FibroGen (FGEN) Reports Positive Phase 3 Pooled Roxadustat Safety & Efficacy Results for Treatment of Anemia in Chronic Kidney Disease

FibroGen (FGEN) Misses Q3 EPS by 2c, Revenues Miss

FibroGen (NASDAQ: FGEN) reported Q3 EPS of ($0.57), $0.02 worse than the analyst estimate of ($0.55). Revenue for the quarter came in at $33.17 million versus the consensus estimate of $31.6 million.

The FibroGen team achieved many milestones over the past few months, culminating with the positive Phase 3 results for roxadustat reported at the American Society of Nephrology conference last week in Washington, D.C., said Jim Schoeneck, Interim Chief Executive Officer, FibroGen. This set... More

FibroGen (FGEN) to Resume Trading at 2:30 pm

FibroGen (NASDAQ: FGEN) to Resume Trading at 2:30 pm

AstraZeneca (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

AstraZeneca (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

FibroGen (FGEN) Announces Positive Phase 3 Pooled Roxadustat Safety and Efficacy Results for Treatment of Anemia in Chronic Kidney Disease

FibroGen, 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) halted, news pending

FibroGen (NASDAQ: FGEN) halted, news pending

FibroGen (FGEN) Highlights Results from Ph. 3 HIMALAYAS Trial Evaluating Roxadustat for Treatment of Anemia in Incident Dialysis Patients

FibroGen, Inc. (NASDAQ: FGEN), today announced results from the Phase 3 HIMALAYAS trial evaluating roxadustat for the treatment of anemia in incident dialysis (ID) patients with chronic kidney disease (CKD), a clinically important subgroup of dialysis-dependent CKD patients. Incident dialysis was defined as those who initiated dialysis within 4 months before randomization to roxadustat or epoetin alfa. In this trial of 1,043 patients, believed to be the largest trial to date investigating an anemia medicine in the ID population, roxadustat achieved both primary efficacy endpoints. The safety profile of roxadustat observed in the HIMALAYAS trial was consistent... More