Biomedicine Daily · Friday, 2 October 2026
CBA FRONTIER INSIGHTS
Retatrutide Delivers Up to 25% Weight Loss in Phase 3, With Gains Beyond the Scale
Once-weekly retatrutide produced mean body-weight reductions of 17.6%, 23.7% and 25.0% at 4, 9 and 12 mg over 80 weeks versus 3.9% with placebo, according to phase 3 results in the New England Journal of Medicine. The triple-hormone receptor agonist also extended efficacy beyond weight: among 574 participants with knee osteoarthritis, WOMAC pain fell 3.5 and 3.6 points at 9 and 12 mg versus 1.9 with placebo, and among 243 participants with obstructive sleep apnea, apnea-hypopnea events per hour fell 34.3 and 31.7 versus 9.9. A companion phase 3 trial, TRIUMPH-2, reported in the Lancet, showed dose-dependent weight loss over 80 weeks in adults with obesity and type 2 diabetes, supporting retatrutide as a treatment option in that population, though discontinuation due to adverse events or death was higher on the active doses than placebo.
Clinical readouts and safety
Retatrutide, a Triple Hormone Receptor Agonist, for Treatment of Obesity.
Once-weekly retatrutide produced mean body-weight reductions of 17.6%, 23.7%, and 25.0% at 4, 9, and 12 mg over 80 weeks in 2339 adults with obesity without diabetes, versus 3.9% with placebo. In subgroups, WOMAC pain fell 3.5 and 3.6 points at 9 and 12 mg versus 1.9 with placebo in 574 participants with knee osteoarthritis, and apnea-hypopnea events per hour fell 34.3 and 31.7 versus 9.9 in 243 participants with obstructive sleep apnea. The phase 3 results extend triple-receptor agonist efficacy beyond weight to obesity-related pain and sleep outcomes.
[News] 2026 ASTRO Annual Meeting
MRI surveillance alone beat prophylactic cranial irradiation plus MRI on cognitive failure-free survival in the phase 3 SWOG S1827 MAVERICK trial. In 304 patients with limited and extensive-stage small-cell lung cancer who had completed initial therapy, MRI-only monitoring improved the primary endpoint (HR 0·60, 90% CI 0·46–0·78; p=0·001) at a median follow-up of 22 months. The result challenges routine prophylactic cranial irradiation, long tied to better survival but more neurological toxicity.
Retatrutide in adults with obesity and type 2 diabetes (TRIUMPH-2): a double-blind, parallel-group, randomised, placebo-controlled, phase 3 trial.
Once-weekly retatrutide produced dose-dependent weight loss in adults with obesity and type 2 diabetes over 80 weeks: mean bodyweight change was -16·8% with 9 mg and -18·8% with 12 mg versus -5·1% with placebo. In the phase 3 TRIUMPH-2 trial of 1152 participants, gastrointestinal adverse events were the most frequent, and discontinuation due to adverse events or death was higher with 9 mg and 12 mg than with placebo. The findings support retatrutide as a treatment option for obesity in people with type 2 diabetes.
Giredestrant plus Everolimus in Advanced Breast Cancer.
An all-oral regimen of giredestrant plus everolimus significantly prolonged progression-free survival over standard endocrine therapy plus everolimus in ER-positive, HER2-negative advanced breast cancer after a CDK4/6 inhibitor. Among 207 patients with ESR1-mutated tumors, median progression-free survival was 10.0 versus 5.5 months (hazard ratio 0.38); in the overall population of 373 patients, it was 8.8 versus 5.5 months (hazard ratio 0.56). Adverse-event rates were similar between groups.
