The global collaboration gives Lilly access to OmniAb’s specialist ion channel discovery and screening capabilities for an undisclosed therapeutic target and modality. Eli Lilly and OmniAb have entered a global collaboration and licence agreement for a new ion channel programme, with OmniAb receiving an undisclosed upfront payment and becoming eligible for up to $370 million in research, development and commercial milestones plus tiered royalties on global net sales. The partnership applies OmniAb’s discovery platform and specialist ion channel capabilities to a new programme, although the companies have not disclosed the therapeutic target, modality or disease area. Field Content Alert Type Deal Companies Eli Lilly and Company; OmniAb Deal Type Global collaboration and licence agreement Asset or Company New undisclosed ion channel discovery programme Technology or Modality Ion channel drug discovery and screening; specific therapeutic modality undisclosed Deal Value Undisclosed upfront payment, plus up to $370 million in research, development and commercial milestone payments and tiered royalties on global net sales. The $370 million represents contingent milestones and is not guaranteed consideration. Development Stage Discovery Geography Global What Happened On 17 August 2026, OmniAb announced a global collaboration and licence agreement with Eli Lilly for a new ion channel programme. Lilly gains access to OmniAb’s technology platform and expertise in ion channel discovery and screening. OmniAb will receive an undisclosed upfront payment and is eligible for up to $370 million in research, development and commercial milestones, plus tiered royalties on global net sales. The therapeutic target, modality and disease indication have not been disclosed. Why It Matters Ion channels are important but technically challenging drug targets because their membrane-bound structures can complicate antigen generation, screening and discovery. The agreement gives Lilly access to OmniAb’s specialist ion channel capabilities while providing OmniAb with another externally funded application of its discovery technology, although the programme is too early and insufficiently disclosed to assess its therapeutic potential. Supporting Context OmniAb’s wider discovery platform combines engineered transgenic animals, computational antigen design and high-throughput screening capabilities. Its technology is designed to support discovery against challenging targets, including multi-transmembrane proteins such as ion channels. Strategic Rationale Lilly gains access to specialised ion channel discovery and screening expertise for an undisclosed programme, while OmniAb receives upfront economics and retains milestone and royalty participation if a resulting programme progresses through development and commercialisation. Potential Impact Successful progression could provide further validation of OmniAb’s ion channel discovery capabilities and generate milestone and royalty income, but the potential clinical or commercial impact cannot yet be assessed because the target, modality and indication remain undisclosed. Key Takeaway Lilly is putting up to $370 million in contingent milestones behind an OmniAb-enabled ion channel discovery programme, with the underlying therapeutic opportunity remaining undisclosed. What to Watch Disclosure of the therapeutic target, modality or disease area and whether the programme progresses from discovery into preclinical and clinical development. Primary Source https://www.businesswire.com/news/home/20260812350809/en/OmniAb-Announces-Global-Collaboration-and-License-Agreement-for-Ion-Channel-Program-with-Eli-Lilly-Company Relevant Date 17 August 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The new device gives adults with hypercholesterolaemia an additional self-administration option for once-monthly Lerochol, while updated prescribing information reflects evidence linking LDL-C reduction with lower cardiovascular event risk. The US Food and Drug Administration (FDA) has approved an autoinjector version of Lerochol (lerodalcibep-liga) 300 mg/1.2 mL and updated the indication statement for the PCSK9 inhibitor, which is used alongside diet and exercise to reduce LDL-C in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia (HeFH). The autoinjector adds a single-use administration option to the existing pre-filled syringe and is expected to become available in the US by January 2027, although approval does not itself establish insurance coverage. Field Content Alert Type Drug Approval Drug Name Lerochol (lerodalcibep-liga) Indication As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia (HeFH). The updated prescribing information also states that cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk of major adverse cardiovascular events in adults at increased risk when treated with statins or monoclonal antibody PCSK9 inhibitors added to statin therapy. (Business Wire) Therapy Area(s) Cardiovascular disease; Lipid management Geography United States (FDA) What Happened On 17 August 2026, the FDA approved a single-use autoinjector for Lerochol (lerodalcibep-liga) 300 mg/1.2 mL, providing an additional delivery option alongside the already available pre-filled syringe. Lerochol is administered subcutaneously once monthly. The FDA also approved an update to the indication statement reflecting evidence that LDL-C reduction lowers major adverse cardiovascular event risk in adults at increased risk when treated with statins or monoclonal antibody PCSK9 inhibitors added to statin therapy. Lerochol itself was originally FDA approved on 12 December 2025 for LDL-C reduction in adults with hypercholesterolaemia, including HeFH. (Business Wire) Why It Matters PCSK9-directed therapy can require long-term treatment, making administration and treatment burden relevant considerations for patients and prescribers. The pressure-activated autoinjector delivers the monthly dose in seconds and provides another self-administration option without replacing the existing pre-filled syringe. Lerochol can also be stored at room temperature for up to 90 days, which may offer additional practical flexibility, although the effect of the new device on adherence has not been established. (Business Wire) Supporting Context Lerochol is a third-generation PCSK9 inhibitor comprising an engineered PCSK9-binding adnectin fused to human serum albumin to extend its plasma half-life. Its original FDA approval was supported by trials including adults with atherosclerotic cardiovascular disease or increased cardiovascular risk and patients with HeFH. (Business Wire) Key Takeaway FDA approval of the Lerochol autoinjector gives eligible patients another way to self-administer their once-monthly PCSK9 therapy while retaining the existing pre-filled syringe option. What to Watch LIB Therapeutics expects to make the autoinjector available in the US by January 2027, with a direct-to-patient cash price of $199 per month, matching the existing pre-filled syringe programme. The company expects insurance coverage to expand gradually during 2027, but reimbursement is separate from FDA approval. (Business Wire) Primary Source LIB Therapeutics FDA approval announcement Relevant Date 17 August 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The designation expands spevatamig’s regulatory support to the broader first-line metastatic pancreatic ductal adenocarcinoma population as Phanes advances its CLDN18.2 × CD47 bispecific antibody through Phase II development. The US Food and Drug Administration (FDA) has granted Fast Track designation to Phanes Therapeutics’ spevatamig (PT886) in combination with chemotherapy for first-line metastatic pancreatic ductal adenocarcinoma (PDAC), expanding on a previous Fast Track designation covering metastatic CLDN18.2-positive pancreatic adenocarcinoma. The designation provides Phanes with opportunities for more frequent FDA interaction as it advances the Phase II TWINPEAK programme, but does not constitute regulatory approval or establish the therapy’s efficacy. Field Content Alert Type Industry Update Topic FDA Fast Track designation; clinical development Organisation(s) Phanes Therapeutics; US Food and Drug Administration (FDA) Affected Stakeholders Pancreatic cancer researchers; oncologists; clinical investigators; patients with metastatic pancreatic ductal adenocarcinoma Therapy Area(s) Oncology; Pancreatic cancer Geography United States What Happened The FDA has granted Fast Track designation to spevatamig (PT886) in combination with chemotherapy for first-line treatment of metastatic pancreatic ductal adenocarcinoma. Spevatamig is Phanes Therapeutics’ investigational bispecific antibody targeting CLDN18.2 and CD47 and is being evaluated in the Phase I/II TWINPEAK study. The new designation is broader than the Fast Track designation granted in 2024 for metastatic CLDN18.2-positive pancreatic adenocarcinoma, removing the biomarker-positive qualification from the designated first-line population. Fast Track status can facilitate more frequent FDA interactions and potentially rolling review if applicable regulatory requirements are subsequently met; it does not represent approval. (BIO International Convention 2026) Why It Matters The broader designation is relevant because Phanes is developing spevatamig as a potential first-line treatment without restricting enrolment to a narrowly defined CLDN18.2-positive population. Pancreatic ductal adenocarcinoma