FibroGen (FGEN) PT Lowered to $55 at Stifel
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FibroGen Announces FDA Advisory Committee to Review Roxadustat New Drug Application Tentatively Scheduled for July 15, 2021
April 6, 2021 7:50 PM EDTSAN FRANCISCO, April 06, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced that the U.S. Food and Drug Administration (FDA) has informed the Company late today it has tentatively scheduled a Cardiovascular and Renal Drug Advisory Committee (CRDAC) on July 15, 2021 to review the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD) in both dialysis-dependent and non-dialysis-dependent patients.
The NDA submission was supported by positive results from a global Phase 3 program encompassing more than 8,000 patients. Roxadustat is approved and launched in... More
FibroGen Provides Additional Information on Roxadustat
April 6, 2021 4:01 PM EDTCompany Continues to be Confident in the Benefit / Risk Profile of Roxadustat
Company to Host Investor Call Today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time)
SAN FRANCISCO, April 06, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (Nasdaq: FGEN) (the Company) today provided clarification of certain prior disclosures of U.S. primary cardiovascular safety analyses from the roxadustat Phase 3 program for the treatment of anemia of chronic kidney disease (CKD).
As members of senior management were preparing for the upcoming FDA Advisory Committee meeting, we became aware that the primary... More
