Pharma Phriday (May 29, 2026)

Written by Duncan Emerton, Pharma Phriday is a comprehensive weekly update on the pharmaceutical industry, covering clinical trial results, regulatory approvals, corporate development activity, and other significant developments. Click below to download a PDF version of this week's note.

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Contents

Artificial Intelligence

• Biomunex announces two AI partnerships to accelerate cancer R&D.

• Perceptic launches with $12 million in seed funding.

• Zuckerberg’s Biohub unveils AI world model for drug discovery.

Clinical

• 858 Therapeutics posts initial Phase I/II data for ETX-19477.

• Aulos posts positive Phase II data for imneskibart in melanoma.

• D&D posts positive 48 week histology for zabopegdutide in MASH.

• Eli Lilly posts new analysis of ATTAIN-1 and ATTAIN-2.

• Eli Lilly unveils Phase Ib data for VERVE-102.

• Ellipses Pharma unveils Phase II data for lunbotinib in RET+ NSCLC.

• GSK unveils functional cure data for bepirovirsen in HBV.

• Merck Group doses first patient with Precem‑TcT in Phase III CRC trial.

• Precision posts early-stage data for its gene editing platform in HBV.

• Sac-TMT/pembrolizumab combo beats pembrolizumab in 1L NSCLC.

• Sobi’s pozdeutinurad delivers in Phase III gout study.

Regulatory

• China’s NMPA approves Hernexeos for 1L HER2-mutant advanced NSCLC.

• Datroway gets FDA nod for 1L metastatic TNBC.

• EMA accepts Regeneron’s Otarmeni for regulatory review.

• EMA’s CHMP recommends 8 new medicines for approval.

• Gilead’s Hepcludex gets FDA nod for chronic hepatitis D.

Commercial

• Apogee announces two key milestones for zumilokibart.

• Eli Lilly continues M&A spree with $3.8 billion buy of three companies.

• Merz expands Inbrija into China through Kvvit licensing deal.

In Other News

• Alfasigma posts positive Phase III data for filgotinib in axSpA.

• Arrowhead presents early-stage data for ARO-INHBE at EASL 2026.

• Asahi Kasei licenses novel ADC technology from The Noguchi Institute.

• Biocytogen launches AI-powered antibody discovery platform.

• Corcept to resubmit Cushing’s disease NDA for relacorilant.

• FDA accepts BridgeBio’s NDA for BBP-419 for LGMD2I/R9.

• Gilead shares new Phase III results for Livdelzi in PBC.

• Marea Therapeutics to present Phase I data for MAR002 in acromegaly.

• Moderna, Merck cancer combo cuts melanoma spread risk at 5 years.

• Sanofi’s venglustat type 3 Gaucher disease NDA accepted by the FDA.

• Tuteur licenses autoimmune biosimilar from Polpharma.

Summary

Artificial Intelligence

Biohub, the Chan-Zuckerberg philanthropic organisation, released an open-source protein AI suite covering 6.8 billion proteins, backed by $500 million in funding, designed to accelerate drug discovery globally without commercial constraint. Perceptic launched with $12 million in seed funding to build an end-to-end AI platform for drug development, building on the enterprise AI deployment model emerging across the sector. Biomunex announced two AI partnerships focused on bsAb target identification, though terms were undisclosed and both partners are relatively unknown in the space.

Clinical

GSK presented pivotal B-Well data showing bepirovirsen achieved a 19% functional cure rate in over 1,800 patients, rising to 26% in patients with lower viral activity, compared to 0% on standard of care, with a PDUFA date of 26 October 2026. Precision Biosciences presented the first clinical evidence of direct cccDNA elimination in liver biopsies via gene editing, establishing pgRNA as a validated biomarker for cure in 16 patients across five cohorts. Eli Lilly's VERVE-102 reduced PCSK9 by up to 88% and LDL-C by up to 62% in a single-dose Phase Ib study with up to 18 months' durability. Sac-TMT plus pembrolizumab reduced disease progression or death by 65% versus pembrolizumab alone in 1L PD-L1-positive NSCLC. Sobi's pozdeutinurad achieved a 69% serum uric acid response rate at 75mg in 811 gout patients. D&D Pharmatech's zabopegdutide met all histological endpoints in MASH at 48 weeks, though the per-protocol population of 35 warrants caution. Merck Group dosed the first patient in its Phase III CEACAM5 ADC trial in colorectal cancer.

Regulatory

Datroway received FDA approval as the first TROP2 ADC for 1L metastatic TNBC in patients ineligible for immunotherapy, with a median OS of nearly two years versus 18.7 months for chemotherapy. Gilead's bulevirtide became the first approved treatment for chronic hepatitis D in the US, six years after EMA conditional approval. The CHMP recommended eight new medicines, including oral Wegovy for weight management, nerandomilast for IPF and PPF, and camizestrant for ESR1-mutant breast cancer. China approved zongertinib as the first targeted oral treatment for first-line HER2-mutant advanced NSCLC.

Commercial

Eli Lilly acquired three vaccine companies for up to $3.8 billion, marking a return to infectious disease and establishing an upstream prevention strategy adjacent to its existing neurology and metabolic franchises. Apogee Therapeutics secured $1.3 billion in non-dilutive financing from Blackstone Life Sciences to fund Phase III development of zumilokibart in atopic dermatitis, though the market reacted negatively, potentially due to the synthetic royalty structure.

In Other News

The Moderna/Merck & Co. personalised cancer vaccine combination reduced melanoma spread risk by 59% at five years, with overall survival of 92% versus 71% for pembrolizumab alone. The FDA accepted priority review of BridgeBio's NDA for BBP-418 in limb-girdle muscular dystrophy, and Sanofi's venglustat received priority review for type 3 Gaucher disease.

Artificial Intelligence

Biomunex announces two AI partnerships to accelerate cancer R&D

What happened? Biomunex Pharmaceuticals (Biomunex) has announced AI collaboration agreements with Gordion Bioscience and Tangramed Biotech. Both collaborations are focused on identifying novel bispecific target combinations for Biomunex's BiXAb platform. No financial terms are disclosed. BiXAb is a plug-and-play bsAb generation platform designed to create bsAbs from any pair of mAbs in a simple, rapid, and cost-effective manner, using proprietary in silico modelling. The platform has been licensed to Sanofi, Ipsen, and Onward Therapeutics. Biomunex's lead scientific differentiator is a programme targeting MAIT cells, a naturally occurring T cell subpopulation particularly abundant in mucosal and barrier tissues, then redirecting them to kill solid tumour cells, which it describes as the first such approach globally.

What does this mean? The press release is typical of early-stage AI collaboration announcements in the European biotech space; two undisclosed-value research agreements with AI companies, framed around accelerating target discovery rather than producing clinical output. Neither Gordion Bioscience nor Tangramed Biotech are well-known names in the AI drug discovery landscape, and the absence of financial terms suggests these are modest research arrangements rather than substantive partnerships. That said, bsAb target combination discovery is a challenge for AI approaches because it’s fundamentally a question of identifying pairs of targets that are co-expressed, co-essential, or co-operative in a way that makes simultaneous engagement clinically superior to hitting either alone. The Gordion approach (i.e., biological network analysis to identify co-essential target pairs that conventional expression-based methods miss) is a logical application of graph-based computational biology to that problem. The Tangramed multimodal data analytics angle is less clearly differentiated from what many other companies are doing.