remains difficult to treat, and the regulatory designation could support closer interaction with the FDA as Phanes determines the programme’s path towards pivotal development. Clinical benefit, however, still needs to be established in prospective trials. Supporting Context Spevatamig is a native IgG-like CLDN18.2 × CD47 bispecific antibody designed to enhance innate immune activity. In previously reported Phase II data from first-line metastatic PDAC, Phanes reported a 40% objective response rate and 93% disease control rate among 15 patients receiving the 2 mg/kg dose with gemcitabine and nab-paclitaxel, with median progression-free survival of 7.3 months; these early findings come from a small, non-randomised cohort and require further confirmation. (Phanes Therapeutics, Inc) Who Is Most Affected Phanes and investigators developing spevatamig are most directly affected because the designation provides a mechanism for increased FDA interaction as the programme advances. Patients with metastatic PDAC are the relevant clinical population, although spevatamig remains investigational and is not currently an approved treatment. Industry Impact The designation supports continued late-stage planning for a differentiated immunotherapy approach in pancreatic cancer based on simultaneous CLDN18.2 and CD47 targeting. Phanes completed enrolment in its Phase II first-line metastatic PDAC study in June 2026 and expects topline results by the end of 2026. (PR Newswire) Key Takeaway The additional Fast Track designation broadens FDA regulatory support for spevatamig as Phanes evaluates whether its CLDN18.2 × CD47 approach can progress towards pivotal development in first-line metastatic pancreatic cancer. What to Watch Topline Phase II results expected by the end of 2026 will be the principal next clinical milestone, particularly whether efficacy and safety findings support Phanes’ plans to move spevatamig towards Phase III development. (PR Newswire) Primary Source Phanes Therapeutics Relevant Date 17 August 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The acquisition adds MediSix’s proprietary T-cell engineering technologies and pipeline to IASO Bio’s integrated cell therapy capabilities while strengthening its presence in Singapore and international markets. IASO Bio has acquired Singapore-based MediSix Therapeutics, bringing the company’s proprietary immune-engineering technologies and cell therapy pipeline into its existing global cell therapy organisation. The transaction expands IASO Bio beyond its established BCMA CAR-T franchise by adding technologies designed to address challenges in T-cell malignancies and other difficult-to-treat diseases, while establishing a stronger R&D presence in Singapore. Field Content Alert Type Deal Companies IASO Bio; MediSix Therapeutics Deal Type Acquisition Asset or Company MediSix Therapeutics and its proprietary T-cell engineering technology and cell therapy pipeline Therapy Area(s) Haematological malignancies; Oncology; Autoimmune diseases Technology or Modality CAR-T cell therapy; T-cell engineering; Protein Expression BLocker (PEBL) technology Deal Value Financial terms of the acquisition have not been disclosed. Development Stage Research and clinical-stage cell therapy programmes Geography Singapore; China; United States; global What Happened IASO Bio has acquired MediSix Therapeutics, a Singapore-headquartered biotechnology company developing engineered T-cell therapies for cancer and autoimmune diseases. The acquisition brings MediSix’s proprietary technologies, intellectual property and development pipeline into IASO Bio’s existing cell therapy organisation. MediSix was founded in 2016 by Professor Dario Campana, whose research contributed to the development of the CAR construct used in the first FDA-approved CAR-T therapy, and has developed technologies including Protein Expression BLocker (PEBL) to address challenges associated with engineering CAR-T cells against T-cell malignancies. Financial terms were not disclosed. (Medisixtx) Why It Matters IASO Bio already has integrated discovery, development, manufacturing and commercial capabilities in cell therapy, anchored by its approved BCMA CAR-T therapy equecabtagene autoleucel. Acquiring MediSix adds a complementary T-cell engineering platform and programmes targeting areas beyond IASO’s established multiple myeloma franchise, while giving the company an R&D base within Singapore’s biotechnology ecosystem. (IASO Bio) Supporting Context MediSix’s PEBL technology is designed to suppress selected proteins inside engineered T cells, an approach intended to overcome challenges encountered when developing CAR-T therapies against targets also expressed by normal T cells. Its pipeline has