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The transaction would give Sobi full ownership of a specialist commercialisation platform spanning seven Latin American markets, building on its $105 million investment in Pint Pharma in 2025. Swedish Orphan Biovitrum (Sobi) is seeking to acquire the remaining shares of Pharma Investments, the parent company of Pint Pharma, giving it full ownership of the Latin American specialist pharmaceutical business following its $105 million investment for 19.9% of voting rights and 60% of economic rights in 2025. The transaction would give Sobi direct control of a regional platform covering regulatory approval, market access and distribution of specialist medicines across seven Latin American markets, supporting its expansion in rare diseases, haematology and oncology. Field Content Alert Type Deal Companies Swedish Orphan Biovitrum (Sobi); Pint Pharma / Pharma Investments Deal Type Acquisition of remaining ownership interest Asset or Company Pharma Investments, parent company of Pint Pharma Therapy Area(s) Rare diseases; Haematology; Oncology Deal Value Consideration for the acquisition of the remaining shares has not been disclosed. In November 2025, Sobi paid $105 million for 19.9% of the voting rights and 60% of the economic rights in Pint Pharma; that amount relates to the earlier investment and is not the consideration for the current transaction. (Dealroom.co) Geography Latin America, including Brazil, Mexico, Argentina and Colombia What Happened Sobi is moving to acquire all remaining shares of Pharma Investments, the parent company of Pint Pharma, according to a transaction submitted to Brazil's competition authority Cade. The proposed acquisition builds on Sobi's 2025 investment, when it acquired 19.9% of the voting rights and 60% of the economic rights for $105 million. Completion would give Sobi full control of Pint Pharma, which operates across seven Latin American markets. The transaction remains subject to the relevant review and has not yet been presented as completed. (Dealroom.co) Why It Matters Full ownership would give Sobi direct control of an established Latin American platform for regulatory approval, market access and distribution of specialist medicines. This could provide Sobi with greater control over launches and commercialisation across markets where navigating country-specific regulatory and access requirements can be important for rare disease and speciality medicines. (Dealroom.co) Supporting Context Sobi and Pint Pharma have maintained a commercial relationship since 2021. The companies expanded that relationship in 2025 when Sobi invested $105 million in Pint Pharma, describing the business as a launch platform for Sobi medicines in Brazil and the wider Latin American region. (Sobi) Strategic Rationale Sobi would move from holding a majority economic interest but minority voting position to full ownership, giving it direct control of Pint Pharma's regional infrastructure and expertise. The transaction therefore deepens an existing partnership rather than representing Sobi's entry into an entirely new commercial relationship. (Dealroom.co) Potential Impact Full ownership could allow Sobi to use Pint Pharma more extensively as a regional launch and commercialisation platform for its specialist portfolio. The eventual impact will depend on transaction completion and Sobi's subsequent decisions regarding which products are introduced through the platform. Key Takeaway Full ownership of Pint Pharma would give Sobi direct control of a seven-market Latin American platform for launching and commercialising rare disease and speciality medicines. What to Watch Review by Brazil's Cade, completion of the acquisition, disclosure of the purchase consideration and Sobi's plans for integrating Pint Pharma into its Latin American commercial operations. (Dealroom.co) Primary Source Brazilian competition filing (Cade); transaction details reported by Dealroom.co based on InvestNews Relevant Date 7 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 rights reversion gives Actimed full control of the muscle-wasting candidate across all indications, with amyotrophic lateral sclerosis remaining its primary development focus. Actimed Therapeutics has reacquired from Faraday Pharmaceuticals the worldwide development, manufacturing and commercialisation rights to S-oxprenolol (ACM-002), ending a 2021 licensing agreement that included up to $126.2 million in potential milestone payments. The transaction consolidates the asset under Actimed's control and gives the company greater flexibility to develop the programme in amyotrophic lateral sclerosis (ALS) and evaluate other muscle-wasting indications. Field Content Alert Type Deal Companies Actimed Therapeutics; Faraday Pharmaceuticals Deal Type Rights reacquisition / termination of licensing agreement Asset or Company S-oxprenolol (ACM-002) Therapy Area(s) Neurology; Muscle-wasting disorders; Cachexia Technology or Modality Anabolic-catabolic transforming agent (ACTA) Deal Value Financial terms of the rights reversion were not disclosed. Under the original 2021 agreement, Actimed received $550,000 in upfront cash and equity, was eligible for a $2.7 million near-term milestone and up to $123.5 million in total potential milestone payments, plus royalties. These contingent payments