What Negative Roxadustat FDA AdCom Vote Means for Fibrogen's (FGEN) Stock?
FREE Breaking News Alerts from StreetInsider.com!
StreetInsider.com Top Tickers, 8/17/2026
- Wall Street indexes slip as oil prices rise, retail results awaited
- Trump threatens to bomb Oman over Iran stance
- Why this Wall Street strategist says the "trade is long gold"
- U.S. EV market shows signs of bottoming out: Bernstein
- Micron rises as White House presses Apple to avoid Chinese memory chips
- Wall Street indexes slip as oil prices rise, retail results awaited
- Trump threatens to bomb Oman over Iran stance
- Oil settles up over $2 as Iran war stalemate stokes supply concerns
- L3Harris CEO steps down amid conduct review, shares drop
- BofA sees Micron EPS topping $230 by FY30, calls peak fears overblown
FibroGen Announces Outcome of FDA Advisory Committee Review of Roxadustat for Treatment of Anemia of Chronic Kidney Disease
July 15, 2021 6:26 PM EDTSAN FRANCISCO, July 15, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted to recommend not approving roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, for the treatment of anemia due to chronic kidney disease (CKD) in adult patients. The Committee based its recommendation on data from a global Phase 3 program encompassing more than 8,000 patients. While the FDA is not required to follow the Committee's vote, the agency considers the Committee's non-binding recommendations when making its decision.
... More