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The Humanitarian Device Exemption provides adults with unresectable, non-metastatic distal bile duct cancer with a new localised radiation option used alongside systemic therapy, although initial US use will be restricted to five centres participating in a post-approval study. The US Food and Drug Administration (FDA) has granted Humanitarian Device Exemption approval to the OncoSil device for patients aged over 21 with unresectable, non-metastatic distal cholangiocarcinoma (dCCA), for use as an adjunct to systemic therapy. The authorisation makes OncoSil the first and only FDA-approved Class III device for dCCA, introducing an intratumoural radiation treatment for a rare cancer with limited treatment options. Field Content Alert Type Drug Approval Drug Name OncoSil Indication For patients aged over 21 with unresectable, non-metastatic distal cholangiocarcinoma, including locally advanced disease or disease otherwise unsuitable for surgery, for use as an adjunct to systemic therapy. (Proactive Investors) Therapy Area(s) Oncology; Biliary tract cancer; Interventional oncology Geography United States (FDA) What Happened The FDA has granted Humanitarian Device Exemption (HDE) approval to OncoSil Medical’s OncoSil device for adults aged over 21 with unresectable, non-metastatic distal cholangiocarcinoma. OncoSil uses radioactive phosphorus-32 microparticles implanted directly into the tumour under endoscopic ultrasound guidance to deliver localised radiation and is approved as an adjunct to systemic therapy. The decision completes the company’s HDE regulatory process and makes OncoSil the first and only FDA-approved Class III device for treatment of dCCA. (Proactive Investors) Why It Matters Distal cholangiocarcinoma is a rare and aggressive bile duct cancer, and more than half of patients are unable to undergo potentially curative surgery. The HDE provides eligible patients with an additional local treatment that can be used alongside systemic therapy, but the authorisation is based on the HDE standard of safety and probable benefit, and initial clinical use will remain restricted while further evidence is collected. (Proactive Investors) Supporting Context Around 8,000 people are diagnosed with cholangiocarcinoma annually in the US, with dCCA estimated to account for 30–40% of cases. OncoSil Medical estimates approximately 1,000 US patients annually could fall within the approved indication; its estimate of an A$80 million annual addressable market is a company commercial projection rather than part of the FDA’s assessment. (Proactive Investors) Key Takeaway FDA HDE approval introduces a localised intratumoural radiation option for adults with unresectable, non-metastatic distal cholangiocarcinoma who have limited treatment options. What to Watch Initial US distribution will be limited to five treatment centres participating in an FDA-required prospective post-approval study of 30 patients assessing safety and probable benefit, with follow-up for up to 24 months. OncoSil is targeting a US commercial launch during the second half of FY2027 while working on treatment-centre establishment, clinician training, reimbursement and market access. (Proactive Investors) Primary Source OncoSil Medical FDA HDE approval announcement Relevant Date 16 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 transaction creates a Nasdaq-listed fibrosis-focused company led by Redx’s management, with financing expected to fund the Phase II development of lead Crohn’s disease candidate RXC008 and provide cash runway into 2029. Skye Bioscience and Redx Pharma have entered a definitive agreement to combine and create Fibrx Therapeutics, alongside approximately $125 million of committed financing from new and existing investors. The combined company will focus on Redx’s fibrosis pipeline, led by Phase II-ready RXC008 for fibrostenotic Crohn’s disease, with the financing expected to support operations into 2029 and topline Phase II data in the second half of 2028. Field Content Alert Type Deal Companies Skye Bioscience; Redx Pharma; Fibrx Therapeutics Deal Type Business combination with concurrent private financing Asset or Company Fibrx Therapeutics, incorporating Redx Pharma’s fibrosis pipeline led by RXC008 Therapy Area(s) Gastroenterology; Fibrotic diseases; Inflammatory bowel disease Technology or Modality Small-molecule ROCK inhibitors; fibrosis-targeted therapeutics Deal Value The transaction is accompanied by approximately $125 million in committed financing, rather than a $125 million acquisition price. This includes approximately $68 million in private financing, a $36 million Series A financing and a $22 million equity line involving Redmile and Skye; the announced financing arrangements are subject to their respective terms and conditions. (Fierce Biotech) Development Stage RXC008: Phase II-ready; DDR inhibitor programme: preclinical; zelasudil (RXC007): Phase II clinical data reported Geography United States and United Kingdom; development programmes have global potential What Happened On 14 August 2026, Skye Bioscience and privately held Redx Pharma announced a definitive agreement to combine and create Fibrx Therapeutics, a publicly traded biotechnology company focused on fibrotic diseases. The combined company will be led by Redx CEO Lisa Anson, headquartered at Redx’s existing Alderley Park site in the UK and is expected to trade on Nasdaq following completion. Pre-transaction Skye shareholders are expected to own approximately 5.38%, existing Redx investors approximately 46.17% and investors participating in the new financing approximately 48.45% of Fibrx. The transaction remains subject to shareholder approvals and other closing conditions. (Fierce Biotech) Why It Matters The combination provides Redx’s fibrosis