Biomedicine Daily · Friday, 23 October 2026
CBA FRONTIER INSIGHTS
Moderna, Merck shares fall on eagerly anticipated cancer vaccine results
In a late-stage trial in post-surgical melanoma, Moderna and Merck's intismeran autogene combined with Keytruda reduced the relative risk of disease recurrence or death by 42% versus Keytruda alone, with a median follow-up of 24.6 months.
Clinical readouts and safety
medicalxpress.comThree-week radiation course a safe option for breast cancer patients undergoing reconstruction, trial shows
The RT CHARM (Alliance A221505) randomized trial showed that for women undergoing reconstruction after mastectomy for breast cancer, a 16-fraction course of radiation over 3–4 weeks was noninferior to the standard 25-fraction, 5–6-week regimen for reconstruction complications.
World's First Implantable Muscle-Nerve Stimulator for Congenital Nystagmus Completes First Implant and Activation After Approval
The world's first muscle-nerve electrical stimulator for congenital nystagmus, developed by Wang Lejin's team at Peking University People's Hospital, has completed its first patient implantation and activation after regulatory approval. The device was approved on March 13, 2026 through the NMPA's green channel for Class III innovative medical devices. Trials of 10 feasibility and 61 confirmatory subjects showed foveation time increased several-fold, nystagmus amplitude and frequency fell markedly, and visual quality and quality of life improved.
2026 ESMO Preview: Pimicotinib MANEUVER 2-Year TGCT Follow-Up and Three Nirogacestat Desmoid Tumor Datasets
Five studies from Merck KGaA's pimicotinib and nirogacestat were accepted for the 2026 ESMO congress, covering long-term follow-up and quality of life in TGCT, as well as dose-reduction, real-world, and indirect comparison evidence in desmoid tumors.
Fenebrutinib cuts annualized relapse rate 55% in two Phase 3 studies, shrinks chronic active lesions up to 30%
Fenebrutinib reduced the annualized relapse rate in relapsing multiple sclerosis by 55% and shrank chronic active lesion volume by up to 30% in the Phase 3 FENhance 1 and FENhance 2 studies. The studies enrolled 746 and 751 adult patients, registered as NCT04586010 and NCT04586023. In the same data set, the primary progressive arm was only noninferior to Ocrevus, and no fenebrutinib safety data were disclosed at the meeting.
ESMO 2026: Merck’s Kelun-partnered ADC hits the ‘Goldilocks zone,’ VP says
A Merck vice president said sac-TMT, its ADC partnered with Kelun-Biotech, uses an irreversible linker that stays stable in the blood until reaching the tumor, with payload release in what he called the "Goldilocks zone." The original contrasts this with the reversible linkers of Trodelvy and Datroway, noting that premature payload release can cause anemia and neutropenia, while overly slow release may also affect other TROP2-expressing tissues.
Hengrui's PD-L1/TGF-βRII Fusion Protein Plus Chemotherapy Extends Overall Survival in Phase 3 RELIGHT Gastric Cancer Trial Published in JCO
Hengrui Medicine's PD-L1/TGF-βRII bispecific antibody fusion protein relafutafusp alfa (brand name Aizele), combined with chemotherapy as first-line treatment for advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma, has been formally published in the Journal of Clinical Oncology as the phase 3 RELIGHT study.
AbbVie’s skin disease drug lessens abscess burden in Phase 3 but falls below expectations
AbbVie's lutikizumab met the primary endpoint in the Phase 3 INTREPID study of about 1,400 patients with hidradenitis suppurativa, but efficacy fell below analyst expectations. The week-16 abscess and nodule count response rate was 31.4% versus 23.4% for placebo, an 8% difference, compared with a 28% placebo-adjusted improvement in earlier Phase 2 data. The study also hit eight secondary endpoints; BMO cited reductions in pain and flares, while Guggenheim said the results could support regulatory approval but expects limited commercial adoption as monotherapy.
medicalxpress.comCAR T-cell therapy shows lasting improvements in stiff person syndrome, study finds
One-year follow-up of the Phase 2 trial of miv-cel, a CAR T-cell therapy, showed that in 26 patients with stiff person syndrome, the 25-foot walk time fell 49% from baseline after a single infusion, and 8 of 12 patients who had needed walking aids no longer required assistance at one year. 92% of patients had stopped immunosuppressive therapy at one year, and clinical benefit persisted even though B-cell repopulation had begun in 65%. Results were presented at MSToronto26, and sponsor Kyverna Therapeutics plans to complete its rolling BLA submission in the fourth quarter of 2026.
