Gyre Therapeutics Announces China’s NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment
Gyre Therapeutics, Inc. (GYRE)
Company Research
Source: GlobeNewswire
SAN DIEGO, March 17, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (Gyre or Gyre Therapeutics) (Nasdaq: GYRE), a San Diego-based innovative commercial stage biopharmaceutical company with operations in the United States and China, today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) for Hydronidone (F351) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus (HBV). This decision by CDE was made following the pre-NDA communication meeting previously announced on January 5, 2026 and is a major milestone in the NDA process. Gyre, through its majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals), plans to submit a formal NDA in the near future. Mr. Ping Zhang, Executive Chairman of Gyre, stated, “I am very pleased to see the decision by
Show less
Read more
Impact Snapshot
Event Time:
GYRE
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
GYRE 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
GYRE alerts
High impacting Gyre Therapeutics, Inc. news events
Weekly update
A roundup of the hottest topics
GYRE
News
- Gyre Therapeutics Announces China's NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment [Yahoo! Finance]Yahoo! Finance
- Gyre Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update [Yahoo! Finance]Yahoo! Finance
- Gyre Therapeutics GAAP EPS of -$0.02 misses by $0.09, revenue of $37.2M beats by $1.76M [Seeking Alpha]Seeking Alpha
- Gyre Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business UpdateGlobeNewswire
- Gyre Therapeutics Enters into Agreement to Acquire Cullgen to Gain Targeted Protein Degradation Platform and Pipeline [Yahoo! Finance]Yahoo! Finance
GYRE
Earnings
- 3/12/26 - Miss
GYRE
Sec Filings
- 3/13/26 - Form 10-K
- 3/12/26 - Form 8-K
- 3/12/26 - Form 8-K
- GYRE's page on the SEC website