programmes with access to the public markets and new capital to advance development, while giving Skye shareholders exposure to a substantially different clinical pipeline after Skye paused development of obesity candidate nimacimab. The immediate development priority is RXC008, a GI-restricted pan-ROCK inhibitor intended to target intestinal fibrosis in fibrostenotic Crohn’s disease, an area where existing therapies do not directly address the underlying fibrosis. (Fierce Biotech) Supporting Context RXC008 has completed Phase I development and received FDA Fast Track designation in January 2026. Beyond RXC008, Fibrx is expected to retain Redx’s preclinical DDR inhibitor programme targeting kidney, lung and liver fibrosis, while selective ROCK2 inhibitor zelasudil (RXC007) is available for partnering following Phase IIa development in idiopathic pulmonary fibrosis. (Fierce Biotech) Strategic Rationale Redx gains a route to the Nasdaq public markets and substantial financing for its fibrosis pipeline, while Skye effectively redirects its corporate platform towards Redx’s programmes following a strategic review of nimacimab. Existing Skye shareholders will retain an additional economic interest in nimacimab through entitlement to 90% of net cash proceeds realised from any future monetisation of the programme and associated intellectual property. (Fierce Biotech) Potential Impact The financing is expected to provide Fibrx with cash runway into 2029 and fund RXC008 through its planned Phase II trial in fibrostenotic Crohn’s disease. Successful development could establish proof of concept for directly targeting intestinal fibrosis, but this remains dependent on prospective Phase II results. (Fierce Biotech) Key Takeaway The Skye-Redx combination creates a newly financed public biotechnology company centred on Redx’s fibrosis pipeline, with RXC008 and its upcoming Phase II Crohn’s disease study as the principal near-term value driver. What to Watch Transaction closing and shareholder approvals, initiation of the RXC008 Phase II study, the planned second-half 2028 topline data, progress of the DDR inhibitor towards an IND/CTA submission in 2027 and any partnering agreement for zelasudil. (Fierce Biotech) Primary Source Skye Bioscience and Redx Pharma definitive transaction announcement, 14 August 2026 Relevant Date 14 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 multi-program deal pairs Aizen’s DaX AI platform with an undisclosed San Diego biotechnology company to design oral peptide therapeutics against nominated immunology and neurology targets. Aizen Therapeutics has entered a multi-program drug discovery collaboration with an undisclosed publicly traded San Diego biotechnology company, providing Aizen with several million dollars in initial revenue and up to $100 million in milestone payments for each nominated target. The partnership will use Aizen’s DaX foundation model to design oral peptide therapeutics for disease-relevant targets in immunology and neurology, providing an early commercial test of its AI-enabled non-canonical amino acid peptide platform. Field Content Alert Type Deal Companies Aizen Therapeutics; undisclosed publicly traded San Diego biotechnology company Deal Type Multi-program drug discovery collaboration Asset or Company Aizen Therapeutics’ DaX foundation model and oral peptide discovery platform Therapy Area(s) Immunology; Neurology Technology or Modality AI-designed oral peptides; non-canonical amino acid (ncAA) peptide therapeutics Deal Value Aizen will receive several million dollars in initial revenue, with the potential for up to $100 million in milestone payments for each nominated target. The number of targets and individual milestone structure have not been disclosed, meaning a total potential transaction value cannot currently be calculated. The $100 million per target is contingent and should not be treated as guaranteed consideration. (PR Newswire) Development Stage Discovery Geography United States What Happened On 15 August 2026, Aizen Therapeutics announced a multi-program collaboration with an unnamed publicly traded San Diego biotechnology company to design oral peptide therapeutics using its DaX foundation model. The programmes will address disease-relevant targets in immunology and neurology, with Aizen receiving several million dollars in initial revenue and becoming eligible for up to $100 million in milestones for each target nominated by its partner. The partner’s identity, number of initial targets, specific programmes and detailed milestone structure were not disclosed. (PR Newswire) Why It Matters The agreement provides external commercial validation for Aizen’s AI-enabled peptide discovery platform while funding work intended to demonstrate that DaX-designed molecules can progress beyond computational design towards viable drug candidates. Aizen is attempting to combine the target specificity associated with peptide therapeutics with properties that could support oral delivery, although the partnered programmes remain at the discovery stage and their ability to produce clinically viable oral medicines has not yet been established. (PR Newswire) Supporting Context Aizen was spun out of Caltech and describes DaX as a computational design platform trained on millions of annotated molecules and receptors. The company says the platform explores the chemical space of non-canonical amino acid peptides at ten times the scale of traditional ncAA discovery methods and is being used across both its proprietary pipeline and biopharmaceutical collaborations. (PR Newswire) Strategic Rationale Aizen gains upfront revenue and the opportunity to demonstrate its platform against externally selected, disease-relevant targets, while the undisclosed partner gains access to DaX for the design of oral peptide candidates in immunology