FDA Grants Rare Pediatric Disease Designation to Omeros’ MASP-3 Inhibitor Zaltenibart for Treatment of C3 Glomerulopathy
Omeros Corporation (OMER)
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Source: Business Wire
-- Phase 3 Studies on the Horizon in both PNH and C3G -- SEATTLE--(BUSINESS WIRE)--Omeros Corporation today announced that zaltenibart (OMS906) has received rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for the treatment of complement 3 glomerulopathy (C3G), an ultra-rare, progressive renal disorder primarily afflicting children and young adults. Caused by dysregulation of the alternative pathway of complement, there is no approved treatment for C3G, which often leads to end-stage renal disease within 10 years of diagnosis. Zaltenibart is the most proximal inhibitor of the alternative pathway. It blocks mannan-binding lectin-associated serine protease-3 (MASP-3), the key activator of the alternative pathway, stopping the conversion of pro-complement factor D (pro-CFD) to mature CFD. Phase 3 clinical trials for zaltenibart in C3G are slated to begin next year.“C3G is devastating for children as well as for adults, and our receipt of FDA’s rare p
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- Omeros Corporation Provides Update on Progress Toward BLA Resubmission [Yahoo! Finance]Yahoo! Finance
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- Omeros Co. (NASDAQ: OMER) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
- Omeros Co. (NASDAQ: OMER) was upgraded by analysts at RODMAN&RENSHAW to a "strong-buy" rating.MarketBeat
- Omeros Co. (NASDAQ: OMER) had its "neutral" rating re-affirmed by analysts at Cantor Fitzgerald.MarketBeat
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