FibroGen Inc. Receives Positive FDA Feedback for Advancing Roxadustat in Phase 3 Trial for Anemia in Lower-Risk Myelodysplastic Syndromes

Reuters
Aug 07
FibroGen Inc. Receives Positive FDA Feedback for Advancing Roxadustat in Phase 3 Trial for Anemia in Lower-Risk Myelodysplastic Syndromes

FibroGen Inc. $(FGEN)$ has announced positive feedback from a Type C meeting with the FDA, paving the way for the advancement of its drug, roxadustat, in treating anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high red blood cell transfusion burden. This follows a post-hoc subgroup analysis from the MATTERHORN Phase 3 trial, which demonstrated a significant treatment effect. The company is preparing for a pivotal Phase 3 trial, with plans to submit the full protocol to the FDA by the fourth quarter of 2025. This regulatory progress highlights roxadustat's potential as an important addition to treatment options for patients with significant unmet needs.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. FibroGen Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9507846-en) on August 07, 2025, and is solely responsible for the information contained therein.

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