and neurology. The milestone-per-target structure also provides a mechanism for the collaboration to expand if additional programmes are nominated. (PR Newswire) Potential Impact Successful generation of orally viable peptide candidates could provide further validation for Aizen’s approach and support expansion of the collaboration or additional platform partnerships. Any therapeutic impact remains dependent on candidate discovery, preclinical validation and subsequent clinical development. Key Takeaway The collaboration gives Aizen several million dollars in initial revenue and potentially up to $100 million per nominated target while putting its AI-designed oral peptide platform to an external drug-discovery test. What to Watch Nomination of additional targets, disclosure of the partner or individual programmes and whether DaX-designed candidates demonstrate sufficient pharmacological and oral-delivery properties to progress towards IND-enabling development. Primary Source https://www.prnewswire.com/news-releases/aizen-enters-into-collaboration-with-san-diego-biopharma-to-advance-oral-biologics-302848775.html Relevant Date 15 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 who have received at least one prior line of therapy with a new iberdomide-based combination, supported by higher minimal residual disease-negative complete response rates than the comparator regimen in EXCALIBER-RRMM. The US Food and Drug Administration (FDA) has granted accelerated approval to Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. The approval introduces an iberdomide-based treatment option earlier in the relapsed or refractory multiple myeloma pathway, with continued approval dependent on verification of clinical benefit. Field Content Alert Type Drug Approval Drug Name Zenbexus (iberdomide) Indication In combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. (U.S. Food and Drug Administration) Therapy Area(s) Haematology; Oncology; Multiple myeloma Geography United States (FDA) What Happened On 13 August 2026, the FDA granted accelerated approval to Bristol Myers Squibb’s Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone. The approved population comprises adults with multiple myeloma previously treated with at least one line containing a proteasome inhibitor and an immunomodulatory agent. Iberdomide is administered orally at 1 mg once daily on days 1–21 of each 28-day cycle alongside subcutaneous daratumumab and hyaluronidase-fihj and dexamethasone, with treatment continuing until disease progression or unacceptable toxicity. (U.S. Food and Drug Administration) Why It Matters The approval makes an iberdomide-based regimen available to patients after at least one prior line of therapy, adding another treatment option in relapsed or refractory multiple myeloma. In EXCALIBER-RRMM, the regimen achieved a 41% MRD-negative complete response rate, compared with 21% for daratumumab and hyaluronidase-fihj, bortezomib and dexamethasone (DVd); however, accelerated approval is based on this surrogate endpoint and clinical benefit still requires confirmation. (U.S. Food and Drug Administration) Supporting Context EXCALIBER-RRMM was a two-stage, randomised, multicentre, open-label trial involving 939 adults with relapsed or refractory multiple myeloma previously treated with one or two lines of therapy. Patients whose disease was refractory to previous anti-CD38 monoclonal antibody therapy or bortezomib were excluded. The primary efficacy analysis compared 207 patients receiving IberDd with 213 receiving DVd. (U.S. Food and Drug Administration) Key Takeaway FDA accelerated approval adds iberdomide to the treatment options available after at least one previous multiple myeloma regimen, based on a significantly higher MRD-negative complete response rate versus DVd. (U.S. Food and Drug Administration) What to Watch Because Zenbexus received accelerated approval, continued approval for this indication may depend on confirmation of clinical benefit. The prescribing information also carries a boxed warning for embryo-fetal toxicity and serious venous and arterial thromboembolism, and iberdomide is available only through the ZENBEXUS REMS restricted distribution programme because of embryo-fetal toxicity risk. (U.S. Food and Drug Administration) Primary Source https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone 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 acquisition would add a BLA-stage, one-time AAV gene therapy to PTC’s rare disease portfolio, with a rolling US submission expected to complete in the fourth quarter of 2026. PTC Therapeutics has been selected as the winning bidder in a competitive bankruptcy auction to acquire ST-920, Sangamo Therapeutics’ BLA-stage AAV gene therapy for Fabry disease, for $111 million upfront plus up to $100 million in regulatory milestones. The transaction gives PTC a late-stage rare disease programme that could use its existing gene therapy and global commercial infrastructure, with a potential US launch in 2027 if the BLA is completed and subsequently approved. Field Content Alert Type Deal Companies PTC Therapeutics; Sangamo Therapeutics Deal Type Asset acquisition following competitive bankruptcy auction Asset or Company ST-920 (isaralgagene civaparvovec) Therapy Area(s) Rare disease; Fabry disease Technology or Modality One-time AAV gene therapy Deal Value $111 million upfront, plus up to $100 million in regulatory milestone payments, giving a maximum potential transaction value of $211 million. The additional $100 million is contingent and should not be treated as guaranteed consideration. (Yahoo Finance) Development Stage BLA-stage; rolling US Biologics License Application submission underway Geography Global What Happened On 12 August 2026, PTC Therapeutics announced that it had been selected as the winning