Abivax Clears Pre-NDA Meeting with FDA for Obefazimod in Ulcerative Colitis
Abivax's obefazimod ulcerative colitis drug achieved 50.8%-51.3% remission rates in Phase 3, clearing FDA pre-NDA meeting for adult patient...
FDA Agrees Single Phase 3 Trial Sufficient for ATH434 MSA Approval Path
FDA accepts single Phase 3 trial for ATH434 in Multiple System Atrophy, with approximately 200 patients and 12-month duration...
EyePoint Completes Enrollment of DURAVYU Phase 3 Trials for Diabetic Macular Edema
EyePoint completes enrollment of DURAVYU Phase 3 trials for diabetic macular edema, testing a six-month dosing schedule against aflibercept.
Karyopharm to Submit Selinexor-Ruxolitinib sNDA for Myelofibrosis in August 2026
Karyopharm plans August 2026 sNDA submission for selinexor-ruxolitinib combination in myelofibrosis, targeting accelerated FDA approval based on spleen response
AbCellera, Vertex Partner on Multispecific T-Cell Engagers for Autoimmune Disease
AbCellera and Vertex partner to develop multispecific T-cell engagers for autoimmune disease, advancing beyond earlier oncology-derived formats.
Capricor’s Deramiocel HOPE-3 Trial Misses Primary Endpoint at p=0.09
Capricor's deramiocel HOPE-3 trial missed its primary endpoint with p=0.09, showing a 1.8 percentage point LVEF improvement in DMD...
PMN310 Shows No ARIA Signals in Early Alzheimer’s Phase 1b Trial
PMN310 demonstrates no ARIA signals in Phase 1b trial for early Alzheimer's disease, positioning oligomer-selective targeting as a safer...
Pulse Biosciences Reaches Midpoint in NANOPULSE-AF Ablation Trial
Pulse Biosciences reaches midpoint in NANOPULSE-AF ablation trial for atrial fibrillation, targeting full enrollment by early Q4 2026.
Viking Therapeutics Advances VK2735 Oral Program Into Phase 3 Trials
Viking Therapeutics advances VK2735 into Phase 3 trials with fully enrolled studies and plans for oral formulation testing by...
Grace Therapeutics Receives FDA Type A Meeting Minutes on GTx-104 Resubmission Path
Grace Therapeutics receives FDA Type A meeting minutes outlining the path for GTx-104 resubmission, focusing on manufacturing and packaging...