Zealand dips as Boehringer Ingelheim-partnered weight loss drug fails to impress—again
Survodutide, Zealand and Boehringer Ingelheim's glucagon/GLP-1 receptor dual agonist, met both co-primary endpoints in the Phase 3 SYNCHRONIZE-2 trial but produced weight loss analysts view as uncompetitive: up to 9.8% weight reduction at the highest 6 mg dose under the NEJM treatment regimen estimand at 76 weeks, versus 3.9% for placebo, and 79.3% of 775 patients lost at least 5% of body weight. About 18% discontinued due to gastrointestinal adverse events. Zealand shares fell more than 8% to $248.50. BMO analysts pointed to fat-mass effects, including 34% visceral fat loss and a 63.1% liver fat drop in SYNCHRONIZE-1, as a possible niche.
Effects of semaglutide on kidney disease in type 2 diabetes: a randomized placebo-controlled trial
A randomized placebo-controlled trial in individuals with type 2 diabetes probed the kidney-protective mechanisms of semaglutide using kidney histology, multiparametric MRI and transcriptomics. The findings indicate how semaglutide acts on the kidney in this population, moving the evidence beyond its established glucose-lowering effect toward direct renal mechanisms.
Merck’s antibody impresses with ‘highly competitive’ data in chronic skin disease
In a Phase 2b trial of 149 patients with hidradenitis suppurativa, Merck's investigational anti-TL1A antibody tulisokibart hit its primary endpoint, with most patients on the high and medium doses achieving at least 50% reduction in skin abscesses and inflammatory nodules. Analysts called the placebo-corrected efficacy potentially differentiated versus Humira and noted the drug's once-every-four-weeks dosing interval. Serious side effects were infrequent and there were no serious or opportunistic infections, setting up a push into late-stage development.
Zasocitinib Beats Deucravacitinib on Complete Skin Clearance in Head-to-Head Phase 3 Plaque Psoriasis Trial
Zasocitinib (TAK-279), an oral TYK2 inhibitor, beat deucravacitinib head-to-head in the phase 3 LATITUDE Atlas trial in adults with moderate-to-severe plaque psoriasis. At week 16, 36.5% of zasocitinib patients (n=301) achieved complete skin clearance (PASI 100) versus 13.9% of deucravacitinib patients (n=303), p<0.001, and PASI 90 rates were 62.5% versus 34.0%. Longer-term LATITUDE PsO 3001 and 3002 data showed durable clearance through week 52 and itch and quality-of-life improvements from week 2.
Permissive Blood Pressure Targets in Pediatric Critical Care: The PRESSURE Randomized Clinical Trial.
A permissive mean arterial pressure target in hypotensive, invasively ventilated children did not change a composite of 30-day mortality and ventilation duration versus usual care (probabilistic index, 0.52; P = .23), while cutting median norepinephrine-equivalent total dose by 37.5%. The trial randomized 1900 patients across 23 PICUs in 3 countries. Kidney replacement therapy, adverse events and most secondary outcomes were similar, though surviving children left the PICU sooner (median 159 vs 166 hours). Clinicians can accept lower MAP targets and reduce vasoactive exposure without worsening outcomes.
BMS reports liver injury events in lung disease program, with key readout near
Bristol Myers Squibb amended the Phase 3 ALOFT protocol for the pulmonary fibrosis candidate admilparant after a limited number of liver injury events, including one death from multi-organ failure after acute liver injury, with the cause unclear because the trial remains blinded. The independent data monitoring committee recommended the trial continue, and the ALOFT-IPF readout in idiopathic pulmonary fibrosis is expected in the fourth quarter. The news hit shares of Contineum Therapeutics, whose rival LPA1-R candidate PIPE-791 is in the Phase 2 PROPEL-IPF trial, though its stock recovered to $13.42.
Axitinib in Progressive Metastatic Pheochromocytoma and Paraganglioma: Results of a Phase II Study
Single-agent axitinib produced confirmed partial responses in 35.3% of 17 treated patients with progressive metastatic or unresectable pheochromocytoma and paraganglioma, with median progression-free survival of 7.9 months and median overall survival of 29 months. Hypertension occurred in 79% of patients but was managed with antihypertensive therapy and dose modification, and no patient stopped treatment for toxicity. The phase II trial's efficacy compares favorably with sunitinib in this rare disease.