included PCART7, a CD7-directed programme investigated for T-cell malignancies. (Medisixtx) Strategic Rationale IASO Bio gains proprietary cell-engineering technologies, additional pipeline assets and an established Singapore operation that complements its existing presence in China and the US. The acquisition follows IASO’s broader international expansion, including the June 2026 Singapore approval of equecabtagene autoleucel, its first marketing authorisation for the therapy outside Greater China. (IASO Bio) Potential Impact Integrating MediSix’s technologies could broaden the range of cell therapy targets and diseases addressed by IASO Bio and support development of future programmes for T-cell malignancies and other indications. The eventual impact will depend on the development progress and clinical performance of the acquired programmes. Key Takeaway The MediSix acquisition adds specialist T-cell engineering technology and a Singapore R&D presence to IASO Bio as it builds a broader international cell therapy platform. What to Watch Integration of MediSix’s Singapore operations and technology platform into IASO Bio, development priorities for the acquired pipeline and whether MediSix’s technologies generate new clinical programmes within IASO’s expanded portfolio. Primary Source IASO Bio / MediSix Therapeutics acquisition announcement Relevant Date 18 August 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The collaboration combines Henlius’ biologics development, manufacturing and supply capabilities with Sandoz’s ex-China commercial infrastructure, initially covering three biosimilars and an option on a recombinant human hyaluronidase programme. Shanghai Henlius Biotech and Sandoz have expanded their existing partnership through a strategic collaboration potentially covering up to 10 monoclonal antibody and/or antibody-drug conjugate biosimilar products or components, with initial arrangements covering three products plus an option on a fourth asset. Under those initial arrangements, Sandoz will pay Henlius upfront, milestone and option payments totalling up to $322 million, of which Henlius expects up to $100.5 million to be invoiced during 2026. Field Content Alert Type Deal Companies Shanghai Henlius Biotech; Sandoz Deal Type Strategic collaboration and licensing agreement Asset or Company Up to 10 proposed mAb and/or ADC biosimilar products or components; initial programmes comprise HLX05-N (cetuximab biosimilar), HLX16 (evolocumab biosimilar), a proposed belimumab biosimilar and an option for HLXTE-HAase1001 recombinant human hyaluronidase Therapy Area(s) Oncology; Cardiovascular disease; Immunology Technology or Modality Biosimilar monoclonal antibodies; potential ADC biosimilar programmes; recombinant human hyaluronidase Deal Value For the three initially agreed products and option on HLXTE-HAase1001, Sandoz will pay Henlius upfront and milestone payments plus a non-refundable option fee totalling up to $322 million. Henlius expects up to $100.5 million to be invoiced in 2026 under the initial arrangements. The $322 million includes contingent payments and should not be treated as guaranteed consideration. (Henlius) Development Stage Predominantly early stage. HLX05-N entered Phase I in July 2026; HLX16 and the proposed belimumab biosimilar are preclinical; HLXTE-HAase1001 is in process development. (Henlius) Geography Primarily global markets outside China. HLX05-N rights include the US, Canada, EU, UK, Switzerland, Japan, Australia and New Zealand, with semi-exclusive rights in certain Asian and other markets; HLX16 and the proposed belimumab biosimilar cover all markets outside China. (Henlius) What Happened On 17 August 2026, Henlius and Sandoz announced an expanded strategic collaboration potentially covering up to 10 proposed mAb and/or ADC biosimilar products or components developed by Henlius. Three initial products have been agreed — HLX05-N, HLX16 and a proposed belimumab biosimilar — while Sandoz has an option on HLXTE-HAase1001. Henlius will undertake development, manufacturing and supply, while Sandoz receives specified ex-China registration and commercialisation rights and will contribute market and commercial input during development. The agreement expands a relationship established in April 2025 through Sandoz’s licensing of ex-China rights to Henlius’ proposed ipilimumab biosimilar HLX13. (Henlius) Why It Matters The agreement moves the Henlius-Sandoz relationship from a single-product oncology biosimilar partnership towards a broader portfolio model spanning development through commercialisation. Sandoz gains access to multiple early-stage biosimilar programmes without building the underlying biologics development and manufacturing platform, while