Last updated
Revenue
R&D Expenses
Operating CF
Total Assets
Total Liabilities
Equity
Shares Out.
D/E Ratio
Dilution Watch
Financials
52W LOW $5.4452W HIGH $9.42
Volume
99.19 K
Value Traded
351.62 K
Short % Float
7.32%
+0.57%Week
-1.81%1 Month
+2.62%3 Month
-2.76%6 Month
-90.75%5 Year
-99.96%All Time
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Market Cap
785.03 M
EPS (TTM)
-0.18
P/E Ratio
-
Ent. Value
681.79 M
Total Shares
111.51 M
Float Shares
23.65 M
Insiders
77.69%
Institutions
4.64%
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
GYRE Catalyst Timeline
Dated clinical, regulatory and corporate events for Gyre Therapeutics, Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Gyre Therapeutics, Inc.
494Total events
10Upcoming
135Tier-1 (high impact)
2013 to 2027Coverage
Upcoming catalysts 2
Event history 50
◆Last Patient Last VisitpirfenidoneTrial
Final patient expected to complete Phase 3 pneumoconiosis study
pneumoconiosissource ↗
●Trial CompletionpirfenidoneTrial
Final patient expected to complete 52-week Phase 3 PD trial in Q3 2026
pneumoconiosis (PD)source ↗
▲NMPA NDA ApprovalF351FiledEx-US Regulatory
NMPA accepted NDA for F351 for CHB-induced liver fibrosis
CHB-induced liver fibrosissource ↗
▲Enrollment CompleteETUARYTrial
Completed enrollment in 52-week Phase 3 ETUARY trial for pneumoconiosis
pneumoconiosissource ↗
▲First Patient DosedETUARYTrial
First patient enrolled in Phase 3 study of ETUARY for radiation-induced lung injury
radiation-induced lung injury with or without immune checkpoint inhibitor-related pneumonitissource ↗
●NDA SubmissionF351FiledRegulatory Filing
NMPA accepted NDA for F351 for CHB-induced liver fibrosis
chronic hepatitis B (CHB)-induced liver fibrosissource ↗
▲FDA Filing AcceptedF351FiledRegulatory Filing
NMPA accepted NDA for F351 for CHB-induced liver fibrosis
CHB-induced liver fibrosissource ↗
▲First Patient DosedETUARYTrial
First patient enrolled in Phase 2/3 trial of ETUARY for RILI
radiation-induced lung injury (RILI) including immune-related pneumonitissource ↗
▲First Patient DosedpirfenidoneTrial
First patient enrolled in Phase 2/3 RILI trial
radiation-induced lung injury (RILI)source ↗
▲Trial InitiationpirfenidoneTrial
Adaptive Phase 2/3 trial initiated for pirfenidone in RILI
radiation-induced lung injury (RILI)source ↗
▲NMPA PriorityHydronidoneFiledEx-US Regulatory
NMPA grants priority review to NDA for Hydronidone (F351) for CHB-induced liver fibrosis
chronic hepatitis B (CHB)-induced liver fibrosissource ↗
◆AcquisitionCorporate
Gyre Therapeutics agrees to acquire Cullgen in all-stock transaction valued at ~$300 million
▲Pre NDA MeetingHydronidoneFiledFDA Meeting
Pre-NDA meeting with CDE of NMPA for Hydronidone conditional approval
liver fibrosissource ↗
●Trial InitiationCG009301Trial
Phase 1 trial of CG009301 in blood cancers ongoing
blood cancerssource ↗
▲NMPA PriorityF351FiledEx-US Regulatory
F351 NDA receives priority review status from CDE of NMPA
chronic hepatitis B (CHB)-induced liver fibrosissource ↗
●NDA SubmissionF351FiledRegulatory Filing
NDA for F351 submitted to China's CDE for conditional approval
CHB-associated liver fibrosissource ↗
▲Priority Review DesignationF351FiledDesignation