should not be treated as consideration received under the new transaction. (Actimed Therapeutics) Development Stage Preclinical / pre-clinical development for S-oxprenolol; Actimed plans to initiate clinical development in ALS following completion of chemistry, manufacturing and controls (CMC) work. (Fierce Biotech) Geography Global What Happened On 6 August 2026, Actimed announced that it had negotiated the return of all rights to S-oxprenolol from Faraday Pharmaceuticals, giving Actimed worldwide development, manufacturing and commercialisation control. Under the original 2021 agreement, Faraday had obtained global rights to develop and commercialise S-oxprenolol for cancer cachexia and other indications outside ALS, while Actimed retained ALS rights. The reversion therefore reunifies the asset's global rights under Actimed. (Fierce Biotech) Why It Matters Reacquiring the rights allows Actimed to determine S-oxprenolol's development and partnering strategy across indications rather than retaining control only in ALS. The company continues to identify ALS-associated muscle wasting and cachexia as its primary focus for the asset, which has received FDA Orphan Drug Designation for ALS, while the wider rights could enable exploration of other muscle-wasting disorders. (Fierce Biotech) Supporting Context Actimed licensed most S-oxprenolol rights to Faraday in 2021 while retaining global ALS rights. S-oxprenolol is an ACTA that has generated preclinical evidence in models of muscle wasting, but its potential clinical benefit remains to be established in human trials. (Actimed Therapeutics) Strategic Rationale Full ownership gives Actimed control over future development, manufacturing, commercialisation and potential partnering of S-oxprenolol worldwide, removing the indication-based division of rights established under the Faraday agreement. (Fierce Biotech) Key Takeaway Reacquiring S-oxprenolol reunifies worldwide rights under Actimed and gives the company control over the asset's future development across ALS and other potential muscle-wasting indications. What to Watch Completion of CMC work and Actimed's planned initiation of an ALS clinical development programme, together with any decision to advance S-oxprenolol in additional muscle-wasting indications or seek new partners. (Fierce Biotech) Primary Source Actimed Therapeutics announcement, 6 August 2026 Relevant Date 6 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 an undisclosed global pharmaceutical company worldwide rights to use Alteogen’s ALT-B4 technology to develop and commercialise a subcutaneous formulation of an existing biologic. Alteogen has signed an exclusive global licensing agreement with an undisclosed pharmaceutical company for ALT-B4 (berahyaluronidase alfa), based on its Hybrozyme platform, in a transaction worth up to $365 million including contingent milestone payments. The agreement extends the commercial reach of Alteogen’s drug-delivery technology, which enables biologic medicines normally administered intravenously to be reformulated for subcutaneous administration. Field Content Alert Type Deal Companies Alteogen; undisclosed global pharmaceutical company Deal Type Exclusive licensing agreement Asset or Company ALT-B4 (berahyaluronidase alfa), based on Alteogen’s Hybrozyme platform, for development of a subcutaneous formulation of an undisclosed biologic Technology or Modality Recombinant human hyaluronidase drug-delivery technology Deal Value Up to $365 million, comprising an upfront payment and potential development, regulatory and commercial milestone payments. The maximum value is contingent and should not be treated as guaranteed consideration. Development Stage The partner’s underlying biologic is already marketed, while the ALT-B4-enabled subcutaneous formulation remains in development. Geography Worldwide What Happened On 6 August 2026, Alteogen announced an exclusive licensing agreement granting an undisclosed global pharmaceutical company worldwide rights to use ALT-B4 to develop and commercialise a subcutaneous formulation of an existing biologic product. The agreement has a potential value of up to $365 million, including contingent development, regulatory and commercial milestones. The partner and underlying biologic have not been disclosed because of competitive considerations. (Yahoo Finance) Why It Matters The agreement adds another pharmaceutical partner for Alteogen’s Hybrozyme platform and extends the potential application of ALT-B4 to an additional commercial biologic. Converting intravenous biologics to subcutaneous administration can reduce administration time and change treatment delivery, although the clinical and commercial significance of this programme cannot yet be assessed fully because the partner and product remain undisclosed. (Yahoo Finance) Supporting Context ALT-B4 temporarily breaks down hyaluronic acid beneath the skin, enabling larger-volume subcutaneous administration of biologics. Alteogen has previously licensed Hybrozyme technology to pharmaceutical companies including MSD, AstraZeneca, GSK, Daiichi Sankyo, Biogen, Sandoz, Intas and Sanofi. (알테오젠 ALTEOGEN) Strategic Rationale The partner gains access to technology that could enable an existing intravenous biologic to be developed as a subcutaneous formulation, while Alteogen expands the number of programmes