Regulatory and policy
China CDE Releases "Pioneer Program" Pilot Plan for New Approach Methodologies
China's Center for Drug Evaluation, with approval from the National Medical Products Administration, has issued the pilot "Pioneer Program" for advancing New Approach Methodologies (NAMs), including organoids and organ-on-chip systems. The plan, notice number 46 of 2026 dated September 30, aims to support research, validation and application of these methods in drug development and took effect upon publication. Companies developing NAMs can now look to the pilot plan for regulatory adoption pathways.
FDA puts Shengnuo Biology's Chengdu plant on Import Alert 66-40 as states squeeze GLP-1 compounders
FDA placed Chengdu Shengnuo Pharmaceutical, a wholly owned subsidiary of the Shanghai STAR-listed peptide maker Shengnuo Biology, on Import Alert 66-40 on September 19, without first issuing a warning letter, meaning its products can be detained at US customs without inspection. The company disclosed the move on September 22. The action comes as US federal enforcers penalize a large Houston compounding pharmacy for GLP-1 weight-loss drugs and attorneys general from 20 states jointly press for tighter controls on GLP-1 compounders.
Kyverna Begins Rolling BLA for miv-cel, Aiming at First Autoimmune CAR-T Approval
Kyverna has started a rolling BLA submission to the FDA for miv-cel and plans to complete it in the fourth quarter of this year. If approved, miv-cel would become the first CAR-T therapy authorized for an autoimmune disease, moving CAR-T beyond oncology for the first time since its commercialization more than a decade ago.
NMPA Approves BMS Iberdomide for Relapsed Multiple Myeloma, First CELMoD Drug Worldwide
China's NMPA has approved Bristol Myers Squibb's iberdomide capsules (brand name Zanfu) via priority review on September 30, 2026, in combination with daratumumab and dexamethasone for adults with multiple myeloma who received at least one prior line including a proteasome inhibitor and an immunomodulatory drug. Iberdomide is the first approved Cereblon E3 ubiquitin ligase modulator (CELMoD) and BMS's first marketed product from its targeted protein degradation work.
NMPA Approves Subcutaneous Pembrolizumab, First of Its Kind in China
China's NMPA has approved Merck's subcutaneous formulation of the PD-1 inhibitor pembrolizumab, covering 19 solid tumour indications, making it the first and currently only subcutaneous PD-1 inhibitor approved in China. The approval, announced on 29 September 2026, is based on data from study MK-3475A-D77. The approval covers the same indication set as the existing intravenous formulation.
Edwards' EVOQUE Transcatheter Tricuspid Valve System Enters China Through Special Access at Fuwai Hospital
Edwards' EVOQUE transcatheter tricuspid valve replacement system, the first such system to hold both CE marking and FDA approval, has received special access in China and completed its first clinical uses at Beijing's Fuwai Hospital. The system offers an interventional option for patients with severe tricuspid regurgitation, including elderly patients with multiple comorbidities or high surgical risk. Broader use in Chinese patients is expected to follow.
FDA Approves First Heart Valve Designed to Grow with Children
The FDA approved the Autus Size-Adjustable Valve, developed by Autus Valve Technologies and approved via Edwards Lifesciences, for pediatric patients with congenital pulmonary valve disease. It is the first heart valve that can be expanded after implantation, growing from about 13 millimeters to up to 22 millimeters, and the first U.S.-approved valve with polymeric rather than animal-derived leaflets. Approval rests on a study of 62 pediatric patients at 12 U.S. sites, with no deaths or clot-related complications; longer-term studies are under way.
FDA Approves New Drug That Extends Survival in Pancreatic Cancer
The FDA has approved a new drug for pancreatic cancer that reportedly extends survival in patients. The approval was reported by Scientific American on August 26 and relayed by Chinese industry media on August 29. No drug name, trial details or dosing information were given in the report.