Ianalumab for the Treatment of Patients with Sjögren’s Disease
The New England Journal of Medicine published a study of ianalumab for the treatment of patients with Sjögren's disease. The article appears in Volume 395, Issue 16, pages 1585-1599, DOI 10.1056/NEJMoa2601088.
[Articles] Endometrial ablation plus levonorgestrel-releasing intrauterine system versus endometrial ablation alone in women with heavy menstrual bleeding in The Netherlands (MIRA2): a multicentre, open-label, randomised, controlled, superiority trial
MIRA2, a multicentre, open-label, randomised controlled superiority trial conducted in the Netherlands, showed that endometrial ablation combined with a levonorgestrel-releasing intrauterine system reduced the incidence of hysterectomy in women with heavy menstrual bleeding compared with endometrial ablation alone. The combined treatment appears to be a safe adjunctive strategy that does not increase the risk of complications.
doi.orgEvaluating a multi-vaccine respiratory immunization strategy involving SARS-CoV-2, pneumococcal, and influenza vaccines in adults: A randomized, open-label, multicenter, controlled, non-inferiority Phase IV trial in China
A randomized, open-label Phase IV trial in China showed that sequential co-administration of WIBP-CorV with PPV23 and IIV4 on Day 0 and Day 28 maintained humoral immune responses against three respiratory pathogens in adults.
In Vivo Aquaporin-1 Circular RNA Therapy for Radiation-Induced Xerostomia
A study by RiboX Therapeutics with the University of Iowa, Johns Hopkins University and the University of Pennsylvania, published in NEJM Volume 395, Issue 16, pages 1659-1661, reports circular RNA encoding Aquaporin-1 administered in vivo to treat radiation-induced xerostomia. The feed provides only the abstract; the full text is not given.
Regulatory and policy
Trastuzumab Deruxtecan Gains Conditional Tumor-Agnostic HER2-Positive Approval in China
Daiichi Sankyo's trastuzumab deruxtecan (Enhertu) has been approved in China for adult patients with unresectable or metastatic solid tumors expressing HER2 IHC 3+ who have received prior treatment or have no satisfactory alternative options. The approval, granted conditionally by the NMPA, covers a tumor-agnostic indication.
FDA grants traditional approval for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for unresectable or metastatic TMB-H solid tumors with updated indication
The FDA has converted the indication for pembrolizumab in unresectable or metastatic TMB-H solid tumors to traditional approval, with TMB-H now defined as ≥13 mut/Mb.
FDA Approves Bepirovirsen Plus NrtI for Certain Non-Cirrhotic Adults With Chronic Hepatitis B
The FDA has approved the antisense oligonucleotide bepirovirsen (brand name Hibsago) in combination with NrtIs for certain adults with chronic HBV infection who do not have cirrhosis. It is the first ASO approved by the FDA for chronic hepatitis B, and reports say the therapy is under priority review in China.
NMPA Approves Merck's HIF-2α Inhibitor Welireg (Belzutifan) for PPGL Indication
Merck's Welireg (belzutifan) has been approved by the NMPA for adolescents and adults aged 12 and older with locally advanced, unresectable or metastatic PPGL. The drug was previously approved in China for adults with VHL disease-associated RCC, CNS hemangioblastoma or pNET not requiring immediate surgery. The new PPGL indication was placed on the priority review list in January 2026.