using ALT-B4 and retains potential milestone-based economics from successful development and commercialisation. Potential Impact If successfully developed and approved, the programme could provide a more convenient administration option for the undisclosed biologic and further validate Hybrozyme as a platform for converting established intravenous therapies to subcutaneous formulations. The impact will depend on the identity of the product, clinical development and regulatory approval. Key Takeaway The $365 million agreement extends Alteogen’s Hybrozyme licensing network by adding another global programme aimed at converting an established biologic to subcutaneous administration. What to Watch Disclosure of the pharmaceutical partner and underlying biologic, initiation of development and subsequent clinical and regulatory milestones for the ALT-B4-enabled formulation. Primary Source Alteogen corporate disclosure, 6 August 2026 Relevant Date 6 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 research collaboration combines Mediar’s fibrosis biology and antibody discovery capabilities with Ono’s drug development expertise to identify new treatments targeting fibro-inflammatory disease mechanisms. Ono Pharmaceutical has entered a drug discovery partnership with Mediar Therapeutics to identify and develop novel antibody therapeutics against an undisclosed target involved in fibro-inflammatory diseases, with Mediar receiving an upfront payment and research funding alongside potential future milestone payments and royalties. The collaboration expands Ono’s access to specialist fibrosis biology while providing Mediar with funding and a potential route to advance newly discovered antibodies into global clinical development and commercialisation. Field Content Alert Type Deal Companies Ono Pharmaceutical; Mediar Therapeutics Deal Type Drug discovery and research collaboration Asset or Company Novel antibody therapeutics against an undisclosed target associated with fibro-inflammatory diseases Therapy Area(s) Fibrosis; Inflammatory diseases Technology or Modality Antibody therapeutics Deal Value Financial terms were not fully disclosed. Mediar will receive an upfront payment and research funding and is eligible for research, development, regulatory and commercial milestone payments, plus tiered royalties on future global net sales. Development Stage Discovery Geography Global What Happened On 6 August 2026, Ono Pharmaceutical and Mediar Therapeutics announced a drug discovery partnership to create novel antibody therapeutics targeting an undisclosed molecule involved in fibro-inflammatory diseases. Mediar will use its expertise in fibrosis biology and antibody discovery to conduct research and identify therapeutic candidates. Ono will have the right to obtain an exclusive worldwide licence to develop and commercialise resulting antibodies, subject to the terms of the agreement. Why It Matters Fibro-inflammatory diseases involve persistent inflammation and pathological fibrosis that can progressively impair organ function, creating a need for therapies that intervene in the biological mechanisms driving fibrosis. The collaboration gives Ono access to Mediar’s specialised fibrosis research capabilities and potential new antibody candidates, while the early discovery stage means their therapeutic potential remains to be established. Supporting Context Mediar Therapeutics focuses on developing therapies that target myofibroblasts, cells involved in the development and progression of fibrosis. The company is building a pipeline of antibody-based programmes intended to intervene in fibrosis across multiple organ systems. Strategic Rationale Ono gains access to Mediar’s expertise in fibrosis biology and antibody discovery without acquiring the company or an existing clinical-stage asset. Mediar receives upfront and research funding while retaining the opportunity to earn milestones and royalties if Ono exercises its licensing rights and resulting programmes progress successfully. Potential Impact If the collaboration identifies viable therapeutic candidates, it could add new antibody programmes to Ono’s pipeline and extend Mediar’s fibrosis research into additional fibro-inflammatory diseases. Any clinical or commercial impact will depend on successful discovery, preclinical development, licensing and subsequent clinical trials. Key Takeaway The partnership gives Ono access to Mediar’s specialised fibrosis discovery capabilities while creating a route for new antibody programmes to progress towards global development. What to Watch Identification of lead antibody candidates, Ono’s exercise of its exclusive licensing rights and any subsequent preclinical or clinical development programmes arising from the collaboration. Primary Source https://www.businesswire.com/news/home/20260806851824/en/Ono-Pharma-Enters-into-a-Drug-Discovery-Partnership-with-Mediar-Therapeutics-to-Create-Novel-Antibody-Therapeutics-for-Fibro-inflammatory-Diseases Relevant Date 6 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 orexin receptor agonist provides adults with a treatment that targets the underlying loss of orexin signalling rather than managing individual symptoms separately. The US Food and Drug Administration (FDA) has approved Orzeyful (oveporexton) for the treatment of adults with narcolepsy type 1, making