White House Prepares to Bring Production of 86 Critical Drugs Back to US
The White House Office of Management and Budget is surveying generic drug manufacturing capacity in the US and nearby regions as a step toward moving production of 86 critical medicines back to the US within 18 months. The aim is to cut dependence on active pharmaceutical ingredients from China and other countries. A June 2026 Council on Foreign Relations report said China controls about 94% of global amoxicillin API or key starting materials.
Industry and deals
Dizhe Pharmaceutical Receives $600 Million Upfront from AstraZeneca, a Record for a Chinese Small Molecule
Dizhe Pharmaceutical announced on the evening of September 29 that it has received the $600 million upfront payment from AstraZeneca, roughly 4 billion yuan. The sum sets a record for the largest upfront payment in an outbound licensing deal for a single Chinese small molecule drug. Founder Zhang Xiaolin has a relationship with AstraZeneca going back nearly twenty years.
Sanofi, Regeneron broaden alliance to find their next Dupixent
Sanofi and Regeneron have expanded their alliance to co-develop and co-commercialize four long-acting, Regeneron-invented antibodies targeting IL-13, IL-4 or an IL-4 subunit, like Dupixent. The most advanced, REGN20423, is in an early-stage eczema trial; the other three should enter human testing next year. Regeneron receives $1 billion up front and as much as $7 billion in milestone payments, and can opt to add Sanofi's lunsekimig after certain late-stage studies. Dupixent, first cleared in 2017, brought in $10.9 billion in net sales in the first half of this year.
Foghorn lays off 40% of staff after Lilly collaboration ends
Foghorn Therapeutics and Eli Lilly ended their oncology collaboration after Phase 1 data on cancer candidate FHD-909 (LY4050784) showed insufficient efficacy, halting its move into clinical development expansion and a SMARCA2 degrader program. Foghorn is cutting about 40% of its workforce, leaving roughly 65 full-time employees, and will refocus on its proprietary programs including EP300 and CBP degraders. The 2021 deal had brought $300 million upfront plus an $80 million equity investment from Lilly's Loxo Oncology, and the changes should extend Foghorn's cash runway into the second half of 2029.
Research papers
Transcriptional rewiring of NF-κB by HBZ and Fra-2 drives inflammatory chemoresistance in Tax-negative adult T-cell leukemia/lymphoma
HTLV-1 antisense protein HBZ stabilizes a Fra-2/p65 complex that rewires NF-κB transcription toward IL-1β in tax-negative adult T-cell leukemia/lymphoma, driving inflammatory chemoresistance. IL-1β was elevated in ATL patient sera and cells independently of proviral load, and blocking IL-1 signaling with anakinra or anti-IL-1β antibodies restored doxorubicin sensitivity in primary ATL cells. The work identifies the Fra-2-NF-κB-IL-1β axis as a targetable driver of chemoresistance.
Early dynamics of a neutrophil interferon program drive immunotherapy resistance and limit durable anti-tumor immunity
An interferon-stimulated gene program in neutrophils, detectable before tumors diverge in their response, predicts resistance to anti-PD1 therapy in preclinical triple-negative breast cancer models. Persistent neutrophil IFN signaling in blood and tumor tracked with treatment failure, while genetic disruption of type I or type II interferon signaling in neutrophils improved anti-PD1 efficacy and durable anti-tumor immune memory. The work positions IFN-responsive neutrophils as blood-based biomarkers and therapeutic targets.
Spatial evolution of a cachexia-promoting microenvironment in pancreatic cancer.
A defined multicellular niche in pancreatic tumors drives cachexia: SEMA4A+ tumor cells induce an AQP9+ macrophage phenotype via BMP2, macrophage-derived CXCL8 activates LOXL2+ fibroblasts, and those fibroblasts reinforce tumor FOSL1/SEMA4A signaling through exosomal N-glycosylated LOXL2. Integrating single-cell RNA sequencing, Xenium spatial transcriptomics, multiplex immunohistochemistry and functional studies in human samples and mouse models, the work shows the niche is progressively enriched with cachexia severity and predicts postoperative cachexia in previously non-cachectic patients. It supplies a spatially resolved circuit connecting the local tumor ecosystem to systemic wasting.
