Celldex Completes Enrollment in Barzolvolimab CSU Trials Six Months Ahead
Celldex completes barzolvolimab CSU trials enrollment six months ahead of schedule across 1,939 patients in antihistamine-refractory chronic spontaneous urticar
FDA Expands Efgartigimod Approval to All Adult Generalized Myasthenia Gravis Patients
FDA expands efgartigimod approval to all adult generalized myasthenia gravis patients, including seronegative cases previously excluded from trials.
One Colonoscopy, Thirteen Years, and a Mortality Signal That Didn’t Arrive: What the NordICC Trial Really Breaks
The NordICC RCT cut colorectal cancer incidence but missed its mortality target — exposing a design flaw that should...
BioAge’s BGE-102 Achieves 86% hsCRP Reduction in Phase 1 Data
BioAge's BGE-102 achieves 86% median hsCRP reduction in Phase 1, with 87–93% of participants reaching normalized levels across dose...
CytomX Plans FDA Meeting on Varseta-M for Late-Line Colorectal Cancer
CytomX plans FDA meeting on Varseta-M colorectal cancer, with registrational trial targeted to start in first half of 2027...
Atsena’s ATSN-201 and ATSN-101 Show Sustained Efficacy in Gene Therapy Trials
Atsena's ATSN-201 and ATSN-101 show sustained efficacy in gene therapy trials with zero serious adverse events through 36 months.
Artiva’s AlloNK Shows 54% ACR50 Response Rate in Refractory Rheumatoid Arthritis
Artiva's AlloNK achieves 54% ACR50 response in refractory rheumatoid arthritis patients, outpacing rituximab alone in early trial data.
Celldex Completes Enrollment of 1,939 Patients in Barzolvolimab Phase 3 Trials
Celldex completes barzolvolimab Phase 3 enrollment of 1,939 patients across two trials, advancing topline data to Q4 2026.
FDA Approves Efgartigimod for All Adult Myasthenia Gravis Types
FDA approves efgartigimod for all adult myasthenia gravis types, including seronegative patients previously excluded from treatment options.
Enpatoran’s Phase 2 Miss Exposes a Protocol Design Flaw That Every SLE Sponsor Needs to Confront
Enpatoran improved BICLA response rates in moderate-to-severe SLE but failed its primary dose-dependent endpoint—a design flaw sponsors can't afford...