it the first medicine approved to address the condition as a complete disorder by restoring orexin signalling. The approval introduces a new therapeutic approach for patients experiencing excessive daytime sleepiness, cataplexy and other symptoms, although commercial launch must await scheduling by the US Drug Enforcement Administration (DEA). Field Content Alert Type Drug Approval Drug Name Orzeyful (oveporexton) Indication Treatment of narcolepsy type 1 in adults. Therapy Area(s) Neurology; Sleep Medicine Geography United States (FDA) What Happened On 5 August 2026, the FDA approved Orzeyful (oveporexton) for adults with narcolepsy type 1. The twice-daily oral treatment is the first approved therapy designed to address the disorder as a whole and the first to directly activate orexin receptors, targeting the loss of orexin signalling underlying the condition. The FDA has recommended scheduling under the Controlled Substances Act, and Orzeyful cannot be marketed until the DEA issues its final scheduling decision. Why It Matters Current narcolepsy treatments generally manage individual manifestations such as excessive daytime sleepiness or cataplexy. Orzeyful introduces a different approach by targeting the underlying orexin deficiency and demonstrated improvements across multiple symptoms, including wakefulness, daytime sleepiness, cataplexy, sleep paralysis, hallucinations and disrupted night-time sleep. Supporting Context Narcolepsy type 1 is caused by the loss of orexin-producing neurons, disrupting regulation of wakefulness, sleep and muscle tone. Approval was supported by two randomised, double-blind, placebo-controlled 12-week trials involving 273 adults, with common adverse reactions including insomnia, increased urinary frequency, urinary urgency and increased saliva production. Key Takeaway Orzeyful is the first FDA-approved treatment to target the underlying orexin deficiency while addressing the broad range of symptoms experienced by adults with narcolepsy type 1. What to Watch The DEA scheduling decision will determine when Orzeyful can enter the US market, after which commercial availability, reimbursement and clinical uptake will determine patient access. Primary Source https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-full-range-narcolepsy-type-1-symptoms Relevant Date 5 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 stock-for-stock acquisition adds a clinical-stage neuroplastogenic pain programme to Ensysce’s pipeline, with concurrent financing expected to fund CY200 through Phase II proof-of-concept data and towards registrational development. Ensysce Biosciences has completed the acquisition of Cy Biopharma in a stock-for-stock merger, adding CY200, a clinical-stage neuroplastogenic therapy with FDA Orphan Drug Designation for complex regional pain syndrome (CRPS) type 1, to its pain portfolio. The transaction is accompanied by $17.1 million of Cy Biopharma cash and up to approximately $60.1 million in new private financing, including a $38.6 million milestone-dependent second tranche, providing potential funding of up to approximately $77 million to advance CY200. Field Content Alert Type Deal Companies Ensysce Biosciences; Cy Biopharma Deal Type Acquisition through stock-for-stock merger, accompanied by private placement financing Asset or Company Cy Biopharma and its lead candidate CY200 Therapy Area(s) Neurology; Pain; Complex regional pain syndrome Technology or Modality Neuroplastogenic therapy Deal Value The acquisition consideration consists of 282,122 shares of Ensysce Series C preferred stock, representing 282.1 million shares on an as-converted basis. Separately, the transaction brings $17.1 million of Cy Biopharma cash from pre-acquisition financing and is accompanied by approximately $43 million of private placement financing across two tranches: approximately $21.5 million at initial closing and up to $38.6 million at the milestone closing, resulting in up to approximately $77 million of potential funding when Cy Biopharma’s cash is included. The second financing tranche is contingent on achievement of a clinical trial milestone. (Newswire) Development Stage Clinical stage; CY200 is being advanced towards a randomised Phase II trial in CRPS type 1. Geography United States What Happened On 6 August 2026, Ensysce Biosciences announced completion of its acquisition of privately held Cy Biopharma through a stock-for-stock merger. Cy Biopharma’s former equityholders received Series C preferred shares and are expected to own approximately 74.94% of the combined company on a fully diluted basis following stockholder approval of their conversion, excluding shares potentially issued in the milestone financing. Concurrently, Ensysce entered a private placement expected to provide approximately $21.5 million initially and up to another $38.6 million following achievement of a clinical trial milestone; Cy Biopharma also brought $17.1 million of cash from pre-acquisition financing. (Newswire) Why It Matters The acquisition expands Ensysce beyond its existing opioid safety programmes into neuroplastogenic treatments for complex pain and gives the company control of CY200, which has FDA Orphan Drug Designation for CRPS. Importantly, the associated financing is expected to support CY200 through Phase II proof-of-concept data and preparations for