Roxadustat Granted Orphan Drug Designation for the Treatment of Myelodysplastic Syndromes by the U.S. Food and Drug Administration
FibroGen, Inc (FGEN)
Last fibrogen, inc earnings: 3/2 04:01 pm
Check Earnings Report
US:NASDAQ Investor Relations:
phx.corporate-ir.net/phoenix.zhtml?c=253783&p=irol-irhome
Company Research
Source: GlobeNewswire
Company is on track to file the Phase 3 protocol in the fourth quarter of 2025 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 finali
Show less
Read more
Impact Snapshot
Event Time:
FGEN
Last Price
Price Change
Price Change%
Volume Shares
Max Up
Max Down
%
Volume Ratio
Performance Comparison
Updated
|
Event Day
Stock performance from the time of news release until the following 4pm ET market close
|
Last price at news event
|
Since Event
Multi-day stock performance from the time of the news release
|
|---|---|---|
|
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
|
LAST
PRICE AT NEWS EVENT |
SINCE EVENT
Multi-day stock performance from the time of the news release
|
| Last Price | ||
| VWAP | ||
|
High:
|
Max Up |
High:
|
|
Low:
|
Max Down |
Low:
|
|
%
|
Post news range |
%
|
|
|
Price change |
|
|
|
Price Change Percentage |
|
|
|
S&P 500 (SPX) |
|
|
%
|
Volume ratio |
%
|
| Volume | ||
| Ticks | ||
|
|
Avg transaction size |
|
Don't Miss Out On The Next BIG Stock Move
Event day
Event Day Chart will not be displayed beyond 90-day period of the event
Performance since event
Time And Velocity Analysis
Be the first to know
Opt in for alerts from News Quantifed
Sign Up Today
Opt-in for
FGEN alerts
Learn More With NQ
Reading the Impact Report
Help Me Understand This Data
Help Me Understand This Data
How NQ Works
What is news-based trading?
And why is it so successful?
And why is it so successful?
Movers & Shakers
The biggest gainers and losers and WHY it moved
FGEN alerts
High impacting FibroGen, Inc news events
Weekly update
A roundup of the hottest topics
FGEN
News
- Roxadustat Granted Orphan Drug Designation for the Treatment of Myelodysplastic Syndromes by the U.S. Food and Drug Administration [Yahoo! Finance]Yahoo! Finance
- 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