FibroGen stock falls ~10% after roxadustat fails phase 3 trial for anemia
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- FibroGen's (NASDAQ:FGEN) oral drug roxadustat failed to meet the main efficacy goal in a phase 3 trial to treat anemia in patients with transfusion-dependent lower risk myelodysplastic syndromes (MDS).
- MDS are a group of disorders in which immature blood cells in the bone marrow do not mature or become healthy blood cells causing chronic anemia — a condition in which the body does not produce enough healthy red blood cells.
- In the study, dubbed MATTERHORN, 140 patients were enrolled who received either roxadustat or placebo. The main goal of the trial is transfusion independence for ≥ 56 consecutive days during the first 28 weeks of therapy.
- The company said the proportion of patients who achieved red blood cell transfusion independence in the first 28 weeks was 47.5% for the roxadustat group, compared to 33.3% for placebo.
- The adverse event profile of roxadustat, as per preliminary safety analysis, was generally consistent with previous data. Safety data will be further evaluated at trial's completion, the company added.
- The MATTERHORN study is part of FibroGen's co-development collaborations with AstraZeneca (AZN) and Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY).
- FGEN -11.74% to $14.74 premarket May 5