FDA approves RYZUMVI, the first non-cholinergic prescription eye drop for presbyopia
On October 16, 2026, the FDA approved RYZUMVI (phentolamine ophthalmic solution 0.75%) from Viatris and Opus Genetics for presbyopia in adults. It is the first prescription eye drop for the condition that does not rely on the cholinergic pathway.
NMPA Approves Bio-Thera's Secukinumab Biosimilar Youzhuomei (BAT2306)
Bio-Thera announced that the NMPA has approved Youzhuomei (BAT2306), a biosimilar of secukinumab, for psoriasis, ankylosing spondylitis, and psoriatic arthritis. The anti-IL-17A monoclonal antibody is described by the company as the world's first approved secukinumab biosimilar, and it has been licensed to multiple partners covering markets including the Middle East and North Africa, Latin America, Southeast Asia, Russia, and the CIS.
Novartis Cosentyx Approved in EU as World's First Targeted Therapy for Polymyalgia Rheumatica
On October 21, Novartis announced that the European Commission has approved Cosentyx (secukinumab) for adults with polymyalgia rheumatica (PMR) who had an inadequate response to glucocorticoids or who relapsed during glucocorticoid tapering. It is the first IL-17A inhibitor approved for PMR worldwide.
Industry and deals
EQT to Acquire QIAGEN in All-Cash Deal Valued at About 10.8 Billion Euros
Swedish private equity firm EQT announced a voluntary public all-cash offer for Dutch molecular diagnostics company QIAGEN through its indirectly controlled Crown NL Bidco B.V., at 46.50 euros per share, for an enterprise value of about 10.8 billion euros (including net debt of about 1.1 billion US dollars and equity value of about 9.6 billion euros). EQT manages 354 billion euros in assets, has invested more than 30 billion euros in healthcare, and its past portfolio includes Galderma, Parexel and Aldevron.
As H-1B visa changes keep coming, biopharmas adjust hiring approach
Changes to H-1B visa fees and selection rules are pushing U.S. biopharmas to cut overseas hiring and focus on candidates already authorized to work in the United States. In May, USCIS announced that properly submitted registrations fell 38.5%, from 343,981 in fiscal year 2026 to 211,600 in fiscal year 2027. Two federal judges have separately blocked the $100,000 new-petition fee, but companies had already reduced lottery participation over cost concerns.
Roche affirms sales outlook amid doubts about its future
Roche's third-quarter 2026 group sales rose 7% to 16.1 billion Swiss francs (about $19.6 billion), beating the consensus estimate of 15.8 billion francs, but Jefferies analysts said a new ERP system boosted revenue and the underlying results fell short of expectations. The company maintained its full-year guidance of mid-single-digit growth.
news.google.comAlcon ponies up $550M for Neurotech, bagging approved cell therapy implant Encelto - Fierce Pharma
Alcon has acquired Neurotech for $550 million, gaining Encelto, an approved cell therapy implant.
Biotech notches 31 IPOs already this year, with 4 more joining queue
Thirty-one biotech companies have completed IPOs so far in 2026, with four more having filed applications. BioSpace data show this total far exceeds the 8 IPOs of 2025 and also tops 2024 (19), 2023 (13) and 2022 (17), but remains well below the nearly 100 of 2021.
Research papers
MCT6 is an intestinal Lac-Phe exporter required for metformin-associated weight loss
Researchers found that the orphan transporter MCT6 is the key exporter moving the meal- and exercise-associated metabolite Lac-Phe from intestinal cells into the blood. Mice lacking intestinal MCT6 cannot maintain normal circulating Lac-Phe levels and are resistant to metformin-associated weight loss, establishing metabolite export as a regulatory node for systemic action.
Lifestyle-induced regulatory T cell fragility primes adverse events after immune checkpoint blockade
Dietary and microbial alterations can increase susceptibility to immune-related adverse events after immune checkpoint blockade by promoting IFN-γ-driven Treg fragility and cytotoxic tissue-resident T cell responses. Treg-specific disruption of IFN-γ signaling restores tissue homeostasis and reduces irAEs without compromising antitumor immunity, suggesting that Treg stability is a potential therapeutic strategy for limiting checkpoint blockade toxicity.
