Anemia

Agios Pharmaceuticals Inc (NASDAQ: AGIO) reported new data from the ongoing long-term extension study assessing the duration of effects of mitapivat in adults with pyruvate kinase (PK) deficiency. Data were featured at the American Society of Hematology (ASH) Annual Meeting and...

GlaxoSmithKline plc (NYSE: GSK) announced positive results from the ASCEND program comprised of five Phase 3 studies assessing daprodustat for anemia due to chronic kidney disease (CKD). Daprodustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (...

FibroGen Inc (NASDAQ: FGEN) has announced topline data from WHITNEY Phase 2 study of roxadustat for chemotherapy-induced anemia (CIA). The trial met the primary efficacy endpoint of maximum change in hemoglobin within 16 weeks from baseline without red blood cell transfusion....

The European Commission (EC) has approved FibroGen Inc (NASDAQ: FGEN) and Astellas Pharma's (OTC: ALPMF) Evrenzo (roxadustat) for anemia caused by chronic kidney disease (CKD), just days after the FDA turned down the drug. Related: FDA Shoots Down Roxadustat...

The FDA has accepted Agios Pharmaceuticals Inc's (NASDAQ: AGIO) marketing application seeking approval for mitapivat for pyruvate kinase (PK) deficiency. Under Priority Review designation, the agency's action date is assigned as of February 17, 2022. Related: Agios...

The FDA has issued a complete response letter regarding the marketing application for FibroGen Inc's (NASDAQ: FGEN) roxadustat for anemia of chronic kidney disease (CKD). The letter indicates the FDA will not approve the roxadustat NDA in its present form and has requested an...

Sanofi SA’s (NASDAQ: SNY) sutimlimab nailed all three of its primary endpoints in its Phase 3 CADENZA study for patients with cold agglutinin disease. This rare disorder can cause severe anemia without a recent history of blood transfusion. Topline results will be presented at...

Akebia Therapeutics Inc (NASDAQ: AKBA) and its collaborator Otsuka Holdings (OTC: OTSKY) have announced that the FDA has accepted to review vadadustat's marketing application for anemia due to chronic kidney disease. The application covers both adult patients, on...

Silence Therapeutics plc (NASDAQ: SLN) has announced topline data from GEMINI Phase 1 study evaluating SLN124 for iron-loading anemia conditions, thalassemia, and myelodysplastic syndrome (MDS). SLN124 is a short interfering ribonucleic acid (siRNA) that targets TMPRSS6. The single-...

FibroGen Inc (NASDAQ: FGEN) stock plummeted after hours on Tuesday after a murky disclosure for roxadustat, the company’s anemia treatment in chronic kidney disease patients. While preparing for an advisory committee meeting ahead of potential approval of roxadustat, FibroGen...