Novo Nordisk's CagriSema met its primary endpoint in the Phase III REIMAGINE 5 trial, a head-to-head comparison against tirzepatide. The fixed combination of the long-acting amylin analogue cagrilintide and the GLP-1 receptor agonist semaglutide also met its primary endpoint in the Phase III REDEFINE 9 weight-loss trial against placebo.
Novo Nordisk's CagriSema beat tirzepatide 5 mg head-to-head in the phase III REIMAGINE 5 study in adults with type 2 diabetes whose blood glucose remained inadequately controlled on metformin or an SGLT2 inhibitor. The parallel phase III REDEFINE 9 study in people with obesity or overweight met its primary endpoint. If approved, CagriSema would be the first GLP-1 plus amylin combination therapy worldwide.
NEJM published a study (Vol 395, Issue 14, pp 1374-1386, 2026-10-08) evaluating the effect of multicancer early detection (MCED) screening on late-stage cancer diagnosis. Only citation information is currently available; the abstract and full text were not provided through the feed.
The PATHFINDER 2 study evaluated the safety and performance of a blood-based multi-cancer early detection test in an intended-use population of more than 35,000 participants aged 50 years or older. It reports outcomes on how the test performs when used prospectively in people without a prior cancer diagnosis. The findings add interventional evidence on safety and performance in the intended-use setting.
Secondary endpoint analyses from the NHS-Galleri randomized controlled trial characterize how a blood-based multi-cancer early detection test performed when added to usual care in more than 142,000 participants without suspicion of cancer. The trial evaluated the test's performance as a screening tool in a general population, offering data on its behavior outside diagnostic settings.
A phase 1b/2 trial tested trastuzumab combined with nivolumab, gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer. The regimen showed encouraging clinical response rates, and HER2 expression was associated with clinical benefit. The results support HER2 status as a marker guiding trastuzumab-based treatment in this population.
Ceperognastat is a potent oral O-linked N-acetylglucosaminidase inhibitor. This randomized clinical trial examined its efficacy and safety in early symptomatic Alzheimer disease.
No results are reported in the available material. The trial randomized patients with localized intermediate-risk prostate cancer to stereotactic body radiotherapy or moderately hypofractionated intensity-modulated radiation therapy. Endpoints were patient-reported urinary irritative/obstructive and bowel quality of life and disease-free survival.
Why it matters: Directly compares two standard radiotherapy options on patient-reported quality of life and survival in localized intermediate-risk prostate cancer.
Laruparetigene zovaparvovec (laru-zova) from Beacon Therapeutics is the first gene therapy to meet the primary endpoint in a Phase III X-linked retinitis pigmentosa trial, improving visual acuity on the low-luminescence visual acuity (LLVA) scale in the VISTA study. Responders gaining 15 letters or more included 31% of patients in the higher-dose cohort and 24.1% in the lower-dose cohort. The result raises the prospect of preventing or delaying blindness in XLRP patients.
Caplyta, Johnson & Johnson's atypical antipsychotic acquired through its $14.6 billion purchase of Intra-Cellular Therapies, has passed a phase 3 trial in manic episodes associated with bipolar disorder. The result moves the drug one step closer to a broader psychiatric label, building on already strong sales. No efficacy figures were reported in the announcement.
Starting resuscitation of 32-to-35-week neonates with Fio2 0.30 instead of 0.21 did not change the primary outcome: ongoing respiratory support when leaving the delivery room occurred in 72.6% vs 73.3% (risk difference, -0.83). In the cluster randomized crossover trial across 26 Australian maternity hospitals, 1818 newborns were enrolled, and Fio2 0.30 was associated with less escalation of delivery room support and less endotracheal ventilation beyond the delivery room (6.4% vs 9.3%).
Alkermes' orexin agonist ALKS 7290 has shown for the first time that this drug class may benefit people with ADHD. In a randomized Phase 1 study, adults with moderate to severe symptoms, starting at a median of 39 on the Adult ADHD Investigator Symptom Rating Scale, took 50 milligrams daily; after two weeks their scores fell by 19 points, to mild symptoms, and the drug was well tolerated.
Hansoh Pharmaceutical's selective allosteric TYK2 inhibitor HS-10374 met both co-primary endpoints and multiple secondary endpoints in a pivotal Phase III trial in adults with moderate-to-severe plaque psoriasis. At week 16, the proportion of HS-10374 patients achieving PASI 75 and the proportion achieving sPGA 0/1 with at least a 2-point reduction from baseline were both significantly greater than with placebo, adding a new candidate for psoriasis treatment.
Hansoh Pharmaceutical's TYK2 selective allosteric inhibitor HS-10374 met the co-primary endpoints and multiple secondary endpoints in a pivotal Phase III trial in adults with moderate-to-severe plaque psoriasis. The randomized, double-blind, placebo-controlled, multicenter trial evaluated the efficacy and safety of HS-10374 in this population. Hansoh plans to file the drug for market approval.
Beacon Therapeutics' gene therapy for X-linked retinitis pigmentosa improved visual acuity in a pivotal trial, positioning the company to seek regulatory approval for the rare vision loss disease. The company plans to file based on the result, which comes in an indication where larger companies have not succeeded.
Ivonescimab, a PD-1/VEGF bispecific antibody, delivered a median progression-free survival of 16.9 months in patients with locally advanced or metastatic non-squamous NSCLC whose disease progressed on third-generation EGFR-TKI treatment, compared with 4-5 months for traditional chemotherapy in this setting. China's NMPA has approved it for this population, giving third-generation EGFR-TKI-resistant disease a new treatment standard.
Abogen published in Cell an mRNA approach encoding a CD19×CD3 T cell engager in vivo, and in 3 patients with refractory autoimmune disease it achieved complete B cell depletion. This moves mRNA-encoded T cell engagers from oncology toward autoimmune disease.
Bristol Myers Squibb has terminated the degrader-antibody conjugate program acquired from Orum Therapeutics for a $100 million upfront payment. The decision came after BMS reviewed phase 1 clinical data.
Ivonescimab (AK112) significantly improved overall survival versus pembrolizumab monotherapy in the phase 3 HARMONi-2 trial, raising median OS to 30.75 months from 22.57 months and reducing the risk of death by 27% in first-line advanced wild-type NSCLC with TPS at least 1%. The OS result, presented at WCLC, follows the previously reported PFS benefit, with median PFS of 11.1 months versus 5.8 months (HR=0.51). AK112 is the first domestic Chinese innovative drug to beat pembrolizumab head-to-head in a phase 3 lung cancer trial.
Long-acting injectable cabotegravir–rilpivirine given every 8 weeks was superior to oral TLD for maintaining virological suppression in adolescents with HIV in sub-Saharan Africa who were already virally suppressed, with no new safety concerns observed. The LATA randomised, open-label, multicentre, 96-week non-inferiority trial supports the regimen as a maintenance option for this population.
Why it matters: Shows a long-acting injectable option can maintain virological suppression in virally suppressed adolescents with HIV in sub-Saharan Africa.