Perceptic launches with $12 million in seed funding

What happened? Supported by $12 million in seed funding, a trio of former Palantir executives have founded a startup called Perceptic that’s building an end-to-end AI platform for drug development, handling everything from drug discovery to clinical trial design. London-based venture capital firm Accel led the funding round, alongside Air Street Capital and Elder Gull. Perceptic said its software is already being used by multiple top-tier pharmaceutical companies, though it was only allowed to name CSL, the Australian biotechnology company. In the past two years, numerous startups have emerged to use AI to speed drug discovery. This includes Isomorphic Labs, which recently announced $2.1 billion Series B funding, Recursion, Insilico Medicine, which recently announced a $2.75 billion collaboration with Eli Lilly, and many others. But so far, no AI-discovered drugs have made it to market, leading some to question whether AI is living up to the hype around revolutionising drug development.

What does this mean? Perceptic appears to be applying the “AI operating system” model pioneered in defence and enterprise analytics to biopharma decision-making, aiming to integrate fragmented scientific, clinical, and operational data into a single workflow layer. That reflects a broader industry shift where pharma companies increasingly believe competitive advantage will come less from standalone AI models and more from embedding AI directly into R&D and portfolio decisions. The announcement also reinforces how crowded and competitive AI-enabled drug discovery has become, with startups now competing not just on molecule generation, but on workflow orchestration, data integration, and enterprise deployment. Think OpenAI/Novo Nordisk and Anthropic/BMS as similar deals. The challenge for Perceptic will be proving that these platforms can deliver measurable improvements in productivity, timelines, or clinical success rates, something the sector has promised for years but has not really delivered on so far.

Zuckerberg’s Biohub unveils AI world model for drug discovery

What happened? Mark Zuckerberg’s Biohub has released an open-source protein AI suite backed by $500 million in funding, which includes $400 million for internal model development and $100 million for external data-generation initiatives funding wet-lab experiments to produce training data. The release comprises three components: the ESM Atlas covering 6.8 billion proteins and 1.1 billion structures; ESMC, a protein language model providing virtual representations of proteins; and ESMFold2, a design engine for predicting 3D protein structures and their interactions with binders. Together they form what Biohub describes as an open discovery engine for protein structure prediction, design, and biological discovery, made freely available to researchers globally. The suite is built on the fourth generation of evolutionary scale modelling, which learns from protein sequences produced by evolution to understand protein biology.

What does this mean? Unlike pharmaceutical companies or venture-backed startups, Biohub is a nonprofit research organisation so doesn’t need to recoup its investment through drug sales or licensing fees. This allows it to release everything as open source without commercial constraint. Biohub’s goal is to accelerate the field, rather than capture commercial value. 6.8 billion proteins is several orders of magnitude beyond what any individual laboratory could catalogue in a lifetime. The human proteome contains around 20,000 protein-coding genes producing perhaps 100,000 distinct protein forms. Biohub's atlas covers the evolutionary protein universe at a scale that dwarfs any previous resource. Whether the breadth translates into practical drug discovery utility depends on the quality and coverage of the structural and functional annotations. There’s a certain degree of heading in the PR. Priscilla Chan's statement that the models have been verified in immune diseases and cancer is cautiously worded, which is appropriate at this stage, but it suggests internal wet-lab validation work is already underway rather than this being purely theoretical.

Clinical

858 Therapeutics posts initial Phase I/II data for ETX-19477

What happened? 858 Therapeutics has announced preliminary safety and efficacy data from its ongoing, first-in-human Phase I/II trial of ETX-19477 (PARG inhibitor) in patients with BRCA-mutated ovarian cancer and HR+/HER2- breast cancer. This data release includes clinical data from N=45 patients enrolled in the Phase Ia/b dose escalation and expansion portions of the study. A poster presentation at ASCO 2026 will include an expanded dataset of N=53 patients, including seven patients who meet the eligibility criteria for the ongoing Phase II expansion cohorts in BRCA-mutated ovarian cancer and HR+/HER2- breast cancer. These criteria limit prior therapy to no more than five lines for ovarian cancer and no more than two lines for breast cancer. In this Phase II-eligible subset, ETX-19477 demonstrated robust antitumor activity, with a 57% ORR (n=7). Durable RECIST responses were observed in both tumour types, providing the first clinical proof-of-concept for PARG inhibition in ovarian and breast cancer patients. ETX-19477 was generally well tolerated, with low rates of hematologic toxicity observed to date.

What does this mean? A 57% ORR in a heavily pre-treated, platinum-resistant BRCA-mutated ovarian cancer population is a robust early signal. The caveat is that this is N=7 patients in the Phase II-eligible subset, which is not a dataset from which robust conclusions can be drawn. Larger, late-stage clinical trials will be needed to validate the result. What’s perhaps more interesting is the MOA. ETX-19477 is an oral, selective inhibitor of PARG (poly(ADP-ribose) glycohydrolase), a DNA damage response enzyme. PARG catalyses the removal of poly-ADP-ribose chains from proteins during the DNA damage response. Inhibiting it leads to selective cell death in tumours with underlying replication fork defects, including BRCA-mutated tumours, through a mechanism distinct from PARP inhibition. Platinum-resistant BRCA-mutated ovarian cancer is a setting where PARP inhibitors (e.g., olaparib, niraparib, rucaparib, talazoparib) have largely failed or where resistance has developed. A drug acting on the same pathway but via a different enzyme, with a different mechanism of resistance, is an elegant solution to that problem. The haematological toxicity profile of PARP inhibitors, particularly anaemia and thrombocytopenia, has been a limiting factor in their use and in combination development. The claim of low haematological toxicity for ETX-19477, if borne out in larger cohorts, would be clinically meaningful. Interestingly, PARG inhibitors are being explored as potential treatments for Parkinson’s disease.

Aulos posts positive Phase II data for imneskibart in melanoma

What happened? Aulos Bioscience has announced positive Phase II data from its ongoing Phase I/II trial of imneskibart in patients with doublet checkpoint inhibitor (CPI)-refractory metastatic melanoma. Imneskibart is a human IgG1 mAb designed using an AI platform that binds IL-2 and selectively blocks its interaction with CD25, the high-affinity IL-2 receptor subunit expressed on regulatory T cells (Tregs). By preventing IL-2 from binding to trimeric receptors on Tregs while still allowing IL-2 to bind and activate effector T cells and NK cells, imneskibart redirects the immune-activating effect of IL-2 away from immunosuppression and towards anti-tumour activity. The Phase II data show that imneskibart-based outpatient regimens are well tolerated and demonstrate durable clinical activity, including ongoing and deepening responses. Patients received either imneskibart plus low-dose, subcutaneous aldesleukin or the triplet regimen of imneskibart plus low-dose, subcutaneous aldesleukin and nivolumab. Across the study, imneskibart treatment was associated with sustained regulatory Treg reduction, increased CD8/Treg ratios and evidence of durable anti-tumour activity, supporting its differentiated IL-2 mechanism. Full data will be presented as a poster at ASCO 2026.

What does it mean? Doublet CPI-refractory metastatic melanoma (i.e., patients who have progressed on both nivolumab and ipilimumab) represents one of the most difficult-to-treat settings in oncology. There is no established standard of care after doublet CPI failure; options include BRAF/MEK inhibitors for the BRAF-mutant subset, tumour-infiltrating lymphocyte therapy (e.g., Amtagvi) and clinical trials. Any meaningful clinical activity in this setting is therefore genuinely noteworthy. The usual caveats apply. This is a small data set, and we do not yet have response rates, patient numbers, or duration of response data. This is likely to come from the full poster presentation at ASCO 2026.

