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Apellis and Sobi

Apellis Pharmaceuticals and Sobi Report P-III (VALIANT) Trial Data of Empaveli for C3 Glomerulopathy (C3G) and Primary IC-MPGN

Shots:Apellis & Sobi have reported data from the open-label period of P-III (VALIANT) trial of Empaveli for the treatment of C3G & primary immune complex membranoproliferative glomerulonephritis (IC-MPGN); regulatory review is ongoing in the US & EUThe P-III (VALIANT) trial assessed Empaveli (Q2W) vs PBO in C3G or primary IC-MPGN pts (≥12yrs., n=124)…

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Otsuka Pharmaceutical Reports Interim P-III (VISIONARY) Trial Data of Sibeprenlimab for Immunoglobulin A Nephropathy (IgAN)

Shots:Otsuka Pharmaceutical has reported interim P-III (VISIONARY) trial data evaluating sibeprenlimab (400mg, SC, Q4W) vs PBO in ~510 IgAN pts, who were on SoC therapyTrial showed a 51.2% reduction in 24hr. uPCR (1EP) at 9mos. (presented at ERA 2025) & will continue to assess kidney function (2EP) via eGFR over 24mos., with completion…

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