Once-weekly oral islatravir-lenacapavir maintained viral suppression as well as once-daily bictegravir-emtricitabine-tenofovir alafenamide in a phase 3 trial of 607 adults with virologically suppressed HIV-1. At week 48, HIV-1 RNA of 50 copies per milliliter or higher was reported in no ISL/LEN participants and 1 (0.3%) on B/F/TAF, meeting a 4-percentage-point noninferiority margin. The finding supports a long-acting weekly oral option for suppressed patients.
Adding the oral SERD giredestrant to everolimus improved progression-free survival in ER-positive, HER-2-negative advanced breast cancer after prior CDK 4/6 inhibitor treatment. In the phase 3 evERA study of 373 patients, median PFS rose from 5.5 to 8.8 months overall (44% risk reduction) and from 5.5 to 10 months in the roughly 55% with ESR1-mutant tumors (63% risk reduction). It offers an all-oral option where post-CDK 4/6 choices are limited.
Pfizer's trispecific antibody tilrekimig, which blocks IL-4, IL-13 and TSLP, beat placebo on skin clearance in a Phase 2 trial in moderate to severe atopic dermatitis. After 16 weeks, 63% of patients on 450 mg every two weeks reached EASI-75 versus 20% on placebo; in Stage 2, 48% to 61% across monthly doses reached EASI-75 versus 9% on placebo. Pfizer has moved the drug into Phase 3 testing, including a head-to-head trial against Dupixent.
VYD2311, a monoclonal antibody against the novel coronavirus on the same backbone as the authorized Pemgarda and the investigational adintrevimab, met the primary safety endpoint in the phase 3 LIBERTY trial of 210 healthy adults aged 18 to 49 across three arms: VYD2311 alone, with an mRNA vaccine, or vaccine alone. Tolerability was better than the mRNA vaccine and VYD2311 did not interfere with vaccine neutralizing titers. The company plans to submit a BLA to the FDA under the accelerated approval pathway as a pre-exposure prophylaxis, with key efficacy data from DECLARATION expected in October 2026.
The GLP-1/GIP dual receptor agonist ribupatide, a weekly injectable from Kailera Therapeutics and Hengrui Pharma, produced dose-dependent weight loss of 10%, 15.1% and 20.2% at 1 mg, 2 mg and 4 mg in a Phase 2 trial of 158 Chinese women aged 18 to 40 with polyendocrine metabolic ovarian syndrome and obesity or overweight, versus 2.6% on placebo at 32 weeks. All ribupatide dose groups also showed increased menstrual frequency, while placebo cycles grew more infrequent, with no serious adverse events or discontinuations. The data suggest an incretin therapy could be developed specifically for PMOS, a condition where semaglutide and tirzepatide are used off-label without indication.
Oleeplutide delivered an average weight loss of up to 19.3% at 48 weeks in the phase 3 LIGHTEN trial, with the weight-loss curve not yet at plateau, and mean waist circumference fell by up to 16.0 cm. Nausea and vomiting occurred at average rates of 7.8% and 4.9%. The data were presented at EASD 2026.
Eloralintide plus tirzepatide (Zepbound) produced 23.3% weight loss at the highest dose after 48 weeks, or 20.3% placebo-adjusted, in Phase IIb obese patients with Type II diabetes. The Eli Lilly combination beat both Novo's CagriSema and Lilly's own triple agonist retatrutide, in a population where weight loss is harder to show than in non-diabetic obesity.
Once-weekly survodutide, a glucagon receptor-GLP-1 receptor dual agonist, produced mean weight reductions of 8.2% at 3.6 mg and 9.8% at 6.0 mg over 76 weeks in 752 adults with type 2 diabetes and BMI of 27 or more, versus 3.9% with placebo. At least 5% weight loss occurred in 57.6% and 64.5% of the survodutide groups versus 35.1% on placebo, with glycated hemoglobin falling 0.9 and 0.8 percentage points. Gastrointestinal adverse events, mostly mild to moderate, occurred in 72.8% and 77.7% of survodutide recipients.
Orforglipron, an oral non-peptide GLP-1 receptor agonist, was non-inferior to insulin glargine for four-component major adverse cardiovascular events in 2749 adults with type 2 diabetes at increased cardiovascular risk: MACE-4 occurred in 57 (4·2%) of 1358 orforglipron participants versus 67 (5·0%) of 1343 insulin glargine participants (HR 0·84; 95% CI 0·59-1·20) over a median follow-up of 2 years. Clinically significant or severe hypoglycaemia was less frequent with orforglipron (93, 6·8%) than insulin glargine (260, 19·2%), while gastrointestinal adverse events were more frequent (62·1% vs 14·2%). The results establish cardiovascular safety for a non-peptide GLP-1 receptor agonist, a class not previously studied for this outcome.
Why it matters: First cardiovascular safety data for an oral non-peptide GLP-1 receptor agonist, a class not previously studied for cardiovascular outcomes.
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.
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.
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.
Why it matters: Second Phase 3 readout for survodutide shows weight loss lagging rivals, moving the drug's prospects toward fat-mass-specific benefits.
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.
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.
Eli Lilly's phase 3 TRIUMPH-1 trial of retatrutide enrolled 2339 adults with obesity but no diabetes. At 80 weeks, mean body weight fell 25.0%, 23.7%, and 17.6% in the 12 mg, 9 mg, and 4 mg groups respectively, all significantly better than 3.9% with placebo (P<0.001).
Why it matters: The phase 3 trial reported weight, knee osteoarthritis pain, and sleep apnea endpoints at 80 weeks, allowing direct comparison of triple-receptor agonist benefits in obesity with comorbidities within one trial.
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.
Why it matters: Phase 3 data show an all-oral targeted combination doubles progression-free survival after CDK4/6 inhibition, especially in ESR1-mutated tumors.
Once-daily oral safiglipron reduced HbA1c by 1.20 to 1.45 percentage points versus placebo at 32 weeks in 284 adults with early type 2 diabetes managed with diet and exercise alone (OUTSTAND-1, phase 3). HbA1c below 7.0% was reached by 71.4-77.8% of safiglipron recipients versus 25.0% on placebo, with modest weight loss and mostly mild or moderate gastrointestinal adverse events. It offers an oral GLP-1 receptor agonist option taken without fasting or dietary restrictions.
Eli Lilly's retatrutide met the 80-week bodyweight primary endpoint in the phase 3 TRIUMPH-2 trial in patients with obesity and type 2 diabetes: mean weight change from baseline was -11.9% with 4 mg, -16.8% with 9 mg, and -18.8% with 12 mg, versus -5.1% with placebo, with estimated treatment differences p<0.0001 for all three doses.
Why it matters: Provides dose-graded weight loss and gastrointestinal adverse event rates in a type 2 diabetes population, enabling comparison with other GLP-1 agents.
RO7589831 (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.
uniQure's Huntington disease gene therapy AMT-130 (ifezuntirgene inilparvovec) continued to slow disease progression in an ongoing Phase I/II study, though effect sizes at 48 months were smaller than at 36 months. In 12 high-dose patients followed to 48 months, cUHDRS slowing was 44% (not statistically significant, p=0.144) and TFC slowing was 61% (nominal p=0.008). A new analysis of all 15 high-dose patients at 36 months, the regulatory anchor point for the submitted BLA and confirmatory studies, showed 80% slowing on cUHDRS (nominal p=0.005) and 67% on TFC (nominal p=0.011).