D&D posts positive 48 week histology for zabopegdutide in MASH

What happened? South Korea’s D&D Pharmatech (D&D) has announced positive top-line 48-week histology results from its Phase II DD01-DN-02 trial evaluating zabopegdutide (DD01) in patients with metabolic dysfunction-associated steatohepatitis (MASH). Zabopegdutide is a long-acting, once-weekly subQ GLP-1/glucagon dual receptor agonist. Following Week 12 data announced in June 2025, the final 48-week biopsy data demonstrate that zabopegdutide produced significant histological improvements in patients with biopsy-confirmed MASH and fibrosis stage F1-F3. The study met all three key histological endpoints, demonstrating the potential of zabopegdutide to both resolve steatohepatitis and reverse liver fibrosis. The placebo-adjusted effect size for fibrosis improvement with no worsening of MASH was 34.2% (p=0.0323), while the placebo-adjusted effect size for MASH resolution with no worsening of fibrosis was 57.2% (p=0.0003). Notably, the placebo-adjusted effect size for achieving both fibrosis improvement and MASH resolution was 32.2% (p=0.0192). These histological improvements were accompanied by significant reductions in liver fat measured by MRI-PDFF, liver stiffness measured by MRE, and multiple fibrosis biomarkers.

What does this mean? Zabopegdutide has been design specifically with a GLP-1 to glucagon receptor potency ratio of 11:1. It’s calibrated to balance metabolic efficacy and weight loss while ensuring sufficient glucagon receptor activity to drive hepatic lipid metabolism directly. That ratio distinguishes zabopegdutide from survodutide (Boehringer Ingelheim/Zealand Pharma), which has a different GLP-1/glucagon balance, and the relative potency ratios across dual agonists in this class are increasingly discussed as a differentiating variable in MASH. While the 57.2% placebo-adjusted MASH resolution figure at week 48 is substantially higher than what approved agents achieved in their much larger Phase III trials, the sample size (N=16) makes it hard to compare efficacy too closely. The confidence intervals around each endpoint will be wide, and the probability of a single outlier response significantly distorting the results is high. The per-protocol population of 35 out of 67 enrolled (with only 16 on active treatment) also reflects a degree of attrition that needs to be understood before the data can be interpreted cleanly. A larger Phase III trial is needed before any firm conclusions can be made. Two therapies currently hold FDA approval for non-cirrhotic MASH with moderate-to-advanced fibrosis: resmetirom (Rezdiffra, Madrigal), a thyroid hormone receptor-beta agonist approved in March 2024, and semaglutide (Wegovy, Novo Nordisk), approved for MASH in August 2025. Crucially, both are indicated for F2-F3 fibrosis only, leaving F1 patients without an approved treatment. Zabopegdutide's Phase II enrolled F1-F3 patients, which, if confirmed in a Phase III, could support a broader label.

Eli Lilly posts new analysis of ATTAIN-1 and ATTAIN-2

What happened? Eli Lilly has announced a post-hoc subgroup analysis of ATTAIN-1 and ATTAIN-2 which was presented at ESC 2026 in Istanbul. The analysis focuses specifically on adults aged 65 and over. In ATTAIN-1 (without type 2 diabetes), adults aged 65 and over on the highest approved dose of 17.2mg orforglipron achieved mean body weight reduction of 13.0% versus 1.6% on placebo at 72 weeks. Interesting, results were numerically comparable or slightly better in the over-65 group than the under-65 group across both trials, showing that the drug did not appear to lose efficacy in older patients. In ATTAIN-2 (with type 2 diabetes), the over-65 group achieved 12.2% weight reduction at the highest dose versus 2.3% on placebo, again broadly consistent with the under-65 cohort. Serious adverse event rates were higher in the over-65 group (9.9% to 13.0% depending on dose vs. 5.4% to 6.2% in younger patients) though Eli Lilly’s PR notes these were generally consistent with the class profile and similar across active and placebo arms in the respective age groups.

What does this mean? With this data Eli Lilly is building the evidence base for Foundayo in older patients ahead of the Medicare GLP-1 Bridge access programme launching on 1 July 2026, which will allow eligible Medicare Part D beneficiaries to access Foundayo at a $50 monthly copay. The combination of an oral, flexible-dosing pill and Medicare access at $50 per month is a telling access improvement for a population that has disproportionately been excluded from GLP-1 therapy by cost and the practical inconvenience of injections and dosing restrictions. Taken together with the TRIUMPH-1 data and the retatrutide pipeline, Eli Lilly has been pushing the obesity narrative on three fronts simultaneously: the pivotal registration data for the next-generation agent, real-world access expansion for the approved oral drug, and a targeted data package for the age group that stands to benefit most from the access programme. This is a well-coordinated commercial and scientific communications strategy.

Eli Lilly unveils Phase Ib data for VERVE-102

What happened? Eli Lilly has announced positive Phase Ib Heart-2 trial results for VERVE-102, an investigational in vivo base editing medicine designed to durably turn off the PCSK9 gene in the liver and lower blood low-density lipoprotein cholesterol (LDL-C) following a single infusion. The Heart-2 trial is evaluating VERVE-102 in adults with heterozygous familial hypercholesterolemia (HeFH) or premature coronary artery disease (CAD). In N=35 participants with HeFH or premature CAD, all on maximally tolerated oral lipid-lowering therapy, a single infusion of VERVE-102 produced dose-dependent reductions in PCSK9 of 51% to 88% and LDL-C reductions of 9% to 62% across six dose cohorts from 0.3 to 1.0 mg/kg. The LDL-C reduction was not perfectly linear, as the 0.6 mg/kg and 0.7 mg/kg produced similar or slightly lower reductions than 0.45 mg/kg and 0.8 mg/kg respectively, though the overall dose-response trend is clear. Importantly, reductions were sustained over follow-up of up to 18 months in the subset followed for that duration, with median follow-up of approximately nine months across the full cohort. No treatment-related serious adverse events and no dose-limiting toxicities were reported. All N=35 participants received the full planned dose, and none withdrew. Phase II enrolment is planned to begin by end of 2026.

What does this mean? As a bit of background, natural loss-of-function variants in PCSK9 were identified in populations with very low lifetime LDL-C and correspondingly very low rates of coronary heart disease. VERVE-102 is an attempt to confer that same permanent advantage through a single clinical intervention by giving patients the genetics they were not born with. The 88% PCSK9 reduction and 62% LDL-C reduction at the 1.0 mg/kg dose are large effect sizes. For context, approved PCSK9 inhibitors (e.g., evolocumab and alirocumab) typically reduce LDL-C by 50-60% on top of statin therapy but require fortnightly or monthly subQ injections indefinitely. Inclisiran, the siRNA-based PCSK9 inhibitor, requires twice-yearly injections. VERVE-102 is proposing to exceed or match that effect size with a single dose that is, in principle, permanent. The 18-month durability data in the subset followed that long, while still a small number of patients, are consistent with the intended mechanism, which is a permanent genomic edit should not wane over time in the way protein-based or RNA-based therapies do. In terms of safety, the population enrolled (i.e., HeFH patients on maximally tolerated lipid-lowering therapy) is high cardiovascular risk, and the absence of any treatment-related serious adverse events across N=35 participants and up to 18 months of follow-up is reassuring. Whether the base editing mechanism translates into a superior long-term safety profile relative to other gene editing approaches will need larger and longer studies to establish. Recall, Eli Lilly acquired Verve Therapeutics in June 2025, integrating its base editing cardiovascular programme alongside the ANGPTL3-targeting VERVE-201. Together these represent Eli Lilly's bet that gene editing will eventually displace chronic therapy in dyslipidaemia management. If VERVE-102 succeeds in Phase II and beyond, the commercial implications extend well beyond HeFH into the much larger population of patients with residual cardiovascular risk despite statin therapy.

Ellipses Pharma unveils Phase II data for lunbotinib in RET+ NSCLC

What happened? Ellipses Pharma (Ellipses) has announced that its partner, Kelun Biotech, will present pivotal trial data for lunbotinib (also called KL590586) in patients with RET-fusion positive NSCLC at ASCO 2026. The data were generated in Kelun Biotech’s Phase II trial that evaluated the efficacy and safety of lunbotinib 90mg orally QD in patients with pre-treated and treatment-naïve RET-fusion positive locally advanced, or metastatic, NSCLC. Lunbotinib demonstrated robust efficacy in both cohorts and an encouraging, manageable tolerability and safety profile. Lunbotinib is under regulatory review in China.