bidder to acquire ST-920 from Sangamo Therapeutics through a competitive bankruptcy auction. PTC will pay $111 million upfront and could pay a further $100 million tied to regulatory milestones. ST-920 is a one-time AAV gene therapy designed to deliver a functional copy of the GLA gene in people with Fabry disease. The programme is already at BLA stage, with completion of the rolling US submission expected in the fourth quarter of 2026. The acquisition remains subject to the applicable bankruptcy court approval and closing process. (Yahoo Finance) Why It Matters PTC is acquiring a regulatory-stage gene therapy rather than an early clinical programme, limiting the additional development required before a potential US regulatory decision. ST-920 also fits PTC’s existing focus on rare diseases and gene therapy, allowing the company to use established infrastructure rather than building a new commercial organisation specifically for the asset. PTC has identified the programme as an opportunity to support short- and intermediate-term revenue growth, although this remains dependent on regulatory approval and successful commercialisation. (Yahoo Finance) Supporting Context Fabry disease is an X-linked lysosomal disorder caused by variants in the GLA gene, resulting in deficient alpha-galactosidase A activity and progressive accumulation of disease-associated substrates. ST-920 has been evaluated in the Phase I/II STAAR study and is designed to enable sustained production of alpha-galactosidase A following a single administration. (Sangamo) Strategic Rationale PTC gains a BLA-stage rare disease asset that complements its existing global commercial and gene therapy capabilities without requiring the lengthy development timeline associated with acquiring an earlier-stage programme. Sangamo’s bankruptcy process, meanwhile, provides a mechanism to monetise the ST-920 programme through the asset sale. Potential Impact If the BLA is successfully completed and FDA approval follows, ST-920 could give PTC a commercial-stage Fabry disease gene therapy as early as 2027. Its eventual clinical and commercial contribution will depend on regulatory review, the durability and safety of the therapy and adoption within the existing Fabry treatment landscape. Key Takeaway The acquisition gives PTC a BLA-stage Fabry gene therapy with near-term regulatory potential for $111 million upfront, substantially accelerating its opportunity to add another commercial rare disease product. What to Watch Bankruptcy court approval and transaction closing, completion of the rolling BLA in the fourth quarter of 2026, subsequent FDA review and whether ST-920 remains on track for a potential 2027 US launch. (Yahoo Finance) Primary Source PTC Therapeutics acquisition announcement Relevant Date 12 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 Canadian authorisation moves Light AI’s AI-enabled throat-image analysis platform from investigational development into its first regulated market, providing healthcare professionals with a software-based tool to support assessment of suspected Group A Streptococcus infection. Health Canada has issued a medical device licence for Light AI’s QuickScan Strep A, a smartphone-enabled Software as a Medical Device designed to assist healthcare professionals in assessing patients with suspected Group A Streptococcus pharyngitis. The authorisation represents a material regulatory step for Light AI, whose platform analyses throat images using artificial intelligence without requiring proprietary diagnostic hardware. Field Content Alert Type Drug Approval Drug Name QuickScan Strep A Indication Software as a Medical Device intended to assist healthcare professionals in the assessment of patients presenting with symptoms consistent with pharyngitis and suspected Group A Streptococcus (Strep A) infection. Therapy Area(s) Infectious diseases; Primary care; Diagnostics Geography Canada (Health Canada) What Happened Health Canada has issued Light AI a medical device licence for QuickScan Strep A, the company’s AI-enabled Software as a Medical Device for assessment of suspected Group A Streptococcus pharyngitis. The platform is designed to analyse throat images captured using compatible smart devices and provide an AI-supported assessment. The authorisation follows Light AI’s completion of ISO 13485:2016 and Medical Device Single Audit Program certification in June 2026, which supported its planned Canadian regulatory submission. Earlier company disclosures described QuickScan Strep A as investigational and unavailable for commercial diagnostic use, meaning the Health Canada licence represents a change in its Canadian regulatory status. (Stockwatch) Why It Matters Strep A and viral pharyngitis can present with overlapping symptoms, while determining whether a bacterial infection is present can influence subsequent testing and treatment decisions. QuickScan’s software-based approach is intended to provide healthcare professionals with an additional assessment tool using compatible smart-device images rather than proprietary diagnostic hardware; the Health Canada licence permits regulated Canadian use within the authorised indication but does not by itself establish reimbursement or widespread clinical adoption. Supporting Context Light AI has been pursuing parallel regulatory development in Canada and the US. In June 2026, it initiated a US pivotal clinical trial comparing QuickScan Strep A with throat culture to generate evidence for a planned FDA Class II submission; the FDA programme remains separate from the Canadian authorisation. (Light AI) Key Takeaway Health Canada’s licence gives Light AI its first regulated pathway for QuickScan Strep A as an AI-supported smartphone tool for assessing suspected Strep A infection. What to Watch Canadian commercial availability and clinical deployment, alongside completion of Light AI’s ongoing US pivotal study and any subsequent FDA submission. (Light AI) Primary Source Light AI / Health Canada medical device licensing announcement Relevant Date 14 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

