Gyre Therapeutics, Inc.
NASDAQ•GYRE
CEO: Dr. Han Ying Ph.D.
Sector: Healthcare
Industry: Biotechnology
Listing Date: 2006-04-12
Gyre Therapeutics, Inc., a pharmaceutical company, engages in the development and commercialization of small-molecule, anti-inflammatory, and anti-fibrotic drugs targeting organ fibrosis. It offers ETUARY (Pirfenidone), an anti-fibrotic drug approved for the treatment of idiopathic pulmonary fibrosis; and under phase 3 studies for dermatomyositis and systemic sclerosis-associated interstitial lung disease, pneumoconiosis, and diabetic kidney disease. The company is also involved the development of F351 (Hydronidone), a structural derivative of ETUARY (Pirfenidone), under Phase 3 studies for the treatment of chronic hepatitis B liver fibrosis; and under Phase 1 studies for liver fibrosis associated with nonalcoholic associated steatohepatitis. In addition, its development pipeline includes F573, under Phase 2 studies for the treatment of acute/acute-on-chronic liver failure; F528, under preclinical stage for the treatment of chronic obstructive pulmonary disease; and F230, under preclinical stage for the treatment of pulmonary arterial hypertension. The company was founded in 2002 and is headquartered in San Diego, California. Gyre Therapeutics, Inc. operates as a subsidiary of GNI USA, Inc.
Contact Information
Market Cap
$618.05M
P/E (TTM)
123.3
17.2
Dividend Yield
--
52W High
$11.78
52W Low
$6.11
52W Range
Rank53Top 76.1%
2.8
F-Score
Modified Piotroski Analysis
Based on 10-year fundamentals
Weak • 2.8 / 9 points
Scoring Range (0-9)
8-9: Excellent Value
6-7: Strong Fundamentals
4-5: Average Quality
0-3: Weak Performance
Data Period: 2016-2025
Financial Dashboard
Q4 2025 Data
Revenue
$37.20M+0.00%
4-Quarter Trend
EPS
-$0.02+0.00%
4-Quarter Trend
FCF
-$5.77M+0.00%
4-Quarter Trend
2025 Annual Earnings Highlights
Key Highlights
Revenue Growth Strong Total revenues reached $116.6M USD, up 10.2%, fueled by $5.5M Contiva® and $4.6M Etorel® sales.
ETUARY® Sales Stable ETUARY® sales were $106.1M USD in 2025, comprising 91.0% of total revenue despite competition.
Hydronidone PRC Data Positive Pivotal Phase 3 Hydronidone trial met primary endpoint; conditional NDA submission expected first half 2026.
Cash Position Improved Cash and equivalents totaled $37.1M USD as of December 31, 2025, up from $11.8M previous year.
Risk Factors
ETUARY® Sales Dependence Business significantly dependent on ETUARY® sales, which accounted for 91.0% of 2025 revenue amid competition.
Merger Completion Uncertain Merger with Cullgen faces closing conditions; delay substantially reduces expected strategic and financial benefits.
Pipeline Development Setbacks Future financial outcomes hinge on pipeline progress; risk exists in finalizing clinical development or securing approvals.
PRC Pricing Pressure Risks Commercialized products face pricing pressure from PRC centralized tender process potentially lowering sales volumes.
Outlook
Hydronidone US IND Filing Plan to file US IND for MASH-associated liver fibrosis in 2026, followed by initiating Phase 2 clinical trial.
Advance Pipeline Candidates Continue evaluating F573 for ALF/ACLF (Phase 2) and F528 for COPD (preclinical submission Q1 2027).
Leverage Commercial Platform Strategy leverages established PRC commercial portfolio to support and de-risk advancement of late-stage candidates.
Funding Future Development Require substantial additional capital to fund future R&D, potentially delaying or halting certain development programs.
Peer Comparison
Revenue (TTM)
$263.50M
$262.60M
$244.06M
Gross Margin (Latest Quarter)
215.9%
100.0%
95.3%
Key Metrics
Symbol | Market Cap | P/E (TTM) | ROE (TTM) | Debt to Assets |
|---|---|---|---|---|
| ERAS | $4.74B | -34.7 | -34.5% | 11.9% |
| TERN | $4.42B | -47.6 | -30.0% | 0.3% |
| DAWN | $2.21B | -20.6 | -23.4% | 0.5% |
Long-Term Trends
Last 4 Quarters
Revenue
Net Income
Operating Cash Flow
4Q Revenue CAGR
19.0%
Strong Growth
4Q Net Income CAGR
N/M
Profitability Shift
Cash Flow Stability
50%
Cash Flow Needs Attention
Deep Research
Next earnings:Mar 31, 2026
EPS:$0.06
|Revenue:$35.43M
Financials
Earnings Calls
Reports
News
Income Statement
Balance Sheet
Cash Flow Statement
Ratios
% Chg.
Income Statement | LTM |
|---|
No Data