Transcription factor clusters enhance gene expression in vivo without modulating bursting dynamics.
Dorsal, an NF-κB homolog, forms clusters in live Drosophila embryos that associate with a subset of endogenous target genes, and binding-site abundance governs that association, which amplifies transcription. Enhancer mutations that disrupt cluster-gene association cause lethal developmental defects. Precise spatiotemporal control of Dorsal concentration showed clusters neither initiate nor sustain transcriptional bursts; they only augment polymerase loading during a burst, challenging prevailing condensate-based models of transcriptional regulation.
IRF1 Takes Over Transcriptional Control from IRF2 to Drive Innate Immune Cell Activation
A Cell study explains a paradox in innate immunity: IRF2 promotes expression of genes such as Gasdermin D, yet loss of IRF2 causes marked skin inflammation. The work shows that transcriptional control switches from interferon regulatory factor 2 to interferon regulatory factor 1, and that this switch drives innate immune cell activation. The finding reframes IRF2 loss as a gain of IRF1-driven activation rather than simple loss of gene expression.
Extracellular Fucosylation Editing Gives Mesenchymal Stem Cells E-Selectin Homing for Osteoporosis
Mesenchymal stromal/stem cells can aid bone regeneration in osteoporosis, but they lack sialyl Lewis X and cannot bind E-selectin on bone marrow microvessels, so intravenously infused cells home poorly to bone. The work applies extracellular fucosylation editing to equip MSCs with sLeX, aiming to restore E-selectin-mediated homing to bone marrow and improve their therapeutic effect on osteoporosis.
Reactivation of the embryonic ζ-globin gene ameliorates severe forms of α-thalassemia
Reactivating the embryonic ζ-globin gene can ameliorate severe forms of α-thalassemia. Liu et al. identify cis-regulatory elements that silence ζ-globin in definitive erythroid cells, and gene-editing strategies targeting them restore ζ-globin expression to therapeutically relevant levels in mouse and human disease models. The work points to a new genome-editing approach for severe α-thalassemia.
Five-year survival with neoadjuvant therapy in melanoma: updated pooled analysis from the International Neoadjuvant Melanoma Consortium (INMC)
Neoadjuvant immune checkpoint inhibitors, alone or in combination, outperformed neoadjuvant BRAF/MEK inhibitors for long-term survival in a pooled analysis of 1,038 melanoma patients with 3-year and 5-year data from the International Neoadjuvant Melanoma Consortium. Patients achieving major pathological responses had better long-term survival across treatment types. The results position pathological response as a key indicator of durable benefit from neoadjuvant therapy.
Sustained Ion Imbalances Enhance Ferroptosis
Sustained imbalances in sodium, potassium and chloride ions drive ferroptosis across chemo-resistant cancer cell lines of different origins. Clinically approved modulators of CFTR and Kv7.2 inhibit ferroptosis independent of ion channel expression, and combining the ferroptosis inducer salinomycin with digoxin, a Na+/K+ ATPase inhibitor, enhanced ferroptotic cell death in vitro and reduced tumor growth in vivo beyond either agent alone. The work points to ion homeostasis as a broadly applicable ferroptosis target and to repurposing approved drugs for ferroptosis-associated diseases.
Phylodynamic analysis reveals asymmetric and accelerating global spread of dengue virus
Urban dengue virus diversity originated in Asia in the first half of the 20th century, and Asia remains the main global source, seeding transmission in Africa and the Americas, according to phylogeographic analysis of global DENV genomes dating from the 1940s. Spread is asymmetric: lineages enter North America mostly from South Asia via a Northern Hemisphere seasonal-synchrony link, and rarely return to Asia. Travel volume, not climate, drives long-term spread, and the rate of spread to the Americas is increasing alongside a substantial rise in global travel from about 2010.