NMPA granted priority review designation to F351
CHB-associated liver fibrosissource ↗
▲Priority ReviewF351FiledRegulatory Filing
Priority review status granted by NMPA for F351 NDA
chronic hepatitis B (CHB)-induced liver fibrosissource ↗
▲Pre NDA MeetingHydronidoneFiledFDA Meeting
Completed Pre-NDA meeting with CDE for Hydronidone
chronic hepatitis B (CHB)-associated liver fibrosissource ↗
◆Timing GuidanceHydronidoneFiledPresentation
NDA submission for conditional approval expected in H1 2026
chronic hepatitis B (CHB)-associated liver fibrosissource ↗
▲Priority ReviewF351FiledRegulatory Filing
Priority Review of NDA by China NMPA
CHB-associated liver fibrosissource ↗
▲Trial CompletionCG001419Trial
Phase 1 study in Australia completed
cancer pain and solid tumorssource ↗
◆Poster PresentationHydronidoneFiledPresentation
Poster of Distinction: Phase 3 Trial of Hydronidone for Liver Fibrosis in Chronic Hepatitis B at AASLD The Liver Meeting 2025
liver fibrosis in chronic hepatitis Bsource ↗
▲Enrollment CompletepirfenidoneTrial
Enrollment completed in 52-week Phase 3 trial of pirfenidone for pneumoconiosis
pneumoconiosissource ↗
▲Full ResultsHydronidoneFiledClinical Data
Positive Phase 3 results presented at The Liver Meeting 2025
liver fibrosis in chronic hepatitis B (CHB)source ↗
▲Enrollment CompletepirfenidoneTrial
Completed patient enrollment in Phase 3 trial of Pirfenidone capsules for pneumoconiosis
pneumoconiosissource ↗
●Trial InitiationF351FiledTrial
Start Phase 2/3 trial for advanced liver fibrosis
Advanced Liver Fibrosissource ↗
◆Enrollment CompleteF573Trial
Complete enrollment for Phase 2 trial of F573 in ALF/ACLF in PRC
Acute Liver Failure / Acute-on-Chronic Liver Failuresource ↗
●Trial InitiationF230Trial
Start Phase 2/3 trial (adaptive approach) for F230 in PAH
Pulmonary Arterial Hypertensionsource ↗
◆Oral PresentationPresentation
Management to present at H.C. Wainwright 27th Annual Global Investment Conference
▲Primary Endpoint MetHydronidoneFiledClinical Data
Positive topline results: primary endpoint met with high statistical significance
CHB-associated liver fibrosissource ↗
●Management ChangeCorporate
Ping Zhang appointed interim CEO; Dr. Han Ying transitions to SVP Science
▲NMPA INDpirfenidoneEx-US Regulatory
NMPA approved clinical trial for pirfenidone in oncology-related pulmonary complications
oncology-related pulmonary complicationssource ↗
●NDA SubmissionHydronidoneFiledRegulatory Filing
NDA submission to NMPA for F351 in CHB-fibrosis
CHB-fibrosissource ↗
◆Trial InitiationpirfenidoneTrial
Anticipated trial initiation in second half of 2025
radiation-induced lung injury (RILI) with or without immune-related pneumonitis (CIP)source ↗
Past FDA Catalysts and PDUFA Decisions
How GYRE actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-06-30 | Hydronidone | NDA Submission | NDA |
Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision
Drug Pipeline Intelligence
D33 / 100
Pipeline Score
$42M
Pipeline Value
Richly Valued
Valuation Signal
1
Drugs Scored
0.1x
rNPV / MCap
Top 61%
Micro Cap(rank 402 of 658)
Percentile Rank
Gyre Therapeutics, Inc. faces pipeline headwinds (33/100), with $302M risk-adjusted pipeline value, led by MarzAA in Hemophilia A (Phase 1).
