Roxadustat Granted Orphan Drug Designation for the Treatment of Myelodysplastic Syndromes by the U.S. Food and Drug Administration [Yahoo! Finance]
FibroGen, Inc (FGEN)
Last fibrogen, inc earnings: 3/2 04:01 pm
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Source: Yahoo! Finance
SAN FRANCISCO, Dec. 15, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted roxadustat Orphan Drug Designation for the treatment of myelodysplastic syndromes (MDS). “The Orphan Drug Designation granted to roxadustat for MDS underscores the significant treatment gap in this indication, and highlights patients' need for additional convenient treatments that can provide durable response,” said Thane Wettig, Chief Executive Officer of FibroGen. “Roxadustat showed an improvement in transfusion-independence in a subset of patients with high transfusion burden in a post-hoc analysis from the Phase 3 MATTHERHORN trial, which along with its favorable tolerability profile and oral route of administration has the ability to set it apart from current second-line treatments. Our team is finalizing the Phase 3 protocol in this patient population for submission to the FDA i
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News
- Roxadustat Granted Orphan Drug Designation for the Treatment of Myelodysplastic Syndromes by the U.S. Food and Drug AdministrationGlobeNewswire
- FibroGen to Present at the Oppenheimer Movers in Rare Disease Summit [Yahoo! Finance]Yahoo! Finance
- FibroGen to Present at the Oppenheimer Movers in Rare Disease SummitGlobeNewswire
- FibroGen Inc (FGEN) Q3 2025 Earnings Call Highlights: Strategic Moves Bolster Financial ... [Yahoo! Finance]Yahoo! Finance
- FibroGen, Inc. (FGEN) Q3 2025 Earnings Call Transcript [Seeking Alpha]Seeking Alpha
FGEN
Earnings
- 11/10/25 - Beat
FGEN
Analyst Actions
- 9/24/25 - HC Wainwright
FGEN
Sec Filings
- 12/9/25 - Form 4
- 12/9/25 - Form 4
- 11/17/25 - Form 4
- FGEN's page on the SEC website