FDA Clears IND Amendment for MAIA’s Ateganosine Phase 2 NSCLC Trial Expansion
FDA clears IND amendment for MAIA's ateganosine Phase 2 NSCLC trial expansion, targeting third-line patients with durable survival signals.
Dapirolizumab Pegol Shows Steroid-Sparing Benefit in Phase 3 SLE Trial
Dapirolizumab pegol achieved steroid-sparing benefit in Phase 3 SLE trial, enabling patients to taper glucocorticoids while maintaining disease control.
Zenagamtide achieves 89% A1C target with 14.6% weight loss in diabetes trial
Zenagamtide diabetes trial shows 89% of participants reached A1C targets with 14.6% weight loss in phase 2 study.
Aleniglipron’s Phase 2b Data Redraws the Oral GLP-1 Efficacy Map — And Raises Hard Questions for Phase 3 Design
Structure Therapeutics' aleniglipron hit 14.7% weight loss in Phase 2b, matching injectable benchmarks. Here's what the trial design signals...
China’s Tenecteplase Trial Just Challenged the Global Stroke Playbook — and the FDA Should Be Paying Attention
A phase 3 RCT from China finds tenecteplase before EVT cuts disability in proximal MCA occlusion strokes 4.5–24 hrs...
TG Therapeutics’ Subcutaneous BRIUMVI Meets Phase 1 Bioavailability Goals
TG Therapeutics' subcutaneous BRIUMVI achieves bioavailability goals in Phase 1, potentially offering quarterly dosing for relapsing multiple sclerosis.
Cabaletta Bio Reports 83% Response Rate for Rese-cel in Dermatomyositis
Cabaletta Bio's rese-cel achieved 83% response rate in dermatomyositis patients, exceeding the 50% threshold needed for regulatory success toward...
Lundbeck’s bocunebart meets primary endpoint in Phase IIb migraine trial
Lundbeck's bocunebart meets primary endpoint in Phase IIb migraine trial, showing 1.38 fewer monthly migraine days versus placebo in...
Cardiff Onvansertib Shows 72% Response Rate in RAS-Mutated Colorectal Cancer
Onvansertib achieved a 72% response rate in RAS-mutated colorectal cancer, prompting Cardiff Oncology to advance to Phase 3 trials.
Kura’s Darlifarnib Shows 67% Response Rate in Pancreatic Cancer Combo Study
Kura's darlifarnib showed a 67% response rate when combined with adagrasib in pancreatic cancer, outperforming historical monotherapy benchmarks.