Argenx has terminated the Phase III UNITY trial of subcutaneous efgartigimod (Vyvgart Hytrulo) in moderate-to-severe Sjögren's syndrome after an interim futility analysis by an independent data monitoring committee showed the study would not meet its primary endpoint. The decision weakens expectations for expanding Vyvgart into a new indication, and argenx shares fell 13.73% premarket on the news.
Nicotinamide riboside, 500 mg twice daily for 52 weeks, did not improve clinical outcomes in early Parkinson disease and was worse than placebo. In the phase 3 NOPARK trial of 393 patients, the MDS-UPDRS parts I-III score worsened by 2.72 points with nicotinamide riboside relative to placebo (P = .02), and nonmotor symptom burden worsened more on treatment (NMSS difference 4.22 points, P = .009). The findings do not support nicotinamide riboside as a disease-modifying treatment.
Oral deucrictibant shortened the time to symptom relief of hereditary angioedema attacks compared with placebo in a phase 3 multicentre, randomised, double-blind, placebo-controlled crossover trial, and was generally well tolerated. The findings support deucrictibant as potentially the first orally administered bradykinin B2 receptor antagonist for treating attacks of bradykinin-mediated angioedema.
Argenx has terminated the Phase 3 UNITY trial of Vyvgart Hytrulo in Sjogren's disease after an independent data committee determined the study could not meet its primary endpoint. The futility analysis included data from more than 500 patients, out of a planned enrollment of 630.
Why it matters: The brief details the futility halt and sample size of UNITY, and compares Phase 3 successes of ianalumab and dazodalibep in the same indication, letting readers gauge the shifting competitive landscape in Sjogren's disease.
Petrelintide, Zealand Pharma's Roche-partnered long-acting amylin analog, met its primary weight-loss endpoint in the Phase 2 ZUPREME-2 trial. Among 220 patients with obesity or overweight and T2D, the drug achieved up to 9.2% mean weight loss at week 28, versus 2% for placebo.
Why it matters: Gives petrelintide's 9.2% weight loss and 0.65% A1C reduction in ZUPREME-2, against 1.3%-2.1% for eloralintide and Zepbound, enabling direct comparison.
Sitagliptin, a diabetes drug, cut the risk of acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantation by half, according to a randomized controlled trial led by the First Affiliated Hospital of Soochow University and published in the Journal of Clinical Oncology. It is described as the first large trial of sitagliptin for aGVHD prevention in transplants from alternative donors.
Allist announced that the FURVENT Phase III trial of furmonertinib as first-line treatment for EGFR exon 20 insertion mutation NSCLC did not meet the primary endpoint of BICR-assessed PFS. The stock fell by its daily limit to 89.26 yuan, with pending sell orders exceeding 3.4 lots in units of ten thousand.
Why it matters: The report specifies the indication and endpoint the Phase III trial missed, letting readers judge the drug's prospects in first-line EGFR exon 20 insertion NSCLC.
The New England Journal of Medicine, Volume 395, Issue 14, 2026, published a clinical study of optogenetic therapy reporting results on restoring aspects of visual function in humans (NEJM, 2026;395:1399-1408).
Why it matters: Readers can access primary clinical endpoint data on optogenetic restoration of human visual function for comparison with other gene therapies.
A fixed-dose intranasal sufentanil-ketamine formulation relieved moderate-to-severe acute pain in emergency department patients aged 1 to under 18 years. In the phase 2/3 study of 152 patients, 88% had a pain intensity score of 4 or lower at 30 minutes and 95.4% achieved at least a 30% pain reduction, with no severe adverse events and median sedation scores of 0 or 1. Median treatment satisfaction was 5 out of 5, with 92% acceptability.
Retatrutide, a first-in-class triple-target hormone receptor agonist, produced clinically meaningful weight loss and improved glycemic control over 80 weeks in adults with obesity or overweight and type 2 diabetes in the TRIUMPH-2 trial, with additional benefits on multiple cardiovascular risk factors. Data were presented at the 62nd EASD meeting in Milan and published in The Lancet.
