlius and Sandoz announced an expanded strategic collaboration potentially covering up to 10 proposed mAb and/or ADC biosimilar products or components developed by Henlius. Three initial products have been agreed — HLX05-N, HLX16 and a proposed belimumab biosimilar — while Sandoz has an option on HLXTE-HAase1001. Henlius will undertake development, manufacturing and supply, while Sandoz receives specified ex-China registration and commercialisation rights and will contribute market and commercial input during development. The agreement expands a relationship established in April 2025 through Sandoz’s licensing of HLX13, Henlius’ proposed ipilimumab biosimilar. (Henlius) Why It Matters The agreement moves the Henlius-Sandoz relationship from a single-product oncology biosimilar partnership towards a broader portfolio model spanning development through commercialisation. Sandoz gains access to multiple early-stage programmes through Henlius’ biologics platform, while Henlius gains an established international partner with registration, market-access and commercial capabilities across major markets outside China. (Henlius) Supporting Context The initial portfolio targets reference products with substantial existing global sales: Henlius cites 2025 worldwide sales of approximately $1.70 billion for cetuximab, $6.60 billion for evolocumab and $2.48 billion for belimumab. These figures relate to the reference products and are not forecasts for Henlius’ proposed biosimilars. (Henlius) Strategic Rationale Henlius retains responsibility for developing, manufacturing and supplying the partnered products while using Sandoz’s international registration, market-access and commercial infrastructure. For Sandoz, the portfolio framework provides access to a pipeline that could expand to as many as 10 programmes rather than relying solely on individual asset-by-asset agreements. (Henlius) Potential Impact If additional programmes are selected and successfully developed, the agreement could broaden the companies’ joint biosimilar portfolio across major international markets. Commercial impact will depend on development success, regulatory approvals, selection of further assets and competitive conditions when individual products reach the market. Key Takeaway Henlius and Sandoz are expanding a single-product relationship into a potentially 10-programme global biosimilars partnership combining Henlius’ development and manufacturing platform with Sandoz’s international commercial reach. What to Watch Selection of additional programmes under the 10-product framework, Sandoz’s decision on the HLXTE-HAase1001 option, clinical progress for HLX05-N and advancement of the earlier-stage HLX16 and belimumab biosimilar programmes. Primary Source https://www.henlius.com/en/NewsDetails-6075-26.html Relevant Date 17 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 reverse-merger transaction gives privately held Slate a Nasdaq listing and additional capital to advance its anti-PACAP migraine portfolio, led by clinical-stage monoclonal antibody SLTE-1009. Slate Medicines and Fulcrum Therapeutics have agreed to merge in an all-stock transaction that will take Slate public through Fulcrum’s Nasdaq listing, alongside approximately $245 million in committed private financing for the combined company. The transaction provides Slate with public-market access and capital to advance its migraine-focused pipeline, led by anti-PACAP/VIP monoclonal antibody SLTE-1009, while existing Fulcrum shareholders will retain a minority interest in the combined business. Field Content Alert Type Deal Companies Slate Medicines; Fulcrum Therapeutics Deal Type All-stock merger / reverse merger with concurrent private financing Asset or Company Slate Medicines and its migraine and headache-disorder pipeline, led by SLTE-1009 Therapy Area(s) Neurology; Migraine; Headache disorders Technology or Modality Monoclonal antibody targeting PACAP/VIP signalling Deal Value The transaction is accompanied by approximately $245 million in committed private financing from new and existing investors. This represents financing for the combined company rather than an acquisition price. Fulcrum shareholders are also expected to receive a pre-closing special cash dividend, subject to the transaction terms and cash available at closing. Development Stage Clinical stage; SLTE-1009 is in Phase I development Geography United States What Happened On 17 August 2026, Slate Medicines and Nasdaq-listed Fulcrum Therapeutics announced a definitive agreement to combine in an all-stock merger. The combined business will operate under the Slate Medicines name and focus on developing therapies for migraine and other headache disorders. Approximately $245 million in committed private financing will accompany the transaction. Existing Fulcrum shareholders are expected to receive a pre-closing special cash dividend and retain a minority ownership position in the combined company. The transaction remains subject to shareholder approval and other customary closing conditions. Why It Matters The transaction provides Slate with a route to the public markets and substantial additional financing for its clinical-stage migraine pipeline without pursuing a conventional IPO. Its lead programme, SLTE-1009, targets PACAP/VIP signalling, providing a mechanism distinct from the CGRP pathway targeted by several established migraine therapies, although its clinical differentiation remains to be demonstrated. Supporting Context Slate launched in 2026 with a $130 million Series A financing and licensed SLTE-1009 from DartsBio Pharmaceuticals. Fulcrum entered a strategic review after discontinuing development of sickle cell disease candidate pociredir following FDA feedback and subsequently implemented substantial workforce reductions to conserve cash. Strategic Rationale Slate gains Fulcrum’s Nasdaq-listed corporate structure and additional capital to fund its pipeline, while Fulcrum shareholders can receive a special cash dividend while retaining an economic interest in the combined company. The structure effectively redirects Fulcrum’s public-market vehicle towards Slate’s migraine-focused development strategy. Potential Impact The financing is intended to support continued development of SLTE-1009 and Slate’s broader headache-disorder pipeline. Whether the transaction establishes a differentiated migraine franchise will depend on clinical results from SLTE-1009 and subsequent programmes. Key Takeaway The Fulcrum merger gives Slate a Nasdaq-listed vehicle and $245 million of committed financing to advance its anti-PACAP migraine development strategy. What to Watch Completion of the merger and financing, the final value of Fulcrum’s special cash dividend and emerging clinical data for SLTE-1009 as Slate advances the programme beyond early-stage development. Primary Source Fulcrum Therapeutics and Slate Medicines transaction announcement / SEC filings Relevant Date 17 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