Interpharma says seven of 22 innovative medicines introduced between January 2025 and June 2026 were not submitted for Swiss reimbursement, as companies consider the potential implications of Swiss prices for the US market. A survey by Swiss pharmaceutical industry association Interpharma found that seven of 22 new innovative medicines introduced between January 2025 and June 2026 were not submitted for inclusion on Switzerland’s reimbursement list, compared with an average of 24 submissions during equivalent 18-month periods between 2019 and 2025. Interpharma attributes the reduction partly to concerns that lower Swiss prices could influence US pricing under international benchmarking policies, creating a potential tension between pharmaceutical pricing strategy and timely Swiss patient access. Field Content Alert Type Industry Update Topic Pricing; reimbursement; market access Organisation(s) Interpharma; Swiss Federal Office of Public Health (FOPH) Affected Stakeholders Pharmaceutical companies launching innovative medicines in Switzerland; Swiss patients; payers and market-access teams Geography Switzerland; United States What Happened Interpharma reported on 13 August 2026 that seven of 22 new innovative medicines introduced between January 2025 and June 2026 were not submitted for Switzerland’s reimbursement list, which determines coverage under mandatory health insurance and establishes reimbursed prices. A further three medicines were not submitted for Swiss marketing approval. Interpharma linked the pattern to pharmaceutical companies’ concerns over the potential effect of Swiss pricing on US prices under the US administration’s most-favoured-nation pricing approach. The 15 medicines submitted for reimbursement compare with an average of 24 during equivalent 18-month periods between 2019 and 2025. (Global Banking & Finance Review) Why It Matters Inclusion on Switzerland’s Specialities List is important for broad access through mandatory health insurance. If manufacturers delay or avoid reimbursement applications because of the potential consequences of Swiss prices for larger markets such as the US, international reference-pricing policies could indirectly affect launch sequencing and patient access outside the country implementing the policy. The reported figures are based on an industry survey, however, and do not establish that US policy was the sole cause of every individual decision. (Global Banking & Finance Review) Supporting Context Switzerland’s FOPH assesses medicines for inclusion on the Specialities List and sets reimbursed prices. Swiss price-setting itself uses both an internal comparison with medicines for the same indication and an external comparison drawing on prices in nine European countries. (Federal Office of Public Health) Who Is Most Affected Pharmaceutical market-access and pricing teams face the most direct strategic issue because decisions on Swiss reimbursement may now need to consider potential international pricing consequences. Swiss patients are also directly affected where medicines are approved but not submitted for reimbursement, because routine access through mandatory health insurance may be unavailable, although reimbursement can be possible in qualifying individual cases. (Global Banking & Finance Review) Industry Impact The findings suggest international price referencing can influence not only medicine prices but also the order and timing in which manufacturers seek reimbursement across countries. If the pattern persists, smaller European markets used as international pricing benchmarks could face greater launch and reimbursement delays as manufacturers seek to manage the potential effect on prices in commercially larger markets. Key Takeaway Interpharma’s findings suggest US international drug-pricing policy is becoming a consideration in Swiss launch and reimbursement decisions, with potential consequences for patient access and pharmaceutical market-access strategy. What to Watch Whether reimbursement submissions remain below historical levels, how manufacturers sequence future Swiss and US launches, and whether Switzerland or the US modifies pricing policies in response to concerns about their effects on medicine availability. Primary Source Interpharma survey, reported 13 August 2026 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 agreement gives Zydus subsidiary Sentynl Therapeutics an option for exclusive US commercial and global manufacturing rights to Mereo BioPharma’s oral neutrophil elastase inhibitor, with Mereo leading preparations for pivotal development. Zydus Lifesciences subsidiary Sentynl Therapeutics has entered an option and licence agreement with Mereo BioPharma covering US commercial and global manufacturing rights to alvelestat, a Phase III-ready oral neutrophil elastase inhibitor for alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD). Mereo will receive an undisclosed non-refundable option fee and, if Sentynl exercises its option, up to $40 million in upfront and R&D payments through NDA filing, with Mereo also eligible for tiered double-digit royalties on US net sales if the drug is approved. Field Content Alert Type Deal Companies Sentynl Therapeutics, a wholly owned subsidiary of Zydus Lifesciences; Mereo BioPharma Deal Type Option and licensing agreement Asset or Company Alvelestat (MPH-966) Therapy Area(s) Respiratory; Rare disease; Alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD) Technology or Modality Oral small-molecule neutrophil elastase inhibitor Deal Value Mereo will receive an