What does this mean? RET fusions occur in approximately 1-2% of NSCLC patients and represent a well-validated oncogenic driver. Selpercatinib (Retevmo/Retsevmo; Eli Lilly) and pralsetinib (Gavreto; Rigel) are both approved and have established efficacy in this population, with selpercatinib the more widely adopted of the two following its 1L approval based on the Phase III LIBRETTO-431 trial. The case for a next-gen treatment therefore rests on demonstrating improvement in areas like activity against resistance mutations that develop on first-generation agents, CNS efficacy, or tolerability. More broadly, this is another example of the Chinese biotech/Western pharma licensing pattern that has become a common occurrence in recent months. Kelun Biotech is responsible for the Chinese pivotal trial, NDA submission, and NMPA review, while Ellipses Pharma holds ex-Greater China rights and is running the Western clinical programme. The Ellipses relationship gives the programme Western regulatory credibility and a pathway to FDA and EMA submissions, while Kelun retains the China commercial opportunity. Recall, Kelun Biotech is also partnered with Merck & Co. on Sac-TMT (see Sac-TMT/pembrolizumab combo beats pembrolizumab in 1L NSCLC).

GSK unveils functional cure data for bepirovirsen in HBV

What happened? GSK and Ionis have presented pooled data from B-Well 1 and B-Well 2, two global Phase III trials covering more than 1,800 patients across 29 countries. The data showed that six months of bepirovirsen treatment achieved a 19% functional cure rate in the overall study population (233 of 1,220 patients versus 0 of 614 on placebo; p<0.001 in both trials). In patients with lower baseline HBsAg of 1,000 IU/ml or below, the functional cure rate was 26%. Both trials met their primary endpoints. An exploratory analysis showed that 49% of bepirovirsen recipients achieved an HBsAg level of 100 IU/ml or below one year after end of treatment, a threshold associated with significantly reduced liver cancer risk. The FDA has assigned a PDUFA date of 26 October 2026, with priority review and Breakthrough Therapy designation in place. Regulatory reviews are also underway in the EU, Japan and China. Bepirovirsen is an antisense oligonucleotide licensed by GSK from Ionis Pharmaceuticals in August 2019.

What does this mean? Functional cure in HBV is defined as sustained loss of HBsAg and undetectable HBV DNA for at least 24 weeks after stopping all treatment. The current standard of care (i.e. nucleos(t)ide analogues such as entecavir, tenofovir disoproxil fumarate and tenofovir alafenamide) achieves functional cure in approximately 1% of patients, often after years of treatment. A 19% functional cure rate from a finite six-month course added to existing therapy is therefore an approximately 19-fold improvement over what the standard alone achieves. The 0% functional cure rate in the placebo arm is also worth noting explicitly. This is not a disease where spontaneous cure occurs at any meaningful rate in trial populations on nucleos(t)ide analogues; it confirms that the bepirovirsen effect is entirely treatment driven. The 49% achieving HBsAg below 100 IU/ml at one year post-treatment is the number that will resonate most in the hepatology community. HBsAg suppression to this level, even without achieving full loss, is associated with significantly reduced liver cancer risk and is considered a clinically meaningful partial response. It means bepirovirsen benefits a substantially larger proportion of patients than the 19% who achieve the strict functional cure definition.

Merck Group doses first patient with Precem‑TcT in Phase III CRC trial

What happened? Merck Group has announced that the first patient has been dosed in the Phase III PROCEADE-CRC-03 trial. The trial is evaluating precemtabart tocentecan (Precem‑TcT) for the treatment of metastatic colorectal cancer (mCRC). The PROCEADE-CRC-03 trial will assess the efficacy and safety of Precem-TcT, alone or with bevacizumab, in patients with mCRC who are intolerant- or refractory-to, or progressed after, systemic therapies. The trial will be conducted in approximately 165 sites in 20 countries and will recruit approximately 1,020 patients with mCRC. Recall, in the Phase I PROCEADE-CRC-01 trial, Precem-TcT as monotherapy or in combination showed manageable safety in more than 100 patients with heavily pretreated mCRC. At the recommended dose for Phase III development (2.8 mg/kg Q3W; n=29), confirmed objective response rate (cORR) was 20.7% (95% CI: 8.0, 39.7), median PFS was 6.9 months (95% CI: 4.4, 9.5) and median OS was not reached (95% CI: 8.7, NE) after a median follow-up of 13.1 months.

What does this mean? As a bit of background, Precem-TcT is an anti-CEACAM5 ADC which combines an antibody targeting carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) with an exatecan payload (i.e., a topoisomerase I inhibitor) which is in the same pharmacological class as the DXd payload used in Enhertu and Datroway. The construct is designed for circulatory stability and includes a bystander killing effect, whereby exatecan permeates cell membranes to induce apoptosis in neighbouring tumour cells that may not express CEACAM5 directly. CEACAM5 is expressed in approximately 90% of colorectal tumours and requires no patient selection, which means that there is no biomarker enrichment required. This is an operational advantage in a tumour type where molecular heterogeneity has historically fragmented patient populations and complicated trial design. The Phase I ORR of 20.7% in 29 patients at the Phase III dose is a modest but clinically meaningful signal in heavily pre-treated mCRC, where approved options at 3L+ include regorafenib (ORR ~1-4%), trifluridine/tipiracil (ORR ~2%), and the KRAS G12C inhibitor sotorasib in the small G12C-mutant subset. A 20% confirmed ORR in an unselected late-line population, if it holds in the Phase III, would represent a meaningful advance. Bevacizumab is already embedded in mCRC treatment algorithms and its combination with cytotoxic agents is well established. Testing Precem-TcT plus bevacizumab adds a combination arm without requiring a novel partner drug, and VEGF inhibition has shown synergy with ADC payloads in preclinical and early clinical work through effects on vascular permeability and drug delivery.

Precision posts early-stage data for its gene editing platform in HBV

What happened? Precision Biosciences (Precision) has announced initial data from its Phase I ELIMINATE-B trial which is open-label, dose escalation and dose expansion study designed to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B (HBV). PBGENE-HBV is an in vivo gene editing programme designed to be a potentially curative treatment for chronic HBV via the elimination of the root cause of chronic HBV, cccDNA. The critical technology behind this is ARCUS, Precision's proprietary nuclease platform, encapsulated in a lipid nanoparticle-delivered mRNA and administered intravenously. As of the 4 May 2026 data cutoff, 38 doses have been administered to N=16 patients across five cohorts. The headline findings are across three distinct datasets. Live analysis showed a 10-fold reduction in cccDNA-derived transcripts after only two doses of PBGENE-HBV 0.4mg/kg. On the pre-genomic RNA (pgRNA) biomarker, 100% of patients with detectable pgRNA at baseline (n=6) achieved durable loss of blood pgRNA across four distinct dosing cohorts. Complete loss of blood pgRNA directly corresponded to undetectable pgRNA in post-treatment liver biopsy, establishing pgRNA as the validated clinical biomarker for cccDNA elimination. On HBsAg, 100% of patients (n=15) experienced substantial HBsAg declines across all dose levels, with duration of response ranging from 1.5 to 12 months or more. In the first patient treated, durable HBsAg decline for more than one year supports the permanence of the gene editing mechanism. On safety, no dose-limiting toxicities were observed.

