Vertex's Phase 3 RAINIER trial of povetacicept in IgA nephropathy met its primary endpoint with a 52% UPCR reduction. The FDA granted rolling review, and Vertex plans full BLA submission by end of March. Shares rose on the news and analyst upgrades.
Vertex completed the rolling BLA submission for povetacicept in IgA nephropathy after positive Phase 3 RAINIER interim data. The company plans to use a Priority Review Voucher to accelerate FDA review.
A matched analysis of 923 men found salvage focal therapy and radical prostatectomy achieved comparable 10-year cancer-specific survival for prostate cancer recurring after radiotherapy, though surgery carried significantly higher complication rates.