undisclosed non-refundable option fee. If Sentynl exercises the option, Mereo is eligible for up to $40 million in upfront and R&D payments through NDA filing, plus tiered double-digit royalties on US net sales if alvelestat is approved. The $40 million is contingent on option exercise and subsequent development and should not be treated as guaranteed consideration. (Economic Times Pharma) Development Stage Phase III-ready Geography United States commercial rights; global manufacturing rights What Happened Sentynl Therapeutics has entered an option and licence agreement with Mereo BioPharma for alvelestat. The agreement gives Sentynl an option to acquire exclusive US commercial rights and global manufacturing rights, while Mereo will lead the global Phase III study and regulatory interactions through completion during the option period. The companies will collaborate on manufacturing and refinement of the Phase III design, with Sentynl expected to sponsor the late-stage programme if it exercises the option. Mereo has previously indicated that a pivotal study could enrol approximately 220 patients over an 18-month treatment period. (Economic Times Pharma) Why It Matters The agreement provides Mereo with a potential route to finance and advance alvelestat into pivotal development while giving Sentynl access to a late-stage rare respiratory disease programme without immediately committing to a full licence. Alvelestat targets neutrophil elastase in AATD-LD, and Mereo has already aligned with the FDA and EMA on independent primary endpoints intended to support potential US and European regulatory submissions. (Mereo BioPharma) Supporting Context AATD-LD is a rare genetic condition caused by alpha-1 antitrypsin deficiency that can lead to progressive lung damage. Alvelestat has received FDA Orphan Drug and Fast Track designations and European orphan designation; Mereo has evaluated the drug across two Phase II studies and completed feasibility work in preparation for pivotal development. (Mereo BioPharma) Strategic Rationale Sentynl gains the option to add a Phase III-ready rare respiratory asset to its portfolio together with global manufacturing rights, while limiting its initial commitment during further development planning. Mereo gains a potential development and commercial partner while retaining responsibility for advancing the global Phase III programme during the option period. Potential Impact If the option is exercised and Phase III development is successful, the partnership could advance alvelestat towards regulatory submissions in AATD-LD and give Sentynl exclusive US commercial rights. Any clinical or commercial impact remains dependent on successful pivotal development and regulatory approval. Key Takeaway The option structure gives Sentynl access to a Phase III-ready rare respiratory programme while providing Mereo with a potential partner to advance alvelestat towards pivotal development and US commercialisation. What to Watch Exercise of Sentynl’s option, finalisation of the Phase III design and initiation of the pivotal programme, which Sentynl expects could begin in early 2027 if the option is exercised. (Economic Times Pharma) Primary Source Mereo BioPharma / Zydus Lifesciences-Sentynl Therapeutics agreement announcement Relevant Date 12 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 Wandercraft’s self-balancing exoskeleton technology beyond supervised rehabilitation, allowing eligible adults with spinal cord injuries to use Eve for hands-free upright mobility and daily activities with a trained companion. The US Food and Drug Administration (FDA) has cleared Wandercraft’s Eve personal exoskeleton for eligible adults with spinal cord injuries at any level who can operate the device’s remote, enabling hands-free walking and activities of daily living on specified level surfaces under the supervision of a trained companion. The clearance creates a personal-use pathway for Wandercraft’s self-balancing technology outside rehabilitation institutions, with a US commercial launch planned for 17 September 2026. Field Content Alert Type Drug Approval Drug Name Eve personal exoskeleton Indication Personal-use powered exoskeleton for eligible adults with spinal cord injuries at any level who can operate Eve’s remote, supporting walking and activities of daily living on level indoor surfaces and immediately adjacent level outdoor areas under the supervision of a specially trained companion. (MassDevice) Therapy Area(s) Neurology; Spinal cord injury; Rehabilitation and mobility Geography United States (FDA) What Happened Wandercraft announced FDA clearance of Eve, its personal self-balancing exoskeleton, on 12 August 2026. Eligible adults with spinal cord injuries at any level who can operate the remote can use the device to walk and perform activities of daily living hands-free on specified level surfaces under supervision of a trained companion. Before use, patients require assessment by a licensed healthcare practitioner, individual device fitting and training alongside their companion. Unlike Wandercraft’s Atalante X, which is designed for use in rehabilitation institutions, Eve provides a pathway for personal use outside the rehabilitation setting. (MassDevice) Why It Matters Existing FDA-cleared personal exoskeletons such as ReWalk and Indego rely on crutches for balance and propulsion, while Eve uses self-balancing technology to enable hands-free upright mobility. For eligible people with spinal cord injuries, the clearance therefore introduces a different personal mobility option designed around standing, walking and performing everyday activities without requiring crutches for balance, although use still requires a trained companion and is restricted to specified surfaces. (MassDevice) Supporting Context FDA clearance was supported by a three-site