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| MarzAA Monoclonal antibodyCompletedNCT04072237 | Hemophilia A | Phase 1 | COMPLETED | 11 | Jun 1, 2020 |
Clinical Trial Results
Readouts, endpoints and source filings for every GYRE program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| Hydronidone Breakthrough | liver fibrosis in patients with chronic hepatitis B | Phase 3 | 2025-05-22 | In a pivotal Phase 3 trial, Hydronidone (270 mg/day) achieved a statistically significant 1-stage regression in liver fibrosis in 52.85% of patients compared to 29.84% in the placebo group, with a p-value of 0.0002 after 52 weeks of treatment.Read More | Gyre Therapeutics' Hydronidone Met the Primary Endpoint and Demonstrated Statistically Significant Fibrosis Regression in Pivotal Phase 3 Trial for the Treatment of CHB-associated Liver Fibrosis in China Achieved statistRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Ye WeiguoOfficer (Chief Operating Officer) | Option | 3,000 703,000 held | $0.75 | 06/18/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in GYRE
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| Octagon Capital Advisors LP | 0.6 % | 6.29 M | 954.42 K |
GYRE Institutional Ownership Trends
Options Data
Option Volume
Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-11-20 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
CallsPutsLog scale
Competitive positioning
How GYRE ranks across every disease it competes in
Competitive Position is a premium feature
See how GYRE ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
Start free trialGYRE News
GYREGyre Therapeutics to Participate in Upcoming September Investor Conferences
Gyre Therapeutics, a commercial-stage biopharmaceutical company, will participate in the Cantor Global Healthcare Conference and the Morgan Stanley Healthcare Conference in September 2026. The events will feature live webcasts and replays available for 30 days. Gyre focuses on developing therapies for organ fibrosis and inflammatory diseases, with a strong pipeline including F351 for liver fibrosis.
Read more →GYREGyre Therapeutics Reports Second Quarter 2026 and Year-to-Date Financial Results and Provides Business Update
Gyre Therapeutics reported a Q2 2026 revenue of $29.1 million and affirmed its full-year guidance of $100.5 to $111.0 million. The company announced the acceptance of its NDA for F351, a treatment for CHB-induced liver fibrosis, by China's CDE. Despite positive developments, Gyre experienced a significant net loss of $14.3 million, attributed to increased operating expenses and decreased sales in certain products.
Read more →GYRE▼ -5.8%on this news
Gyre Therapeutics Appoints Three New Members to its Board of Directors
Gyre Therapeutics has appointed three new members to its Board of Directors, effective August 1, 2026. The new members include Yue Xiong, Ph.D., Maxwell Kirkby, and Claire Weston, Ph.D., who bring extensive experience in scientific leadership and biopharmaceutical operations. These appointments aim to strengthen the company's governance and support its broad pipeline targeting various therapeutic areas.
Read more →GYREA Fully-Integrated Biopharmaceutical Company Focused on Fibrosis, Inflammatory Diseases and Cancer This presentation contains "forward-looking statements" within the meaning of the federal securities laws, including Sect
Gyre Therapeutics has recently presented its strategic vision focusing on fibrosis, inflammatory diseases, and cancer, while noting the substantial risks associated with forward-looking statements. The company aims to leverage its operations in China for enhanced drug discovery and development to advance its therapeutic pipeline. Key product candidates include CG923308 and ETUARY, which are currently in various stages of clinical development. However, Gyre also cautions about the challenges related to regulatory processes and competitive market pressures impacting its financial outlook.
Read more →GYREA Fully-integrated Biopharmaceutical Company Focused on Fibrosis, Inflammatory Diseases and Cancer May 2026 This presentation contains "forward-looking statements" within the meaning of the federal securities laws, inclu
Gyre Therapeutics, a biopharmaceutical company, has outlined its strategy and plans focusing on fibrosis, inflammatory diseases, and cancer. The company is leveraging its Chinese operations for drug discovery and development. Gyre's pipeline includes both investigational and marketed products, with a focus on innovative therapeutics such as protein degraders. The presentation also highlights the challenges associated with forward-looking statements and the inherent risks in clinical development.