What does this mean? A landmark result for the HBV cure landscape. What’s most important from this data is evidence of direct cccDNA elimination, an outcome the field has been waiting for. Every other approach (e.g., nucleos(t)ide analogues, RNA interference, capsid assembly modulators) work downstream of cccDNA. PBGENE-HBV is the first therapeutic to show, in human liver tissue, that cccDNA can be directly targeted and eliminated. The 10-fold reduction in cccDNA transcripts and 80% editing of remaining cccDNA after three doses at the doses tested is a mechanistic PoC that has not previously been demonstrated by any drug in development. The hypotension signal is the main safety concern that needs monitoring. The mitigation protocol appears to be working, but LNP-related hypotension will need to be characterised carefully as doses escalate and more patients are treated. The absence of Hy's law signals in any patient is an important reassurance on hepatotoxicity.

Sac-TMT/pembrolizumab combo beats pembrolizumab in 1L NSCLC

What happened? Phase III OptiTROP-Lung05 data presented ahead of ASCO 2026 showed that Merck & Co./Kelun Biotech’s sacituzumab tirumotecan (sac-TMT; anti-TROP2 ADC) plus pembrolizumab reduced the risk of progression or death by 65% and the risk of death by 45% compared with pembrolizumab alone in N=413 patients with treatment-naive, PD-L1-positive, EGFR/ALK-negative advanced NSCLC. Median PFS was not reached with the combination versus 5.7 months with pembrolizumab alone (HR 0.35; p<0.0001). Overall response rate was 70.2% versus 42% for pembrolizumab monotherapy. OS data were not mature at the data cutoff but showed a preliminary 45% improvement in favour of the combination. This is the first Phase III trial of an ADC combined with a checkpoint inhibitor to achieve its primary endpoint in first-line NSCLC.

What does this mean? A 65% risk reduction in progression or death is an impressive result in 1L NSCLC. The ORR of 70.2% is similarly impressive. But without the full data set it’s hard to draw any firm conclusions. The broader significance is that sac-TMT is now demonstrating efficacy across multiple tumour types. In addition to this positive readout in 1L PD-L1 positive NSCLC, Sac-TMT has delivered positive results in endometrial cancer and EGFR-mutant NSCLC. The question for Merck is how quickly it can translate these China-led readouts into Western approvals, and whether the comparator choices in the Chinese trials will satisfy regulators and payers in the US and Europe without additional head-to-head data against the chemotherapy-containing standards. Approved TROP2-directed ADCs include Trodelvy (Gilead) and Datroway (AstraZeneca/Daiichi Sankyo). Sac-TMT is the most advanced TROP2-directed pipeline ADC.

Sobi’s pozdeutinurad delivers in Phase III gout study

What happened? Sobi has announced positive topline results from the pivotal Phase III REDUCE 2 trial which is evaluating pozdeutinurad (AR882), an investigational next-generation once-daily oral selective URAT1 inhibitor, in N=811 adults with gout including those with uncontrolled gout (also referred to as progressive gout) and inadequately controlled by existing therapies. Both doses of pozdeutinurad (50 mg or 75mg OD) met the primary efficacy endpoint, defined as the proportion of patients achieving a serum uric acid (sUA) level <6 mg/dL at month 6 (75 mg: 69.2% vs 8.1% 50mg: 56.6% vs 8.1%. The safety profile was consistent with previous studies. Detailed results are expected to be presented at a forthcoming scientific congress. REDUCE 1, the companion trial with more than 800 patients, is fully enrolled and expected to read out in the second half of 2026.

What does this mean? As a bit of background, Sobi acquired pozdeutinurad in February 2026 via its $950 million acquisition of Arthrosi Therapeutics. China rights are separately licensed to ApicHope Pharmaceuticals. Gout is one of the most undertreated common diseases in medicine. It affects approximately 40 million people globally, is strongly associated with cardiovascular and renal comorbidities, and yet the treatment landscape has barely changed in two decades. The withdrawal of lesinurad in the US in February 2019, and Europe in June 2020, left a gap in the oral treatment algorithm for patients who do not achieve target uric acid on xanthine oxidase inhibitors alone. Pozdeutinurad is well positioned to fill that gap, and the REDUCE 2 response rate of nearly 70% at the 75mg dose in a treatment-resistant population looks promising. The REDUCE 1 data in the second half of 2026 are the next important milestone. Two positive pivotal trials would provide the evidence base for regulatory submissions in the US, EU, and other markets, with earliest approval potentially by 2027-2028. The combination use data, adding pozdeutinurad to allopurinol or febuxostat rather than replacing them, broadens the addressable population further and gives clinicians a flexible tool rather than a straight substitution.

Regulatory

China’s NMPA approves Hernexeos for 1L HER2-mutant advanced NSCLC

What happened? China's NMPA has granted conditional approval for Boehringer Ingelheim’s Hernexeos (zongertinib) as a monotherapy initial treatment for adult patients with unresectable, locally advanced or metastatic NSCLC harbouring activating HER2 tyrosine kinase domain mutations. The approval is based on Phase Ib Beamion LUNG-1 data in 74 treatment-naïve patients, which showed an ORR of 75.7%, including 10.8% complete responses, with a median duration of response of 15.2 months. Full data was published in the NEJM in April 2026. Full approval is contingent on confirmation of clinical benefit in an ongoing confirmatory trial. The drug is also approved in China for previously treated patients. The China approval follows US accelerated approval in February 2026 and approvals in Hong Kong and Japan, making zongertinib the first orally administered targeted therapy approved in multiple markets for HER2-mutant NSCLC.

What does this mean? The 75.7% 1L ORR with 10.8% CR is a robust efficacy number in a population historically underserved by targeted therapy. HER2 mutations in NSCLC affect approximately 2-4% of patients and until recently had no approved targeted oral option. The prior standard was trastuzumab deruxtecan (Enhertu), approved in the pre-treated setting in October 2024. Existing pan-HER TKIs have consistently failed in HER2-mutant NSCLC not because of inadequate HER2 inhibition but because of dose-limiting EGFR toxicity: you cannot reach the HER2-inhibiting dose without intolerable diarrhoea and skin toxicity. Zongertinib's selectivity allows full target engagement without that ceiling, and the tolerability data reflects that cleaner profile in practice. As mentioned above, Enhertu is approved in the pre-treated HER2-mutant NSCLC setting and has solid efficacy data. The question the oncology community will want answered is whether 1L zongertinib followed by later-line Enhertu represents a superior sequential strategy to earlier Enhertu use, or whether the two are complementary across different disease stages.

Datroway gets FDA nod for 1L metastatic TNBC

What happened? Daiichi Sankyo and AstraZeneca have received FDA approval for Datroway (datopotamab deruxtecan; anti-TROP2 ADC) for the treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval follows Priority Review by the FDA and is based on results from the Phase III TROPION-Breast02 trial which were announced in October 2025. In the trial, Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median OS vs. investigator’s choice of chemotherapy. Median OS was 23.7 months for patients treated with Datroway versus 18.7 months for those treated with chemotherapy. Datroway reduced the risk of disease progression or death by 43% compared to chemotherapy as assessed by blinded independent central review (BICR). Median PFS was 10.8 months for patients treated with Datroway versus 5.6 months for those treated with chemotherapy in patients with metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway was also associated with more robust treatment responses compared to chemotherapy, with an ORR of 64% vs. 30% for those treated with chemotherapy. In terms of safety, the most common (≥20%) adverse reactions, including laboratory abnormalities, were stomatitis, increased amylase, nausea, alopecia, decreased haemoglobin, decreased white blood cells, constipation, decreased calcium, decreased lymphocytes, fatigue, decreased neutrophils, increased alanine aminotransferase, increased aspartate aminotransferase, dry eye, keratitis, decreased albumin, vomiting, musculoskeletal pain, decreased sodium and increased blood alkaline phosphatase.