clinical study involving people with spinal cord injuries and their companions. Participants underwent structured training followed by functional, usability and task-based assessments, with the programme evaluating whether users and companions could learn to operate Eve and complete activities relevant to personal use. (MassDevice) Key Takeaway FDA clearance moves Wandercraft’s self-balancing exoskeleton technology from rehabilitation-centre use towards personal mobility for eligible adults living with spinal cord injury. What to Watch Wandercraft plans to launch Eve commercially in the US on 17 September 2026 and anticipates potential Medicare reimbursement eligibility within 60–90 days; reimbursement is not yet confirmed. The company has also established evaluation, training and distribution partnerships ahead of launch. (MassDevice) Primary Source Wandercraft FDA clearance announcement; US Food and Drug Administration Relevant Date 12 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 Sentynl an exclusive pathway to commercialise the Phase III-ready rare lung disease therapy in the US while providing global manufacturing rights and funding support for late-stage development. Mereo BioPharma has entered into an option and licence agreement with Sentynl Therapeutics for alvelestat in alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD), under which Mereo will receive a non-refundable option fee and, if the option is exercised, up to $40 million in upfront and R&D payments, up to $435 million in regulatory and commercial milestones, plus tiered royalties on US sales. The agreement allows Mereo to retain commercial rights outside the United States while partnering with Sentynl to prepare the Phase III programme for a therapy that could become the first oral treatment for AATD-LD. Field Content Alert Type Deal Companies Mereo BioPharma Group plc; Sentynl Therapeutics (Zydus Lifesciences) Deal Type Option and licence agreement Asset or Company Alvelestat for alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD) Therapy Area(s) Rare respiratory diseases; Pulmonology Technology or Modality Oral small-molecule neutrophil elastase inhibitor Deal Value Non-refundable option fee (undisclosed); if exercised, up to $40 million in upfront and R&D payments, up to $435 million in regulatory and commercial milestone payments, plus double-digit tiered royalties on US net sales. Maximum disclosed potential value: up to $475 million, excluding royalties. Development Stage Phase III-ready Geography United States (commercial rights); Global manufacturing; Mereo retains commercial rights outside the US What Happened On 11 August 2026, Mereo BioPharma and Sentynl Therapeutics announced an option and licence agreement covering US commercial rights and global manufacturing rights for alvelestat in AATD-LD. Mereo will continue to lead global Phase III development and regulatory interactions until completion of the study, while the companies collaborate during the option period to refine the Phase III design and manufacturing strategy. The agreement remains contingent on Sentynl exercising its commercialisation option. Why It Matters The transaction provides Mereo with a development and commercial partner for the US market while allowing it to retain ex-US commercial rights. For Sentynl, the agreement expands its rare disease portfolio with a Phase III-ready programme targeting a rare genetic lung disease that currently has no approved oral treatment. Supporting Context Alvelestat is an oral neutrophil elastase inhibitor being developed for AATD-LD and has demonstrated positive Phase II efficacy in two studies. It has received FDA Fast Track designation and Orphan Drug Designation in both the US and EU. If approved, it could become the first oral therapy specifically indicated for AATD-LD. Strategic Rationale Mereo secures non-dilutive funding for late-stage development while retaining long-term commercial rights outside the US. Sentynl gains a late-stage rare disease asset that complements its existing portfolio and provides an opportunity to build its respiratory rare disease franchise. Potential Impact If the option is exercised and Phase III development is successful, the partnership could accelerate the introduction of a targeted oral therapy for AATD-LD while expanding Sentynl's presence in rare respiratory diseases. Clinical success and regulatory approval remain dependent on future trial outcomes. Key Takeaway The agreement combines late-stage development funding with a territory-specific commercial partnership, allowing Mereo to retain ex-US rights while positioning Sentynl to expand its rare disease portfolio in the United States. What to Watch Exercise of Sentynl's commercialisation option, refinement of the Phase III study design, initiation of the global Phase III programme in early 2027, and subsequent regulatory milestones. Primary Source https://www.sec.gov/Archives/edgar/data/1719714/000119312526343482/0001193125-26-343482.txt Relevant Date 11 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 collaboration combines HanchorBio's immuno-oncology platform with Taiwan's national precision oncology programme to support biomarker-driven clinical development and translational research. HanchorBio has entered into a strategic research collaboration with Taiwan's Cancer Moonshot team to evaluate precision immunotherapy approaches using the company's immuno-oncology pipeline and biomarker capabilities. The partnership is intended to strengthen translational research and patient selection strategies while supporting the clinical development of HanchorBio's next-generation immunotherapies. Field Content Alert Type Deal Companies HanchorBio; Taiwan Cancer Moonshot team Deal Type Strategic research collaboration Asset or Company HanchorBio's precision immunotherapy