Read more →GYREGyre Therapeutics Announces NMPA Acceptance of New Drug Application for F351 (hydronidone) for CHB-Induced Liver Fibrosis Treatment
Gyre Therapeutics announced the acceptance of its New Drug Application for F351 (hydronidone) by China's NMPA for treating chronic hepatitis B-induced liver fibrosis. This follows a priority review status granted earlier, marking a significant milestone for Gyre. The drug aims to address a critical medical need for millions of patients in China suffering from HBV-related liver damage.
Read more →GYRE▼ -12.1%on this news
Gyre Therapeutics Reports First Quarter 2026 Results and Provides Business Update
Gyre Therapeutics reported its first quarter 2026 financial results, showing a revenue increase to $22.5 million with a net loss of $9.9 million. The company has affirmed its full year revenue guidance between $100.5 and $111.0 million. Notably, they submitted a New Drug Application (NDA) for F351 to treat CHB-associated liver fibrosis and completed the acquisition of Cullgen to expand its pipeline. Furthermore, the first patient has been enrolled in a Phase 2/3 trial of ETUARYTM for radiation-induced lung injury, reflecting ongoing development efforts.
Read more →GYREGyre Therapeutics Completes Acquisition of Cullgen to Create U.S.- and China-based Fully Integrated Biopharmaceutical Company
Gyre Therapeutics has successfully acquired Cullgen Inc. in a $300 million all-stock deal, creating a fully integrated biopharmaceutical company with a focus on fibrosis and inflammatory diseases. The combined entity will leverage its commercial asset, ETUARY®, and a robust pipeline including targeted protein degraders. Leadership changes include Dr. Ying Luo as CEO, aiming for global growth and expansion of product development.
Read more →GYREGYRE THERAPEUTICS: Kaskela Law Announces Investigation of Gyre Therapeutics, Inc. (GYRE) and Encourages Shareholders to Contact the Firm
Kaskela Law LLC has announced an investigation into Gyre Therapeutics, Inc. due to potential violations of securities laws and breaches of fiduciary duties by the company's officers and directors. This investigation is aimed at determining the legality of recent corporate actions taken by Gyre. Shareholders are encouraged to reach out to the law firm for more information regarding their legal rights concerning this matter.
Read more →GYREGyre Therapeutics Announces China’s NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment
Gyre Therapeutics announced that China's NMPA has granted priority review status to its NDA for Hydronidone (F351), aimed at treating chronic hepatitis B-induced liver fibrosis. This milestone follows a pre-NDA communication meeting and highlights the urgent medical need for effective therapies in this area. The company plans to submit the formal NDA soon.
Read more →GYRE▼ -6.3%on this newsshared move
Gyre Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update
Gyre Therapeutics reported a 10% increase in full-year 2025 revenue, reaching $116.6 million. The company anticipates a decline in revenue for 2026, projecting between $100.5 million and $111.0 million. Gyre is advancing its Hydronidone drug towards conditional approval in China and has completed enrollment for a Phase 3 trial on pneumoconiosis. Additionally, Gyre plans to acquire Cullgen to enhance its drug development capabilities.
Read more →GYRE▲ +6.3%on this news
Gyre Therapeutics Enters into Agreement to Acquire Cullgen to Gain Targeted Protein Degradation Platform and Pipeline
Gyre Therapeutics has announced an agreement to acquire Cullgen in an all-stock transaction valued at approximately $300 million. This acquisition aims to enhance Gyre's capabilities in targeted protein degradation and expand its therapeutic pipeline. Following the transaction, Cullgen will operate as a wholly owned subsidiary, with its CEO expected to lead Gyre. The deal is anticipated to close in early Q2 2026, pending regulatory approvals.
Read more →GYRE▲ +16.3%on this news
Gyre Therapeutics Announces Alignment with China’s CDE on Conditional Approval Pathway and Priority Review Eligibility for Hydronidone Following Pre-NDA Meeting
Gyre Therapeutics announced a successful Pre-NDA meeting with China's CDE regarding Hydronidone, its anti-fibrotic therapy for chronic hepatitis B-associated liver fibrosis. The CDE found existing Phase 3 data supportive for a conditional approval NDA submission. Hydronidone has also been designated as a Breakthrough Therapy, facilitating an expedited review process. The company plans to submit the NDA in the first half of 2026.