Henlius gains an established global partner to support registration, market access and commercialisation across major markets outside China. (Henlius) Supporting Context The initial portfolio targets reference products with substantial existing global sales: Henlius cites 2025 worldwide sales of approximately $1.70 billion for cetuximab, $6.60 billion for evolocumab and $2.48 billion for belimumab. These figures describe the reference-product markets and do not represent projected sales for the Henlius biosimilars. (Henlius) Strategic Rationale Henlius retains responsibility for developing, manufacturing and supplying partnered products while using Sandoz’s presence in around 100 countries for ex-China registration and commercialisation. For Sandoz, the portfolio framework provides access to a pipeline that can potentially be expanded to as many as 10 programmes rather than relying on individual asset-by-asset agreements. (Henlius) Potential Impact If additional programmes are selected and successfully developed, the agreement could substantially broaden the companies’ joint biosimilar portfolio across major international markets. The eventual commercial impact will depend on development success, regulatory approvals, selection of further assets and competitive conditions when individual biosimilars reach the market. Key Takeaway Henlius and Sandoz are expanding a single-product relationship into a potentially 10-programme global biosimilars partnership, combining Henlius’ development and manufacturing platform with Sandoz’s international commercial reach. What to Watch Selection of additional programmes under the 10-product framework, Sandoz’s decision on the HLXTE-HAase1001 option, clinical progress for HLX05-N and advancement of the earlier-stage HLX16 and belimumab biosimilar programmes. Primary Source https://www.henlius.com/en/NewsDetails-6075-26.html Relevant Date 17 August 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The reverse-merger transaction gives privately held Slate a Nasdaq listing and additional capital to advance its anti-PACAP migraine portfolio, led by clinical-stage monoclonal antibody SLTE-1009. Slate Medicines and Fulcrum Therapeutics have agreed to merge in an all-stock transaction that will take Slate public through Fulcrum’s Nasdaq listing, alongside approximately $245 million in committed private financing to support the combined company. The transaction gives Slate additional capital and public-market access to advance its migraine-focused pipeline, including lead anti-PACAP/VIP monoclonal antibody SLTE-1009, while Fulcrum shareholders are expected to receive a special cash dividend and retain a minority interest in the combined business. Field Content Alert Type Deal Companies Slate Medicines; Fulcrum Therapeutics Deal Type All-stock merger / reverse merger with concurrent private financing Asset or Company Slate Medicines and its migraine and headache-disorder pipeline, led by SLTE-1009 Therapy Area(s) Neurology; Migraine; Headache disorders Technology or Modality Monoclonal antibodies targeting PACAP/VIP signalling Deal Value The transaction is accompanied by approximately $245 million in committed private financing from new and existing investors. This financing represents capital for the combined company rather than consideration paid to acquire Fulcrum. Fulcrum shareholders are also expected to receive a pre-closing special cash dividend, subject to the transaction terms and Fulcrum’s available cash at closing. Development Stage Clinical stage; SLTE-1009 is in Phase I development Geography United States What Happened Slate Medicines and Nasdaq-listed Fulcrum Therapeutics have entered a definitive agreement to combine in an all-stock merger. Following completion, the combined business will operate under the Slate Medicines name and focus on developing therapies for migraine and other headache disorders. The transaction is accompanied by approximately $245 million in committed private financing, while existing Fulcrum shareholders are expected to receive a pre-closing special cash dividend and retain a minority ownership position in the combined company. The merger follows Fulcrum’s June 2026 decision to discontinue development of sickle cell disease candidate pociredir and begin a strategic review after FDA feedback left the company without what it considered a viable regulatory path for the programme. Why It Matters The transaction provides Slate with a route to the public markets and additional financing as it advances a differentiated approach to migraine prevention. Its lead candidate, SLTE-1009, targets PACAP/VIP signalling, a mechanism distinct from the CGRP pathway targeted by several established migraine therapies, and has