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FibroGen Begins Study on Roxadustat for Chemo-Induced Anemia

Zacks Equity Research

FibroGen, Inc. FGEN announced that it has dosed the first patient in a phase II study on roxadustat for the treatment of chemotherapy-induced anemia (CIA) in cancer patients receiving chemotherapy, an area with highly unmet medical need.

The mid-stage study will evaluate the safety and efficacy of roxadustat in anemia patients, who are undergoing chemotherapy and the anticipated outcome is non-curative. Patients will receive roxadustat orally thrice a week for a period of 16 weeks. The primary efficacy endpoint of the study is to see the maximum change in hemoglobin level from baseline without red blood cell transfusion.

Shares of FibroGen have lost 18.4% so far this year against the industry's increase of 5.2%.

Notably, last week, FibroGen and Japan's Astellas Pharma Inc. received a marketing approval for Evrenzo (roxadustat) in Japan for the treatment of anemia caused by chronic kidney disease (CKD) in dialysis-dependent patients.

FibroGen is collaborating with Astellas for developing roxadustat in Japan, Europe, the Middle East and South Africa.

We remind investors that roxadustat, a first-in-class hypoxia-inducible-factor prolyl hydroxylase inhibitor, is being jointly developed by FibroGen and AstraZeneca AZN for treating anemia in CKD patients in the United States and China. A regulatory application seeking approval for roxadustat in the United States is already underway.

Last December, the Chinese regulatory agency approved roxadustat for treating anemia in CKD patients who are on dialysis.

Meanwhile, last month, FibroGen China, a wholly-owned subsidiary of FibroGen, received a second marketing approval for roxadustat in China. This time, the Chinese regulatory authority approved the drug for the treatment of anemia caused by CKD in non-dialysis-dependent patients.

Moreover, roxadustat is being evaluated in a phase III study for treating anemia associated with myelodysplastic syndromes (MDS) in the United States and Europe. The same is also being investigated in a phase II/III study for treating anemia associated with MDS in China.

Zacks Rank & Other Key Picks

FibroGen currently sports a Zacks Rank #1 (Strong Buy). Other stocks worth considering in the same sector include Verrica Pharmaceuticals Inc. VRCA and Spectrum Pharmaceuticals, Inc. SPPI, both flaunting the same solid Zacks Rank as FibroGen. You can see the complete list of today’s Zacks #1 Rank stocks here.

Verrica Pharmaceuticals' loss per share estimates have been narrowed 7.4% for 2019 and 0.5% for 2020 over the past 60 days. The stock has soared 57.3% year to date.

Spectrum Pharmaceuticals' loss per share estimates have been narrowed 18.3% for 2019 and 19.8% for 2020 over the past 60 days. The stock has gained 4.2% year to date.

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