Read more →GYREGyre Therapeutics Reports Third Quarter 2025 and Year-to-Date Financial Results and Provides Business Update
Gyre Therapeutics announced its financial results for Q3 2025, reporting a net income of $5.9 million. The company revised its full-year revenue guidance down to $115-118 million due to delays in the rollout of Etorel® and uncertainties in government procurement. Despite these challenges, Gyre continues to advance its clinical pipeline, including the NDA submission for Hydronidone in China.
Read more →GYRE▲ +10.7%on this news
Gyre Therapeutics Announces Completion of Patient Enrollment in Phase 3 Clinical Trial of Pirfenidone Capsules for the Treatment of Pneumoconiosis
Gyre Therapeutics has announced the completion of patient enrollment in a Phase 3 clinical trial for Pirfenidone capsules, aimed at treating pneumoconiosis. The trial, involving 272 patients across 18 centers in China, will assess the drug's efficacy and safety over 52 weeks. This development highlights the significant unmet medical need for effective therapies targeting this chronic lung disease.
Read more →GYREGyre Therapeutics to Present Results from Positive Phase 3 Clinical Trial Evaluating Hydronidone for the Treatment of Liver Fibrosis in Chronic Hepatitis B at AASLD—The Liver Meeting® 2025
Gyre Therapeutics announced positive results from its Phase 3 clinical trial of Hydronidone for treating liver fibrosis in chronic hepatitis B. The findings will be presented at The Liver Meeting® 2025, where the abstract has been recognized as a Poster of Distinction. The meeting is scheduled for November 7-10, 2025, in Washington D.C.
Read more →GYRE▲ +6.5%on this news
Developing Anti-Fibrotic Therapeutics for Chronic Organ Diseases H.C. Wainwright Global Investment Conference September 2025 Forward Looking Statements 2 This presentation contains "forward-looking statements" within the
Gyre Therapeutics presented at the H.C. Wainwright Global Investment Conference, discussing its forward-looking strategies and plans for anti-fibrotic therapeutics. The company is advancing its products targeting chronic organ diseases, highlighting the encouraging clinical trial results of Hydronidone for liver fibrosis. Gyre maintains a strong market presence in China with its leading product ETUARY for Idiopathic Pulmonary Fibrosis (IPF). The company has also made strategic acquisitions to bolster its offerings in the IPF and liver disease treatment markets.
Read more →GYREGyre Therapeutics to Present at the H.C. Wainwright 27th Annual Global Investment Conference
Gyre Therapeutics will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 10, 2025. The company focuses on fibrosis-first therapies, particularly for liver fibrosis. The presentation will be available via live webcast and later as a replay on their website.
Read more →GYRE▲ +8.3%on this news
Gyre Therapeutics Announces the Appointment of Dan Weng, M.D., to Board of Directors
Gyre Therapeutics has appointed Dr. Dan Weng to its Board of Directors, effective August 18, 2025. Dr. Weng brings nearly four decades of experience in managing global clinical trials and has held leadership roles in various contract research organizations. His expertise is expected to support Gyre's strategic growth and expansion of its multi-national pipeline.
Read more →GYREGyre Therapeutics Reports Second Quarter 2025 and Year-to-Date Financial Results and Provides Business and Leadership Update
Gyre Therapeutics recently released its financial results for Q2 2025, showcasing a net income of $1.6 million and reaffirming revenue guidance of $118-128 million for the full year. The company highlighted the successful Phase 3 trial of its lead compound, Hydronidone, for treating CHB-associated liver fibrosis, which demonstrated significant fibrosis regression. Leadership changes include the appointment of Ping Zhang as interim CEO following Dr. Han Ying's transition to a scientific leadership role. Additionally, Gyre has successfully launched Etorel in the PRC and is set to conduct further clinical trials in the second half of 2025.
Read more →About Gyre Therapeutics, Inc.
Headquarters12730 HIGH BLUFF DRIVE, SAN DIEGO, CA, 92130
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