What does this mean? A median OS of approximately two years in 1L metastatic TNBC is a genuinely significant result. The historical median OS in this setting has been 12-18 months with chemotherapy, and pembrolizumab plus chemotherapy in PD-L1-positive patients improved this meaningfully but left PD-L1-ineligible patients without an equivalent option. The patient population targeted by this approval covers approximately 70% of 1L mTNBC patients (i.e., those who cannot receive immunotherapy), which is a substantial commercially addressable group. Establishing Datroway as the new standard of care in this population, backed by NCCN Category 1 Preferred guideline inclusion, creates an enviable commercial position. The OS hazard ratio of 0.79 is modest in absolute terms, but still statistically significant. The PFS hazard ratio of 0.57 is arguably the more clinically meaningful number for day-to-day treatment decisions. The 34-percentage-point difference in ORR (64% vs. 30%) is likely to resonate with oncologists, as higher response rates can sometimes translate to earlier symptomatic benefit and better quality of life. From a competitive perspective, Trodelvy (sacituzumab govitecan; Gilead) is approved in 2L+ TNBC but has not demonstrated a 1L OS benefit. Gilead's Ascent-04 data show Trodelvy plus pembrolizumab improving outcomes in PD-L1-positive 1L TNBC, but that targets a different patient population from this Datroway approval. The two drugs are therefore not directly competing in the same 1L slot, though sequencing questions will arise in practice. The one caveat worth noting is that the OS hazard ratio, while statistically significant, has a confidence interval reaching 0.98. This is barely crossing the conventional significance threshold. The trial was powered to detect this magnitude of benefit, and the data are robust, but the OS benefit’s not as dramatic as the PFS and ORR data suggest. Long-term durability data from the trial will be important for confirming the magnitude of benefit over time.

EMA accepts Regeneron’s Otarmeni for regulatory review

What happened? Regeneron has announced the EMA has accepted for review under Accelerated Assessment the MAA for Otarmeni (lunsotogene parvec), an in vivo adeno-associated virus (AAV) vector-based gene therapy for the treatment of biallelic OTOF variant-associated hearing loss. Otarmeni previously received Orphan Designation from the EMA. If approved, Otarmeni will be the first gene therapy for OTOF-related hearing loss in the European Union (EU). The MAA is supported by data from the pivotal Phase I/II CHORD trial, in which N=20 participants (aged 10 months to 16 years) received a single dose of Otarmeni via intracochlear infusion, either unilaterally (in one ear; N=10) or bilaterally (in both ears; n=10). 16/20 patients (80%) experienced hearing improvements per pure tone audiometry assessments at a threshold of ≤70 dB HL at 24 weeks and 14/20 patients (70%) demonstrated an auditory brainstem response.

What does this mean? As someone who suffers from hearing loss, this is massive news. Until recently, the only treatment for genetic deafness was cochlear implantation, which is effective but doesn't restore natural hearing. Originally developed by Decibel Therapeutics (acquired by Regeneron in September 2023), Otarmeni was approved by the FDA in April 2026. Subject to approval in Europe, it will become the first gene therapy ever approved for a genetic form of hearing loss. In the US Regeneron announced that it would provide Otarmeni for free. It remains to be seen if this happens in Europe. Other companies running clinical trials targeting the same OTOF gene as Otarmeni include Eli Lilly (via AK-OTOF which it gained from its October 2022 acquisition of Akouos) and Sensorion (via SENS-501 which is in Phase I/II trials). Eli Lilly has also partnered with Seamless Therapeutics to develop and commercialise treatments for hearing loss based on gene editing techniques.

EMA’s CHMP recommends 8 new medicines for approval

What happened? During its May 2026 meeting, the EMA’s CHMP recommended eight new medicines for approval, plus extensions of indication for 13 already-authorised products. Some of the most clinically significant approvals included Jascayd (nerandomilast; Boehringer Ingelheim) for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis and Etcamah (camizestrant; AstraZeneca) for locally advanced or metastatic breast cancer with ESR1 mutation. Vijoice (alpelisib; Novartis) received a conditional marketing authorisation for PIK3CA-related overgrowth spectrum (PROS). The CHMP also recommended extending the Wegovy (semaglutide) marketing authorisation to include a daily oral tablet formulation for weight management. The medicines the CHMP recommended to receive extensions of indication included Braftovi, Enhertu, Erbitux, Fasenra, Hetronifly, Iclusig, Keytruda, Maviret, Padcev, Palynziq, Sogroya, Tepkinly and Trodelvy.

What does this mean? Subject to the EC formally approving Jascayd for use in Europe, this means that it has now been approved as a treatment for IPF and PPF in several key markets, including the US and Japan. For Etcamah, the CHMP nod flies in the face of the FDA’s ODAC which in April 2026 did not vote in favour of camizestrant plus a CDK4/6 inhibitor in first-line HR+/HER2- advanced breast cancer with emergent ESR1 mutation. Both regulators saw the same data (i.e., from the Phase III SERENA-6 trial), but the FDA didn’t see the benefit. Perhaps unsurprisingly, AstraZeneca has announced that the FDA has extended the PDUFA data for camizestrant, citing the FDA’s need to “review additional data requested to support the NDA”. This kind of transatlantic regulatory divergence is not unprecedented but is commercially significant. AstraZeneca may find itself with EU approval and no US approval for the same indication, at least until OS data from SERENA-6 (one of the key sticking points for the FDA) mature. The approval of Vijoice is welcome news for patients suffering from PROS, as there is currently no authorised medicine for PROS in the EU, with treatment limited to surgery and supportive care. The CHMP recommending the approval of oral Wegovy (semaglutide) for weight management is a significant development for the GLP-1 class in Europe. An oral weight management option from the market leader will broaden the eligible and willing patient population considerably. The timing is also notable given the news flow out of Eli Lilly in recent weeks for Foundayo and retatrutide, two oral options for weight management. Positive extension recommendations for Enhertu, Padcev, and Trodelvy are consistent with the ongoing broadening of ADC indications in Europe that mirrors the US approval trajectory. Fasenra's extension is consistent with its expansion beyond severe eosinophilic asthma into other eosinophil-driven conditions, including hypereosinophilic syndrome which received FDA approval recently.

Gilead’s Hepcludex gets FDA nod for chronic hepatitis D

What happened? Gilead Sciences (Gilead) has received FDA accelerated approval for Hepcludex (bulevirtide; 8.5 mg) for the treatment of adults living with chronic hepatitis delta virus (HDV) infection, making it the first and only approved treatment for HDV in the US. Bulevirtide is a lipopeptide entry inhibitor that mimics the preS1 domain of the hepatitis B surface antigen and blocks the NTCP receptor, preventing both HBV and HDV from entering liver cells. HDV is a satellite virus that can only infect people already carrying HBV, and is the most severe form of viral hepatitis, with the highest risk of cirrhosis, liver failure, and hepatocellular carcinoma. The FDA granted accelerated approval based on data from the Phase III MYR301 trial, which showed treatment with bulevirtide reduced HDV RNA and normalised alanine aminotransferase (ALT). At Week 48, the study demonstrated a statistically significant improvement versus the control (delayed treatment) group in a combined virologic and biochemical response. Continued treatment with bulevirtide demonstrated sustained efficacy and was generally well tolerated through up to 144 weeks of on-treatment exposure. Improvement in disease-related clinical outcomes has not been established, and continued approval for the approved indication may be contingent on verification and description of clinical benefit in a confirmatory trial.