been designed with half-life extension to support subcutaneous administration. (Slate Medicines) Supporting Context Slate launched in February 2026 with a $130 million Series A financing and SLTE-1009, which it licensed from DartsBio Pharmaceuticals. The company is developing the antibody for migraine prevention and other headache disorders, particularly with the aim of providing another mechanistic approach for patients who have an inadequate response to existing standards of care. (Slate Medicines) Strategic Rationale Slate gains Fulcrum’s Nasdaq listing and access to additional capital without pursuing a conventional IPO, while Fulcrum provides shareholders with a route to realise much of its remaining cash through the planned special dividend while retaining an interest in Slate’s pipeline. Fulcrum entered its strategic review after discontinuing pociredir and subsequently reduced its workforce by approximately 85% to preserve capital. Potential Impact The combined financing is intended to support clinical development of SLTE-1009 and Slate’s broader headache-disorder pipeline. Whether the transaction establishes a clinically differentiated migraine franchise will depend on results from SLTE-1009 and subsequent development programmes. Key Takeaway The Fulcrum merger gives Slate a Nasdaq-listed vehicle and substantial additional financing to move its anti-PACAP migraine strategy through clinical development. What to Watch Completion of the merger and financing, the final value of Fulcrum’s special cash dividend and clinical progress for SLTE-1009, including emerging Phase I data and subsequent migraine efficacy studies. Primary Source Fulcrum Therapeutics and Slate Medicines transaction announcement / SEC transaction filings Relevant Date 17 August 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The global collaboration gives Lilly access to OmniAb’s specialist ion channel discovery and screening capabilities for an undisclosed therapeutic target and modality. Eli Lilly and OmniAb have entered a global collaboration and licence agreement for a new ion channel programme, with OmniAb receiving an undisclosed upfront payment and becoming eligible for up to $370 million in research, development and commercial milestones plus tiered royalties on global net sales. The partnership applies OmniAb’s discovery platform and specialist ion channel capabilities to a new programme, although the companies have not disclosed the therapeutic target, modality or disease area. Field Content Alert Type Deal Companies Eli Lilly and Company; OmniAb Deal Type Global collaboration and licence agreement Asset or Company New undisclosed ion channel discovery programme Technology or Modality Ion channel drug discovery and screening; specific therapeutic modality undisclosed Deal Value Undisclosed upfront payment, plus up to $370 million in research, development and commercial milestone payments and tiered royalties on global net sales. The $370 million represents contingent milestones and is not guaranteed consideration. (Business Wire) Development Stage Discovery Geography Global What Happened On 17 August 2026, OmniAb announced a global collaboration and licence agreement with Eli Lilly for a new ion channel programme. Lilly will gain access to OmniAb’s technology platform and expertise in ion channel discovery and screening. OmniAb will receive an undisclosed upfront payment and is eligible for up to $370 million in research, development and commercial milestones, plus tiered royalties on global net sales. The companies have not disclosed the programme’s therapeutic target or modality. (Business Wire) Why It Matters Ion channels are therapeutically important but technically challenging drug targets because their membrane-bound structures can complicate antigen generation, screening and discovery. OmniAb has built dedicated capabilities around ion channels and transporters alongside its broader therapeutic discovery platform, so the Lilly agreement provides another commercial application of this specialist technology while giving Lilly access to established discovery tools for an otherwise undisclosed programme. (OmniAb) Supporting Context OmniAb’s wider platform combines engineered transgenic animals, computational antigen design, high-throughput screening and computational tools to discover therapeutic antibodies and other target-binding proteins. Its antigen platform can produce full-length membrane proteins, including multi-transmembrane proteins such as ion channels, for use in discovery campaigns. (OmniAb) Strategic Rationale Lilly gains access to OmniAb’s specialised ion channel discovery and screening expertise without the companies disclosing the underlying target or therapeutic approach. OmniAb