The Smac mimetic drug Xevinapant sensitizes triple negative breast cancer to radiotherapy-induced cell death in a TNFα dependent manner
The Smac mimetic Xevinapant (AT406) sensitized triple-negative breast cancer cell lines to radiotherapy-induced cell death in vitro, with clonogenic assays in MDA-MB-231 cells showing a dose-enhancing factor of 1.57. Radiosensitization was significantly enhanced by TNF and mediated by TNF-dependent apoptosis, assessed by western blotting, flow cytometry and cell cycle analysis. The findings support combining radiotherapy with Xevinapant to improve local control in TNBC.
Retraction Note: Ribosomal frameshifting in the CCR5 mRNA is regulated by miRNAs and the NMD pathway
Nature has retracted the 2014 Article claiming that ribosomal frameshifting in the CCR5 mRNA is regulated by miRNAs and the NMD pathway. TheEditors no longer have confidence in a key conclusion: the putative CCR5 -1 PRF sequence contained a cryptic 3' splice acceptor site that generated artefactual splice variants in the original dual luciferase reporter, and an improved reporter with a CMV promoter and no artificial intron showed no detectable programmed -1 ribosomal frameshifting. Four authors agree with the retraction; four, including corresponding author Jonathan D. Dinman, disagree.
Whole-genome characterization of Plasmodium falciparum population structure and drug resistance across Uganda and neighboring countries
Whole-genome analysis of 249 monoclonal Plasmodium falciparum samples from 26 Ugandan sentinel sites in 2023 shows high diversity and low differentiation nationwide, with structure only in the low-transmission southwest, where parasites share ancestry with western Tanzian isolates. Selection signals include the PfPX1 PIN haplotype (L1222P, M1701I, D1705N) at 70% prevalence, with D384A-carrying variants concentrated in northern and eastern Uganda, and PfKelch13 C469Y enriched on the PfPX1 D384A-PIN background. The data set a 2023 baseline for tracking drug resistance mediators across Uganda and its neighbors.
Survodutide Once Weekly in Adults with Obesity and Type 2 Diabetes
Methods and resources
The Genome In A Bottle HG002 assembly-based variant benchmark set enables comprehensive benchmarking of small and structural variants.
The Genome in a Bottle Consortium's HG002 v5.0q benchmark set, built from a fully phased, highly curated diploid assembly, delivers confident small- and structural-variant calls in previously inaccessible regions such as segmental duplications, tandem repeats, homopolymers, and complex immune loci. Relative to v4.2.1 it adds 200 Mbp of callable sequence, increases variant detection by 18% for small variants and 3-fold for structural variants, and is available for GRCh37, GRCh38, and CHM13.
Deep learning perturbation models can outperform baselines on calibrated metrics
Standard perturbation-modeling benchmarks can be misleading because control bias and signal dilution let uninformative mean baselines score highly; in Replogle22 K562 GWPS, with only 3.25 DEGs per perturbation on average versus 102.09 in Norman19, the technical-duplicate positive control underperformed the mean baseline on MSE in roughly 95% of perturbations. The authors propose an interpolated duplicate baseline blending both controls and a meta metric, the dynamic range fraction (DRF), to quantify how well benchmarking metrics distinguish positive from negative controls across 14 datasets. This reframes evaluation of transcriptomic perturbation models away from MAE, MSE and Pearson of control-referenced deltas alone.
Silver(I)-mediated amide-to-ester transformation on unprotected peptides for protein chemical synthesis and engineering.
A silver(I)-mediated reaction converts backbone amides in unprotected peptides into salicylaldehyde esters in aqueous acetic acid, without detectable epimerization. The N,S-benzylidene thioacetal scaffold enables the transformation, which supported total syntheses of mirror-image histones H2A, H2B, H3 and H4. The method provides a general route to the peptidyl salicylaldehyde esters needed for serine/threonine ligation in protein chemical synthesis.
