Clinical Trial Materials

Phio's PH-762 posted a 70% response rate in skin cancer, supporting its FDA briefing package for a planned phase 2b trial.

With 15 patients now dosed in its pivotal EMERALD trial, Resolution will build on the 70% 4-year transplant-free survival seen with RTX001 in earlier data.

Del-desiran missed its primary endpoint in a phase 3 DM1 trial, though secondary measures showed signs of clinical activity.

BrainChild Bio's BCB-276 extended survival to 19.8 months from diagnosis in phase 1, backing its $116 million-funded pivotal DIPG trial.

9MW1911 cut severe COPD exacerbations by up to 100% at the highest dose, supporting Mabwell's push toward phase 3 development.

Apazunersen missed its primary endpoint in a phase 3 Angelman syndrome trial, meaning that patient population remains without an approved treatment option.

Teva's TEV '408 blocked gluten-induced gut damage in a phase 2a trial, supporting its use for celiac disease, which has no approved drug treatment.

LIlly reports that Taltz plus Zepbound helped 30.6% of psoriasis patients clear skin and lose 10%+ weight at 1 year, versus 4.4% on Taltz alone.

AbbVie's bispecific antibody posted a 90% response rate in squamous NSCLC, headlining the company's expanding lung cancer pipeline data.

Merck and Moderna report that the personalized mRNA plus mAb cancer therapy cleared its first phase 3 hurdle, cutting recurrence risk beyond pembrolizumab alone.

The independent data monitoring committee's finding leaves clinicians without a new option for PD-L1-low NSCLC, a population historically underserved by current immunotherapies.

Silence's siRNA drug freed 88% of trial patients from ongoing phlebotomies, a chronic burden for people with polycythemia vera.

Akeso is pairing a next-gen bispecific ADC with its PD-1/VEGF antibody, ivonescimab, in a first-line push against hard-to-treat breast cancer.

Nonhealing wounds precede 80% of diabetes-related amputations, and BIOxHEAL is now cleared to test whether it can change that in a controlled trial.

Oblenio Bio has dosed the first patients in a phase 1a trial of tri-specific T-cell engager LBL-051 for refractory autoimmune disease.

Rocket Pharmaceuticals has reported a positive safety update for RP-A501 from the first 3 patients treated under a modified phase 2 protocol in Danon disease.

Novo Nordisk's ziltivekimab failed to reduce cardiovascular events in the phase 3 ZEUS trial despite confirmed IL-6 target engagement.

AbelZeta has received FDA RMAT clearance for a registrational phase 2 trial of its bispecific CAR-T therapy, C-CAR168, in refractory lupus nephritis.

GSK reports that dostarlimab (Jemperli) monotherapy achieved sustained clinical complete responses in the phase 2 AZUR-1 trial for dMMR/MSI-H locally advanced rectal cancer, with data to be submitted for regulatory review.

The company reported that phase I data show approximately 40% of patients remained cancer-free at 10 years, while 2 phase 2 trials are ongoing.

The company reported that all three participants in the 3 µg/kg dose cohort achieved a ≥25% SALT score reduction following single-dose subcutaneous administration, with dose escalation ongoing toward a recommended phase 2 dose.

Johnson & Johnson reported that the MonumenTAL-3 trial showed 24-month progression-free survival up to 81.3% and overall survival up to 89.2% with the GPRC5D bispecific combination versus standard of care.

Gan & Lee has reported positive topline trial results for insulin ludefen in type 2 diabetes and the GLP-1 bofanglutide in obesity.

Phase 3 data from Boehringer Ingelheim’s SYNCHRONIZE-1 and SYNCHRONIZE-MASLD trials meet their primary endpoints, with glucagon/GLP-1 dual agonism showing targeted metabolic fat reduction beyond body weight loss at 76 and 48 weeks.

Dual primary endpoints were met in both PANKU-Breast02 and PANKU-Esophagus01 phase 3 trials based on interim analyses, while priority review is underway for the esophageal cancer indication in China, Bristol Myers Squibb and Biokin stated.