Charting the silent variation within us.
The SMaHT Network releases benchmarked tools and the first body-wide map of somatic mosaicism, establishing a baseline of "normal" somatic variation so its roles in development, aging, and disease can be tested.
Nature study shows single tRNA molecule tRNA1Arg(UCU) rewrites prostate cancer cell fate and controls drug resistance
On October 7, a team at Fred Hutchinson Cancer Center published a study in Nature showing that the tRNA molecule tRNA1Arg(UCU) acts like a switch to determine prostate cancer cell fate: reduced levels lead to drug resistance, while restoring them recovers drug sensitivity. This is the first evidence that a single tRNA can actively rewrite cancer cell fate.
DIRAS3 broadly suppresses signaling from diverse oncogenic KRAS hotspot variants through an inhibitory interface
A bioRxiv preprint shows that a DIRAS3 α5 mimetic broadly suppresses MAPK and PI3K signaling driven by diverse KRAS hotspot variants through an inhibitory interface. Immunoprecipitation results show the mimetic reduces KRAS association with RAF1 and p110α in both G12 and Q61 mutants, whereas RMC-7977 inhibits the association of Q61 KRAS with p110α more weakly.
medicalxpress.com'Digital twins' of immune system in pregnancy identify drugs to prevent early labor
A Stanford Medicine team publishing in Science Advances used SIMCO, a digital twin of the immune system, to identify an aspirin-lansoprazole combination that prevents preterm birth 15 times more effectively than aspirin alone. The work drew on longitudinal data from 63 pregnancies and roughly 250 million single-cell measurements; the FDA has approved the combination for clinical trials in humans, and folic acid was also found to have immunomodulatory effects. DOI: 10.1126/sciadv.aed2741
Metazoan lagging-strand DNA synthesis is distributive
Single-molecule imaging shows that metazoan lagging-strand DNA synthesis is distributive, driven by repeated recruitment of Pol α and Pol δ rather than their stable association with the replisome. This mechanism uncouples leading- and lagging-strand synthesis, distinguishing it from the classical replication fork model in which the two act together. Link: https://www.cell.com/cell/fulltext/S0092-8674(26)01204-3?rss=yes
Multiomic characterization of microsatellite-stable colorectal cancer reveals distinct biology and targetable vulnerabilities
Sadanandam et al. integrated multiomic, single-cell, and clinical data from about 2,000 microsatellite-stable colorectal cancers (about 4,500 multiomic profiles, 195,246 cells/nuclei). The analyses identify replication stress, right-sided tumors, glutaminolysis, and MYC-E2F epigenetic programs as key biological features, and FAK, PDK1/2, and proteasome inhibition combined with trametinib as potential therapeutic strategies.
Lung neuroendocrine cancer induces immunosuppressive macrophages via serotonin to drive resistance to the T cell engager tarlatamab
Nomura et al. found that lung neuroendocrine cancer uses tumor-derived serotonin acting through the HTR7 pathway to shape immunosuppressive macrophages, mediating resistance to tarlatamab and ICB. This neuroimmune mechanism holds in both SCLC and LCNEC, and points to HTR7 as a potentially druggable therapeutic vulnerability.
Vitamin D binding protein in ventral CA3 of the hippocampus drives stress-induced depression.
Researchers found up-regulated expression of vitamin D binding protein (VDBP) in CaMKIIα excitatory neurons of the ventral CA3 region of the hippocampus in mice susceptible to chronic unpredictable mild stress (CUMS), and this up-regulation correlated with the severity of depression-like behaviors.
A scalable in vitro cell competition model identifies preleukemic super competitor clones
A bioRxiv preprint describes a scalable in vitro clonal competition platform showing that ~10% of TET2-mutant clones actively and selectively suppress wild-type cell expansion. In some cases these clones completely eliminate WT clones, and molecular profiling and functional assays point to inhibition of RAC1-GEF signaling as a WT-cell-specific vulnerability. DOI: https://doi.org/10.64898/2026.10.21.760611
HP1 can act independently of H3K9 methylation to promote heterochromatin focus formation, gene repression, and organogenesis
Delaney et al. report that in C. elegans the HP1 homolog HPL-2 can form heterochromatin foci, silence genes, and restrict organogenesis independently of H3K9 methylation. HP1/HPL-2 and the H3K9 methyltransferase SETDB1/MET-2 form heterochromatin foci by binding distinct cofactors, and it is these foci, not H3K9me3, that track with silencing activity.