Cargo size matters when designing lipid nanoparticles for delivery of large gene editors.
Screening ionizable lipids with a gene-editor-sized RNA yielded LC-1, a lipid that forms a structure enhancing endosomal escape of large editor mRNAs. Lipid nanoparticles built on LC-1 achieved efficient genome editing in the liver, lung and brain of mice. The work points to cargo size as a design criterion for lipid nanoparticles delivering large gene editors.
Rapid whole genome- and annotation-based multilocus sequence typing of the fungal pathogen Histoplasma capsulatum
Genome-based MLST schemes for Histoplasma capsulatum were built from 406 genome assemblies generated from public Illumina short-read samples, each with BUSCO completeness above 98%. Schemes derived from whole genome sequences and two annotation sources yielded over 8,000 markers and reproducibly separated all 7 lineages and 6 Suramericanum sublineages, with r2 values of 0.8-1.0 between schemes. The schemes run without high-performance computing, putting high-resolution typing within reach of ordinary laboratories.
Fractional Order Temporal Dynamics of Tumor Immune Chemotherapy Interactions: A Reproducible Dimensionless Analysis and a Pharmacokinetic Caveat
A dimensionless commensurate Caputo fractional model of tumour, immune, normal cell and drug dynamics shows that equilibrium locations are independent of the fractional order: lowering the order changes transient time scales only, not asymptotic states. After a unit bolus the drug concentration is C(τ)=Eα(-Kτ^α), peaking at the initial value, and for 0<α<1 its infinite-horizon area under the curve diverges, so apparent late tumour reduction at small α reflects persistent modelled drug exposure, not superior therapy. Source code and generated tables make every numerical statement reproducible.
Opinion and commentary
CSCO 2026 Liver Cancer Guideline Raises Yttrium-90 Microsphere SIRT to Grade I Recommendation
The 2026 edition of the CSCO primary liver cancer guideline has raised yttrium-90 microsphere SIRT (selective internal radiation therapy) to a Grade I, Category 1A recommendation. At the CSCO annual meeting's nuclear medicine session, Professors Yang Aimin of the First Affiliated Hospital of Xi'an Jiaotong University and Jia Weidong of the First Affiliated Hospital of USTC presented a new Chinese expert consensus on whole-process nuclear medicine management of Y-90 SIRT for liver malignancies. Jia Weidong discussed SIRT as a new option in conversion therapy for liver cancer.
Also today
19 events that did not make today's daily, one table per category, one row per event. Open a category to expand.
RegulatoryJUVMO（tavapadon） · ifinatamab deruxtecan（I-DXd） · Camzyos3 ▾▴
Filings, acceptances, designations, approvals and withdrawals at a regulator.
- JUVMO（tavapadon）UpdateThe FDA approved AbbVie's JUVMO (tavapadon) on September 25, 2026 for the treatment of Parkinson's disease in adults. JUVMO is the first and currently only selective D1/D5 receptor agonist approved for adult Parkinson's disease, and the article describes it as the first breakthrough in dopaminergic therapy for Parkinson's in decades.FDA
- ifinatamab deruxtecan（I-DXd）UpdateMerck & Co. and Daiichi Sankyo withdrew their BLA for ifinatamab deruxtecan two weeks before its PDUFA date; the partners had sought accelerated approval for extensive-stage small cell lung cancer in patients whose disease progressed on platinum chemotherapy. The withdrawal leaves at least five FDA decisions on the PDUFA calendar for October. The article does not state what the companies plan to do next with the programme.FDA
- CamzyosUpdateFDA
ClinicalRO7589831（VVD-133214） · Four · Petrelintide · VYD2311 …8 ▾▴
Trial starts, early and mid-stage data, and results that did not make the daily.