registrational development, reducing the immediate financing requirement around a key clinical milestone. (Newswire) Supporting Context CRPS is a severe chronic pain disorder with limited effective treatment options. Cy Biopharma is developing CY200 as an approach intended to address the underlying neurobiology of CRPS rather than solely managing symptoms, although its clinical benefit remains to be established through controlled trials. (Newswire) Strategic Rationale Ensysce gains a clinical-stage programme addressing complex pain while continuing development of its existing PF614-MPAR opioid overdose-protection programme. Cy Biopharma gains access to a public-market platform and financing intended to support CY200 through its next major clinical development milestones. (Newswire) Potential Impact If CY200 produces supportive Phase II results, the transaction could give Ensysce a second differentiated pain-development platform alongside its TAAP and MPAR programmes. Progress towards registrational development will depend on the clinical results, achievement of financing milestones and subsequent regulatory requirements. Key Takeaway The Cy Biopharma acquisition adds a clinical-stage neuroplastogenic pain programme to Ensysce while providing potential financing through CY200’s Phase II proof-of-concept milestone. What to Watch Topline results from the planned randomised Phase II CY200 trial, achievement of the clinical milestone required to unlock the second financing tranche, and Ensysce stockholder approval for conversion of the Series C preferred shares into common stock. (Newswire) Primary Source https://www.newswire.com/news/ensysce-biosciences-announces-acquisition-of-cy-biopharma-and-up-to-77-million Relevant Date 6 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 proposed acquisition would add Xycota’s preclinical CNS pipeline and exosome-based delivery platform to NexTel Medical, including lead programme XYCO-01 for frontotemporal dementia. NexTel Medical Corp. has signed a letter of intent to acquire 100% of Xycota Biosciences, an early-stage biotechnology company developing exosome-delivered neuroplasticity therapeutics for neurodegenerative conditions. If completed, the transaction would give NexTel access to Xycota’s preclinical pipeline and delivery technology, led by XYCO-01, an exosome-formulated psilocin candidate being developed initially for frontotemporal dementia (FTD). Field Content Alert Type Deal Companies NexTel Medical Corp.; Xycota Biosciences Deal Type Proposed acquisition under letter of intent Asset or Company 100% of Xycota Biosciences, including its neuroplasticity therapeutic pipeline and exosome delivery platform Therapy Area(s) Neurology; Neurodegenerative diseases Technology or Modality Exosome-delivered neuroplasticity therapeutics Deal Value Financial consideration for the proposed acquisition has not been disclosed. Development Stage Preclinical Geography United States What Happened NexTel Medical Corp. announced that it has executed a letter of intent to acquire 100% of Xycota Biosciences. The proposed transaction would give NexTel ownership of Xycota’s CNS drug-development platform and preclinical programmes. Xycota’s lead asset, XYCO-01, is an exosome-formulated psilocin candidate initially targeting FTD, with additional programmes or potential applications in mild traumatic brain injury, ALS and other neurodegenerative conditions. The announcement represents a proposed transaction rather than a completed acquisition, and completion remains dependent on definitive documentation and other agreed conditions. (Xycota Biosciences) Why It Matters The proposed acquisition would extend NexTel’s biotechnology portfolio into CNS drug development and give it access to a differentiated approach combining neuroplasticity pharmacology with exosome-based delivery. Xycota is attempting to exploit the BDNF-TrkB neuroplasticity pathway while reducing or avoiding the hallucinogenic effects associated with conventional psychedelic administration, but these delivery and therapeutic hypotheses remain to be validated clinically. (Xycota Biosciences) Supporting Context Xycota describes XYCO-01 as an exosome-formulated psilocin programme intended initially for FTD. Its strategy is supported by preclinical research investigating the role of BDNF-TrkB signalling in psilocybin-associated neuroplasticity, but Xycota states that its programmes remain preclinical and that clinical trials have not begun. (Xycota Biosciences) Strategic Rationale NexTel would gain ownership of an early-stage CNS platform and pipeline that could broaden its biotechnology activities into neurodegeneration. For Xycota, the proposed transaction could provide access to NexTel’s public-company infrastructure and resources as its lead programme moves towards regulatory and clinical development. Potential Impact If completed and successfully developed, the acquisition could give NexTel a platform spanning several neurodegenerative indications. Any clinical or commercial impact remains highly uncertain because the programmes are preclinical and their safety and efficacy have not been established in patients. (Xycota Biosciences) Key Takeaway The proposed acquisition would give NexTel ownership of Xycota’s preclinical neuroplasticity platform, but its strategic value will depend on completion of the