FibroGen’s Anemia Candidate Fails In Myelodysplastic Syndrome Study – FibroGen (NASDAQ:FGEN)

  • FibroGen Inc FGEN released data from the MATTERHORN Phase 3 trial of roxadustat for anemia in patients with transfusion-dependent lower-risk myelodysplastic syndromes (MDS).

  • The 140-patient study did not meet its primary endpoint. 

  • The study’s primary endpoint was transfusion independence for ≥ 56 consecutive days during the first 28 weeks of treatment. 

  • The proportion of patients who achieved red blood cell transfusion independence in the first 28 weeks was 47.5% for the roxadustat arm compared to 33.3% for the placebo, but this difference was not statistically significant (p=0.217). 

  • The adverse event profile of roxadustat observed in the preliminary safety analysis was consistent with previous findings, and safety will be further evaluated at study completion.

  • Roxadustat is an oral medication that promotes erythropoiesis, or red blood cell production.

  • Earlier this week, FibroGen announced a non-dilutive term loan facility of up to $150 million from Morgan Stanley Tactical Value.
  • The company expects to report topline data from the China Phase 3 study of roxadustat for chemotherapy-induced anemia (CIA) expected 2Q 2023.

  • Price Action: FGEN shares are up 2.57% at $17.13 on the last check Friday.

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