receives upfront economics while retaining substantial milestone and royalty participation if the partnered programme progresses through development and commercialisation. (Business Wire) Potential Impact Progression of the programme could provide further validation of OmniAb’s ion channel capabilities and generate additional milestone payments, but its therapeutic potential cannot yet be assessed because the target, modality and disease indication remain undisclosed. Key Takeaway Lilly’s agreement puts up to $370 million in contingent milestones behind an OmniAb-enabled ion channel discovery programme, while leaving the underlying target and therapeutic modality undisclosed. What to Watch Disclosure of the therapeutic target, modality or disease area and whether the programme progresses from discovery into preclinical and clinical development, triggering future milestone payments. Primary Source https://www.businesswire.com/news/home/20260812350809/en/OmniAb-Announces-Global-Collaboration-and-License-Agreement-for-Ion-Channel-Program-with-Eli-Lilly-Company Relevant Date 17 August 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The submission seeks approval for a next-generation mitomycin formulation designed for intravesical treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, building on the same drug-delivery platform as FDA-approved Zusduri. The US Food and Drug Administration (FDA) has accepted UroGen Pharma’s New Drug Application for UGN-103 for the treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), with a PDUFA target action date of 18 December 2026. If approved, UGN-103 would provide a next-generation formulation using UroGen’s sustained-release RTGel technology, but the NDA acceptance represents the start of regulatory review rather than an approval. Field Content Alert Type Industry Update Topic Regulatory review; New Drug Application Organisation(s) UroGen Pharma; US Food and Drug Administration (FDA) Affected Stakeholders Urologists; patients with recurrent LG-IR-NMIBC; oncology and urology treatment centres Therapy Area(s) Urology; Oncology; Bladder cancer Geography United States What Happened The FDA has accepted UroGen Pharma’s NDA for UGN-103 for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer and assigned a PDUFA target action date of 18 December 2026. UGN-103 is an investigational intravesical formulation of mitomycin using UroGen’s RTGel sustained-release technology. The application is supported by the Phase III UTOPIA trial and relies in part on the FDA’s 505(b)(2) regulatory pathway. Acceptance means the application has entered substantive FDA review and does not constitute approval. Why It Matters Recurrent LG-IR-NMIBC has traditionally required repeated surgical procedures, particularly transurethral resection of bladder tumour. UGN-103 is designed to provide sustained exposure of bladder tissue to mitomycin through a non-surgical intravesical treatment, potentially providing another treatment option if the FDA determines that the application meets requirements for approval. Supporting Context UGN-103 is a next-generation formulation related to UroGen’s Zusduri (mitomycin) for intravesical solution, which received FDA approval in June 2025 for adults with recurrent LG-IR-NMIBC. UroGen developed UGN-103 using a different mitomycin manufacturing process intended to support its longer-term bladder cancer franchise. Who Is Most Affected Urologists and patients managing recurrent LG-IR-NMIBC are the principal stakeholders because an approval could add another intravesical mitomycin formulation using sustained-release technology to the US treatment pathway. UroGen is also directly affected because the review concerns a potential successor within its commercial bladder cancer portfolio. Industry Impact The NDA demonstrates UroGen’s effort to extend its RTGel-based bladder cancer platform beyond its existing Zusduri product. Any effect on treatment practice or the commercial market will depend on FDA approval, the final label, availability and subsequent clinical adoption. Key Takeaway FDA acceptance moves UGN-103 into formal regulatory review for recurrent LG-IR-NMIBC, with a decision expected by 18 December 2026. What to Watch The 18 December 2026 PDUFA target action date, the final FDA decision and, if approved, how UGN-103 is positioned relative to UroGen’s existing Zusduri treatment. Primary Source UroGen Pharma regulatory announcement Relevant Date 18 August 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The 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 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 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 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