transaction and subsequent clinical validation. What to Watch Execution of a definitive acquisition agreement, disclosure of the transaction consideration and closing conditions, and Xycota’s progress towards regulatory clearance and first-in-human development of XYCO-01. Primary Source Morningstar/Accesswire announcement supplied: https://www.morningstar.com/news/accesswire/1201772msn/nextel-medical-corp-executes-letter-of-intent-to-acquire-100-of-xycota-biosciences-llc Relevant Date 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 engineered oncolytic viral therapy, used with nivolumab, provides a new treatment option for adults with unresectable cutaneous melanoma that has progressed despite prior PD-1-based immunotherapy. The US Food and Drug Administration (FDA) has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma whose disease has progressed on a PD-1-blocking antibody-based regimen. The approval introduces an engineered oncolytic viral immunotherapy for this treatment-resistant population, with continued approval dependent on confirmation of clinical benefit in post-approval trials. Field Content Alert Type Drug Approval Drug Name Tudriqev (vusolimogene oderparepvec-wtpg) Indication In combination with nivolumab for adults with unresectable advanced cutaneous melanoma who experienced disease progression with a PD-1-blocking antibody-based regimen. (U.S. Food and Drug Administration) Therapy Area(s) Oncology; Melanoma Geography United States (FDA) What Happened On 6 August 2026, the FDA granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), Replimune's genetically modified oncolytic viral therapy, in combination with nivolumab for adults with unresectable advanced cutaneous melanoma that has progressed following PD-1-based therapy. Tudriqev is a modified herpes simplex virus type 1 (HSV-1) injected directly into tumours and engineered to destroy cancer cells while stimulating an anti-tumour immune response. The application received Breakthrough Therapy and Priority Review designations. (U.S. Food and Drug Administration) Why It Matters Patients whose advanced melanoma progresses despite PD-1-based immunotherapy have a need for additional effective treatment options. Tudriqev provides a new approach combining direct tumour injection with systemic nivolumab and is intended to stimulate an immune response in disease that has stopped responding to previous immunotherapy; however, the approval is based on response data rather than confirmed survival benefit. (U.S. Food and Drug Administration) Supporting Context In an open-label, single-arm trial enrolling 140 adults with Stage IIIB, IIIC or IV unresectable melanoma that had progressed following prior anti-PD-1-based therapy, 91 patients were evaluable for efficacy. The objective response rate was 24%, with a median duration of response of 14.1 months. Important safety warnings include possible herpes infection or reactivation, accidental transmission of herpes infection to close contacts and complications associated with the injection procedure. (U.S. Food and Drug Administration) Key Takeaway Tudriqev provides a new FDA-approved viral immunotherapy option for adults with unresectable advanced melanoma whose disease has progressed despite PD-1-based treatment. What to Watch Replimune must conduct post-approval trial or trials to verify Tudriqev's clinical benefit, and continued approval may depend on the results of this confirmatory evidence. (U.S. Food and Drug Administration) Primary Source https://www.fda.gov/news-events/press-announcements/fda-approves-new-engineered-viral-immunotherapy-patients-treatment-resistant-advanced-melanoma Relevant Date 6 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 draft guidance could reduce reliance on animal studies for some oncology products while increasing the importance of analytical characterisation and weight-of-evidence approaches during development. The US Food and Drug Administration (FDA) has issued draft guidance recommending streamlined approaches to general toxicology studies for certain oncology biologics and conjugated products, including antibody-drug conjugates (ADCs), as part of its programme to reduce unnecessary animal testing. The proposals could alter nonclinical development strategies by allowing some studies to use fewer animal species or be replaced by evidence-based approaches, while requiring sponsors to establish that the alternative evidence adequately addresses product safety. Field Content Alert Type Industry Update Topic Nonclinical safety; regulatory guidance; animal testing Organisation(s) US Food and Drug Administration (FDA) Affected Stakeholders Developers of oncology biologics and conjugated products, including ADC manufacturers; nonclinical safety scientists; regulatory affairs teams Therapy Area(s) Oncology Geography United States What Happened On 29 May 2026, the FDA issued draft guidance titled Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products. The guidance describes circumstances in which general toxicology programmes for certain oncology products could be reduced, including situations where studies may not be necessary, where testing in one relevant species may be sufficient, or where some longer-duration non-human primate studies could be replaced by a weight-of-evidence risk assessment. The recommendations remain