What does this mean? Hepcludex’s regulatory history provides another example of transatlantic regulatory divergence (see EMA’s CHMP recommends 8 new medicines for approval and coverage of AstraZeneca’s camizestrant). First, there is the timing. The FDA’s approval comes six years after the EMA granted conditional approval in July 2020 based on Phase II data. European approval was granted based on incomplete evidence with the expectation that further data from the Phase III MYR301 trial would confirm the benefit. Full approval for Hepcludex followed in Europe in July 2023. Hepcludex’s path to market in the US has not been helped by an FDA Complete Response Letter issued in October 2022 which cited concerns about manufacturing and delivery of the medication rather than clinical efficacy. Then there’s a difference in the approved dose. Hepcludex is approved in the EU at 2mg OD, whereas the FDA has approved 8.5mg OD. This reflects the MYR301 trial design, which studied 2mg and 10mg doses. As mentioned above, the EU approval was based on earlier Phase II data at 2mg. The FDA's accelerated approval was based on the MYR301 data that showed the 8.5mg dose producing 48% combined response, a dose not included in the EMA's original approval. Whether the EU label will be updated to include the higher dose as MYR301 data are submitted to the EMA remains to be seen.

Commercial

Apogee announces two key milestones for zumilokibart

What happened? Apogee Therapeutics (Apogee) has announced two significant milestones related to the development of zumilokibart (anti-IL-13 mAb) which is currently in development as a potential treatment of atopic dermatitis (AD). APEX Part B, the company’s Phase IIa dose optimisation study, met all primary and secondary endpoints with high statistical significance. In N=346 adults with moderate-to-severe AD, the mid-dose achieved EASI-75 in 65.9% versus 23.4% on placebo at 16 weeks. Secondary endpoints at mid-dose included IGA 0/1 in 46.0%, EASI-90 in 47.4%, meaningful itch improvement in 50.5%, and virtual loss of disease activity in 20.6%. The mid-dose has been selected for Phase III, with initiation planned for the second half of 2026. Regarding zumilokibart’s Phase III programme, Apogee has entered into a strategic financing collaboration with funds managed by Blackstone Life Sciences (BLS) for up to $1.3 billion in flexible, non-dilutive total capital to support the continued development and potential commercialisation of zumilokibart.

What does this mean? As a bit of background, zumilokibart is a subQ, engineered anti-IL-13 mAb designed for extended half-life, enabling dosing every 3-6 months in the maintenance phase, which is substantially less frequent than any currently approved biologic for AD. It’s the same mechanistic class as tralokinumab and lebrikizumab. Zumilokibart's dosing proposition is its primary differentiator; dosing quarterly or half-yearly in the maintenance phase would reduce injection visits by up to 80% compared with dupilumab's (Dupixent; Sanofi/Regeneron) fortnightly schedule and lebrikizumab's (Ebglyss; Almirall/Eli Lilly) monthly maintenance requirement. While BLS’ synthetic royalty deal provides non-dilutive capital, it carries a longer-term cost. BLS will receive a royalty on future net sales, which reduces Apogee's long-term economics if the drug succeeds commercially. Whether it’s the right capital structure depends on how strongly one believes in the eventual commercial outcome. The market's reaction (Apogee’s share price fell after the announcement) suggests institutional investors are not as convinced.

Eli Lilly continues M&A spree with $3.8 billion buy of three companies

What happened? Eli Lilly (Lilly) has announced agreements to acquire three vaccine companies for a combined total of up to approximately $3.8 billion in cash, subject to milestones. The companies include Curevo, LimmaTech Biologics (LimmaTech) and Vaccine Company, Inc. (Vaccine Company).

• Curevo (up to $1.5 billion). Lead asset is amezosvatein, an adjuvanted subunit shingles vaccine in Phase II, head-to-head trials against Shingrix. In that trial it matched immune response across all primary endpoints while reducing activity-limiting fatigue, chills, and injection-site pain by more than half.

• LimmaTech Biologics (up to $780 million). Developing vaccines against difficult-to-treat and increasingly AMR-affected bacterial pathogens, including Staphylococcus aureus, Neisseria gonorrhoeae, and Chlamydia trachomatis. Lead programme LTB-SA7 is a Phase I Staphylococcus aureus vaccine targeting toxins and superantigens. The pipeline also covers pathogens linked to infertility and other downstream consequences of infection, particularly in women.

• Vaccine Company (up to $1.55 billion). Developing a proprietary In Vivo Nanoparticle (IVN) platform that aims to generate virus-like particle-level immune responses without the manufacturing complexity of traditional VLP production. Lead programme is a five-antigen, mRNA Epstein-Barr Virus vaccine which is in a Phase I trial.

What does this mean? This marks Lilly's return to infectious diseases after the company deprioritised the category and slowly withdrew over several years. These deals should be viewed as a return to the company’s historical legacy rather than being seen as a new direction (note: Lilly was one of the original manufacturers of the Salk polio vaccine in the 1950s). It also adds to a sustained acquisition programme that has already included deals in ADCs, bispecific antibodies, ophthalmology, myelofibrosis, hearing loss, sleep disorders, and in vivo CAR-T therapy. First the when. The genesis of these deals can perhaps be traced back to October 2025 when Peter Marks, the FDA’s former head of CBER, joined Lilly as head of infectious disease and senior vice president of molecule discovery at Eli Lilly. Dr Marks, one of the most prominent scientific voices in defence of vaccine science while at the FDA, is now running Lilly's infectious disease division. These three acquisitions are his first major strategic move in that role and are deliberate steps in rebuilding Lilly's infectious disease capability. Then comes the why. Lilly has invested in these three companies to take advantage of potential adjacencies. For example, a shingles vaccine that demonstrably reduces dementia risk is directly adjacent to Lilly's Alzheimer's franchise. An EBV vaccine that reduces MS incidence has the potential to support Lilly’s neurological disease ambitions. The infectious disease re-entry is therefore not a diversification away from Lilly's core, it’s an upstream prevention play that opens potential patient populations that would otherwise need Lilly's downstream treatments.

Merz expands Inbrija into China through Kvvit licensing deal

What happened? Merz Therapeutics (Merz) and Jiangxi Kvvit Pharmaceutical (Kvvit) have announced an exclusive license and collaboration agreement regarding Inbrija (levodopa inhalation powder) and its proprietary ARCUS inhalation device. Inbrija is widely approved outside of China (e.g., US, Europe) and is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor. Kvvit gains access to Inbrija in mainland China, Hong Kong and Macao.​ Inbrija is currently not approved in China, Hong Kong and Macao. Under the agreement, Merz will supply Inbrija and retain responsibility for global product quality and key regulatory activities. Kvvit will lead development, regulatory activities and commercialisation in the licensed territories under a jointly agreed China Development Plan. Merz will act as Overseas Holder of the Drug Registration Certificate and Kvvit will serve as Domestic Responsible Person, funding local clinical development and regulatory submissions.​ Under the agreement, Merz Therapeutics will receive an upfront payment, in addition to development and commercial milestone payments, as well as tiered supply and royalty arrangements linked to commercial performance in the territory.

What does this mean? By means of some background, Inbrija has been approved in the US since 2018 and in Europe since 2019. Merz acquired Inbrija and Fampyra (fampridine) from Acorda Therapeutics for $185 million in a court-structured bankruptcy sale in July 2024. Chance Pharmaceuticals had previously held the rights to Inbrija in China under Acorda's ownership, meaning Merz has effectively replaced the prior Chinese partner with Kvvit following the acquisition. The China Parkinson's disease market is large (estimated at 3 million patients) and growing. Access to advanced symptomatic management for OFF episodes is limited compared to Western markets, and Inbrija’s MOA (i.e., rapid pulmonary absorption of levodopa bypassing delayed gastric emptying) addresses a genuine clinical gap. One thing to note is that the regulatory path in China will require local clinical data. China’s NMPA generally requires bridging studies or local trials rather than simply accepting Western approval data, particularly for novel delivery technologies. The jointly agreed China Development Plan will define that scope and timeline, and the deal's milestone structure will likely be gated against regulatory submission and approval milestones rather than just commercial ones.