pipeline, including HCB101 and associated biomarker research programmes Therapy Area(s) Oncology; Precision medicine; Immuno-oncology Technology or Modality Multi-target immunotherapy platform and biomarker-driven precision oncology Geography Taiwan What Happened HanchorBio announced a strategic collaboration with Taiwan's Cancer Moonshot team to advance precision immunotherapy research. The collaboration is designed to integrate HanchorBio's immunotherapy platform with the Cancer Moonshot programme's clinical and translational research capabilities to improve biomarker-driven patient selection and support future clinical development. The announcement relates to a research partnership rather than a licensing agreement or acquisition, and no financial terms were disclosed. Why It Matters The partnership strengthens the translational research infrastructure supporting HanchorBio's immunotherapy programmes and could improve the identification of patients most likely to benefit from targeted immunotherapies. It also demonstrates increasing collaboration between biotechnology companies and national precision medicine initiatives to accelerate oncology drug development. Supporting Context HanchorBio is developing a portfolio of next-generation immunotherapies using its proprietary FBDB™ platform and has been expanding collaborations to support clinical development and global partnering. The company has identified precision medicine and biomarker-guided development as central elements of its long-term strategy. Strategic Rationale HanchorBio gains access to clinical research expertise, translational data and biomarker resources that may support development of its oncology programmes, while the Taiwan Cancer Moonshot team expands its collaboration with an immunotherapy developer focused on precision oncology. Potential Impact If successful, the collaboration could strengthen evidence supporting biomarker-guided immunotherapy development and accelerate future clinical studies. Any impact on regulatory progress or commercialisation will depend on the results generated through the collaboration. Key Takeaway The collaboration aligns HanchorBio's immunotherapy pipeline with Taiwan's national precision oncology programme to support biomarker-driven cancer drug development. What to Watch Initial translational research outputs, incorporation of biomarker findings into ongoing clinical programmes and any expansion of the collaboration into additional oncology indications or clinical studies. Primary Source https://biopharmaapac.com/news/29/8302/hanchorbio-partners-with-taiwan-cancer-moonshot-team-to-advance-precision-immunotherapy.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 amended agreement strengthens Exor's long-term commitment to Philips while allowing the healthcare technology investor to increase its maximum shareholding from 20% to 22% Philips and Exor have agreed to extend their long-term relationship agreement and amend its terms to allow Exor to increase its maximum ownership stake in Philips from 20% to 22%. The revised agreement reinforces Exor's role as a long-term strategic shareholder while providing Philips with continued shareholder stability as it executes its healthcare technology strategy. Field Content Alert Type Deal Companies Royal Philips; Exor N.V. Deal Type Amendment and extension of relationship agreement Asset or Company Long-term strategic shareholding in Royal Philips Technology or Modality Healthcare technology Deal Value No financial consideration was disclosed. The amended agreement increases Exor's permitted maximum ownership stake from 20% to 22%. Geography Global What Happened Philips and Exor agreed to extend their existing relationship agreement, originally signed in 2023, while increasing the maximum ownership threshold Exor may hold from 20% to 22% of Philips' outstanding ordinary share capital. The agreement maintains Exor's position as a long-term minority shareholder and continues the governance framework established between the companies. No acquisition has taken place and the revised ownership limit does not require Exor to increase its holding. Why It Matters The amended agreement reinforces Philips' relationship with a long-term strategic investor while giving Exor additional flexibility to increase its investment if it chooses. For Philips, the arrangement supports continuity in governance and shareholder alignment as the company continues to focus on healthcare technology and long-term value creation. Supporting Context Exor became Philips' largest shareholder in August 2023 after acquiring a 15% stake and entering into a relationship agreement that permitted it to increase its ownership to a maximum of 20% while granting the right to nominate one Supervisory Board member. Strategic Rationale The extension confirms both parties' intention to continue their long-term partnership while providing Exor with greater investment flexibility without altering Philips' governance structure or strategic direction. Potential Impact If Exor increases its shareholding, Philips could benefit from an even more committed long-term investor. Any effect on corporate strategy or governance would remain subject to the existing terms of the relationship agreement and applicable regulations. Key Takeaway The amended agreement deepens Exor's long-term commitment to Philips by increasing its permitted ownership ceiling while preserving the existing strategic shareholder relationship. What to Watch Whether Exor chooses to increase its holding towards the new 22% limit and whether the extended relationship results in further governance or strategic collaboration announcements. Primary Source https://www.massdevice.com/philips-and-exor-extend-relationship-agreement-lift-ownership-cap-to-22/ 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