Signal
33 articles covering "clinical-trial"
Biogen's diranersen, an antisense drug aimed at tau, missed its Phase 2 dose-response endpoint but slowed cognitive decline and cut brain tau across all doses. Biogen is advancing to Phase 3.
The FDA approved Celcuity's gedatolisib for PIK3CA wild-type HR+/HER2- advanced breast cancer after it more than tripled progression-free survival over fulvestrant alone in the Phase 3 VIKTORIA-1 trial.
BeOne Medicines' chemo-free BRUKINSA plus rituximab regimen met its primary endpoint against bendamustine-rituximab in untreated mantle cell lymphoma.
PROPEL 3 met its primary endpoint, positioning infigratinib as a potential first oral rival to BioMarin's injectable Voxzogo. NDA filing is planned for Q3 2026.
Pfizer's integrin beta-6 ADC failed to beat docetaxel on overall survival across the full SigVie-002 population, but showed a stronger trend in the two-thirds of patients with one prior line of therapy.
Merck says its TL1A antibody tulisokibart met the primary and key secondary endpoints in the Phase 3 ATLAS-UC induction study, a first for the drug class.
An interim analysis of Humacyte's V012 Phase 3 trial found its acellular tissue engineered vessel gave women on dialysis 220 catheter-free days versus 129 for an AV fistula.
A Shanghai-built AAV gene therapy delivering two dopamine-synthesis genes to the putamen was safe in 10 patients, with motor improvements at one year.
GSK's antisense drug bepirovirsen cleared chronic HBV in 20% and 19% of patients across two Phase 3 trials, versus none on placebo, the NEJM reports.
The SENTRY trial of selinexor plus ruxolitinib met its spleen-volume endpoint and missed its symptom endpoint, with an immature overall survival signal favoring the combination.
Full Week 52 data from MoonLake's VELA program show sustained response rates for the IL-17 Nanobody, nine months after one of its two pivotal trials missed its primary endpoint.
Vera Therapeutics' dual BAFF/APRIL inhibitor reduced proteinuria 45.7% at week 36 in the NEJM-published ORIGIN 3 trial, with an FDA accelerated-approval decision due July 7.