In Other News

Alfasigma posts positive Phase III data for filgotinib in axSpA

Alfasigma has announced positive results from the Phase III OLINGUITO Phase III trial which assessed the efficacy and safety of filgotinib (Jyseleca) in adult patients with active axial spondyloarthritis (axSpA). The trial demonstrated patients treated with 200mg filgotinib showed sustained improvements in the signs and symptoms of axSpA, including disease activity and inflammation, vs. placebo. Safety was consistent with the known profile of filgotinib, indicating a favourable benefit-risk profile for patients with active axSpA. Filgotinib is already approved in several markets, including Europe, for the treatment of moderate to severe active RA in adults who have not responded adequately or cannot tolerate other DMARDs, and for the treatment of adult patients with moderate to severe active UC. Alfasigma acquired Jyseleca from Galapagos in February 2024.

Arrowhead presents early-stage data for ARO-INHBE at EASL 2026

Arrowhead Pharmaceuticals has presented new clinical data for its RNAi-based obesity and MASH candidate ARO-INHBE at EASL 2026. The interim Phase I/IIa results showed that the drug achieved meaningful reductions in liver fat, visceral fat, and body weight both as a standalone therapy and in combination with low-dose tirzepatide (Mounjaro; Eli Lilly). In patients with obesity and elevated liver fat, ARO-INHBE monotherapy delivered placebo-adjusted liver fat reductions of 44%, while combination therapy enhanced reductions in visceral adipose tissue and liver fat compared with tirzepatide alone. The drug also produced deep and durable suppression of Activin E, its biological target, with effects lasting beyond three months after a single dose.

Asahi Kasei licenses novel ADC technology from The Noguchi Institute

Asahi Kasei Life Science (Asahi) has acquired the license rights for a novel ADC technology from The Noguchi Institute. This modality enables precise control over the drug-to-antibody ratio and attachment site of single- and dual-payload ADCs, representing a potential breakthrough toward more effective and safer use in a broad range of therapies. Under this agreement, the two partners will advance initiatives to commercialize ADC drug platforms, including possible future sub-licensing to biopharma companies and Contract Development and Manufacturing Organizations (CDMOs) such as Bionova Scientific, an Asahi Kasei company. In addition, both parties will engage in joint research to further refine the technology to solve medical challenges.

Biocytogen launches AI-powered antibody discovery platform

Biocytogen has announced the launch of RenSuper Workstation, a next-generation AI-powered antibody discovery platform providing off-the-shelf access to a large-scale, experimentally validated library of fully human therapeutic antibody sequences, together with the RenSuper High-Throughput Antibody Manufacturing Automation Center, a fully automated infrastructure designed to accelerate antibody validation and production. Built on Biocytogen’s proprietary RenMice platforms, RenSuper establishes a closed-loop antibody discovery engine combining in vivo immune repertoires, AI-driven candidate selection, automated experimental validation, and scalable manufacturing infrastructure. The platform supports the discovery and development of mAbs, bsAbs, multispecifics, ADCs, VHHs, and other advanced therapeutic modalities, significantly reducing the time and risk associated with antibody discovery.

Corcept to resubmit Cushing’s disease NDA for relacorilant

Following the FDA’s January 2026 rejection of Corcept’s selective glucocorticoid receptor antagonist (SGRA), relacorilant, as a potential treatment for Cushing’s disease related hypertension, the company has announced that it will resubmit its NDA to the FDA. Recall, relacorilant (brand name, Lifyorli) was approved, in combination with nab-paclitaxel, for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in March 2026.

FDA accepts BridgeBio’s NDA for BBP-419 for LGMD2I/R9

BridgeBio Pharma (BridgeBio) has announced the FDA has accepted for filing its NDA with Priority Review for oral BBP-418 for the treatment of individuals living with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026, and BridgeBio is poised to launch BBP-418 upon approval. No advisory committee meeting is planned to discuss the application. The application is supported by data from the Phase III FORTIFY trial.

Gilead shares new Phase III results for Livdelzi in PBC

Gilead has reported an encouraging post-hoc analysis of data from the Phase III ASSURE trial of Livdelzi (seladelpar) in primary biliary cholangitis (PBC). The analysis focused on patients with mildly elevated alkaline phosphatase (ALP) levels, a key biomarker linked to disease progression and showed that 83% of evaluable patients achieved composite ALP normalization at 12 months, with 74% maintaining that response at 24 months. ALP normalization is increasingly viewed as a clinically meaningful target in PBC, associated with lower risk of liver transplantation and disease progression. The data also suggest durability, an important differentiator in chronic autoimmune liver disease where long-term control is essential. Exploratory analyses further showed that most responders maintained or improved liver stiffness measurements over three years, hinting at potential disease-modifying effects.

Marea Therapeutics to present Phase I data for MAR002 in acromegaly

Marea Therapeutics will present Phase I data from its first-in-human Phase I study of MAR002 at ENDO 2026 (June 13-16 in Chicago, IL). MAR002 is a first-in-class allosteric mAb targeting the growth hormone receptor (GHR). In January 2026, Marea announced positive topline Phase I results supporting a potential best-in-class profile across safety, tolerability, PD effect and dosing convenience, with deep, durable IGF-1 suppression that may enable dosing as infrequently as once every two weeks, compared to the daily subQ injections required by the current standard of care (e.g., somatostatin analogies, growth hormone receptor antagonists). Marea remains on track to initiate a Phase II/III study of MAR002 in acromegaly in 2026.

Moderna, Merck cancer combo cuts melanoma spread risk at 5 years

Moderna and Merck & Co. have announced that its combination therapy for skin cancer helped reduce risk of cancer spreading to another ‌part of the body by 59% after five years of ‌follow-up. The study tested Moderna's experimental personalized cancer ​vaccine intismeran autogene, in combination with Merck's pembrolizumab, in melanoma patients after surgery to assess whether the combination prevented their cancer from returning. The trial enrolled N=157 patients from 2019 to 2021. After five ‌years of follow-up, overall ⁠survival was 92.2 % for the combination arm, while the Keytruda-alone group recorded 71.3 %, the results showed. The data ⁠follow earlier results showing the combination cut the risk of recurrence or death by 49 % after five years, consistent with the three-year follow-up data ​published in ​2023.

Sanofi’s venglustat type 3 Gaucher disease NDA accepted by the FDA

The FDA has granted priority review to the NDA for venglustat, a novel, investigational oral glucosylceramide synthase inhibitor (GCSi), for the treatment of type 3 Gaucher disease (GD3). If approved, venglustat would become the first treatment available in the US to address the progressive neurological manifestations associated with GD3 and expand Sanofi’s portfolio of treatment options for patients living with lysosomal storage diseases. The target action date for the FDA decision is November 25, 2026. The NDA is supported by positive data from the Phase III LEAP2MONO trial which evaluated the efficacy and safety of venglustat in adults and paediatric patients, with neurological manifestations of GD3, who previously achieved stabilization of systemic manifestations with enzyme replacement therapy (ERT).

Tuteur licenses autoimmune biosimilar from Polpharma

Argentina-based Tuteur has licensed exclusive rights to commercialise a biosimilar for autoimmune diseases across Latin America (LATAM), excluding Brazil, from Polpharma Biologics (Polpharma). Polpharma will retain full responsibility for the development and manufacturing of the biosimilar. Tuteur will be responsible for commercialisation, marketing, and distribution in the licensed territories. No deal terms or the identity of the biosimilar in question were provided.

About the Author

Duncan Emerton is a pharmaceutical industry professional with a background spanning clinical R&D, medical affairs, and strategic consulting. He brings a commercially minded perspective to complex scientific and market developments, with experience in competitive intelligence, business analysis, and portfolio strategy across the life sciences sector. Through Pharma Phriday, Duncan provides concise, insight-driven commentary on the stories shaping the pharmaceutical and biotech landscape, helping readers filter out the noise to understand what really matters for companies, competitors, and patients alike.