BAK and BAX form a multiprotein complex to drive mtDNA efflux and caspase-independent cell death
BAK and BAX form a multiprotein complex that drives mtDNA efflux and caspase-independent cell death. The paper was published in Science, Volume 394, Issue 6822, DOI 10.1126/science.aea2181; the current material does not provide experimental methods or data details.
Chromosomal instability drives continual flux in cancer genomes
Using single genome sequencing across 34 cancer cell lines and organoids, researchers found that chromosomal instability (CIN) generates one to five new copy number alterations (CNAs) per cell cycle. The study covered high-grade serous ovarian carcinoma, pancreatic ductal adenocarcinoma, colorectal cancer, breast cancer and sarcoma. New CNAs were largely randomly distributed across the genome, large CNAs were under negative selection, and whole genome duplication acutely increased CIN rates. Under chemotherapy selection pressure, genomes evolved convergently towards recurrent therapy-associated CNAs while CIN remained high.
medicalxpress.comReducing nuclear damage improves heart function and survival in mice
A Cornell team publishing in Circulation Research used the DN KASH protein to disrupt the LINC complex, cutting nuclear damage in heart muscle cells of mice with LMNA dilated cardiomyopathy by more than half. Cardiac function returned close to normal, and survival extended from weeks to over a year.
Methods and resources
Systematic mapping of the prokaryotic noncoding sequence space with a genomic language model
Researchers used a genomic language model fine-tuned on prokaryotic intergenic sequences to organize 376 million intergenic regions from 1.3 terabase pairs of genomes and metagenomes into 5.14 million clusters.
High false sign rates in transcriptome-wide association studies
An article by Peter A. Gerlach in Nature Genetics finds that the direction of effect captured by transcriptome-wide association studies is often reversed relative to the true biological mechanism. Published online on 22 October 2026, the article cautions care when interpreting such studies and applying their results downstream.
SPATNIC enables H&E-grounded cancer-cell identification across spatial and single-cell transcriptomic modalities in colorectal cancer
SPATNIC is a variational autoencoder trained on Xenium cells labeled through pathologist review of matched H&E images to distinguish individual cancer cells from normal cells. The model matches or exceeds existing tools in primary colorectal cancer and liver and lung metastases, and generalizes zero-shot to Visium, Visium HD, CosMx, Xenium, MERSCOPE, and single-cell RNA sequencing.
Genome-wide LD scores enable robust heritability and genetic correlation estimation from summary statistics across genetic ancestries
SUMMIT is a statistical framework that combines genome-wide LD scores with GWAS summary statistics to estimate genome-wide and annotation-specific heritability and genetic correlation in European, South Asian, and admixed African-European populations.
Opinion and commentary
medicalxpress.comSubstance use disorder recovery, remission linked with genetic, psychosocial factors
A University of Illinois team analyzed 7,257 U.S. adults from the All of Us program and found that recovery capital and genetic risk jointly associate with the probability of 12-month remission from substance use disorder. The study measured recovery capital, including employment and housing, with 21 indicators and incorporated nearly 585,000 genetic variants. The combination of high recovery capital and low genetic risk corresponded to an 8–11 percentage point increase in 12-month remission probability. In the sample, 2,413 participants had at least one recorded remission. The paper was published in Addiction, DOI: 10.1111/add.70582.
In brief
- Development and design rules for a modular human peptide-tag adaptor CAR T cell systembiorxiv.org
- Existing cancer drug reduces blood vessel malformations in the brainmedicalxpress.com
- Experimental treatment selectively reduces harmful protein in lab models of rare inherited brain disordermedicalxpress.com