Neoadjuvant niraparib monotherapy produced anti-tumour activity and enabled R0 resection in selected patients with HRD-positive, unresectable, high-grade serous ovarian cancer who were initially unsuitable for primary debulking surgery. The authors state the approach remains investigational and requires randomised validation against standard platinum-taxane neoadjuvant chemotherapy.
Why it matters: It suggests a PARP inhibitor could replace platinum-taxane neoadjuvant chemotherapy in HRD-positive ovarian cancer pending randomised testing.
AiCuris presented pivotal phase 3 data at the TANDEM conference for pritelivir, an oral HSV helicase-primase inhibitor in development for refractory herpes simplex virus infections, with or without resistance, in immunocompromised patients. The company positions the drug as the first new agent of its kind in more than 20 years, moving it closer to market.
Vaxcyte announced that its thirty-one-valent pneumococcal conjugate vaccine VAX-31 met all prespecified primary endpoints in the pivotal adult trial OPUS-1. In head-to-head comparisons with Pfizer's Prevnar twenty and Merck's Capvaxive, VAX-31 was non-inferior for all shared serotypes and superior for serotypes unique to VAX-31. The company plans to submit a BLA to the FDA in the first half of the year after next, and shares rose more than thirty percent intraday on the news.
Solengepras shortened daily "off time" in a Phase 3 trial, positioning Cerevance to discuss an FDA approval path for the Parkinson's therapy. In 341 patients with motor fluctuations on levodopa, 150 mg of solengepras as adjunct treatment cut average daily off time by 1.56 hours from a baseline of 5.65 hours, versus a 0.95-hour drop with placebo, a 0.61-hour placebo-adjusted benefit at week 12 that appeared by week two. On time without dyskinesia also improved, with no serious adverse events in the high-dose group.
The SMARTEST randomized trial, presented at the EASD annual meeting in Milan, found that starting dapagliflozin directly was no better than metformin at reducing long-term complications in patients with early type 2 diabetes and no evident cardiovascular or kidney disease. The result challenges the assumption that newly diagnosed patients must begin with metformin, though it offers no basis for preferring dapagliflozin as first-line therapy.
Retatrutide, the first triple hormone receptor agonist to complete Phase III with key efficacy data, was published in NEJM and The Lancet on the same day. The Eli Lilly drug activates GIP, GLP-1 and glucagon receptors in a single molecule and is given as a once-weekly subcutaneous injection. Nearly a quarter of participants with obesity lost more than 35% of their body weight.
Takeda's zesosutinib (TAK-279), an oral high-selectivity TYK2 inhibitor in development, showed statistical superiority over deucravacitinib on the primary endpoint and all key secondary endpoints in the Phase 3 LATITUDE Atlas head-to-head study in adults with moderate to severe plaque psoriasis. Complete skin clearance was seen in more patients as early as week 8, and by week 16 more than 2.5 times as many patients on zesosutinib achieved complete clearance as on deucravacitinib.
In the CompassHER2-pCR trial, 43.8% of 2,141 early-stage HER2-positive breast cancer patients achieved a pathologic complete response after 12 weeks of neoadjuvant taxane, trastuzumab and pertuzumab, rising to 63.7% in ER-negative disease. The HER2DX test, analyzed in 569 participants, showed pCR rates of 68% with high scores versus 19% with low scores, an association that held after adjustment for clinical factors. The results support using tumor markers to select patients for less intensive chemotherapy.
ArriVent BioPharma announced topline results from the global pivotal Phase III FURVENT trial (NCT05607550). Furmonertinib monotherapy as first-line treatment for advanced non-squamous non-small cell lung cancer with EGFR exon 20 insertion mutations failed to meet the primary endpoint of progression-free survival as assessed by blinded independent central review. The company's share price fell 60% to 63 on the day of the announcement.
Gene therapy was tied to slower functional decline in Huntington's disease over 4 years, according to an industry and regulatory news report. The headline frames the finding as an open question of signal or noise, meaning the 4-year functional data have not been confirmed as a clear treatment effect. The report names no trial, dosing details or numerical outcomes.