- RO7589831（VVD-133214）UpdateRO7589831 (VVD-133214), a first-in-class covalent inhibitor of Werner syndrome helicase, showed manageable safety and early antitumor activity in 88 patients with MSI and/or mismatch repair-deficient advanced solid tumors in part 1 of a phase 1 trial. TEAEs were mostly grade 1-2, with no grade 5 events and discontinuation in 3.4% (3/88). In 66 MSI efficacy-evaluable patients, disease control rate was 74.2%, objective response rate 10.6% (7 partial responses), median PFS 6.7 months and median OS 17.6 months; 150 mg and 600 mg BID were selected as recommended phase 2 doses.
- FourUpdateFour-year data on uniQure's Huntington disease gene therapy show a smaller effect on the composite endpoint than at three years, clouding the outlook for durability. Results on functional capacity still preserve a case for accelerated approval, though full approval would depend on a confirmatory study. Payer willingness to cover the cost given the duration of benefit remains unclear.
- PetrelintideUpdateRoche returned Emugrobart, a Phase II muscle-building asset, to its originator Chugai on September 28, the same day it launched three Phase III trials of Petrelintide, a long-acting amylin analog developed with Denmark's Zealand Pharma. The ZUPREME programme of randomized, double-blind, placebo-controlled studies plans to enrol about 7000 people in total, with percentage change in body weight from baseline at week 64 as the primary endpoint. ZUPREME-3 targets about 3900 overweight or obese subjects without type 2 diabetes, ZUPREME-4 about 600 with type 2 diabetes, and ZUPREME-5 about 2500 overweight or obese patients with established cardiovascular disease.
- VYD2311Update
- #EASD26Update
- 3 takeaways from a European obesity scientific meetingUpdate
- Patient death raises liver questions ahead of Bristol Myers readoutUpdate
- PML Resolution after Treatment with VirusUpdate
Deals and financingAstraZeneca Takes $2 Billion Stake of About 12% in Summit Therapeutics · Novo gets shot at weekly obesity pill as Hengrui gets another MNC deal · Merck Pays $400 Million Upfront for Global Rights to Sipurui's KRAS G12D Inhibitor SPR2015 · Kallyope rebrands after Novo obesity deal, gets $94M for Phase 3 migraine drug …7 ▾▴
Licensing, M&A and financing that did not make the daily.
- AstraZeneca Takes $2 Billion Stake of About 12% in Summit TherapeuticsUpdateAstraZeneca will invest $2 billion in Summit Therapeutics by subscribing to convertible preferred shares, giving it about 12% of the company after conversion. Alongside the equity stake, announced September 28, the two firms signed a binding clinical collaboration combining Sone-Ve with Ivonescimab in GI tumors, plus a non-binding MOU to explore pairing Ivonescimab with more of AstraZeneca's ADC portfolio.
- Novo gets shot at weekly obesity pill as Hengrui gets another MNC dealUpdateNovo Nordisk has in-licensed ex-China rights to a once-weekly oral dual agonist of GLP1R and GIPR from Jiangsu Hengrui Pharmaceuticals for $300 million up front, in one of the largest preclinical deals to date. The compound is intended for obesity, a core therapeutic area Novo Nordisk is building out through a series of deals this year. Hengrui continues its run of MNC partnerships.
- Merck Pays $400 Million Upfront for Global Rights to Sipurui's KRAS G12D Inhibitor SPR2015UpdateMerck has licensed SPR2015, a preclinical molecular-glue KRAS G12D (ON) inhibitor, from Shanghai-based Sipurui, gaining worldwide rights to the candidate. Sipurui receives $400 million upfront, about 2.684 billion RMB, plus potential milestone payments tied to development and commercialization across multiple indications. KRAS was long considered undruggable because its protein lacks a clear binding pocket.
- Kallyope rebrands after Novo obesity deal, gets $94M for Phase 3 migraine drugUpdate
- Vertex ← CrineticsUpdate
- Devoted HealthUpdate
- Parakeet HealthUpdate
OtherFresenius Kabi1 ▾▴
Everything else with a concrete event that did not make the daily.
- Fresenius KabiUpdateFDA