FGEN - FibroGen stock rises after roxadustat matches Sepo in Chinese trial for anemia

2023-05-18 08:20:30 ET

FibroGen's ( NASDAQ: FGEN ) oral drug roxadustat was good as recombinant erythropoietin alfa (SEPO) in improving hemoglobin (Hb) level in a phase 3 trial to treat anemia in patients receiving chemotherapy for non-myeloid malignancies in China.

Anemia is a condition in which the body produces lower-than-normal amount of healthy red blood cells.

The company said roxadustat showed non-inferiority compared to recombinant erythropoietin alfa (SEPO) on the main goal of change in Hb level from baseline to the average level during weeks 9-13.

SEPO is marketed by China-based 3SBio.

As per preliminary safety analysis, the adverse event profile of roxadustat was generally consistent with previous data and supports a positive benefit risk in this patient population, the company added.

"Chemotherapy-induced anemia remains an unmet medical need in China, and we believe that roxadustat has potential to improve the lives of these patients," said FibroGen's Chief Medical Officer Mark Eisner.

Detailed results will be filed for presentation at an upcoming medical conference, according to the company.

In the study, 159 patients with solid tumors who had  baseline hemoglobin level at or below 10 g/dL were enrolled.

This Chinese phase 3 study was sponsored and conducted by and FibroGen and is part of a collaboration with AstraZeneca ( AZN ).

FibroGen said it will work with with AstraZeneca and the China Health Authority to submit a supplemental new drug application.

Earlier this month, foxadustat failed to meet the main efficacy goal of a phase 3 study called MATTERHORN, to treat anemia in patients with transfusion-dependent lower risk myelodysplastic syndromes. This study was part of FibroGen's co-development collaborations with AstraZeneca and Astellas Pharma ( OTCPK:ALPMF ) ( OTCPK:ALPMY ).

FGEN +4.99% to $18.71 premarket May 18

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