The U.S. Food and Drug Administration (FDA) has approved Apellis Pharmaceuticals' EMPAVELI® (pegcetacoplan) as the first treatment for the rare kidney diseases C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients aged 12 and older. The therapy demonstrated a 68% reduction in proteinuria and stabilization of kidney function, addressing an unmet need for approximately 5,000 affected patients. Following the approval, Apellis Pharmaceuticals reported its second quarter 2025 financial results, generating $178 million in revenue, including $171 million in U.S. net product sales. The company's SYFOVRE® (pegcetacoplan injection) demand grew 6% quarter-over-quarter, with U.S. net product revenue of $151 million. Apellis posted a GAAP loss per share of $0.33, beating estimates by $0.15, while revenue missed expectations by $10.15 million. In related biotech updates, argenx reported a $4 billion run rate with Vyvgart sales reaching $949 million in 2Q25, driven by approximately 15,000 patients globally, including over 2,500 with chronic inflammatory demyelinating polyneuropathy (CIDP). Alnylam Pharmaceuticals also released its second quarter 2025 financial results, with its stock rising on strong sales of its rare disease drug.
Alnylam reaches new highs on strong sales of closely watched rare disease drug https://t.co/R2m24TEzGP $ALNY + 15% $BBIO $PFE
$ARGX reported ~15K pts globally across all indications are now on Vyvgart including >2,500 CIDP pts. Mgmt commented that early uptake is largely being driven by ptsswitching from IVIg (~85-90% of scripts). $IMVT $BHVN https://t.co/ZFJS1ViJ2J
$ARGX 4 BILLION dollar run rate now - $ ARGX reported 2Q25 Vyvgart sales $949mn - significantly above consensus https://t.co/hZ5BT3lhEP