draft guidance and are not currently binding requirements. Why It Matters Traditional nonclinical toxicology programmes can require extensive animal studies before and during clinical development. For ADC and oncology biologic developers, the FDA's proposed framework could allow more product-specific safety programmes that reduce unnecessary studies where existing pharmacological, analytical or toxicological evidence adequately characterises risk, potentially changing how companies plan nonclinical development. Supporting Context The guidance forms part of the FDA's broader effort to reduce reliance on animal testing in drug development and follows analysis of whether conventional toxicology studies consistently provide information needed for oncology development. ADCs present particular nonclinical considerations because their safety profiles can reflect the antibody, linker, cytotoxic payload and conjugated product. Who Is Most Affected Oncology companies developing ADCs, monoclonal antibodies and other conjugated products are most directly affected, particularly nonclinical and regulatory teams deciding which studies are necessary to support first-in-human and subsequent clinical development. Industry Impact If finalised, the guidance could shift some oncology nonclinical programmes away from standardised animal-study packages towards scientifically justified, weight-of-evidence strategies. Any reduction in studies would remain product-specific, meaning the guidance should not be interpreted as removing the need for nonclinical safety assessment across ADC development generally. Key Takeaway The FDA's draft framework gives oncology developers a potential route to reduce unnecessary animal toxicology studies where existing evidence provides an adequate scientific basis for a streamlined approach. What to Watch The FDA's response to stakeholder comments and publication of final guidance will determine whether the proposed approaches become part of the agency's formal recommendations for oncology biologic and ADC development. Primary Source https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oncology-pharmaceuticals-streamlined-nonclinical-safety-studies-biologics-and-conjugated-products Relevant Date 29 May 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 messenger RNA influenza vaccine into the US market, expanding vaccine technology options for seasonal influenza prevention in older adults. The US Food and Drug Administration (FDA) has approved mFlusiva (mRNA-1010), Moderna's seasonal influenza vaccine, for the prevention of influenza in adults aged 50 years and older, making it the first mRNA-based influenza vaccine approved in the United States. The approval expands the use of mRNA technology beyond COVID-19 and respiratory syncytial virus vaccines, although commercial availability for the 2026–2027 influenza season will depend on existing supply contracts and distribution timelines. Field Content Alert Type Drug Approval Drug Name mFlusiva (mRNA-1010) Indication Active immunisation for the prevention of influenza in adults aged 50 years and older. (The Wall Street Journal) Therapy Area(s) Infectious Diseases; Vaccines Geography United States (FDA) What Happened On 5 August 2026, the FDA approved mFlusiva (mRNA-1010) for the prevention of seasonal influenza in adults aged 50 years and older. The decision makes mFlusiva the first mRNA-based influenza vaccine licensed in the United States following a positive recommendation from the FDA's Vaccines and Related Biological Products Advisory Committee. The approval follows additional regulatory review after Moderna amended its application in response to earlier FDA concerns regarding trial design. (The Wall Street Journal) Why It Matters The approval introduces mRNA technology to seasonal influenza vaccination, providing an alternative manufacturing platform that could support future vaccine development and updates. It also represents an important regulatory milestone for Moderna as the company broadens its respiratory vaccine portfolio beyond COVID-19 and RSV, although real-world uptake will depend on procurement, reimbursement and clinician adoption. (Barron's) Supporting Context In a Phase III study involving more than 40,000 adults aged 50 years and older, mFlusiva demonstrated approximately 26.6% greater efficacy against influenza than a standard-dose comparator vaccine and reduced severe influenza requiring hospitalisation or urgent care by 47.9%. A post-marketing study in older adults is planned as part of the approval. (The Wall Street Journal) Key Takeaway FDA approval establishes mFlusiva as the first licensed mRNA seasonal influenza vaccine in the United States, expanding vaccine technology options for older adults. What to Watch Commercial rollout during the 2026–2027 influenza season, completion of the required post-marketing study and continued development of Moderna's combined influenza/COVID-19 vaccine programme. (Barron's) Primary Source https://www.fda.gov/news-events (FDA approval announcement); https://investors.modernatx.com (Moderna press release) Relevant Date 5 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 orexin receptor agonist provides adults with a treatment that targets the underlying loss of orexin signalling rather than managing individual symptoms separately. The US Food and Drug