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.
Tenaya’s TN-201 Gene Therapy Shows Cardiac Remodeling in MYBPC3-HCM Trial
TN-201 gene therapy reduces left ventricular mass and wall thickness in MYBPC3-HCM patients, with five of six achieving NYHA...
Obexelimab Meets Primary Endpoint in Phase 3 IgG4-RD Trial, BLA Submitted
Obexelimab met its primary endpoint in Phase 3 IgG4-RD trial with 56% flare risk reduction, prompting FDA BLA submission...
PROTEUS Trial: Apalutamide Plus ADT Cuts Metastasis Risk in Prostate Cancer
Apalutamide plus ADT reduced metastasis risk by 20% in high-risk prostate cancer, with nine times higher pathologic response than...
FDA Accepts Pharming’s Leniolisib Resubmission for Children 4-11 With APDS
FDA accepts Pharming's leniolisib resubmission for children 4-11 with APDS, targeting October 2026 decision after resolving manufacturing documentation issues.
AI Site Selection Sounds Fast — Until You See What Happens After the Algorithm Picks Your Site
ASCO and Ryght AI are using algorithms to select CDK4/6 inhibitor trial sites. Here's what ops teams need to...
The Neurological Drug Development Machine Is Broken. Platform Trials Are the Wrench.
MAMS platform trials could cut neurodegenerative drug timelines—but adaptive stopping rules and FDA guidance gaps threaten to stall the...