FibroGen (FGEN) Misses Q3 EPS by 2c, Revenues Miss
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FibroGen (FGEN) PT Raised to $72 at Mizuho Securities on Strong Ph3 MACE Data
November 11, 2019 7:08 AM ESTMizuho Securities analyst Difei Yang raised the price target on FibroGen (NASDAQ: FGEN) to $72.00 (from $65.00) after the company reported the long-awaited MACE data from the global Phase 3 clinical trials of roxadustat on Friday. Data was positive with non-inferiority to placebo in the non dialysis-dependent... More
FibroGen (FGEN) Reports Positive Phase 3 Pooled Roxadustat Safety & Efficacy Results for Treatment of Anemia in Chronic Kidney Disease
November 8, 2019 3:00 PM ESTFibroGen, Inc. (NASDAQ: FGEN), today announced results from the pooled analyses of data from six global pivotal Phase 3 trials investigating roxadustat, a first-in-class, orally-administered inhibitor of hypoxia-inducible-factor (HIF) prolyl hydroxylase activity. The pooled analyses assessed the safety and efficacy of roxadustat as a treatment for anemia in chronic kidney disease (CKD) compared to placebo in Non-Dialysis-Dependent (NDD) patients and to standard of care epoetin alfa in Dialysis-Dependent (DD) patients, including the clinically important Incident Dialysis (ID) patient subgroup. These Phase 3 trials conducted by FibroGen and collaboration partners AstraZeneca and... More
FibroGen (FGEN) to Resume Trading at 2:30 pm
November 8, 2019 2:12 PM ESTFibroGen (NASDAQ: FGEN) to Resume Trading at 2:30 pm
... MoreAstraZeneca (AZN) and FibroGen Inc. (FGEN) Roxadustat Phase III Program Pooled Analyses Showed Positive Efficacy and No Increased Cardiovascular Risk in Patients with Anemia from Chronic Kidney Diseas
November 8, 2019 2:09 PM ESTAstraZeneca (NYSE: FGEN) and FibroGen Inc. (FibroGen) (Nasdaq: FGEN) today presented pooled efficacy and cardiovascular (CV) safety analyses from the pivotal Phase III program assessing roxadustat for the treatment of patients with anemia from chronic kidney disease (CKD).
The pooled CV safety analyses showed that roxadustat, an oral investigational hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), did not increase the risk of MACE, MACE+ and all-cause mortality in non dialysis-dependent (NDD) compared to placebo and dialysis-dependent (DD) patients compared to epoetin alfa, a current medicine used to treat... More