Administration (FDA) has approved Orzeyful (oveporexton) for the treatment of adults with narcolepsy type 1, making it the first medicine approved to address the condition as a complete disorder by restoring orexin signalling. The approval introduces a new therapeutic approach for patients experiencing excessive daytime sleepiness, cataplexy and other symptoms, although commercial launch must await scheduling by the US Drug Enforcement Administration (DEA). Field Content Alert Type Drug Approval Drug Name Orzeyful (oveporexton) Indication Treatment of narcolepsy type 1 in adults. Therapy Area(s) Neurology; Sleep Medicine Geography United States (FDA) What Happened On 5 August 2026, the FDA approved Orzeyful (oveporexton) for the treatment of adults with narcolepsy type 1. The twice-daily oral therapy is the first approved medicine to directly activate the orexin receptor and treat the disorder by addressing the underlying loss of orexin signalling rather than targeting individual symptoms. Marketing cannot begin until the DEA completes scheduling under the Controlled Substances Act. Why It Matters Existing treatments generally focus on individual symptoms such as excessive daytime sleepiness or cataplexy. Orzeyful introduces a disease-targeted approach that demonstrated improvements across multiple symptoms of narcolepsy type 1, providing clinicians with a new treatment option that addresses the condition more broadly. Supporting Context Narcolepsy type 1 is caused by the loss of orexin-producing neurons, leading to excessive daytime sleepiness, cataplexy, sleep paralysis, hallucinations and disrupted night-time sleep. FDA approval was supported by two Phase III clinical trials involving 273 adults with narcolepsy type 1. Key Takeaway FDA approval makes Orzeyful the first therapy to target the underlying orexin deficiency responsible for narcolepsy type 1 while addressing the full spectrum of the condition's symptoms. What to Watch The DEA's scheduling decision will determine when Orzeyful becomes commercially available in the United States, followed by reimbursement decisions and clinical adoption. Primary Source https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-full-range-narcolepsy-type-1-symptoms Relevant Date 5 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 all-stock transaction combines complementary central nervous system portfolios spanning neuroscience and addiction medicine, creating a larger commercial-stage company with a broader product portfolio and pipeline. Supernus Pharmaceuticals and Indivior have agreed to merge in an all-stock transaction that will create a combined central nervous system (CNS) biopharmaceutical company with approximately $2.2 billion in annual revenue, with Indivior shareholders also receiving a $1 billion special dividend before closing. The merger brings together complementary commercial portfolios and development pipelines in neuroscience and addiction medicine while aiming to strengthen long-term growth through greater scale and operational efficiencies. Field Content Alert Type Deal Companies Supernus Pharmaceuticals; Indivior Pharmaceuticals Deal Type Merger (all-stock transaction) Asset or Company Combined CNS biopharmaceutical businesses and product portfolios Therapy Area(s) Neuroscience; Psychiatry; Addiction medicine Deal Value All-stock merger creating a company with approximately $2.2 billion in annual revenue. Indivior shareholders are expected to receive a $1 billion special dividend before closing. (Reddit) Geography Global What Happened On 3 August 2026, Supernus Pharmaceuticals and Indivior announced an agreement to merge in an all-stock transaction. Under the terms announced, Supernus shareholders will receive 1.5401 Indivior shares for each Supernus share, while Indivior shareholders will receive a $1 billion special dividend before completion. The combined company will continue to focus on CNS disorders, bringing together commercial products and development programmes across neuroscience and addiction medicine. (Reddit) Why It Matters The merger creates a larger CNS-focused pharmaceutical company with a broader commercial portfolio, increased revenue base and a more diversified pipeline. Combining complementary expertise across neurology, psychiatry and addiction medicine could support future product development and commercial execution, although the anticipated benefits will depend on successful integration. (Reddit) Supporting Context Supernus has an established portfolio in neurological disorders including ADHD and Parkinson's disease, while Indivior specialises in treatments for opioid use disorder and addiction. The transaction combines businesses with different but complementary CNS therapeutic focuses. (Supernus Pharmaceuticals) Strategic Rationale Supernus gains greater commercial scale and access to Indivior's addiction medicine franchise, while Indivior broadens its CNS portfolio through Supernus' neuroscience products and development capabilities. (Reddit) Potential Impact If completed, the merger could strengthen the combined company's competitive position within the CNS market through a broader portfolio and increased financial scale. Realisation of these benefits will depend on shareholder approvals, regulatory clearances and successful integration. 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