Celldex’s Barzolvolimab Phase 3 CSU Trial Enrolls 1,939 Patients Across 43 Countries
Celldex's barzolvolimab Phase 3 CSU trial enrolls 1,939 patients across 43 countries, the largest antihistamine-refractory urticaria study ever conducted.
FDA Approves Efgartigimod Alfa for All Serological Types of Generalized Myasthenia Gravis
FDA approves efgartigimod alfa for generalized myasthenia gravis across all serological types, including triple-seronegative patients previously without labeled
Denali Launches AVLAYAH for Hunter Syndrome; DNL628 Tau Program Advances
Denali launches AVLAYAH for Hunter Syndrome following FDA accelerated approval, with confirmatory Phase 2/3 COMPASS trial required to sustain...
CytomX Dose Optimization for Varsetatug Masetecan Due H2 2026
CytomX's dose optimization for varsetatug masetecan in colorectal cancer readout expected H2 2026 will determine monotherapy selection and registrational...
Atsena’s ATSN-201 and ATSN-101 Show Durable Effects in XLRS and LCA1 Trials
Atsena's gene therapies show durable structural and functional improvements in XLRS and LCA1 trials, with safety sustained through 36...
Artiva’s AlloNK Plus Rituximab Achieves 71% Response in Refractory RA
Artiva's AlloNK Plus Rituximab achieved 71% ACR50 response in refractory RA patients with Phase 3 trial now underway.
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.
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...