GRAIL's Galleri Vote Puts Label and Coverage in Focus & Roche Posts Phase 3 Kidney Win

GRAIL’s Galleri won backing from FDA advisers, but the narrow effectiveness split and a missed late-stage-cancer endpoint keep the label and coverage case in focus. Roche and Ionis report that sefaxersen reduced proteinuria in Phase 3 IgA nephropathy, while longer-term kidney-function data remain blinded and Novartis’s Fabhalta (iptacopan) sets the benchmark. Vertex tests inaxaplin in additional APOL1 kidney disease groups, and Amgen’s dazodalibep succeeds in systemic Sjögren’s disease. Plus: Immunovant halts its cutaneous lupus program, Oruka extends psoriasis follow-up, Boehringer Ingelheim signs an Envisagenics cancer-target pact, and Enveda raises $311 million.Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.